Paige v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-627V

Filed: April 12, 2021

PUBLISHED

Special Master Horner

SHERRI PAIGE,

Petitioner, Finding of Fact; Influenza

v. Vaccination; Vaccination

Record; Date of Vaccination

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Bridget Candace McCullough, Muller Brazil, LLP, Dresher, PA, for petitioner.

Mary Eileen Holmes, U.S. Department of Justice, Washington, DC, for respondent.

FINDING OF FACT 1

On May 2, 2018, petitioner, Sherri Paige, filed a petition under the National

Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that she

suffered transverse myelitis (“TM”) resulting from adverse effects of an influenza (“flu”)

vaccination she received while at work as a nurse at Generations Family Health on

October 9, 2015. (ECF No. 1, p. 1.) Although petitioner alleged a vaccination date of

October 9, 2015, her petition was accompanied by an employee vaccine administration

record filed as Exhibit 1 which reflected a vaccination date of November 11, 2015. (Ex.

1, p. 1.)

On November 24, 2020, petitioner moved for a ruling on the record finding that

petitioner did receive her 2015 flu vaccination on October 9, 2015 as she alleged. (ECF

No. 72.) However, for the reasons discussed below, I find that petitioner more likely

than not received her vaccination on November 11, 2015 as reflected in her

contemporaneous vaccine administration form.

1 Because this finding contains a reasoned explanation for the special master’s action in this case, it will

be posted on the United States Court of Federal Claims’ website in accordance with the E-Government

Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic

Government Services). This means the finding will be available to anyone with access to the

Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact

medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.

If the special master, upon review, agrees that the identified material fits within this definition, it will be

redacted from public access.

1

I. Procedural History

In the affidavit accompanying her petition, petitioner explained the circumstances

of her vaccination as follows:

I received the influenza vaccination on October 9, 2015. At the time of the

vaccination, I was employed at Generations Family Health Clinic, Inc. . . .

On that date, my supervisor administered the vaccination while we were

operating a mobile health clinic. The paperwork documenting my

vaccination was completed two days later on October 11, 2015.

(ECF No. 1-13; Ex. 8, p. 1.)

Respondent filed his Rule 4 Report on April 29, 2019, along with a motion to

dismiss. 2 (ECF No. 23.) Respondent noted the discrepancy between the date of

vaccination alleged in the petition and the date reflected on petitioner’s vaccination

record. He contended that petitioner’s vaccination could not be the cause of her injury

because her symptoms began in early October and the correct date of vaccination was

November 11, 2015 rather than October 9, 2015. (Id. at 2, 10.)

In response, petitioner sought and received authorization to subpoena

Generations Family Health for petitioner’s employment records. (ECF Nos. 25-26.)

Those records were later filed on June 3, 2019. (ECF No. 30; Ex. 14.) In the interim,

petitioner also filed a copy of a text message from her supervisor, Nicole Jones,

discussing petitioner’s efforts to obtain documentation of her flu vaccination and

referencing the date of vaccination as “10/9/15.” (ECF No. 28; Ex. 13.)

Petitioner was then provided further opportunity to investigate her allegation

regarding the date of her vaccination and subsequently filed a further affidavit. (ECF

No. 35; Ex. 15.) She also received authorization to serve a further subpoena upon

Generations Family Health for records relating to the mobile health clinic at which she

alleged her vaccination was administered. (ECF Nos. 33, 36.) Additionally, petitioner

sought to subpoena T-Mobile for further documentation of the previously filed text

message with Nicole Jones. (ECF Nos. 37-38.)

This case was reassigned to me on August 27, 2019. (ECF NO. 41.) Petitioner

subsequently filed responses from the two outstanding subpoenas on September 30,

2019. In response to the second subpoena, Generations Family Health reproduced

portions of petitioner’s employment file. (ECF No. 42-1; Ex. 16.) T-Mobile advised that

they do not store or maintain the contents of text messages and did not otherwise

produce any relevant records. (ECF No. 42-2; Ex. 17.)

On November 19, 2019, petitioner filed an e-mail from the director of human

resources at Generations Family Health. (ECF No. 44; Ex. 18.) It confirmed that

petitioner had worked on the mobile health clinic with Ms. Jones on October 9, 2015,

2 The motion to dismiss was later withdrawn. (ECF No. 46.)

2

but indicated that Ms. Jones would not be made available for any informal conversation

regarding the matter. (Id.)

I held a follow up status conference on November 21, 2019. (ECF No. 45.) I

noted that the question of the date of petitioner’s vaccination implicates the

circumstances of both October 9, 2015, and November 11, 2015. I suggested that

petitioner seek time and attendance records for both petitioner and Nicole Jones for

October and November of 2015. I also suggested that the parties depose both petitioner

and Ms. Jones. (Id.)

Deposition transcripts were filed on March 19, 2020. (ECF No. 58 (Paige

Deposition as Exhibit 24 and Jones Deposition as Exhibit 25).) A follow up status

conference was held on April 16, 2020. (ECF No. 62.) During that status conference,

the parties discussed two additional lines of inquiry. First, during her deposition

petitioner identified an additional witness, Ingrid Aldrige, who was allegedly present

when the vaccination record at issue was created. Second, testimony suggested that

Generations Family Health may be able to identify the dates on which doses from the

multidose vial identified on petitioner’s vaccination record were administered.

On July 26, 2020, petitioner filed responses to interrogatories from Generations

Family Health and an affidavit by Ingrid Aldridge. (ECF No. 68; Exs. 41-42.) I

subsequently required the parties to file a joint status report indicating how they propose

to proceed. The parties advised in a status report filed August 19, 2020, that “[t]he

parties have conferred and respectfully request that the Special Master resolve the

factual issue of petitioner’s vaccination date by a ruling on the record.” 3 (ECF No. 69.)

Petitioner filed her motion for a ruling on the record on November 24, 2020. (ECF

No. 72.) Respondent filed his response on January 25, 2021. (ECF No. 73.) Petitioner

filed no reply. Accordingly, the motion is ripe for resolution.

II. Factual History 4

A. As reflected in petitioner’s medical records

During the relevant period, petitioner received her primary healthcare through

Generations Family Health Center, which was also her employer. (Ex. 2; Ex. 14.)

3 I also determined that the parties have had a full and fair opportunity to present their cases and that it is

appropriate to resolve this issue without a hearing. See Vaccine Rule 8(d); Vaccine Rule 3(b)(2);

Kreizenbeck v. Secretary of Health & Human Services, 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that

“special masters must determine that the record is comprehensive and fully developed before ruling on

the record.”).

4 Although I have reviewed the entirety of the record compiled to date, including petitioner’s complete

medical history and employment file, the factual history discussed in this decision is limited to describing

the evidence bearing on the correct date of petitioner’s 2015 flu vaccination. In addition to reviewing the

transcripts of the two depositions conducted in this case, I have also reviewed the accompanying video

recordings.

3

Petitioner’s patient records from Generations Family Health do not include an

immunization history. (Ex. 2, p. 18.) Prior to the period at issue, petitioner was last seen

by her primary care provider, Family Nurse Practitioner Erica Lyons, on June 18, 2015.

(Ex. 2, pp. 19, 70.) At that time, she had a follow up on her diabetes and transitioned to

Nurse Practitioner Lyons’s care. (Id.)

Petitioner was next seen by Nurse Practitioner Lyons on November 4, 2015. (Ex.

2, pp. 66-69.) This encounter follows both the October 9, 2015 date of vaccination and

October 16, 2015 date of onset of symptoms alleged by petitioner (Compare Ex. 2, p.

66 and Ex. 24, pp. 7-9, 14-15), but precedes the date of vaccination reflected in her

vaccine administration record (Compare Ex. 2, p. 66; Ex. 1). Petitioner’s November 4,

2015 encounter was characterized as a follow up appointment. (Ex. 2, p. 66.) No History

of Present Illness was recorded 5; however, petitioner’s Review of Systems was positive

under musculoskeletal for “[b]ack symptoms and leg symptoms,” and under neurological

for “[t]ingling of the legs and numbness of the legs.” (Id.) Petitioner was assessed with

bilateral sciatica. (Id. at 67.) Petitioner declined medication and a physical therapy

referral was provided. (Id. at 68.) This record contains no reference to petitioner’s

vaccination history generally or her alleged October 9, 2015 flu vaccination specifically.

Petitioner returned to Nurse Practitioner Lyons on November 17, 2015. (Ex. 2,

pp. 49-55.) At this appointment, petitioner expressed concern regarding possible

neurological symptoms and requested an appointment with a neurologist. (Ex. 2, p. 49.)

Nurse Practitioner Lyons documented that the prior November 4 encounter had

demonstrated only intermittent symptoms consistent with sciatica and no loss of

function, saddle paresthesia, gastrointestinal symptoms, or weakness, all of which

would have been “red flags.” (Id.) As of November 17, however, petitioner described

increased frequency of symptoms and weakness, but still without loss of function. (Id.)

Bilateral leg weakness and peripheral neuropathy were added to petitioner’s active

problems list and petitioner received a referral to neurology as well as an order for x-

rays and EMG testing. MRI was not ordered at that time but was “likely needed.” (Ex. 2,

pp. 49, 54.) This record contains no reference to petitioner’s vaccination history

generally or to any prior influenza vaccination of any date. Petitioner also had a

physical therapy evaluation that day. (Ex. 2, p. 313.) Her vaccination history was not

discussed.

Thereafter, petitioner continued to seek care and pursue a diagnosis for the

remainder of 2015, throughout 2016, and into 2017. During that period, petitioner

returned to Nurse Practitioner Lyons on December 29, 2015, and February 19, 2016.

(Ex. 2, pp. 27-29, 39-44.) She consulted multiple neurologists, including Dr. Michelle

Boudreau. 6 (E.g. Ex. 2, pp. 194, 210-13 (Dr. Chozick) 280 (Dr. Calderon); Ex. 11 (Dr.

5There is a notation without a heading that indicates “Reviewed and unchanged since last visit.” (Ex. 2, p.

66.)

6 When petitioner was admitted to the hospital in April of 2016 she had a neurology consult with Dr.

Boudreau on April 23, 2016. (Ex. 2, pp. 284-85.) This is the earliest available encounter record by Dr.

Boudreau in the record of this case; however, in the record of that consult, Dr. Boudreau indicates that

she had previously seen petitioner in her outpatient clinic. (Id. at 284.) Dr. Boudreau’s own practice

4

Khan); Ex. 6 (Dr. Boudreau).) She underwent multiple MRIs and an EMG study. (Ex. 2,

pp. 54, 310-12; Ex. 6, pp. 48-52, 55-58, 60.) She was hospitalized on two separate

occasions, in April of 2016 for IV treatment related to suspected transverse myelitis (Ex.

2, pp. 243-54, 280-93) and in June of 2016 for decompressive laminectomies at T9-T10

(Ex. 2, pp. 194, 210-13). She was subsequently transferred to rehabilitation on both

occasions. (Ex. 2, p. 243; Ex. 4, p. 150-51.) She later had a second physical therapy

evaluation in January of 2017. (Ex. 5, p. 20.) She saw a gastroenterologist for

abdominal pain in early June of 2017, which was assessed as neuropathic pain rather

than any gastrointestinal issue. (Ex. 7, p. 59.) Throughout this period petitioner’s

physicians primarily suspected that petitioner was suffering either a demyelinating

condition, such as multiple sclerosis or transverse myelitis, or a degenerative spinal

condition. Upon my review, none of petitioner’s medical records during this period

discuss her vaccination history.

On June 9, 2017, petitioner had a follow up appointment with Dr. Boudreau. (Ex.

6, pp. 19-33.) At this visit, Dr. Boudreau recorded that petitioner “states that when she

first had the symptoms in October 2015 she now remembers that she had a flu shot one

week prior to this.” (Id. at 25.) Both parties identify this encounter, more than a year and

a half after onset of her condition, as the point at which petitioner began associating her

vaccination and injury to her doctors. (ECF No. 72, p. 9; ECF No. 73, p. 8.)

B. As reflected in petitioner’s employment records

As noted above, petitioner’s employment file contains a vaccine administration

record for an influenza vaccination signed and dated November 11, 2015. (Ex. 14, p. 5;

Ex. 16, p. 8.) Petitioner filed this record along with her petition as evidence of her

vaccination. (Ex. 1.) Timecard records for petitioner produced in connection with the

deposition of Nicole Jones confirm that petitioner worked from approximately 7:08AM to

12:38PM on October 9, 2015. (Ex. 34, p. 3.) She worked from approximately 6:44AM to

6:12PM on November 11, 2015. 7 (Id. at 5.) An e-mail from the Generations Family

Health Director of Human Resources to petitioner’s counsel dated November 1, 2019,

further confirms that October 9, 2015 is the only date upon which petitioner worked at

the mobile health unit and also that Ms. Jones was also present with petitioner on that

date. (Ex. 18.)

records as produced by Saint Francis Hospital and Medical Center do not include any encounter record

from this period. (Ex. 6.) Dr. Boudreau later submitted a report in this case in which she advised that “I

am no longer employed by Saint Francis/Trinity Health of New England. Therefore, I can only base my

opinion upon the records provided to me, as I no longer have access to the electronic medical records at

these facilities. For this reason, I cannot confirm when I first began treating Ms. Paige nor can I provide

any additional records that were not included.” (Ex. 21, p. 1.) Petitioner has not suggested that she

discussed her vaccination with Dr. Boudreau at any point prior to June of 2017. (ECF No. 72, p. 9 (citing

Ex. 6, p. 25).)

7 There are handwritten notations on the time records indicating that petitioner was on the mobile unit on

October 9th and that she was vaccinated on November 11th (Ex. 34, pp. 3, 5); however, Ms. Jones

confirmed in her deposition that these notations were not contemporaneous, likely made in 2019, and

were based on the vaccination record in petitioner’s employee file. (Ex. 25, pp. 43-44, 46.)

5

On April 29, 2016, petitioner applied for Family Medical Leave Act (“FMLA”)

benefits based on a certification of healthcare provider by Dr. Boudreau. (Ex. 14, pp. 52-

55.) Prompted to describe other relevant medical factors, Dr. Boudreau described

petitioner’s condition as “work up pending. Likely has transverse myelitis which is either

idiopathic or secondary to MS. If it is secondary to MS, this will be a chronic illness.” (Id.

at 53.) Dr. Boudreau did not discuss petitioner’s vaccination history. On May 3, 2016,

petitioner was advised that her request for FMLA benefits was granted, applying to all

leave taken from March 31, 2016 through June 5, 2016. (Id. at 27.)

Petitioner subsequently submitted further certifications by Dr. Boudreau in

support of FMLA benefits dated June 16, 2016, and July 28, 2016. (Ex. 14, pp. 65-72.)

In both certifications, Dr. Boudreau characterized petitioner’s condition as secondary to

cord compression from spinal stenosis and again did not reference petitioner’s

vaccination history. (Id. at 66, 70.)

Petitioner was subsequently advised on August 31, 2016, that her Family

Medical Leave Act benefit had been exhausted. (Ex. 14, p. 16.) Her employer

subsequently contacted Dr. Boudreau to discuss accommodations requested by

petitioner; however, petitioner was later advised by letter dated October 26, 2016, that

she was terminated effective immediately due to exhausting her medical leave. (Id. at 9,

13.) She was advised that if circumstances change in the future, she could reapply for

any position for which she is qualified. (Id. at 9.)

C. As described in testimony

1. Petitioner’s affidavits

As noted above, petitioner’s first affidavit accompanying her petition indicated

that she received her flu vaccination from her supervisor while operating a mobile health

unit on October 9, 2015. (Ex. 8.) In this affidavit she indicated that her vaccination was

documented two days later. (Id.)

In the context of further litigating her allegation that she was vaccinated on

October 9, 2015, petitioner later filed a supplemental affidavit on June 28, 2019. (Ex.

15.) In her supplemental affidavit, petitioner stressed that October 9, 2015 was the only

date that she worked on the mobile health unit and further indicated that she

volunteered to work at the mobile health unit that day so that her supervisor would not

have to work alone. (Id. at 1.) She explained that “[t]he patients that were vaccinated on

the mobile health unit had their data input in to an electronic chart. As an employee, I

did not have an electronic chart and the vaccination was not documented

contemporaneously with its administration. Instead, it was recorded on a worksheet

several weeks later.” (Id.)

Petitioner further indicated that “I distinctly remember that I was going to be

attending a Taj Mahal concert the following week, Friday, October 16, 2015 at the

Garde Theater in New London, Connecticut. I was looking forward to this concert and

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remember thinking I would surely be free of any residual effects from the vaccination in

time for the concert.” (Id.)

2. Petitioner’s deposition

During her deposition, petitioner explained that she began working at

Generations Family Health as a nurse case manager in October of 2012. (Ex. 24, p. 6.)

Her regular duties were within the “Ryan White Program” (an HIV clinic). (Id.) During

the period at issue, Nicole Jones was petitioner’s direct supervisor. (Id. at 7.)

Petitioner’s regular duties within the Ryan White Program included, inter alia,

vaccinating her patients and completing vaccine administration forms. (Id. at 32-34.)

Petitioner recalled that employee flu vaccinations became mandatory beginning in 2014.

(Id. at 53.) If an employee refused to be vaccinated by a certain date, that employee

would have to wear a mask. (Id. at 11.) However, petitioner could not recall the date by

which vaccination was required. (Id.)

Petitioner described working on the mobile health unit on one occasion, October

9, 2015. (Id. at 7-8.) On that date, the mobile unit went to a location known as “Pride’s

Corner” to provide flu vaccinations and informational pamphlets to migrant farm

workers. (Id. at 8.) Ms. Jones and petitioner administered vaccinations while two others

handed out the educational materials. (Id.) To petitioner’s knowledge this is the only

date that year that the mobile unit administered vaccinations. (Id. at 9.) She recalled the

mobile unit being out from about 10:00AM to 1:00PM. (Id. at 12.)

Petitioner described the mobile health unit as a “motorhome” with two stations

inside. (Id. at 9.) She confirmed that vaccinees were presented with a screening and

consent form that she reviewed with them to obtain consent. (Id.) Asked specifically how

vaccinations were recorded, she indicated “[t]here is a document that, that you fill out

and they get a copy of it and we get one. Generations, it would be one for them and one

for us to keep for our records.” (Id.)

Petitioner described her own vaccination as follows:

So we could get a rush of, you know, influx of the workers coming to get

their shots, and then there would be lulls. And so there weren’t many people

there, it started to thin out, and so we said, like, do you want to do it now,

this would be a good time to do it, this would be. No one is here. And she

[referring to Ms. Jones] proceed to give me my vaccine.

(Id. at 10.) Petitioner recalled this as occurring after lunch. (Id.) Petitioner noted that

she was the only employee vaccinated at that time and further indicated that it would be

unusual for Ms. Jones to administer a vaccine to her staff. (Id. at 10-11.)

However, during her deposition, petitioner also authenticated the vaccine

administration record filed as Exhibit 1. (Id. at 16.) She confirmed her own signature on

the document and confirmed that she completed the questionnaire portion of the

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document. (Id.) Petitioner also confirmed that she marked the document as reflecting

that the vaccine was administered at her employer’s Willimantic work site and that she

dated the document twice as November 11, 2015. (Id. at 17.) Petitioner indicated that

all writing on the document above the heading “clinic use” is her writing and that all

writing below that heading is Ms. Jones’s. (Id. at 37.) She confirmed that she completed

her portion of the form first and that she signed the document on November 11, 2015.

(Id. at 17-18, 38.) She explained:

So, on the date that I received the flu shot, it was never documented, and

my supervisor’s job, as infection control, was to insure [sic.] that all the staff

was vaccinated. So she stopped by my office one day, November 11, and

said Sherri, we got to get documentation on that shot that I gave you. And I

said, okay, no problem. So I began to fill it out, and she signed and

completed it.

(Id. at 18.)

Asked how Ms. Jones knew which arm to document for administration, petitioner

suggested that Ms. Jones would have asked her. Petitioner indicated she was confident

she would not have received any vaccination in her dominant arm. (Id. at 39-40.)

However, petitioner does not know how Ms. Jones determined the vaccine lot

information and does not recall providing that information to her. (Id. at 40.)

Petitioner explained that at the time she shared an office with a coworker, Ingrid

Aldridge, who may have been present at the time she completed this form. (Id. at 18,

53-54.) However, petitioner did not know whether she would have overheard her

conversations with Ms. Jones about the vaccination record. (Id. at 53-54.)

Petitioner was asked whether she ever discussed with Ms. Jones “the difference

in the dates that you received the vaccination and the difference in the date that this

document was created.” (Id. at 19.) She responded, “eventually,” further indicating that:

[O]nce it was brought to my attention about the immunization, you know,

the correlation of the flu shot and transverse myelitis, I called Generations

to find out when my last flu shot was to see if it applied to me. And initially

they had 2014 because this flu shot wasn’t entered into my shot chart, but

then when I got this form, you know, when I had this form it says, November

11th. So I called Nicole Jones and said that the date that my flu shot was

documented and the day that it was actually done are two different dates,

and I need proof of the date the vaccine was actually given.

(Id. at 19.) Petitioner described this interaction as culminating in the text message

response discussed further below which she indicated she received in March of 2016.

(Id. at 20-23.)

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3. Ms. Jones’s deposition

Ms. Jones confirmed that she has been the director of the Ryan White HIV

program since June of 2015 and that she was responsible for supervising petitioner in

2015. (Ex. 25, pp. 11, 15.) She also confirmed that she and petitioner administered flu

vaccinations to farm workers at Pride’s Corner on one occasion on October 9, 2015. (Id.

at 16-17.) Ms. Jones indicated that the vaccinations administered that day were

documented strictly on paper and were entered into the electronic health record later.

(Id. at 19.) Ms. Jones suggested that it was not until after the event that they realized

the vaccinations needed to be entered into the electronic record “as given” rather than

merely scanning the paper form. (Id. at 21-22.) This process was completed on

November 2, 2015. (Id. at 22.)

Ms. Jones denied that she administered a flu vaccination to petitioner on October

9, 2011. (Id. at 22.) Rather, she indicated that she recalled giving petitioner her

vaccination in November. (Id. at 22-23.) Asked if she had personal knowledge of the

vaccination being given on November 11, she testified:

A. I know it was November. I absolutely did not give it on the van.

Q. Why are you sure that it was November?

A. Because I am pretty sure it was getting closer to Thanksgiving, and we

have a cutoff date for our employees that we like them to get the flu

shot, and she was after that. And that is November 1st, and she was

after that date.

(Id. at 23.) On later questioning, however, Ms. Jones could not specifically recall

whether the vaccination deadline was November 1st in 2015. (Id. at 46-47.) She

reasoned that the deadline would have been the same, but could only specifically recall

that it had not changed in the prior three years. (Id. at 47.) Ms. Jones could not recall

whether petitioner ever wore a mask in 2015. (Id.)

Ms. Jones testified that she vaccinated petitioner at the Willimantic clinic because

petitioner had asked her to do so on that same day. No one else was present when

petitioner was vaccinated. (Id. at 24.) Ms. Jones recalls petitioner being adamant that

Ms. Jones administer the vaccine instead of another nurse, but did not know the reason

why. (Id. at 24-25.) Administering vaccines is not a part of Ms. Jones’s typical work

function. (Id. at 34-35.)

Referring to petitioner’s Exhibit 1, Ms. Jones confirmed her handwriting on the

“clinic use” portion of the document, including her notation regarding the injection site,

lack of any vaccine reaction, and the manufacturer and lot information. (Id. at 26-27.)

She denied dating the document, but confirmed that she completed her portion of the

form on the date indicated, which was the date of administration. (Id. at 27.) Ms. Jones

agreed that petitioner completed her portion of the form first. (Id.) Petitioner signed and

9

dated the form in front of Ms. Jones and Ms. Jones subsequently took the document to

human resources. (Id. at 28.) She confirmed that the type of employee immunization

form used for petitioner’s vaccination would not have been available on the mobile

health unit. (Id. at 35-36.) Ms. Jones denied that she has ever had occasion to

complete a vaccine administration form several weeks after administration. (Id. at 40.)

4. Ms. Aldridge’s affidavit

Petitioner’s former coworker, Ms. Ingrid Aldridge, submitted an affidavit in which

she indicated in relevant part that:

Sometime after the Pride’s Corner Clinic event, I recall Sherri Paige asking

me to assist her in looking up the lot numbers for the vaccinations that were

given at the Pride’s Corner event. Sherri told me that she needed this

information to fill out her own vaccine administration form. We joked that

she was not good at using the computer. I do not recall the date of this

conversation.

(Ex. 42, p. 1.) Ms. Aldridge is no longer employed at Generations Family Health. (Id.)

D. As evidenced by additional documents

1. E-mails produced by Nicole Jones at her deposition

In connection with her deposition, Ms. Jones produced several separate e-mail

chains which were marked as Deposition Exhibits 9-12 and petitioner’s Exhibits 36-39.

She explained that these e-mails were gathered by searching petitioner’s name within

her e-mail history for the period from June of 2015 to June of 2016. (Ex. 25, p. 41.)

They are not representative of the entirety of her e-mail communications with petitioner.

(Id.) Not all of the e-mails are between petitioner and Ms. Jones.

The first set of e-mails marked as Exhibit 36 reflect informal exchanges between

petitioner and Ms. Jones from October to December of 2016 regarding adjustments to

petitioner’s working hours due to illness and sick leave. In one exchange, petitioner

wrote on November 2, 2015, in apparent reference to the Pride’s Corner vaccination

event:

COLEY JONES, I THINK YOU OWE ME YOUR LIFE AND LUNCH! THOSE

DARNED FLU SHOTS OMG. I SHALL NOT VOLUNTEER NEXT YEAR

UNLESS WE TAKE A LAPTOP AND DOCUMMENT THERE!!!!! UGH!!!!!!!!

JK, IT WAS VERY TIME CONSUMING BUT NOT DIFFICULT . . . .

(Ex. 36, p. 2.) The majority of the remaining e-mails pertain to petitioner’s separation

from Generations Family Health and her follow up communication seeking documents

related to her vaccination, but are not illuminating as to the details of petitioner’s

vaccination. (Exs. 37-39.)

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2. Text message by Nicole Jones

Petitioner also filed a single page document that appears to be a screen capture

from a cell phone which appears under a separate heading indicating a date of June 30,

2017. (Ex. 13.) The text is from “Coley Jones” and states:

Sorry it’s taken a while to get back to you. Your Flu shot documentation from

10/9/15 was in your HR file since it was done as an employee not a patient.

HR has sent it to your last address on file with them. You can ask medical

records to have it put into your chart if needed, but HR nor I can put it in

your chart since it wasn’t given during a visit. If you need something else

give me a call at work . . . Thanks!

(Ex. 13, p. 1.) During her deposition, Ms. Jones confirmed that the telephone number

reflected on the text message is her telephone number; however, she does not recall

when she sent the text. (Ex. 25, p. 28-29.) She denied that the text message is an

acknowledgement that she vaccinated petitioner on October 9, 2015, suggesting she

would not have had access to the vaccination record and would have merely repeated

back whatever date petitioner had stated in requesting her record. (Id. at 29-32.)

Petitioner indicated during her testimony that June 30, 2017, is not the date that

she received the text message and questioned whether it might be the date on which

she sent it to her counsel. (Ex. 24, p. 46.) She indicated that to the best of her

recollection, she received this message in March of 2016; however, she had also

previously testified that she could not recall when she sent the text that prompted this

response. (Id. at 21-23.) Notably, petitioner described the entire course of

communication leading up to this text message as being prompted by her discovering

the possible connection between her vaccination and transverse myelitis. (Id. at 19.) As

discussed above, petitioner is first recorded as having discussed this with her

physicians in June of 2017 (Ex. 6, p. 25), which is potentially consistent with the June

30, 2017 heading accompanying the text message (Ex. 13).

3. Generations Family Health response to petitioner’s interrogatories

Finally, Generations Family Health confirmed in written interrogatory responses

that a search of their records indicates that 1,952 individuals were vaccinated using the

flu lot listed on petitioner’s immunization record between September 21, 2015, and June

24, 2016, including doses administered on both October 9, 2015, and November 11,

2015. (Ex. 41, p. 1.) However, all individuals vaccinated by the mobile health clinic on

October 9, 2015, were vaccinated using doses from a different lot. (Id.) This

information is confirmed both by individual chart entries in the provider’s electronic

health records (“Greenway Integrity” suite) as well as signed consent forms scanned

into each individual’s chart. (Id.)

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III. Legal Standard

Petitioner has the burden of demonstrating the facts necessary for entitlement to

an award by a “preponderance of the evidence.” § 300aa-12(a)(1)(A). Under that

standard, the existence of a fact must be shown to be “more probable than its

nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring).

Moreover, the Vaccine Act states that “[t]he special master or court may not make such

a finding [of eligibility and compensation] based on the claims of a petitioner alone,

unsubstantiated by medical records or by medical opinion.” § 300aa-13(a)(1).

Nonetheless, special masters are not bound by the reports, summaries, or conclusions

contained in the medical records. § 300aa-13(b)(1). Rather, the special master must

consider the entire record. Id.

The fact of a vaccination need not itself be proven by medical records or medical

opinion. See, e.g. Wonish v. Sec’y of Health & Human Servs., No. 90-667V, 1991 WL

83959, at *4 (Cl. Ct. Spec. Mstr. May 6, 1991)(stating with regard to § 300aa-13(a)(1)

that “it seems obvious then that not all elements must be established by medical

evidence” and that “vaccination is an event that in ordinary litigation could be

established by lay testimony. Medical expertise is not typically required.”) Nor, for that

matter, does it necessarily have to be evidenced by contemporaneous documentation.

See, e.g. Centmehaiey v. Sec’y of Health & Human Servs., 32 Fed. Cl. 612, 621 (1995),

(noting that “the lack of contemporaneous documentary proof of vaccination, however,

does not necessarily bar recovery.”), aff’d 73 F. 3d 381 (Fed. Cir. 1995); see also

Woodson v. Sec’y of Health & Human Servs., No. 91-263V, 1992 WL 59707, at *2 (Fed.

Cl. Spec. Mstr. Mar. 5, 1992)(noting that “[t]he petition should not be dismissed as a

matter of law, merely because there is no documentary evidence that the vaccination

took place and [petitioner] is the only witness claiming personal knowledge of the

vaccination. Her testimony on this point must be weighed in the context of the entire

record.”).

Importantly, however, the instant case is not one of a merely missing or

inadequate vaccination record. Rather, in this case a facially valid vaccination record

does exist that is contradictory to petitioner’s allegation. Accord Muller v. Sec’y of

Health & Human Servs., No. 14-801, 2017 WL 2334031, at *8 (Fed. Cl. Spec. Mstr.

Feb. 27, 2017) (declining to accept testimonial evidence over a contemporaneous

medical record regarding the date of vaccination).

In that regard, medical records do ordinarily “warrant consideration as trustworthy

evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528

(Fed.Cir.1993). Where subsequent testimony conflicts with contemporaneous medical

records, special masters frequently accord more weight to the medical records. See,

e.g., Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993)

(“[W]ritten documentation recorded by a disinterested person at or soon after the event

at issue is generally more reliable than the recollection of a party to a lawsuit many

years later.”); See also Vergara v. Sec’y of Health & Human Servs., 08-882V, 2014 WL

2795491, *4 (Fed. Cl. Spec. Mstr. July 17, 2014) (“Special Masters frequently accord

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more weight to contemporaneously-recorded medical symptoms than those recorded

later in medical histories, affidavits, or trial testimony.”).

Special masters are cautioned against favoring contemporaneous records

“reflexively” and must not overemphasize individual records at the expense of a

comprehensive evaluation of the entire record. Shapiro v. Sec’y of Health & Human

Servs., 101 Fed. Cl. 532, 539-40 (2011). “Medical records are only as accurate as the

person providing the information.” Parcells v. Sec’y of Health & Human Servs., No. 03-

1192V, 2006 WL 2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006). However, “the

absence of a reference to a condition or circumstance is much less significant than a

reference which negates the existence of the condition or circumstance.” Murphy v.

Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (Fed. Cl. 1991), aff’d 968 F.2d

1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992).

There are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate.

Campbell v. Sec'y of Health & Human Servs., 69 Fed.Cl. 775, 779 (2006) (“like any

norm based upon common sense and experience, this rule should not be treated as an

absolute and must yield where the factual predicates for its application are weak or

lacking”); Lowrie v. Sec'y of Health & Human Servs., No. 03–1585V, 2005 WL 6117475,

at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005) (“[w]ritten records which are, themselves,

inconsistent, should be accorded less deference than those which are internally

consistent”) (quoting Murphy, 23 Cl.Ct. at 733). However, when witness testimony is

offered to overcome the presumption of accuracy afforded to contemporaneous medical

records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez v.

Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec.

Mstr. Apr. 10, 2013 (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V,

1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)), mot. for rev. denied, 142

Fed. Cl. 247, 251-52 (2019), vacated on other grounds and remanded, 809 Fed. Appx.

843 (Fed Cir. 2020).

IV. Party Contentions

Although petitioner acknowledges the importance of contemporaneous medical

records, she notes that special masters are required to weigh medical records against

other evidence, including oral testimony. (ECF No. 72, pp. 7-8.) She further stresses,

as noted above, that it is within the special master’s discretion to weigh other

circumstantial evidence more heavily than contemporaneous medical records,

especially with regard to the fact of a vaccination having occurred. (Id. at 8 (citing Brown

v. Sec’y of Health & Human Servs., 18 Cl. Ct. 834 (1989), rev’d on other grounds, 920

F.2d 918 (Fed. Cir. 1990)).)

In her motion, petitioner urges consideration of four circumstantial factors. First,

the evidence shows that the vaccinations administered at the mobile health clinic on

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October 9, 2015 were not contemporaneously documented. 8 (Id. at 8-9.) Second, if

petitioner had not been vaccinated by November 1, 2015, then she would have faced a

requirement to wear a mask when having patient contact; however, there is no evidence

that she wore a mask at that time. 9 (Id. at 9.) Third, petitioner did ultimately report to

her neurologist that her symptoms began in October of 2015, which she indicated at

that time was one-week after her influenza vaccination. (Id. at 9 (citing Ex. 6, p. 25).)

And, fourth, petitioner specifically recalled that she had received her vaccination prior to

a specific concert she attended on October 16, 2015, which is also when she placed

onset of her symptoms. (Id.)

In response, respondent contends that petitioner’s testimony was inconsistent

and her recollection that she was vaccinated on October 9, 2015, uncorroborated. (ECF

No. 73, p. 6.) Respondent also stresses that petitioner did not associate onset of her

injury to her vaccination when speaking with her physicians until18 months after the

fact. (Id. at 8.) Respondent further contends that petitioner has not provided a cogent

explanation for why she signed and dated an incorrect vaccination record. (Id. at 8.)

Finally, respondent also notes that petitioner’s medical records include some

evidence that she began experiencing memory problems and cognitive issues prior to

completing her sworn statements in this case. (Id. at 8-9 (citing Ex. 4, p. 943, 948; Ex. 7

pp. 1-2.) Respondent indicates that petitioner’s recollections include a “confusing

premise.” That is, petitioner indicates she was not aware her record was incorrect until

preparing for this litigation despite contending she has a detailed and accurate

recollection of when and how the record was created. 10 (Id. at 9.)

V. Discussion

As explained above, the record evidence in this case includes a facially valid and

complete vaccine administration form identifying November 11, 2015 as the date of

8 Petitioner’s suggestion that these vaccinations were not contemporaneously documented is not strictly

accurate. Both petitioner and Ms. Jones testified that vaccine administration records were created for

patients at the time of vaccination. (Ex. 24, p. 9; Ex. 25, p. 19.) However, it was later discovered that the

administrations had to be additionally documented in a different, electronic, format. (Ex. 25, pp 21-22.)

9 Notably, however, although petitioner testified that masks were required for unvaccinated employees

beginning in 2014, she was never asked whether she was ever required to wear a mask nor did she

otherwise at any point deny wearing a mask. (Ex. 24.) In any event, Ms. Jones offered testimony that has

suggested that enforcement of this requirement may have been less than complete. Specifically, she

indicated at the time of her deposition that the requirement “is more enforced now.” (Ex. 25, p. 32.) She

noted that it “is something we have gotten better at,” explaining that “our vaccination rate was only 60

percent last year, and it is at 90 percent this year.” (Id.) Ms. Jones was unaware of any specific tracking

system for employee vaccination compliance during 2015. (Id. at 33.) Ms. Jones could not recall whether

petitioner ever wore a mask in 2015. (Id. at 47.)

10 Although petitioner indicated that she initially contacted her employer to confirm the date of her prior

vaccination, a close reading of petitioner’s testimony does not necessarily reveal her to have indicated

that she was surprised that she was provided an incorrectly dated vaccination record. (Ex. 24, p. 19-20.)

Petitioner’s testimony focused on her need to prove the October 9, 2015 vaccination allegation. She did

not actually express that she was confused by the discrepancy.

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vaccination at issue. (Ex. 1.) This document is styled as “Generations Family Health

Center, Inc. EMPLOYEE INFLUENZA IMMUNIZTION” and the employment records

subpoenaed by petitioner also appear to reflect that this record was kept in the ordinary

course as part of petitioner’s employee file. (Ex. 14, p. 5; Ex. 16, p. 8; Ex. 1.) This

document is signed by both petitioner and Ms. Jones, the person who administered the

vaccination. (Id.) Moreover, both Ms. Jones and petitioner further confirmed in

testimony that this record was completed on the date indicated on the form. (Ex. 24, pp.

17-18, 38; Ex. 25, pp. 26-27.) Additionally, petitioner confirmed her signature on the

document, which is itself also dated November 11, 2015. (Ex. 24, p. 16.) In response to

petitioner’s inquiry, Generations Family Health confirmed via interrogatory response that

the vaccine lot listed on this administration record is distinct from the lot used for

vaccinations at the mobile health clinic on October 9, 2015, but is consistent with the lot

used by Generations Family Health for vaccinations on a wide range of dates

throughout the 2015-2016 influenza season, including November 11, 2015. (Ex. 41, p.

1.)

Despite significant efforts seeking to investigate the circumstances of petitioner’s

2015 flu vaccination, petitioner was unable to discover any significant evidence, apart

from her own testimony, contradicting her vaccination record. Moreover, no error or

omission is evident on the face of the document. Accordingly, in light of the above-

discussed legal standard, petitioner’s vaccine administration record is entitled to

substantial weight. Petitioner, of course, urges that her testimony that she instead

received her vaccination on October 9, 2015, should overcome the weight of this record.

And, to be sure, petitioner’s testimony did include a seemingly clear recollection of

having received her vaccination on October 9, 2015. (Ex. 24, pp. 7-10.) However,

although it is possible for persuasive testimony to overcome the weight afforded

contemporaneous medical records, there are several issues with petitioner’s testimony.

Accordingly, petitioner’s account is not sufficiently reliable to challenge her facially valid

vaccine administration record.

First, the arguments advanced in petitioner’s motion are unavailing. The fact that

the vaccinations administered by the mobile health unit on October 9, 2015 were not

correctly documented on site does not provide any significant support for petitioner’s

assertion that she was among those vaccinated. Nor does the absence of evidence she

wore a mask or her recollection of attending a concert point to any meaningful

corroboration. (See also n. 9, supra.) Rather, contrary to the arguments raised in

petitioner’s motion, her account remains both uncorroborated and contradicted by other

record evidence.

Ms. Jones, the only available witness who was present with petitioner on both

October 9, 2015 and November 11, 2015, disputes petitioner’s recollection that she was

vaccinated on October 9, 2015, and separately testifies that she does recall vaccinating

petitioner in November of 2015 at the Willimantic worksite documented on the vaccine

administration record. (Ex. 25, pp. 22-24.) Petitioner testified that Ms. Aldridge may

have witnessed the creation of her vaccination record on November 11, 2015 (Ex. 24,

pp. 18, 53-54); however, Ms. Aldridge’s affidavit did not support petitioner’s recollection

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of her interaction with Ms. Jones (Ex. 42). Rather, Ms. Aldridge recalled only that she

assisted petitioner in looking up the lot numbers for the vaccinations given by the mobile

health unit. (Ex. 42.) Although Ms. Aldridge indicated that “Sherri told me that she

needed this information to fill out her own vaccine administration form” (Ex. 42), as

noted above, petitioner’s own vaccination record was completed using a lot number

different than what was administered by the mobile health unit (compare Ex. 1 and Ex.

41). Moreover, petitioner testified that she did not recall providing vaccine lot

information to Ms. Jones for her own administration record. (Ex. 24, p. 40.) Instead,

evidence shows that during the period at issue petitioner was involved in early

November in an effort to retroactively ensure proper electronic logging of the vaccine

administrations performed at the mobile health clinic on October 9, 2015. (Ex. 25, pp.

21-22; Ex. 36, p. 2.) Especially in light of the lot number included on her own

vaccination record, this provides a more likely explanation for her interaction with Ms.

Aldridge.

Moreover, as respondent notes in his motion response, petitioner did not initially

discuss the possible relationship between her vaccination and her injury with her

physicians and did not raise that possibility until 18 months later. (Ex. 6, p. 30.)

Accordingly, petitioner’s contemporaneous medical records also fail to corroborate her

recollection of the date of her vaccination. The only possible piece of corroborating

evidence is the text message in which Ms. Jones purportedly identified the date of

petitioner’s vaccination as “10/9/15.” (Ex. 13.) However, Ms. Jones denied that the text

was an acknowledgement of petitioner’s correct vaccination date and testified that she

did not have petitioner’s record at that time and merely repeated the date stated by

petitioner. (Ex. 25, pp 29-32.)

Second, other aspects of petitioner’s testimony are not clear and consistent. As

respondent noted, in her first affidavit petitioner initially recalled that her vaccination

record was created only two days after she was vaccinated at the mobile health clinic

whereas in her second affidavit she indicated the vaccination was recorded weeks

later. 11 (Ex. 8, p. 1; Ex. 15, p. 1.) More significantly, in her second affidavit, petitioner

indicated that the specific reason her vaccination was not recorded as of October 9,

2015 was that the patient vaccinations administered at the mobile health unit that day

were documented in electronic patient charts while as an employee she did not have an

electronic chart. (Ex. 15, p. 1.) In her deposition, however, she testified that the mobile

clinic used paper records. (Ex. 24, pp. 9-10,35.) In fact, in her motion petitioner

stresses the fact of a contemporaneous e-mail in which petitioner complained of the

11During her deposition, petitioner offered unclear testimony regarding the first affidavit. When asked if

she drafted the affidavit, she initially indicated “yes.” (Ex. 24, pp. 41-42.) However, she then noted some

details of the affidavit and indicated “I wouldn’t have known how to compile this.” (Id. at 42.)

Respondent’s counsel specifically drew petitioner’s attention to the specific statement in the affidavit that

petitioner’s vaccination was documented two days later. Asked if she wrote that specific statement,

petitioner indicated “I don’t believe I did.” (Id.) Asked if she was ever under the impression that her

vaccination was documented on October 11, 2015, petitioner responded “No.” (Id. at 42-43.)

Nonetheless, she acknowledged that the document was sworn and subscribed with her signature before

a notary. (Id. at 43.)

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lack of a laptop to document patient vaccinations on site. (ECF No. 72, p. 8 (citing Ex.

36, p. 2).) Although Ms. Jones testified that the specific employee immunization forms

were not available on the mobile unit (Ex. 25, pp. 35-36), nothing in the record suggests

that petitioner’s vaccination could not have been documented for her employee file

using a standard vaccine administration form. Thus, this inconsistency directly

implicates the rationale underlying petitioner’s description of events. Petitioner also

offered confused testimony with regard to what file, and in what format, her prior 2014

influenza vaccination would have been documented. 12 (Ex. 24, pp. 44, 54.)

Third, petitioner’s testimony creates a credibility issue in itself due to the

particular circumstances of this case. As discussed during her testimony, petitioner is a

nurse experienced in administering vaccinations and completing administration records,

received her vaccination in the context of her employment, and allegedly participated in

the after-the-fact creation of her own vaccination record. (Ex. 24, pp. 16-17, 37-38.)

Indeed, petitioner confirmed during her testimony that she dated her vaccination record

herself. (Id. at 17.) Thus, in order to accept her own account of her vaccination as

credible, I would also have to accept that she either mistakenly or willfully completed

and signed a vaccination record falsely identifying the date of her vaccination. Yet,

petitioner did not provide any explanation or rationale as to why her vaccination record,

even if circumstances caused it to be created belatedly, would have reflected this

incorrect information.

Petitioner was asked during the deposition whether she asked Ms. Jones at any

point to fill out a vaccine administration record. She responded: “I did not. She

administered the vaccine. It is her role to document her work. And she is my supervisor.

And as infection control, that is all her job, to make sure that the shots were administer

[sic.] and there is documentation thereof. So it wouldn’t have been my place to, sort of,

keep track of her work.” (Ex. 24, p. 50.) This provides some rationale as to timing;

however, petitioner confirmed in her testimony that when the time did come to complete

the administration record she completed her portion of the form – which included the

date in two locations – before Ms. Jones completed the clinic use portion. (Id. at 17-18,

38.) She also testified that she did not discuss the date of her vaccination with Ms.

Jones until much later when she began to connect her medical condition to her

vaccination and received a copy of her vaccination record. (Id. at 19.) Accordingly, her

testimony indicates that she documented the November 11, 2015 administration date on

her own initiative with no explanation for why she would have initially completed the

form incorrectly.

12 Initially, petitioner testified that she knew that her 2014 flu vaccine was documented in her patient chart,

because it would have been entered into her electronic patient chart at the time of administration. (Ex. 24,

p. 44.) Later, she indicated the vaccination was not administered to her as a patient and would have

been done “very much the same as what we did with Nicole Jones.” (Id. at 54.)

17

VI. Conclusion

In light of all of the above, there is preponderant evidence that petitioner received

an influenza vaccination on November 11, 2015. There is not preponderant evidence

that petitioner received an influenza vaccination on October 9, 2015.

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

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