Adverse Event Reporting
| VAERS ID | 971286 |
|---|---|
| Gender | Female |
| Age | 62 |
| StateCode | IL |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | GL3248 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-01-07 |
| Onset | 2021-01-01 |
| Condition | Permanent Disability |
Symptoms
- Arthralgia
- Fatigue
- Chills
- Defaecation urgency
- Asthenia
- Somnolence
- Mobility decreased
- Feeling cold
- Gastrointestinal disorder
- Flatulence
Current Illness
Diabetic (Additional Information for Other Conditions: Diagnosed about 6 years ago.); Hyperthyroidism (Additional Information for Other Conditions: Diagnosed about 6 years ago.)
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient).
A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.
)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients.
Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control.
There were no concomitant medications.
Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm).
On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms.
Her lower GI symptoms included diarrhea.
Then caller clarified that it was not diarrhea but the urge to go.
The stools were solid.
She also had lots of flatulence.
She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted.
The patient is a nurse.
She was in her office that day and had to literally lay on the floor because she was so wiped out of energy.
She left work early and went to bed.
Then the next day 12Jan2021, she was unable to get out of bed the whole day.
She is so sleepy and has no energy.
She went to bed last night at 08:30, but is still so sleepy.
Today she is feeling better, but still had lower GI symptoms.
She was also feeling cold, which she normally is always hot.
She was having to put 5 blankets on her.
Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown.
The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.
; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.