Adverse Event Reporting
|Number of vaccinations||1|
- Pain in extremity
- Skin warm
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Test Name: temperature; Result Unstructured Data: Test Result:Unknown result
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself.
This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation.
Medical history and concomitant medications were none.
The patient did not have anything with the first shot except a sore left arm on 18Dec2020.
She stated that if she lays on left side it is sore.
The patient had the sore left arm both times that she got the vaccine.
She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021.
She did not have a fever but her skin felt hot on 05Jan2021.
She stated that she had dry heaves on 05Jan2021.
The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed.
Stated that the chills and dry heaves started then and throughout the night.
The chills stopped an hour before she got up.
Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot.
Stated that nausea started about 10 at night on 05Jan2021.
Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious.
The patient took Ibuprofen for the headache.
Stated that she was going to try to drink something.
The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021.
The outcome of other events was recovering.
The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.
; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship.
There is limited information provided in this report.
Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.
This case will be reassessed once additional information is available.
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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.