Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  events including chills, tremor in fingers,  headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable 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.