Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Dizziness, Headache, Immunisation
Clinical narrative: 14 hours after the booster dose she had a fever up to 105F; She had severe headache; She was very dizzy and had to lay down on the floor as she almost fell; Thought she was going to die; Her bones were aching; Booster dose of the Pfizer-BioNTech COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 06Dec2021 15:35 (Lot number: FJ1620, Expiration Date: 31May2022) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SHINGRIX, administration date 05Nov2021; FLU, administration date Oct2021. Vaccination history included: Bnt162b2 (Dose 01, Lot: ER8732,), administration date: 28Mar2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (Dose 02, Lot: EW0169,), administration date: 19Apr2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "temperature maxed out at 101-102 degrees", "headache", "hurts her stomach". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 15:35, outcome "unknown", described as "Booster dose of the Pfizer-BioNTech COVID-19 Vaccine"; PYREXIA (medically significant) with onset 07Dec2021, outcome "recovered" (08Dec2021), described as "14 hours after the booster dose she had a fever up to 105F"; HEADACHE (medically significant) with onset 07Dec2021, outcome "recovered" (08Dec2021), described as "She had severe headache"; DIZZINESS (medically significant) with onset 07Dec2021, outcome "recovered" (08Dec2021), described as "She was very dizzy and had to lay down on the floor as she almost fell"; NEAR DEATH EXPERIENCE (medically significant) with onset 07Dec2021, outcome "recovered" (08Dec2021), described as "Thought she was going to die"; BONE PAIN (non-serious) with onset 07Dec2021, outcome "recovered" (08Dec2021), described as "Her bones were aching". The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) 101 degrees; body temperature: (06Dec2021) 105 Fahrenheit. Therapeutic measures were taken as a result of pyrexia.  Additional information included: The patient wanted to know if there were problems with the lot number of Pfizer product, but upon checking it was clear that there were no problems or issues with that lot number. It was reported that the fever started about 14 hours after getting the vaccine; her temperature started at 101. She took Tylenol which didn't do anything, and her temperature ended up at 105 at about 24 hours after the vaccine. She took Motrin at midnight around 2:30 pm and her fever went back down to 101 degrees. Then she took the Motrin again around midnight to make sure her fever didn't go back up. She tried not to take it because it hurted her stomach, but she took it at midnight because she was afraid she was going to wake up dying again. It was clarified that she took 2 tablets of withheld brand Acetaminophen, 500mg tablets (lot number 1KV1764; expiry date Aug2023). The events of fever, bone aching, severe headache and dizziness were related to the Covid-19 vaccine. It was stated that the severe headache was considered as medically significant because it was so bad that she didn't know if she had a blood vessel that was bursting in her head. It was also stated that the dizziness was considered medically significant because she could have fallen; she had to lay down on the floor until the dizziness passed.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Immunisation, Pyrexia, headache, dizziness, near death experience, bone pain  and other reported events and the suspect drug BNT162B2 cannot be excluded.       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.