Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Headache, Interchange of vaccine products, Off label use, Product use issue
Clinical narrative: received two doses of Moderna Vaccine (Unspecified Vaccine) previously/eceived the Pfizer COVID-19 Vaccine as 3rd dose/booster dose; received two doses of Moderna Vaccine (Unspecified Vaccine) previously/eceived the Pfizer COVID-19 Vaccine as 3rd dose/booster dose; received two doses of Moderna Vaccine (Unspecified Vaccine) previously/eceived the Pfizer COVID-19 Vaccine as 3rd dose/booster dose; received two doses of Moderna Vaccine (Unspecified Vaccine) previously/eceived the Pfizer COVID-19 Vaccine as 3rd dose/booster dose; feeling tired; felt like it might be a stroke; Tremendous headache/"starburst" pain headache; Swollen area on the right side of her ear with a tenderness; Tenderness was actually on the scalp behind my right ear where that intense pain came from; Tenderness was actually on the scalp behind my right ear where that intense pain came from; I was so scared from the experience; This is a spontaneous report from contactable HCP (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 3 via an unspecified route of administration on 29Aug2021 at 16:00 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took moderna covid-19 vaccine for covid-19 immunisation, moderna covid-19 vaccine for covid-19 immunisation, tylenol and experienced drug hypersensitivity, tylenol and experienced headache (described as "convulsing with tremendous headaches").  The patient reported that she has received her two doses of the Moderna vaccine previously and then received her third dose/booster dose of the Pfizer covid 19 vaccine on 29Aug2021 at 16:00. The patient reports feeling tired after receiving the vaccine, which she expected, and later that evening on 29Aug2021 at around 20:00 or 21:00, she experienced a"starburst pain headache/tremendous headache. She said, while she has never had a stroke, it was scary, felt like it might be a stroke. I was so scared from the experience. The patient said the headache was inside her head, next to her right ear; she reports never having a headache there before. The same pain came back half hour later. The patient said the powerful pain only happened twice, a dull pain remained. She said she has a swollen area near her right ear which had a tenderness that lasted until last night. The tenderness was actually on the scalp behind my right ear where that intense pain came from. The patient said she is highly allergic to Tylenol and wanted to know if there was a chemical like Tylenol in the vaccine. She has previously taken Tylenol twice before and has convulsing with tremendous headaches after taking Tylenol. With the Moderna vaccine, she said she "felt like I got hit by a truck" but nothing compared to this. The patient was recovering from the event, tremendous headache/starburst pain headache. Outcome of the other events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of stroke.  The reported event may likely represent intercurrent medical condition. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI at baseline and post vaccination, counteractive treatment measures and concomitant medications.    This case will be reassessed upon receipt of follow-up information.   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.