Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer Covid vaccine for all 4 doses/Covid home test: 20Jun2022 positive; Pfizer Covid vaccine for all 4 doses/Covid home test: 20Jun2022 positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 12Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot (she had a side effect with the flu shot one time, where she had swelling in her arm and an itchy patch on her left arm.), reaction(s): "swelling in her arm and an itchy patch on her left arm". The following information was reported: COVID-19 (medically significant) with onset 20Jun2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Pfizer Covid vaccine for all 4 doses/Covid home test: 20Jun2022 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: Caller tested positive for COVID on 20Jun2022 with a home test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Suspect Product: Pfizer Covid vaccine for all 4 doses. Caller states she doesn't know where her card is with all the information. States her first dose was 30Jan2021 and she believes her 2nd dose was 20Feb2021, she thinks they did it 3 weeks after the 1st dose. States the 1st booster was Sep2021, she thinks the 12th or something, and her 2nd booster was Apr2022. States she got all doses in her left arm. Caller does not have NDC, lot or expiry to provide. History of all previous immunization with the Pfizer vaccine considered as suspect: States her first dose was 30Jan2021 and she believes her 2nd dose was 20Feb2021, she thinks they did it 3 weeks after the 1st dose. States the 1st booster was Sep2021, she thinks the 12th or something, and her 2nd booster was Apr2022. States when she got the Pfizer Covid vaccines she did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised. States she panicked. States that was 2 days after the vaccine and she saw her dermatologist and they said it looked like a dog scratch and she feels it's from the vaccine. States that took 2 weeks to go away. Caller states that was with the 1st dose. States with the second dose she got 3 weeks later she got a hive on her face in a different spot on the same side of her face and it didn't last very long and went away. States that started 2 days after the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.