Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Interchange of vaccine products, Off label use, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: FT8762) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Moderna covid 19 vaccine (Dose:1, Anatomical location: left arm), administration date: 12Mar2021, when the patient was 47 years old, for COVID-19 immunization; Moderna covid 19 vaccine (Dose:2, Lot: 037A2113, Expiry: Unknown, Anatomical location: left arm), administration date: 09Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 03Dec2021 14:00, outcome "unknown" and all described as "received Moderna for her 1st 2 doses/received the Pfizer Covid 19 vaccine as her booster"; IMMUNISATION (non-serious) with onset 03Dec2021 14:00, outcome "unknown", described as "Booster"; VACCINATION SITE REACTION (non-serious) with onset 05Dec2021 19:30, outcome "recovered" (08Dec2021), described as "the 1st most significant adverse event was a significant reaction at the injection site on her left arm"; VACCINATION SITE URTICARIA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 05Dec2021 19:30, outcome "recovered" (08Dec2021) and all described as "Significant hive at injection site that was raised, red, burning and itchy"; HEADACHE (non-serious) with onset 04Dec2021 09:00, outcome "recovered" (06Dec2021), described as "Headache". Therapeutic measures were taken as a result of vaccination site reaction, vaccination site urticaria, vaccination site pain, vaccination site pruritus, headache.  Additional information: Patient's Medical History (including any illness at time of vaccination), AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) was provided as None. AE(s) not require a visit to Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was None. Patient stated that the 1st most significant adverse event was a significant reaction at the injection site on her left arm. She developed a large hive that spread over her entire deltoid region at the injection site, that was raised, red, burning, and itchy. She would say that it was severe. This developed around 7:30pm on 05Dec2021. Around 9am on 04Dec2021, she developed a moderately severe headache. She self treated at home for both events; no further details provided regarding treatment. These events occurred after she received the Pfizer Covid 19 vaccine as her booster. States that she received Moderna for her 1st 2 doses.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.