Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sensation of foreign body, Vaccination site erythema
Clinical narrative: Redness around the site; Burning; Swollen arm; Swollen lymph nodes; Sore throat; Lack of appetite; Lethargic; sore throat like 'it' was closing up; had the 'upper side' it was swollen like a golf ball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 08:00 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: OMEPRAZOLE; COZAAR taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (Dose: 1, Lot No: EK5730), administration date: 30Dec2020, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot No: EL3302), administration date: 20Jan2021, when the patient was 55 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness around the site"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Lack of appetite"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; SENSATION OF FOREIGN BODY (non-serious), outcome "unknown", described as "sore throat like 'it' was closing up"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "had the 'upper side' it was swollen like a golf ball". Therapeutic measures were taken as a result of vaccination site erythema, burning sensation, peripheral swelling, lymphadenopathy, oropharyngeal pain, decreased appetite, lethargy, sensation of foreign body, peripheral swelling.  Additional information: Dates for Redness around the site: burning, swollen arm, swollen lymph nodes, dates for sore throat, dates for Lack of appetite and dates for Lethargic were from unspecified to unspecified. The COVID-19 Vaccine was a Pfizer product.  COVID-19 Vaccine manufacturer was unspecified. Dates for COVID-19 Vaccine were from unspecified to unspecified. NDC number of COVID-19 Vaccine was unknown. UPC number of COVID-19 Vaccine was unknown. Reason for no lot number of COVID-19 Vaccine Other LOT# Consumer stated, "FJ87, it looks like a 02."(Consumer was unsure). Expiry Date of COVID-19 vaccine was unknown. The patient had other Products. The start and stop dates for concomitant products Omeprazole were unspecified. Investigation assessment was not provide. Consumer stated, "She just wanted to report an adverse reaction to the shot. She had the shot on Friday and she just wanted to report some of her reaction." When asked the name of the vaccine as Pfizer COVID-19 Vaccine, Consumer stated, "Yes, the booster." When asked for the adverse reactions, Consumer stated, "She had redness around the site, burning, swollen arms, swollen lymph nodes, sore throat like 'it' was closing up (further clarification unknown), and lack of appetite. She was lethargic and then she also had the 'upper side' it was swollen like a golf ball. So she was better today because she packed her arm in ice and her lymph nodes in ice, over the 4 weekends she did miss 2 days of work. She also had to take the Benadryl and Advil and she was better today, much better, third day (Further clarification unknown)." Consumer was informed about the role of Pfizer Drug Safety. When asked if it was the first time consumer called Pfizer drug safety, Consumer stated, "It's the first time she had the reactions every time but not this bad. She had it on last Friday, this 14th and she had it 8 O'clock in the morning and she started about probably 5 O'clock in the evening and it progressively got worst. Her age, she was 56. LOT#: Consumer stated, "FJ87, it looks like a 02. For expiration date consumer stated, "It did not say that on here." LOT# for first and second shot Consumer stated, "My first dose was 30Dec2020 and it was, this is the number EK5730 then my second shot was 20Jan2021 and it was EL3302." For expiration date consumer stated, "There was no expiration date." Causality consumer stated, "Yes". Consumer stated, "she was taking blood pressure pill, Cozaar she believe and then she also took Hydrochloride tablet (Consumer was unsure)." Treatment in response to adverse reaction Consumer stated, "Yes, she took Benadryl and Advil." The patient had no prior vaccination within 4 weeks. Vaccination facility Consumer stated, (Institution name). Telephone Consumer stated, "she don't have that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.