Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: head + body aches; rash, reddened & non-raised neck upper chest upper back/rash was a little itchy; low grade fever; head + body aches; joint pain; Nausea; chills; rash; This spontaneous report from a contactable nurse (patient). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0142, expiration date: not reported), via intramuscular route , administered in deltoid right (arm right) on 10Jan2021 10:00 as dose 2,single dose for Covid-19 immunization at Workplace clinic (56 Years old at time of vaccination). The patient medical history of any previous allergies to specific products or any conditions indicative of an allergy included ampicillin medication. Concomitant medications included levothyroxine from 2005 ,25 mcg PO ; ascorbic acid (VITAMINS C) from 2005; pravastatin from 2005,20 mg PO ; calcium, colecalciferol (CALCIUM W/VITAMIN D3) from 2005; chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN) from 2005; zinc from 2005; tocopherol (VITAMIN E) from 2005; vitamin b complex from 2005. No adverse event following prior vaccinations. No recent vaccines for any other conditions prior to the event being reported. No recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Previously, patient received first dose of  PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: EK5730, expiration date: not reported), dose 1 intramuscular, administered in deltoid right on 20Dec2021 (at the age of 56years) as single dose for Covid-19 immunization at Workplace clinic. On 10Jan2021 23:00, the patient experienced low grade fever, head + body aches, joint pain, nausea, chills and rash, reddened & non-raised neck upper chest upper back/rash was a little itchy. Therapeutic measures were taken for low-grade fever (pyrexia) as Tylenol . The events were not considered serious by reporter. The outcome of all events was recovered on unknown date in 2021. Clinical course was as follow: The patient reacted to her second dose of Pfizer Covid 19 vaccine and had low fever 99.6, Head & body aches, joint pain, nausea, chills. The patient got the second vaccine at 10:00, reactions started about at 23:00 (11PM). The patient was not admitted to hospital. No treatment was required, no emergency room and physician office visit, no hospitalization or intensive care unit. No predisposing factors, no culture performed, no serotyping performed. Extra strength TYLENOL (PRNS-tablet per oral every 6 hours) from 20Dec2020 22:00 to 01Jan2021 used as antipyretic with both doses of vaccine. ALEVE was none with second vaccine. On 10Jan2021 (12-13hrs after vaccine), Pfizer-BioNTech COVID-19 Vaccine anaphylactic was noted. Signs and symptoms of the anaphylactic reaction included headache, chills, body & joint ache, low grade fever, nausea, rash. The patient did not require medical intervention. Multi organ involvement with organ systems (Dermatological/Mucosal and other) as rash, reddened & non-raised neck upper chest upper back, nausea, body & joint pain/ache noted. No respiratory involvement, no bilateral wheeze/bronchospasm, no stridor, no upper airway swelling, no respiratory distress, no tachypnoea, no increased use of accessory respiratory muscles, no recession, no cyanosis, no grunting, no dry cough, no hoarse voice, no difficulty breathing (without wheeze or stridor), no sensation of throat closure, no sneezing, no rhinorrhea, no other details. no cardiovascular, no generalized urticaria (hives), no angioedema (not hereditary), no generalized pruritus with skin rash, no, generalized pruritus without skin rash. Generalized prickle sensation was there in form of rash was a little itchy. That's how the patient discovered she had a rash, and she did not scratch it. No localized injection site urticaria, no red and itchy eyes, no diarrhea, no abdominal pain, no vomiting. Gastrointestinal involvement had nausea with both vaccines the day after-Monday mornings. The patient's outcome following the potential anaphylactic reaction was recovered. Causal Relationship: Is there a reasonable possibility that the event is related to suspect product/s: Yes Do you consider the Pfizer product had a causal effect to the adverse event? Yes Follow-up attempts completed. No further information expected.