Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Rash, SARS-CoV-2 test
Clinical narrative: Rash developed 11 days after 3 rd vaccineFeet hands back neck scalp arms/rash on feet, hand, arms, fingers, toes, head- Raises on hands, feet heal; Enlarged lymph nodes neck and glands neck swollen; Rash developed 11 days after 3rd vaccine; It was a viral infection; Fatigue; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient. A 60-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 17:00 (Lot number: 30125BA) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Shellfish nuts" (ongoing), "Allergies: Shellfish nuts" (ongoing), "High Blood Pressure", start date: Dec2019 (ongoing), "Reflux" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 2019 (ongoing), PREVACID taken for reflux gastritis, start date: 2018 (ongoing), SYNTHROID taken for hypothyroidism, start date: 1990 (ongoing), NASONEX taken for hypersensitivity, start date: 2015 (ongoing), ZENAX (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Route of administration: Intramuscular, Vaccine Administration Time: 17:00, No events reported), administration date: 10Feb2021, when the patient was 59 years old, for COVID-19 Immunisation, Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Route of administration: Intramuscular, Vaccine Administration Time: 17:00, No events reported), administration date: 03Mar2021, when the patient was 59 years old, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Sep2021 17:00, outcome "unknown", described as "Rash developed 11 days after 3rd vaccine", VIRAL INFECTION (non-serious) with onset 2021, outcome "unknown", described as "it was a viral infection", RASH (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Rash developed 11 days after 3 rd vaccine Feet hands back neck scalp arms/rash on feet, hand, arms, fingers, toes, head- Raises on hands, feet heal", FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue", LYMPHADENOPATHY (non-serious) with onset 13Oct2021, outcome "recovering", described as "Enlarged lymph nodes neck and glands neck swollen". The events "it was a viral infection", "rash developed 11 days after 3 rd vaccinefeet hands back neck scalp arms/rash on feet, hand, arms, fingers, toes, head- raises on hands, feet heal" and "enlarged lymph nodes neck and glands neck swollen" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, lymphadenopathy.  Additional information: No other vaccine was administered in four weeks. The patient did not have covid prior to the vaccination. The patient saw her doctor yesterday and she said might be viral but can't rule out vaccine reaction. The route of Nasonex was reported as spray and Zenax was used occasionally. The events resolved mostly after 10 days with Zyrtec and Steroid cream. No oral steroid were taken. The patient went to dermatologist and Primary Care Doctor/internal medicine doctor. Patient received vaccine facility in Pharmacy or Drug Store.  Description of Product Complaint: Consumer (Pfizer representative) stated that she has had a rash. She thought it was like 13 days after she had the vaccine. The third booster and there was no way to know if it was due to like a virus that was provoked by the vaccine. Like it was not a direct call. So she still got to finish the paper work and sent her something on the computer and she said she already told about by the paper. Now they sent her a form of anaphylaxis that her neck was swollen, her neck was not swollen. She did not have anaphylaxis. She did not know why they sent her this paperwork and she was not filling it out but she did want to know if there had been other people that have had viral infection induced problems due to booster. She did not know why she needed to send this kind of letter form. When probed when did the consumer came to know about the adverse event: Consumer stated that she reported this within less than 24 hours. She already reported. She did not want paper work again. She already reported it. She reported it like. She reported it exactly when it happened. 13 days after the vaccine she started to develop a rash all over her body. She was a little fatigue from weekend and rash all over her body. She reported it like and it was sort of rash and she still did not know if it was related (Further clarification unknown)."  Consumer stated  that she did all the paper work and now they sent her additional paper work on anaphylaxis. She was just asking if she needed me to fill that out. She was gonna have to go through the whole thing again.  QR comment: Reporter type was not available over the call hence captured as consumer or non health professional by default.  No follow-up attempts are possible. No further information is expected.