Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Immunisation, Pain in extremity
Clinical narrative: Shingles; Fatigue; Sore arm; Received the Pfizer COVID booster on Monday; This is a spontaneous report received from contactable reporter(s) (nurse). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 18:00 (Lot number: FFZ593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation.  Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Breast cancer", start date: Aug2017 (unspecified if ongoing); "lymph node removal" (unspecified if ongoing). Caller mentioned she had bilateral breast cancer with lymph node removal so she was hesitant on receiving the COVID vaccine intramuscularly (IM). Concomitant medication(s) included: ARIMIDEX taken for cancer but confirmed she had been on this medication for a while, beyond the 2 week time period leading up to her shingles diagnosis. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EN6208, Anatomical Location: Right glute.), administration date: 11Mar2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "No problems"; Bnt162b2 (Dose 2, Lot Number: ER8733, Anatomical Location: Left gluteus.), administration date: 01Apr2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "No problems"; Zoster vaccine (She verifies she has no NDC, Lot number and expiry date for the herpes zoster vaccine.), administration date: 2015, for Immunization. The caller stated she had the other two Pfizer COVID vaccines and had no problems. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021 18:00, outcome "unknown", described as "Received the Pfizer COVID booster on Monday"; HERPES ZOSTER (medically significant) with onset 24Nov2021, outcome "unknown", described as "Shingles"; FATIGUE (non-serious) with onset 23Nov2021, outcome "unknown", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021, outcome "unknown", described as "Sore arm". The event "shingles" was evaluated at the physician office visit. Clinical course: The caller clarified she received the Pfizer COVID booster on Monday, 22Nov2021. She had a little bit of fatigue yesterday and sore arm, which was to be expected. She woke up this morning with shingles. She went to her primary care provider and she confirmed. The caller stated she talked with her HCP and was told shingles was a possibility. Caller mentioned she had bilateral breast cancer with lymph node removal so she was hesitant on receiving the COVID vaccine intramuscularly (IM) in either arm. However, her third those was given in her left arm because no one would give it in her glute. She had her first two doses administered by her PCP. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations (within 4 weeks). No relevant tests: none, just the expense of antiviral medications and prednisone. Causality was reported as unknown, but suspicious.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relation, the association between the events of Immunisation and Herpes Zoster and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.