Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Burning sensation, Diarrhoea, Disease recurrence, Herpes zoster
Clinical narrative: Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They were flu-like symptoms; Diarrhea; Nausea; achiness; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: unknown), intramuscular, administered in the right deltoid (also reported as right arm) on 03Mar2021 16:00 at a single dose for covid-19 immunisation. Medical history included patient had anxiety all her life (ongoing), but reported 'started the medication about 10 years ago for the first time'; and patient had hypothyroidism, which she found out when she was going through the in-vitro fertilization. It was further reported that she was diagnosed with hypothyroidism when she and her husband were going through In-vitro fertilization and were having trouble conceiving and her TSH levels were off (date unknown). She didn't feel any different and didn't feel any different now since being on Synthroid; that was the only reason she found out. She was fairly healthy. Patient mentioned that when she was 7 years old she had her first shingles outbreak. Concomitant medications included oral levothyroxine sodium (SYNTHROID) taken for hypothyroidism at 75 ug, daily from an unspecified start date (approximately started 3 years ago) and ongoing; and oral sertraline hydrochloride (ZOLOFT) taken for anxiety at 50 mg, once a day from an unspecified start date (started about 10 years ago) and ongoing. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated she do not want COVID and she is a pro-vaccines. Patient received first vaccine shot on 03Mar2021 and was diagnosed with shingles on the morning of 19Mar2021 and wanted to know if it was okay to take second dose of the vaccine next Thursday with active shingles diagnosis and being on antiviral medication, or should she wait. Patient stated that shingles, she was sure it was shingles, will not prevent her from getting second dose. She mentioned she was stuck, this was all new, and her doctor couldn't tell her because he didn't know. She was not sure what to do. She was not sure if she should delay getting the vaccine until she has stopped the antiviral medication, which she later clarified as Famciclovir. She stated initially her symptoms started Monday (Mar2021). They were flu-like symptoms on 17Mar2021. She was having diarrhea and feeling nauseated on 16Mar2021, thought coming down with the flu. On Wednesday (Mar2021), she felt pain, the shingles was on her buttocks. She went to the bathroom and saw red. Yesterday, 17Mar2021, she got a closer look because a burning sensation. When she looked closer, she realized it was shingles. It started more of a flu-ish feeling on Monday and noticed rash erupt on Wednesday. She also started to experience achiness on Monday (Mar2021). She was seen at her physician's office today, 19Mar2021 and was diagnosed with shingles this morning. The events shingles, nausea, diarrhea, flu-like symptoms and achiness were reported as not serious. The event burning sensation was reported as medically significant. Therapeutic measures were taken as a result of the events which included famciclovir, oral from 19Mar2021 and ongoing, at 500 mg, three times a day for shingles.  The patient had not recovered from the events burning sensation (reported as worsened), shingles (reported as worsened), nausea, flu-like symptoms, and achiness. The event diarrhea was recovering. The events diarrhea, nausea, achiness, and burning sensation were reported as unrelated to the vaccine suspect product.; Sender's Comments: The events burning sensation, diarrhea, nausea and pain are considered not related to BNT162B2, but intercurrent medical conditions. 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.