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Life Threatening? No
Write-up: sore arm; Breathlessness/ catch her breath/ felt a bit breathless; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA); the Regulatory Authority report number is GB-MHRA-WEBCOVID-202106050949340740-OJZJA and the Safety Report Unique Identifier is GB-MHRA-ADR 25425397. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jun2021 around 2:20 pm (batch/lot number was not reported) at 24 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date. The patient was initially suspected and was diagnosed of COVID-19 from 28Dec2020; patient tested yes - positive for COVID-19 test on 29Dec2020. She had symptoms such as fatigue, breathlessness, high temperature, changes to taste and smell, olfactory hallucination, muscle aches, increased skin sensitivity, foggy feeling in head (also reported as "brain fog"), etc. She was never admitted to hospital. The symptoms gradually got better but persisted for about 3 months. Patient was unsure when symptoms stopped. The patient was not enrolled in clinical trial. Patient was not pregnant and not currently breastfeeding. Concomitant medications were not reported. The patient experienced breathlessness on 04Jun2021 and sore arm on an unspecified date. It was reported that by 8pm of 04Jun2021, patient was talking on the phone to someone and realized she needed to stop talking and catch her breath, which she would never normally need to do. The next morning (05Jun2021), she felt a bit breathless sitting down and when she was doing something like making her bed, it was really noticeable. She had COVID-19 in 28Dec2020 and one of her symptoms was breathlessness. Patient stated it was much worse than this at first which slowly got better but the symptom lingered for a couple of months. Although she has not experienced any breathless in about 2/3 months until she had the vaccine. Patient also reported having a sore arm on an unspecified date. The patient has not recovered from the event breathlessness. Outcome of the event sore arm was unknown. The events were reported as serious, medically significant. The patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
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