Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Back pain, Chills, Condition aggravated
Clinical narrative: Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient).  A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization.  Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.