Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) back muscle inflammation problems; Fatigue problems/extremely tired/extreme fatigue; Falling asleep; Back muscle inflammation was intense in the upper back and neck, her upper back became hard like a rock.; Eyes were impacted after the second dose- they were itchy and sore.; Eyes were impacted after the second dose- they were itchy and sore.; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support reported from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171), via an unspecified route of administration on 21Apr2021 as 2nd dose, single for COVID-19 immunization. Medical history included ongoing slightly hypothroid (has been stable for 25-30 years), and flu. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from 20Apr2021. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150), via an unspecified route of administration on 31Mar2021 as first dose, single for COVID-19 immunization, after which the patient experienced back muscles became very inflamed and couldn't use the toilet because of the screaming pain; Historical vaccines included flu vaccine in 2009 and 11Nov2011 for influenza immunization after which the patient had serum sickness (in 2011 she was so sick after the flu vaccine that she had to stay in bed for 2 weeks and then she got the flu anyways. She had headache, puffy face and puffy eyes, nausea fever, and achy joints. She stated she was in bed for almost two weeks. Her primary diagnosis was serum sickness and secondary diagnosis was bronchitis). The patient experienced fatigue problems from 21Apr2021 and back muscle inflammation problems on 29Apr2021 after receiving the second dose. The back muscle inflammation was intense in the upper back and neck, her upper back became hard like a rock on an unspecified date. She was screaming if she had to sneeze and could not reach out with her arms. This was not in her lower back. After the second dose it was better but was still pretty bad. This back muscle inflammation lasted at least 10 days, the patient is still having some problems and takes ibuprofen when it gets really bad. The patient's eyes were impacted after the second dose they were itchy and sore, on an unspecified date. The patient's eyes were like this for 3 days and she recovered completely. However it was also reported that the patient's eyes were not impacted with the second dose (clarification pending). Her allergist told her to take a cetirizine hydrochloride (ZYRTEC) starting the day before she received her second dose and then for a few days after the second dose. She was also told to take 2 extra strength Tylenol right after the second dose to help with the muscle soreness. She saw her ophthalmologist 2 weeks after the second vaccine. The last time the she saw her ophthalmologist was 2 weeks before the first vaccine, so 6 weeks before this event, and her eyes were fine at that time. When the ophthalmologist looked at the eyes after receiving the second dose, told the patient that she needs to get her thyroid checked. She had been extremely tired and falling asleep during the day for 2-4 hours since she received the second vaccine. She is going to get an ultrasound on her thyroid 6 weeks after she received the second dose of the vaccine. She is also going to an endocrinologist to get her thyroid blood work done. The patient had not recovered from fatigue/extremely tired and falling asleep, was recovering from back muscle inflammation and muscle tightness, had recovered from eyes itchy and sore.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138461 Same patient/drug/event and different dose