Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Malaise, Pain, Pyrexia
Clinical narrative: really sick; In bed 2 days; Could not eat; Hurting all over and joints aching; Hurting all over and joints aching; Fever and really cold; Fever and really cold; Left arm was sore after injection; Left arm was sore after injection and she had a lump and was itching; Left arm sore after injection with lump and itching; This is a spontaneous report from a contactable Nurse reported for mother. An 84-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via intramuscular at arm left on 13Jan2021 13:00 at single dose for prevention because of age group. Medical history included hypothyroid diagnosed many years ago, having Covid in Jun2020. Concomitant medications were unknown. The patient was really sick from an unspecified date. The reporter was starting to wonder if the patient should take the second dose. The patient was in bed for 2 days, could not eat and was hurting all over at 23: 00 on 13Jan2021. Her joints were aching at 23: 00 on 13Jan2021.  She had a fever and not really chills, but she just never could get warm and was really cold at 23: 00 on 13Jan2021. She went to bed and woke up on that same date, 13Jan2021, and it started at 11pm.  She guessed it was disabling.  As it went on, it got better. By Friday, she was finally able to eat. She has plenty of weight to fall back on for not eating. By Friday, she started eating again. She was still not back to normal yet though. She just felt like she could not get up. The fever only went on for a few days. Left arm was sore after injection and she had a lump and was itching 13Jan2021. It worried her.  The lump was still itching and sore, but was getting better. Reporter stated that the shingles vaccine did the exact same thing to her with the lump under her skin and itching.  It was given on her hip because she had small arm and they were scared to give it in her arm. The reporter wanted to know if there were elderly people in the trial and did any of them have COVID. No additional vaccines administered on same date of the pfizer suspect. Seriousness for In bed 2 days was reported as disabling. Seriousness for Could not eat, Fever and really cold was reported as not serious. Seriousness for Left arm sore after injection with lump and itching was reported as medically significant. Outcome of the events Fever and really cold, really sick was unknown, of other events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.