Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Chills, Feeling cold, Headache, Insomnia
Clinical narrative: she saw stars; arm soreness in her left arm/same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose; Headache; Chills; Was very cold; Couldn't sleep last night; Swollen; This is spontaneous report received from a contactable nurse (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in the right arm, at age 69 years, on 11May2021 at about 12-12:30 in the afternoon (lot number: EW0170) as 2nd DOSE, SINGLE for COVID-19 immunization, patient did not have choice for getting COVID-19 vaccine as it was mandatory for school. She did not want to get it but, she did what she had to do. Relevant medical history includes blood pressure measurement (unspecified), cholesterol, dyspepsia/heartburn, and Gastrooesophageal reflux disease (GERD) from unspecified dates. Everyone in her family that she knows did not have much many problems at all like she did. Concomitant medications included amlodipine taken for blood pressure measurement (unspecified) from an unspecified start date and ongoing at 5 mg per tablet, by mouth, once daily; pravastatin taken for cholesterol from an unspecified start date and ongoing at 20 mg per tablet, once at night, by mouth; esomeprazole magnesium (NEXUM) taken for dyspepsia/heartburn and GERD from an unspecified start date and ongoing at 40 mg per capsule, by mouth, once a day. No additional vaccines was administered on the same date as Pfizer suspect. Patient historically received first dose of BNT162B2 (Lot number: ER8734) on 20Apr2021 for COVID-19 immunization and experienced soreness at her injection site/arm would be sore, arm was also bruised and swollen, headache, tired, fever, and muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking. Patient reported that she had her 2nd shot yesterday and had a crazy reaction. After talking to her Pharmacist, he recommended that she should call Pfizer to see if this was something that she should report. Patient reported that after the second injection on 11May2021, she had arm soreness in her left arm but, it was in the opposite arm she got the injection. It was really strange. After her first shot her arm was killing her, it got swollen and it was bruised. That same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose. It was the craziest thing she knew her arm would be sore after the shot but, not the opposite arm. For the first dose, patient had soreness at her injection site after the 1st injection. Arm was also bruised and swollen. Left arm: She got it 12 in the afternoon but, the stuff showed up 5-6 hours later, nothing right away. It was the same yesterday with her shot, she was ok and about 6-7 hours after is started bothering her. She got the 1st injection on 20Apr2021. She knew her arm would be sore. She checked off everything on her a list she got from the pharmacy; she had fever, her muscles were sore enough where she had a difficult time walking, her arm was sore after the first shot. She figured after the second shot the arm she got the shot in would be sore but, it was the opposite arm. It was improved but it started happening again after the 2nd shot. She reported that she couldn't sleep last night, it hurt, every time she rolled over on it and she saw stars.  Outcome: She reports its about the same, she is not leaning on it but, it was sore and swollen yesterday. The swelling is down a little bit today. Patient doesn't know if the antibodies gravitated to that arm or what. Patient reported that she had headache, was tired, muscle soreness to where she couldn't even walk that happened after her first shot on 20Apr2021 was improved but some started happening again after the 2nd shot. She did not have a fever after the 2nd dose but, had a headache, chills, she was very cold and arm soreness in the left arm. She mentioned that she had a hard time with both of the shots, she is glad Pfizer only has 2. She is still doing things still, she is a little sore today it may be a few more days until it clears up. Patient thought she would switch up the arm for the 2nd dose as to not agitate it but, she ended up doing it anyway, agitating the arm of the 1st dose injection. No treatment was sought. The AEs did not require a visit to emergency room or physician office. The outcome of the event swollen was recovering, for arm soreness in her left arm/same arm is sore after the 2nd shot and she did not even get the shot in that arm for the 2nd dose it was not recovered, while for the other events, it was unknown.; Sender's Comments: Based on temporal relation and available clinical data, a causal relation between the reported events and vaccination with BNT162B2 cannot be excluded.  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.