Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscular weakness, Vaccination site pain, Vein disorder
Clinical narrative: Right at the fold of her arm, she can see that her vein is popped out and red, but it is not itchy, it is warm to the touch very slightly and spotted; size of a medium tomato in circumference; Redness on left arm; looks like when babies have Rubella, it is spotted. Caller states it does not look like a typical injection site where it is all reddened, it is a weird redness; it was painful at the injection site and she could feel it radiating; Arm feels weak. Caller states that is ongoing from before but it feels more weak; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 (at the age of 66 years old) as dose 2, single for COVID-19 immunization. Medical history included Asthma, Diabetes, COPD, She was allergic to quite a few things, She was sensitive to medications and some IV meds and a lot of antibiotics. No family Medical History Relevant to AE. The patient's concomitant medications were not reported. No Other Products. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 as dose 1, single for COVID-19 immunization. The patient stated that she went to the urgent care a few weeks ago because she thought she tore her tendon but that was not related. The patient stated that she did not want to take COVID vaccine because on OCP and had a reaction when she young and afraid of blood clots. The patient stated that she called about the booster for the Covid Vaccine she received several hours ago; verified Pfizer Covid Vaccine, second dose. The patient stated that typically she would have assumed a reaction would start at the injection site. The patient stated that adverse event happened within half an hour afterwards. The patient stated that she noticed an hour ago that right at the fold of her arm, she can see that her vein is popped out and red, but it is not itchy, it is warm to the touch very slightly and spotted; size of a medium tomato in circumference. The patient stated that at first it was radiating to just about 5" below the deltoid area, but that has subsided. The patient stated that it was probably the size of a medium tomato in circumference and the area was spotted, but not itchy. The patient stated that it happened when she got her vein drawn or an IV. She noticed it shortly after, but she had been in so much pain herself. She did not felt bad but her vein was protruding. The patient stated that her arm hurts quite a bit. The patient stated that pharmacist, gave her the IM, it was more painful than the last time. She did not wanted to say he did it wrong, but she felt some air and then it was painful at the injection site and she could feel it radiating where the redness was. She stated that the pain in her arm had worsened but the redness just below the deltoid area had improved and then it went to where the redness was and now it was gone in that area but her arm feels weak. She stated that was ongoing from before, but it feels more weak and the injection site was painful. She stated that it looked like when babies have Rubella, it was spotted. She stated that it did not look like a typical injection site where it was all reddened, it was a weird redness. She stated that her arm was beat red, and her arm feels like when they draw blood in the wrong site or area. She stated that her vein in popping out. She stated that it looked like that when she has her blood drawn or an IV in it when it was not done properly, she only had one vein they can draw. She stated that she had no problem the last time. The patient stated that she would say Seriousness Criteria as Medically Significant. The patient stated that something seems not right. The patient stated that she had COPD, but no shortness of breath, and she was not in the best of health, but that did not seem normal, it seems like a weird reaction. She did not recall hitting herself and she was right-handed so she would not have used that left arm. She stated that the redness started above and went to that area. She stated that she was out and about, and she was diabetic, and she had to get her blood sugar up and she was trying to hydrate herself and she took a shower and now she is sitting down. She knew her blood sugar was getting low and she gets goofy and she was on the go and she had to go pick up her grandson and she did not pay attention to it being like that. She had been trying to think if it could be something else, but she cannot think of anything that would make the injection site look like this. The patient stated that she just did not want to occupy a bed in the ER. Adverse event did not require a visit to emergency room/physician office. No Investigation Assessment. Relevant Tests were None. The reporter assessed the seriousness criteria as other medically important condition (medically significant). The clinical outcome of the events right at the fold of her arm, she can see that her vein is popped out and red, but it is not itchy, it is warm to the touch very slightly and spotted; size of a medium tomato in circumference, arm hurts quite a bit; arm pain; pain at injection site/the IM, it was more painful than the last time and she felt some air and then it was painful at the injection site and she could feel it radiating, arm feels weak. caller states that is ongoing from before, but it felt weaker, was not recovered, redness on left arm; looks like when babies have rubella, it is spotted. caller states it does not look like a typical injection site where it is all reddened, it is a weird redness was recovering, at first the redness was radiating to just about 5" below the deltoid area was recovered. The events relatedness to COVID vaccine was unknown.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the events and the suspect drug 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.