Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: arm she received the injection in was red, swollen and itchy/developed a red rash and swelling at the injection site; arm she received the injection in was red, swollen and itchy/ little itching; developed a red rash and swelling at the injection site/ It has gotten darker and reddish; arm she received the injection in was red, swollen and itchy/developed a red rash and swelling at the injection site/ It has gotten darker and reddish/ red spot; This is spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL1283; Expiration Date: 30Apr2021) via an unspecified route of administration in the arm right on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis, and retirement.  There were no concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. She stated that she received the first dose 9 days ago and then a few days ago (15Jan2021) she noticed that the arm she received the injection in was red, swollen and itchy. She stated that this morning the symptoms had not changed and she took an naproxen sodium (ALEVE) which made all of the symptoms disappear. She said, "it worked like magic." Caller has felt fine. She was thrilled she could get the Pfizer Vaccine. She was 9 days out, and developed a red rash and swelling at the injection site. She wanted to make sure that was okay. She worked in a dialysis center as a social worker. She was retired. She received the Pfizer COVID vaccine. She did not have the HCP information at this time. She was itchy yesterday too. She really wanted to get the second dose. It has gotten darker and reddish from the first time she noticed it. She felt nothing just a little itching. That was why she looked. She hadn't looked until Friday, so that is when she first saw it. Now it kind of looked like it was the same color, but the swelling was down somewhat. A half an hour ago, she took naproxen sodium (ALEVE). She took that to see if it would help. The itching was okay this morning. It did not itch if she did not scratch it. She did not feel it at all this morning since the naproxen sodium. Yesterday, if she scratched it, it would make it worse. It was much worse Saturday and Sunday. If she did not touch it, it won't itch. She got the vaccine in her right arm. The next time, she would ask for it to be administered in her left arm. She got it because she wanted to be safe. She did not want to get sick, and she is dying to see her grandchildren. She felt perfectly fine. It was not itching now. The red spot might have started earlier (Jan2021) than the 15Jan2021, but that was the first time she noticed it. The itching, swelling, and rash were right near the injection site. It was very mild swelling. These events did not require a visit to emergency room or physician office. Treatment received for the events. The outcome of the events vaccination site erythema and vaccination site rash was not recovered, of other remain events was recovering.  She wanted to know if it is okay that she took naproxen sodium after receiving the vaccine. The response is "the interim guidelines note that, antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time. If you are a patient, you should discuss this with your healthcare provider". The patient wanted to know if these symptoms were common this long after receiving the first dose of the vaccine. The response is "let the caller know if the symptoms that she is experiencing do not subside that she should not hesitate to notify her HCP". The patient wanted to know if these symptoms would prevent her from getting the second dose of the vaccine. The response is "reviewed serious allergic reaction symptoms with caller and reiterated that if her symptoms did not go away or became worrisome to not hesitate to contact her HCP as Pfizer could not make a treatment recommendation".