Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021  for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered.  Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely 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.