Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Itching on head, arms, legs, ankle and foot; Fatigue, described as feeling tired with a heavy feeling; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:15 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history included Autoimmune hemolytic anemia from 2003 and ongoing; Mild Thalassemia from 2003 and ongoing; Lupus from around 2006 and ongoing; Dermatomyositis from around 2007 and ongoing. She has had autoimmune issues for years. Concomitant medications included 15 different medications. She had taken the same medication for years. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient did not receive any additional vaccines on same date of the Pfizer Suspect. The patient had no prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. The patient previously received some different medications and had body rashes in the past (many years ago). This included a body rash with Hydroxychoroquine (does not have the NDC, Lot or expiration date); unsure if she got a rash or sores in her mouth with Hydroxychoroquine (PLAQUENIL, does not have the NDC, Lot or expiration date); a rash with Latex (No identifying information provided); had a hot feeling and her skin turned red with Cat Scan dye (does not know the name of the dye or have an NDC, Lot, or expiration date); unsure if caused a rash or sores in her mouth with Azathioprine (does not have an NDC, Lot or expiration date), it happened back in 2004. The patient experienced fatigue, described as feeling tired with a heavy feeling since 27Apr2021 13.00 and itching on head, arms, legs, ankle and foot since 27Apr2021 13.30. On Tuesday (27Apr2021), she went to pharmacy and got her first vaccine at 12:15 pm. All of her doctors recommended her to get the vaccine because she was immunocompromised. She waited at the vaccine site, for 30 minutes, reclarified, because she was high risk and has many autoimmune issues. She felt fatigued and tired, which she thinks is normal. At 2 pm she started to itch, reclarified as on her head, her side, down her leg to her foot, and it was constant, until about 10 pm that night. She had no rash. The itch was gone the next day. The patient reported that, got first shot of the Pfizer on Tuesday but of course, she got the normal fatigue and tiredness afterwards which was fine now. She got it at 12:15 in the afternoon and then at about 1:30 in the afternoon, she started to get itchy like from head to toe and it was like in different spots that had reached her head, reached arm and all over in different spots and it lasted for about 10 hours. She didn't have a rash, she didn't have any hives and she didn't have anything like that. So, she was just like is this, she didn't know if this was a side effect. She had been reading and trying to figure it out but everything kind of leads to a rash and she didn't have one. Patient asked that when she gets the second vaccine, the itch would happen again, or she would have a worse reaction. Patient had spoken to her primary doctor and her rheumatologist, and they both encouraged her to get the second vaccine. Patient states they recommend that she stay at the vaccine site longer for about like one and a half hour later and put the distance, to be monitored. for about like one and a half hour later and put the distance Patient spoke to her Pharmacist and Pharmacist stated the itching was a red flag and recommended that if her doctor wanted her to get the second vaccine, maybe the doctor can order an EpiPen, in case she has a worse reaction. Patient even asked her hematologist if she should get the second vaccine and he agreed that she should. All of her physicians want her to get the second vaccine, and if she has a bad reaction, it can be dealt with at the time. Patient states she has had autoimmune issues for years, and she was cautious. Patient asked if she goes for the second vaccine, she would have a worse reaction. Reclarified, the Patient states her main concern is getting the second vaccine. Patient states she was afraid of getting a bad reaction, versus actually getting the Covid virus. Patient states she has some protection from the virus after getting the first vaccine. Patient was notified that Medical Information and/or Pfizer was unable to provide medical advice but may have resources to help answer some questions. Patient was encouraged, due to her history, to have another conversation with her healthcare provide regarding her concern. AE(s) did not require a visit to Emergency Room or Physician Office. The patient had no relevant tests. Outcome of the event Itching was recovered on 27Apr2021; Fatigue was recovered on 30Apr2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.