Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Gene mutation identification test, Headache, Infection, Pyrexia
Clinical narrative: She developed a red spot around the injection site a day or two later; It is warm with some discoloration around the area; Fever; Headache; Almost sounded like infection to me; The one spot felt warm like a sunburn; It is warm with some discoloration around the area; The other part of her arm felt clammy; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot number was not reported) via an unspecified route of administration at arm left on 10Aug2021 (at the age of 40-years-old)as a single dose for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Historical Vaccine BNT162B2 solution for injection, dose 1 (Batch/Lot number was not reported) via an unspecified route of administration at arm left on 21Jul2021 as a single dose for COVID-19 immunisation. Per reporter his wife and daughter received their Pfizer Covid 19 Vaccine two days early. Reporter reached out to the vaccination provider to ask if he could receive his Pfizer Covid 19 Vaccine one day early. Provider declined the request. Reporter asking if he can receive his second dose of the Pfizer Covid 19 Vaccine one day early due to his schedule. Reporter mentioned that he would like to take aspirin after receiving his second Pfizer Covid 19 Vaccine?. Reporter: Per reporter he takes a medication that kind of thins his blood. Reporter asked why was the following mentioned in the Fact Sheet?. Tell the vaccination provider about all of your medical conditions, including if you have a bleeding disorder or are on a blood thinner. Spoke from the attached document. When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine should only be administered as an intramuscular injection. Per reporter after his wife received her Pfizer Covid 19 Vaccine she developed "a red spot around the injection site a day or two later. It's warm with some discoloration around the area. Almost sounded like infection to me. It's not a perfect circle. The other part of her arm felt clammy. The one spot felt warm like a sunburn. She had a fever the night of the vaccine. That has broken and has been under control. She also had a headache." Reporter asked if symptoms have been reported? Spoke from the PI under "Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: injection site redness fever headache." LAB-Withheld Revised: 12Aug2021. Spoke from the attached document VR-Consumer Inquiry Management (Off-Label or No Info) in response to the question feeling warm. LAB-Withheld Revised: 12Aug2021. Reason for no lot number: of COVID vaccine: Complainant does not have the product with them at the time of call. His wife received the second COVID vaccine and developed a red spot that was warm to the touch a day or two after the vaccine. She had discoloration around the area. It was in the arm she received the injection in. He called asking if it had been reported it. It reminded him of a sunburn area. She also ran a fever the night after that, but it broke and has been under control since then. The reporter reporter confirmed the details provided by the transferring agent. He doesn't remember if the healthcare provider is a doctor or a NP. The doctor is unaware of this though. The office is 45 minutes away. He doesn't know the doctor's information at this time. She just got the second shot Tuesday 10Aug2021. The red spot started 11Aug2021. It was still there today/ He doesn't know if it has improved or not. She sent him a picture of it. It is a good portion of her upper shoulder where she got the shot in her left arm. It is probably 4 in by 3in. Her first dose was 21Jul2021. He thinks she got that one in her left arm. For treatment she rested and took aspirin and Tylenol. The fever broke. He thinks the fever was the night of 11Aug2021. Overall, she was improving but feels out of it. She went to work today. She has had genetic testing done. She has one copy of the hemochromatosis genes. He has two copies. They also found a gene they are investigating for cancer, but she doesn't have cancer. They are just following up over the years. Verbatim and Event Description: Swap from FC reporter wants to receive the 2nd dose of Covid vaccine 1 day early since it's the only option his schedule will allow, but vaccination providers have declined offering that. Reporter wife and daughter were given their 2nd dose 2 days early so reporter wants to know what the issue was. Read ISI Transferred to PMI Withheld CEP Withheld. The patient underwent lab tests and procedures which included gene mutation identification test has one copy of the hemochromatosis genes on an unspecified date they also found a gene they are investigating for cancer, but she doesn't have cancer. Outcome of the events was Vaccination site erythema not recovered, skin warm, skin discolouration, skin cold clammy, headache, infection, sunburn was unknown, and other event pyrexia was recovering.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.