Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) along with his wife reported that: A 73-years-old male patient received bnt162b2 second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date in Feb2021 (at the age of 73-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included ongoing type 2 diabetes mellitus, ongoing chronic obstructive pulmonary disease, ongoing renal disorder Kidney disease. And hypersensitivity from an unknown date and unknown if ongoing last time patient was tested for allergies patient had 3 pages, 2 columns of allergies. The patient family medical history (wife) included type 2 diabetes mellitus, ongoing chronic obstructive pulmonary disease, ongoing renal disorder kidney disease. The patient's concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in 2021, the patient experienced first day after second shot patient had a small patch of rash around the injection site and two days after the second shot patient had a bright red kind of bumpy rash that went from the should down to the elbow. It was reported that patient was inquiring if you are offering Covid-19 Booster vaccinations for individuals with diabetes, COPD, kidney disease. Patient wife and he have these conditions were fully vaccinated since February. They was in the process of discussing with their physician whether to get an assay of current antibodies present as a result of vaccination in order to determine if they need further boosting of the protection. Callback placed 29Jul2021 1:52PM ET- Spoke from attached FAQ-the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized. First day after second shot patient had a small patch of rash around the injection site and two days after the second shot patient had a bright red kind of bumpy rash that went from the should down to the elbow. This lasted for 11 days. Patient talked to the pharmacist and they said yea it was the vaccine. The last time patient was tested for allergies he had 3 pages, 2 columns of allergies. In the beginning they were going to wait and see where it goes and then we quickly changed to they were getting. The rash was something he could live with. patient had what was called COVID arm and it occurs in 0.3% of people. patient wanted to know if I had a reaction to the second dose does that mean he will have a reaction to the booster. Response: Stated if the booster dose is authorized for use by the FDA they would provide what percentage of participants experienced adverse events after the dose. Also state per the attached document that we did see more side effects after the second dose than the first dose. Everyone reacts differently to the vaccine so it would be hard to say if you would have a reaction or not. Has Pfizer provided a statement on the need for a booster dose (3rd dose). Is Pfizer investigating the need for a booster dose. Have you done any clinical trial with the booster. Stated there was a booster dose being studied in clinical trials per the attached FAQ and the Pfizer update at (withheld). My husband and I both have type 2 diabetes and we both have some other issues. Diabetes effect so many systems of the body, do you have any idea of or studies if diabetes would effect the efficacy of the vaccine. Spoke from PI table 7 Diabetes (Type 1, Type 2 or gestational) was a comorbidity included in the clinical trial study and were also included in the participants that were tested and found to have 95% efficacy. The outcome of events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.