Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Immunisation, Off label use, Overdose, Pain
Clinical narrative: Fever; Body aches; 3rd dose on 23Sep2021; 3rd dose on 23Sep2021; Received dose that was not diluted; This is a spontaneous report received from a contactable consumer (patient himself) from a Pfizer-sponsored program. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: 301358A, Expiration date: 14Oct2021), via an unspecified route of administration in arm right on 23Sep2021 at 14:00 (at the age of 52-years-old) as a dose 3 (booster), single for COVID-19 immunization. The family medical history relevant to AE(s) was reported as none. The patient's medical history (including any illness at time of vaccination) included ongoing diabetes, diagnosed about 15 years ago. The patient's concomitant medications included ongoing losartan, 100 mg, 1x/day, taken for Blood pressure high and ongoing omeprazole (PRILOSEC), once daily, taken for heartburn, takes the over the counter product. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, NDC/Expiry date was unknown), via an unspecified route of administration on 19Jan2021 (at the age of 51-years-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3302, NDC/Expiry date was unknown), via an unspecified route of administration on 05Feb2021 (at the age of 51-years-old) as a dose 2, single for COVID-19 immunization and the patient had a fever with the 2nd dose. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was reported as none. The AE(s) following prior vaccinations was reported as none. It was reported that, warm transfer from (withheld) transferring agent stated that, the reporter received his booster of the Pfizer Covid vaccine last Thursday. Stated that, he only had 2 days of fever and that was pretty much it, but the pharmacy called him and said that they didn't dilute the vaccine before they gave it to him. Stated that, he was called to ask whether there was anything that they recommend or that he should watch out for. Stated that, the agent provided reporter with phone number. Stated that, reporter was told by the pharmacy that they contacted the regulatory authority. The reporter verified the contact information provided by the transferring agent. Clarified that, he really didn't had any questions. Stated that, the pharmacy told him that they contacted the regulatory authority and filed a report with them about what happened. Stated that, he contacted his doctor and was told not to worry, but if he began to had any severe side effects or difficulty breathing to go to the emergency room. Stated that, on 23Sep2021, he only had body aches and fever, which are expected side effects and they only lasted 2 days. He also had a fever with the 2nd dose, which he received on 05Feb2021. Stated that, the main reason for his call was because his sister thought they might want to know about this and may want a blood sample from him. Stated that, he didn't know whether the company received reports from the regulatory authority. Stated that, otherwise, he played golf this weekend and feels good, he feels like the most protected man on the planet right now. Stated that, the fever and body aches began the day he received the vaccine. On Friday night, around 11pm, he woke up in a pool of sweat and his fever had broken, but he was still achy and sore, but by Saturday morning he felt fine. Stated that, he received the first 2 doses of the vaccine so early because at that time he was married to a cancer patient, they were going through a divorce now. Stated that, he received the booster, 3rd dose on 23Sep2021 because he was diabetic, 52-years-old and works with the public. Stated that, he looked it up online after he spoke with the pharmacy and it has happened before just not a lot, when people got their first round of vaccines. Stated that, this pharmacy had never given out the Pfizer vaccine before, they had always had only the Moderna one. Stated that, he was their very first Pfizer dose ever, so the person that gave him the vaccine didn't realize she was supposed to dilute it, but they know now. Stated that, the patient received dose that was not diluted on 23Sep2021. The reporter seriousness for the events was reported as unspecified. The events did not result in emergency room and physician office, stated that, called the doctor, but was told not to worry. On 23Sep2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as unknown result. The outcome of the events for fever and body aches was recovered on 25Sep2021 while for the events was unknown.  Follow-up attempts are completed. No further information is expected.