Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Poor quality product administered, Product preparation error
Clinical narrative: The vaccine was not diluted when given; The vaccine was not diluted when given/Given 6 times the the normal amount because they didn't dilute the vial; The vaccine was not diluted when given/Given 6 times the the normal amount because they didn't dilute the vial; Arm is feeling sore; not anything extreme; This is a spontaneous report from a contactable consumer (wife, caregiver). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jun2021 at 10:00 (at the age of 63-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Patient medical history included cardiac disorder from 2019 and implantable defibrillator insertion from 2019 both were ongoing. Patient had covid-19 In Sep. Concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO), carvedilol (COREG) ), clopidogrel (CLOPIDOGREL), atorvastatin (LIPITOR [ATORVASTATIN]), all were taken for Heart Disease, Started 2 Years Ago which were Ongoing. Reporter said that, been wanting to get it (vaccine dose) but had to get Echo and tests, got approval from heart doctor yesterday. History of all previous immunization with the Pfizer vaccine considered as suspect was None.Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were None. patient's Medical History (including any illness at time of vaccination)? Heart Disease and Defibrillator Family Medical History Relevant to AE(s) was None. It was reported that, Patient who received the first dose of the Pfizer BioNTech COVID-19 Vaccine today, 29Jun2021", received "6 times than the normal dose". It was reported that, "The vaccine was not diluted when given" according to the reporter. Reporter called the "CDC and they referred her to Pfizer Medical information". Reporter wanted to know if there was any information about patient's experience. Reporter seriousness for the events were Unspecified. Reporter stated that, patient got the shot today, 29Jun2021 at 10:00a.m. and then the pharmacy called about an hour later stating that they accidently gave him 6 times the normal amount because they didn't dilute the vial. patient was already nervous as it was, and he just got a release from his heart doctor yesterday because he has heart issues and a defibrillator, and he took a bunch of heart medications, but he knew it was important and then this happened. Patient's arm was feeling sore, but he is taking it easy not doing much. According to the phamacist that administered the shot, this is not the first time that this has happened, and they only type of reactions known with more dose is severe arm soreness. Patient's arm soreness is not anything extreme. patient had Covid in September and was hospitalized for 4 days. he got plasma, the shot for antibodies in the hospital, and they said he should be good to go, so first thing this morning, he got the shot. Treatment received for the event was None. Events did not require a visit to, Emergency Room or Physician Office. Relevant Tests performed were None. Outcome of the event was unknown.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.