Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Pain, Pyrexia
Clinical narrative: fever (low grade); fatigue; body aches; COVID-19 bivalent booster; accidently was given 2 doses; This is a spontaneous report received from contactable reporter (Other HCP and Nurse) from medical information team, Program ID:   A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (batch/lot number: GH9703) at the age of 69 years intramuscular, in arm for covid-19 immunization. The patient's relevant medical history included: "reflux (acid)" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (ongoing); "allergic rhinitis" (ongoing); "osteopenia" (ongoing); "vitamin D deficiency" (ongoing); "arthritis" (unspecified if ongoing); "essential hypertension" (ongoing). Concomitant medications included: ALBUTEROL SULFATE HFA oral taken for bronchitis (ongoing); BIOTIN oral taken for supplement (ongoing); FAMOTIDINE oral taken for reflux/GERD (ongoing); OMEPRAZOLE oral taken for reflux/GERD (ongoing); VITAMIN B12 [CYANOCOBALAMIN] oral taken for supplement (ongoing); VITAMIN D3 oral taken for supplement (ongoing); LORATADINE oral taken for hypertension, allergic rhinitis (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing); BISOPROLOL /HCTZ oral taken for HTN (ongoing); LISINOPRIL oral taken for GERD (ongoing); MAGNESIUM GLYCINATE oral (ongoing). Vaccination history included: BNT162b2 (dose 1, batch/lot number EN6198, route of administration intramuscular), administration date: 25Feb2021, when the patient was 67-year-old, for COVID-19 immunization, reactions: "fatigue", "body aches", "low grade fever"; BNT162b2 (dose 2, batch/lot number EN6207, route of administration intramuscular), administration date: 18Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reactions: "fatigue", "body aches", "low grade fever"; BNT162b2 (dose 3, batch/lot number FF8841), administration date: 28Sep2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (dose 4, batch/lot number unknown), route of administration intramuscular, anatomical site of injection one dose each arm), administration date: 03Mar2022, when the patient was 68-year-old, for Covid-19 immunization, reaction: "received 2 doses of this vaccine at the same visit"; flu vaccine high dose 65 + (dose 7, batch/lot number 4T7729CA, route IM, anatomical site of injection, L deltoid, at least 6 previous doses, administration date: 10Jun2022, when the patient was 69-year-old, for immunization; flu vaccine (dose 1), for immunization; flu vaccine (dose 2), for immunization; flu vaccine (dose 3), for immunization; flu vaccine (dose 4), for immunization; flu vaccine (dose 5), for immunization; flu vaccine (dose 6), for immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 29Sep2022, outcome "unknown", described as "COVID-19 bivalent booster; accidently was given 2 doses"; PYREXIA (non-serious), outcome "unknown", described as "fever (low grade)"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".   Additional information: The historical vaccine dose 4 batch/lot number was also reported "GH9703" (for further clarification). An agent stated she had an HCP on the line calling about the COVID-19 bivalent booster. It was reported that a patient accidently was given 2 doses. The patient was coming in for the flu vaccine and the COVID-19 bivalent booster but the bivalent booster was accidentally given twice. The patient and spouse came into clinic for seasonal flu vaccine and COVID Pfizer booster vaccine. The nursing staff prepared vaccines for both patient and spouse. All vaccines were in the same transport tray. The nursing staff administered COVID vaccine and flu vaccine. The nursing staff noted giving 2 COVID booster vaccines to the patient in error instead of 1 COVID booster and one seasonal flu booster. The patient provided information regarding the adverse event with the use of product. The Pfizer product had no causal effect to the adverse event. The patient was still taking medication move free ultra-joint health, was used as oral supplement. The reporter informed that albuterol sulfate was administered through inhalation route. The reporter informed that no lab test was conducted. The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient received move free joint health for arthritis. On 28Feb2023, the nurse informed that the patient did provide information regarding the reported adverse events with the use of the product. The nurse informed that the patient experienced fever (low grade), fatigue and body aches. The nurse did not consider the events mentioned above had a causal effect with the Pfizer product. The reporter informed that the patient and her spouse came to office for COVID booster and seasonal flu vaccine, administering nurse drew up vaccine for both persons (4 syringes). The nurse gave her (patient) 2 vaccines. The nurse went to give spouse his flu and COVID vaccines. The nurse saw she had two syringes of flu vaccine on tray. The nurse informed that the patient was informed of the error and got a COVID vaccine for spouse; gave him vaccines as requested. The patient returned to office two weeks later for her flu vaccine.  Follow-up attempts are completed. No further information is expected.  Follow-up (04Nov2022): This is a spontaneous follow up report received from a contactable other HCP. This other HCP reported for the patient in response to HCP letter sent via follow-up letter which included that: Updated information included: Patient information (historical vaccine details updated and relevant medical history details added); Suspect product information (dose description details updated and vaccine facility information updated); Concomitant drugs added; event information (event onset time added, outcome, treatment and physician office visit details updated as reported). Additional information updated with clinical course of event.  Follow-up attempts are completed. No further information is expected.  Follow-up (19Dec2022): This is a spontaneous follow-up report from a contactable Other-HCP. This Other-HCP reported in response to HCP letter sent in cross referenced case which included that: Updated information: Patient details, concomitant drugs were added, event details were added.  Follow-up (15Feb2023): Follow-up attempts are completed. No further information is expected.  Follow-up (28Feb2023): This is a spontaneous follow-up report received from a contactable Nurse. This Nurse reported in response to HCP letter sent. Updated Information included: reporter information, historical vaccine data, relevant medical history data, concomitant drug data, course of events (COVID-19 bivalent booster; accidently was given 2 doses), reaction data (fever (low grade), fatigue, "body ache"), causality.; Sender's Comments: A contributory role of BNT162B2 to the events low grade fever, fatigue and body ache is possible based on presumed temporal relationship and product profile. Case will be reassessed if additional information becomes available. Linked Report(s): PFIZER INC-202201196125 same patient, different dose/event; PFIZER INC-202201196124 same patient, different dose/event;PFIZER INC-PV202200129754 same patient, different dose/event;