Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose, Product preparation error, SARS-CoV-2 test
Clinical narrative: the patient had the Johnson and Johnson covid vaccine prior to this dose; the patient had the Johnson and Johnson covid vaccine prior to this dose; dministrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; dministrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; Headache; Nausea; vaccine overdose of chronic cough; various unspecified problems; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 61 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 13Jan2022 (Lot number: 33130BA, Expiration Date: Feb2022) at the age of 61 years as dose 2 (booster), 1.8 ml, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Johnson and johnson covid vaccine (1st dose), administration date: Mar2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 13Jan2022, outcome "unknown" and all described as "the patient had the Johnson and Johnson covid vaccine prior to this dose"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 13Jan2022, outcome "unknown" and all described as "dministrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose"; HEADACHE (non-serious) with onset 2022, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 2022, outcome "not recovered", described as "Nausea"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "vaccine overdose of chronic cough"; ADVERSE EVENT (non-serious) with onset 2022, outcome "not recovered", described as "various unspecified problems". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of overdose, headache, nausea, cough, adverse event.  Additional Information: The caller had a pharmacist administer 1 vial of the medication to three patients, so each patient received a full vial of the vaccine that was undiluted. Per the previous agent this was the patient's booster dose, but the patient had the Johnson and Johnson COVID vaccine prior to this dose so she was unsure how many COVID vaccines the patient has received. Patient was not received other products. Investigation Assessment: Unknown. The pharmacist reported that the patient was still complaining of headache and nausea and various unspecified problems that are not resolved and keeps coming back to report the issues. Phone out 4:20pm: call answered by pharmacist who provided an update. The Patient came to pharmacy for prescriptions of the antibiotic Doxycycline hyclate 100mg, Spiriva inhaler, and Promethazine w/ codeine to treat adverse events attributed to the vaccine overdose of chronic cough. The patient also took a rapid covid test at the pharmacy on 21Feb2022 and was negative. Narrative: Phone-out 11:44 am to reporter for week 7 of 5xOD phone call follow-up. Phone answered by the reporter who stated that patient has not contacted them and so no new information to report.  No follow-up attempts are possible. No further information is expected.  Follow-up (16Feb2022): This is a spontaneous follow-up report from a contactable consumer. This consumer (pharmacy clerk) reported in response to via telephonic follow-up activity that included: New reporter, vaccination facility information, new events (Headache, nausea and various unspecified problems) and patient age at time of vaccination (61-year-old) were added.  Follow-up attempts are completed. No further information is expected.  Follow-up (24Feb2022): This is a follow up spontaneous report from a contactable pharmacist. This pharmacist reported in response to HCP telephonic follow up activity which included that: Updated information included the following: Treatment received, event and lab data was added.   Follow-up attempts are completed. No further information is expected.  Follow-up (02Mar2022): This is a spontaneous follow-up report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent which included that: Updated information included the following: Institution name updated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200064592 same reporter/drug, different patient/ event.;US-PFIZER INC-202200065430 same reporter/drug, different patient/ event.