Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Incorrect dose administered, Injection site pain
Clinical narrative: injection site soreness; slight headache; received the contents of a full vial instead of just one dose; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 61-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Dec2021 12:50 (Lot number: FJ1620) at the age of 61 years as dose 3 (booster), 2 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLINDAMYCIN HYDROCHLORIDE; JARDIANCE; LISINOPRIL; METFORMIN; METFORMIN ER; NOVOLOG; ATORVASTATIN; CIALIS; INSULIN. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 03Dec2021, outcome "unknown", described as "received the contents of a full vial instead of just one dose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; HEADACHE (non-serious), outcome "unknown", described as "slight headache".  Additional information: 3 patients received a booster dose of the Pfizer Biontech Covid 19 vaccine for adults but was given incorrect doses. The product was diluted appropriately, however, each patient received the contents of a full vial instead of just one dose. NDC number and expiry date of Pfizer covid vaccine was unknown. When probed with specific seriousness criteria the caller states that the Medical Provider at the location said that all of the patients were doing okay. Reporter does not have the information of patient's previous doses of the Pfizer Covid Vaccine. Accu Chek Aviva Plus test strips, filled on 29May2020, BD Ultra-Fine short pen needle 31 gauge x 5/16", filled on 30Nov2020, BD Veo insulin syringe ultra-fine 0.3 ml 31 gauge x 5/64", filled on 29May2020, Lantus solostar U-100 insulin 100 unit/ml (3 ml) subcutaneous pen, filled on 09Jan2021, Inject 20 Units under the skin every night, Novolog Flexpen U-100 Insulin apart 100 unit/ ml (3 ml) subcutaneous, filled on 18Mar2021 Inject 5 units under the skin three times daily with meals, Novolog U-100 Insulin apart 100 unit/ ml subcutaneous solution, filled on 26Mar2020. Novolog Flexpen U-100 Insulin apart 100 unit/ ml (3 ml) subcutaneous, filled on 18Mar2021 Inject 5 units under the skin three times daily with meals. Novolog U-100 Insulin apart 100 unit/ ml subcutaneous solution, filled on 26Mar2020. At 3:23pm phone was ringing, and Phone answered by reporter who provided an update. She said they check in with the patient each day and they are doing fine. They have not reported any adverse events to her knowledge. She said her director is out of the country and has not been able to sign off on the follow-up questionnaire we sent them. As soon as he returns, they will send it back to us. She did not want to go through it over the phone or provide additional patient details without the director's approval. Patient was Inadvertently given 2ml (whole reconstituted vial) of the 0.3ml recommended dose of this vaccine. Only reactions that were reported over a 3-day post event were injection site soreness and slight headache. No treatments were needed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow-up.  Follow-up (06Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow up (07Jan2022): This is a follow-up spontaneous report from a contactable Consumer. This Consumer reported in response to HCP letter sent to Physician via telephonic follow-up activities which included that no adverse events was reported.  Follow-up (09Feb2022): New information received from a contactable Other HCP. This Other HCP reported for a patient in response to HCP letter sent that included: Updated Information Included: Dosage Regimen slider#2,  Event slider#2 and slider#3 and additional information added.  Pfizer product had a causal effect to the adverse event reported as none.