Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Pain, Pyrexia, Vaccination site pain
Clinical narrative: sore injection site; Fatigue; body aches; fever; Received the contents of a full vial instead of just one dose/inadvertently given 2ml (whole reconstituted vial) of the 0.3ml recommended dose of this vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Dec2021 13:30 (Lot number: FJ1620) at the age of 54 years as dose 3 (booster), 2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 03Dec2021 13:30, outcome "unknown", described as "Received the contents of a full vial instead of just one dose/inadvertently given 2ml (whole reconstituted vial) of the 0.3ml recommended dose of this vaccine"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "sore injection site"; FATIGUE (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Fatigue"; PAIN (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "body aches"; PYREXIA (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "fever". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, pain, pyrexia.  Additional information: Nurse reported that 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 received the contents of a full vial instead of just one dose. Phone out 3:23pm. 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 did not provide information regarding the reported adverse event with the use of the product. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications)  The lot number for bnt162b2 was not provided and will be requested during follow-up.  Follow-up (07Jan2022): This is a follow up spontaneous report from a contactable other HCP. This Nurse reported in response to HCP letter sent to physician via telephonic follow-up activity which included that: clinical information updated.  The lot number for BNT162B2 was not provided and will be requested during follow-up.  Follow-up (09Feb2022): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP letter sent to other nurse; Updated Information Included: Reporter information (true reporter slider 02), patient information (initials), Patient details (age, age at vaccination), relevant medical history, dosage regimen (dose start/stop time, dose, dose description, lot number, expiration date), vaccine information (anatomical location). vaccination facility information. new event sore injection site, body aches, fever, fatigue and concomitant therapy.  Follow-up (15Feb2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721802 Same reporter/ drug/ event for different patients;US-PFIZER INC-202101724657 Same reporter/ drug/ event for different patients