Age: 18.0
Sex: F
Vaccine: COVID19, FLUX, MEN, TDAP
Symptoms: Malaise, Off label use, Overdose, Pain in extremity, Product use issue
Clinical narrative: did not want to leave her dorm room for not feeling good; dizziness; but had not been eating since she; Received the whole vial of a multidose vial unintentionally; the patient reported having an immense fever; headache; right arm pain/extreme pain in R arm (where Covid dose was given)/sore arm; intermittent cough; fatigue; She does not usually recommend patient get both Pfizer COVID and the flu vaccine the same day, but the patient wanted it.; Patient also received Influenza, Tdap and MCV4 vaccines at the same time; This is a spontaneous report received from contactable reporter(s) (Nurse and Other HCP) from medical information team, Program ID.  An 18-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 11:30 as dose 4 (booster), 1.8 ml single (Lot number: GH9702, Expiration Date: 30Jun2023) at the age of 18 years, in right deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine (MENINGOCOCCAL VACCINE), on 16Sep2022 as dose 2, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: HEP B VACCINE ADULT CIPLA taken for immunisation, on 15Aug2021 as dose 2, single. Vaccination history included: BNT162b2 (dose 1, single), administration date: 24Aug2021, when the patient was 17-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single), administration date: 28Oct2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "Dose 1: 24Aug2021; Dose 2: 28Oct2021"; BNT162b2 (dose 3, single), administration date: 02May2022, when the patient was 18-year-old, for Covid-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Sep2022 at 11:30, outcome "unknown", described as "Patient also received Influenza, Tdap and MCV4 vaccines at the same time"; OVERDOSE (non-serious) with onset 16Sep2022 at 11:30, outcome "not recovered", described as "Received the whole vial of a multidose vial unintentionally"; OFF LABEL USE (non-serious) with onset 16Sep2022 at 11:30, outcome "unknown", described as "She does not usually recommend patient get both Pfizer COVID and the flu vaccine the same day, but the patient wanted it."; DECREASED APPETITE (non-serious) with onset 16Sep2022 at 11:30, outcome "recovered", described as "but had not been eating since she"; FATIGUE (non-serious) with onset 16Sep2022 at 11:30, outcome "recovered"; HEADACHE (non-serious) with onset 16Sep2022 at 11:30, outcome "recovered"; COUGH (non-serious) with onset 16Sep2022 at 11:30, outcome "recovered", described as "intermittent cough"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2022 at 11:30, outcome "not recovered", described as "right arm pain/extreme pain in R arm (where Covid dose was given)/sore arm"; PYREXIA (non-serious) with onset 16Sep2022 at 11:30, outcome "recovered", described as "the patient reported having an immense fever"; DIZZINESS (non-serious) with onset 17Sep2022, outcome "recovered"; MALAISE (non-serious), outcome "recovered", described as "did not want to leave her dorm room for not feeling good". Therapeutic measures were taken as a result of pyrexia, dizziness, decreased appetite, malaise, headache, pain in extremity, cough, fatigue.  Additional information: Caller was a registered nurse calling about Pfizer COVID 19 gray cap vaccine bivalent. Patient had no other medications in 2 weeks. Patient was unintentionally given full vial (1.8mL) of bivalent vaccine grey cap instead of the intended 0.3mL dose. A patient received a whole vial of Bivalent multi-dose vial, after further information, that the patient received 5 doses and not the 6 doses. The nurse in the office provided vaccines to a patient 4-5 times over the dose. It was one of her Medical Assistants today that did not follow procedure. The Medical assistant had not given a dose before. She had been trained though. Instead of pulling 0.3mL up she pulled up the vial and gave the vial to the patient . It was reported that, contributing factors to the medication error were human error, not following protocol, and a lack of a double check step. Patient also received Influenza, Tdap and MCV4 vaccines on the same day; the nurse does not usually recommend patient get both Pfizer COVID and the flu vaccine the same day, but the patient wanted it. Patient reported fever, extreme pain in R arm (where Covid dose was given), severe headache, fatigue and intermittent coughing x 2 days post vaccination. On Friday 16Sep2022, the day of the overdose event, she spoke with the patient who reported no adverse events yet. However, on Saturday when the nurse checked in again, the patient reported having an immense fever, dizziness (but had not been eating since she did not want to leave her dorm room for not feeling good, so dizziness may be from lack of food), headache, right arm pain, and intermittent cough. The nurse has not spoken to her since but did hear an update, and it is her understanding that the patient was doing better today (on 16Sep2022). Most of the adverse events reported have resolved and the only remaining complaint was the sore arm. Therpeutic meaures included, Tylenol, ice pack for comfort. It was unknown If patient had Covid prior vaccination. But she had not tested Covid post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (16Sep2022) and (19Sep2022): This is a spontaneous follow-up report from a contactable Nurse.  Updated information included: reporter details (new reporter added), relevant medical history, historical vaccine, concomitant medications, suspect dose details, event details, new events of Fever, Dizziness, Appetite lost, Feeling unwell, Headache, Pain in arm, Cough, Fatigue.  Follow up (23Sep2022): This is a spontaneous follow up report from a contactable Nurse.  Updated information included: Expiration date of COVID-19 Vaccine Bivalent vaccine added, products (NFLUENZA VACCINE; MENINGOCOCCAL VACCINE and TDAP) updated from concomitant to suspect products, historical vaccine reaction (Inappropriate schedule of product administration) added, new events (off label use and product use for unapproved combination) added and clinical course updated.