Menveo – 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.

Menveo – 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 5 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.

Menveo – 1 vial was ordered by Physician and given by RN, but is meant for patients aged 10-55 years, and this patient was 8 when she received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.

tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jan2025, outcome “unknown” and all described as “tested positive for covid”. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2025) Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. No follow-up attempts are possible.

Injection site bruising; Feeling abnormal/ out of it/ feeling terrible; Malaise; Nausea; Personality change/ persona began to decline; Vomiting; This serious case was reported by a consumer via other manufacturer and described the occurrence of injection site bruising in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5H1GY99SAY) for prophylaxis. Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis and Influenza vaccine inact sAg 3v (Fluad) (batch number 33T4PAB0B1) for prophylaxis. The patient’s past medical history included chronic obstructive pulmonary disease (COPD) and restless legs syndrome. Concurrent medical conditions included seasonal allergy (possible). Concomitant products included umeclidinium bromide (Incruse Ellipta), pramipexole, potassium chloride and acetylsalicylic acid (Baby Aspirin). On 19-NOV-2024, the patient received Arexvy (intramuscular, left arm), the 1st dose of Novavax COVID-19 Vaccine (intramuscular, left arm) .5 ml and Fluad (intramuscular, right arm). On 21-NOV-2024, 2 days after receiving Arexvy, the patient experienced injection site bruising (Verbatim: Injection site bruising) (serious criteria hospitalization), feeling abnormal (Verbatim: Feeling abnormal/ out of it/ feeling terrible) (serious criteria hospitalization), malaise (Verbatim: Malaise) (serious criteria hospitalization), nausea (Verbatim: Nausea) (serious criteria hospitalization), personality change (Verbatim: Personality change/ persona began to decline) (serious criteria hospitalization) and vomiting (Verbatim: Vomiting) (serious criteria hospitalization). The outcome of the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting were not resolved. It was unknown if the reporter considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be related to Arexvy. The company considered the injection site bruising, feeling abnormal, malaise, nausea, personality change and vomiting to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was vaccinated with Arexvy, Fluad and Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), lot number was reported as JIRJ22I041PQLNM on 19 Nov 2024. On 21-Nov-2024, on 3rd day after vaccination the patient experienced feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting. A discrepancy was identified in the source document where Novavax lot number JIRJ22I041PQLNM was not captured in the structured field as this lot number does not pertain to Novavax. However, this case was processed as confirmed exposure to Nuvaxovid as Novavax was mentioned under the Manufacturer section of the source document. Patient received three vaccines, RSV and covid in left arm and flu in the right arm. On day 1 patient was fine, by day 3 patient had developed a bruise where RSV shot was given and began to feel nausea and out of it. Vomited once, and experienced nausea. Over the course of ten days patient’s persona began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. They had been trying blood tests to try to figure out what has been going on, with no clear diagnosis. The patient had been in hospital since Saturday or Sunday at this point. They were suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. She had been feeling less nauseated, although she was still in hospital under medical care. The bruise had turned to a purple at this point. The event feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was reported as serious. Based on the spontaneous nature of the report, the causal relationship between the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) and feeling abnormal, injection site bruising, malaise, nausea, personality change, and vomiting was considered possible. It was unknown if the reporter considered the feeling abnormal, injection site bruising, malaise, nausea, personality change and vomiting to be related to Fluad.; Sender’s Comments: Malaise and Nausea are listed events which, due to the following criteria (Suspected carbon monoxide excess patient was on a cpap machine and insufficient information provided about the clinical description) are considered unrelated to GSK vaccine Arexvy. Injection site bruising, Feeling abnormal, Personality change and Vomiting are unlisted events which are considered unrelated to GSK vaccine Arexvy.

No additional AE/No symptoms reported; HCP calling regarding GARDASIL-9 dosing schedule for a 13 year old female patient. Caller stated that the third dose was administered a “little after” 6 months.; This spontaneous report was received from a consumer and refers to a 13-year-old female patient. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date and on an unknown date in 2024, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), respectively. On 21-JAN-2025, the patient was vaccinated with the third dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W026152, expiration date: 29-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). Reporter stated that this third dose was administered a “little after” 6 months (Inappropriate schedule of product administration). No symptoms reported. No further information was provided. Lot # is being requested and will be submitted if received.

No adverse event; Nurse calling to report inadvertently administering an expired dose of PNEUMOVAX 23. vaccine expired on 11/22/2024 and was administered on 1/22/2025.; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient’s medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 22-JAN-2025, the patient was inadvertently vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, prefilled syringe, administered for prophylaxis (lot number X014729 has been verified to be a valid number for pneumococcal 23v polysaccharide vaccine [PNEUMOVAX23], expiration date 22-NOV-2024; dose, anatomical site of injection and route of administration were not provided) (Expired product administered). It was reported that the product did not underwent temperature excursion. No additional information or adverse event was reported for the patient.

HCP wanted to know if patient started vaccination series at 14 years of age, if they come in at 15, what is recommended for the series.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (also reported as at 14 years of age), the patient started vaccination series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Healthcare professional (HCP) wanted to know if patient come in at 15, what was recommended for the vaccination series (Inappropriate schedule of product administration). No additional adverse event was reported. Lot # is being requested and will be submitted if received.

Slight Headache; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), since 01Aug2024 (ongoing)) at 300 mg weekly, subcutaneous for asthma. The patient’s relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL; BUDESONIDE; BREO ELLIPTA; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; SPIRIVA; MAGNESIUM OXIDE; VITAMIN D [COLECALCIFEROL]; CALCIUM CARBONATE. The following information was reported: HEADACHE (non-serious), outcome “unknown”, described as “Slight Headache”. The action taken for dupilumab was dosage not changed. Additional information: It was reported that, “the patient asking if okay to inject Dupixent the day after her Covid vaccine. I advised no issue. The patient has a slight headache after getting vaccine. Batch/lot number is not provided, and it cannot be obtained.

treated for gout; my leg still wobble, numb and hurts; my leg still wobble, numb and hurts; vein replacement; instant leg pain; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 67-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient’s relevant medical history included: “A-fib” (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for atrial fibrillation; LISINOPRIL taken for atrial fibrillation; XARELTO taken for atrial fibrillation. Vaccination history included: bnt162b2 (dose 1, single; left arm), administration date: 22Dec2020, when the patient was 65-year-old, for covid-19 immunization; bnt162b2 (dose 2, single; intramuscular; left arm), administration date: 11Jan2021, when the patient was 65-year-old, for covid-19 immunization, reaction(s): “CHF”, “taste/ want my taste back”, “grinding teeth”, “interrupting sleep”, “nauseating”, “kidney damage”, “wobble right leg”; bnt162b2 (dose 3 (booster), single; left arm), administration date: 11Dec2021, when the patient was 66-year-old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome “unknown”, described as “instant leg pain”; VEIN DISORDER (medically significant) with onset Feb2023, outcome “unknown”, described as “vein replacement”; GOUT (non-serious), outcome “unknown”, described as “treated for gout”; HYPOAESTHESIA (non-serious), GAIT DISTURBANCE (non-serious), outcome “unknown” and all described as “my leg still wobble, numb and hurts”. The events “vein replacement”, “instant leg pain”, “treated for gout” and “my leg still wobble, numb and hurts” required physician office visit. Therapeutic measures were taken as a result of vein disorder, pain in extremity, gout, hypoaesthesia, gait disturbance. Clinical course: In Dec2022, the patient had instant leg pain. Treated for gout. In Feb2023, vein replacement, felt ok, but neurologist still cannot figure out why leg still wobble, numb, and hurt. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender’s Comments: Linked Report(s) : US-PFIZER INC-PV202400163246 same patient, different dose/AE;