graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient’s relevant medical history included: “asthma attacks”, start date: 2019 (unspecified if ongoing); “throwing up” (unspecified if ongoing). The patient’s concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): “asthma attack”; Metoprolol for blood pressure, reaction(s): “phlegm”; Metoprolol for blood pressure, reaction(s): “spasms”; Metoprolol for blood pressure, reaction(s): “vasomotor reaction”. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): “had pain in her arms”, “she also felt sick like had the flu for about 24 hours”. The following information was reported: GRAVES’ DISEASE (medically significant), outcome “unknown”, described as “graves”; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome “unknown”, described as “thyroid eye disease”; PAIN IN EXTREMITY (non-serious), outcome “unknown”, described as “had pain in her arms”; INFLUENZA LIKE ILLNESS (non-serious), outcome “unknown”, described as “she also felt sick like had the flu for about 24 hours”; EYE PAIN (non-serious), outcome “unknown”; EAR PAIN (non-serious), outcome “unknown”; DRY EYE (non-serious), outcome “unknown”; OCULAR DISCOMFORT (non-serious), outcome “unknown”, described as “EYE PRESSURE”; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome “unknown”, described as “the first was done on 31Jul2021/the second dose was on 13Aug2021”. The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves’ disease (methimazole).; Sender’s Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;

Deep vein thrombosis; Blood clot in lungs; pneumonia; Type 2 Diabetic, borderline Type 1; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (hospitalization), outcome “unknown”, described as “Blood clot in lungs”; DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome “unknown”; PNEUMONIA (medically significant), outcome “unknown”; TYPE 2 DIABETES MELLITUS (medically significant), outcome “not recovered”, described as “Type 2 Diabetic, borderline Type 1”. The patient was hospitalized for pulmonary thrombosis (hospitalization duration: 11 day(s)). The patient underwent the following laboratory tests and procedures: lab: Unknown results. Therapeutic measures were taken as a result of pulmonary thrombosis, deep vein thrombosis. Clinical course: Patient who received the latest Comirnaty vaccine. He is having side effects that he was calling to report and wanted to speak to someone about that. After transfer clarified it’s been a while since had the vaccine, but saw a published list of side effects and have couple those wanted to discuss. Clarified side effects she experienced as having deep vein thrombosis and had blood clots in lungs. Deep Vein Thrombosis, he explained he is on blood thinners to keep it from happening. Blood Clot in Lungs, confirmed he thinks itis gone. They pumped him with anticoagulants while in the hospital. He was in the hospital for 11 days due to this. He also added, now he is a Type 2 Diabetic, borderline Type 1 and he was not a diabetic before. He is on a lot of medication. Outcome is unable to provide, stated he is still holding on. He has to watch what he eats and take medication. Treatment: He clarified later the blood thinner as, Eliquis- 2.5mg twice a day, tablet, by mouth. He also clarified, the diabetic medication as Jardiance, dosage unknown and, Rybelsus dosage unknown. He confirmed this was the only Pfizer Comirnaty Vaccine he received. He added that he had pneumonia several times after receiving the vaccine. This occurred months after experiencing deep vein thrombosis and blood clot in lungs. However, does not know the dates to provide. He was hospitalized for a week(as reported). He had labs done during this time, but no further details provided. Prior Vaccinations (within 4 weeks): None. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.

hospitalization due to COVID/she is getting over COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (hospitalization due to COVID/she is getting over COVID) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy to chemicals (Allergy to polysorbate). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalization due to COVID/she is getting over COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (hospitalization due to COVID/she is getting over COVID) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. The patient’s age was reported to be over 65 years. No concomitant medications were reported. The reporter stated that the patient had specifically asked for Moderna as she was getting over COVID. The reporter stated that she ended up in hospital. The reporter believed the patient previously received a dose of Moderna since the patient had specifically asked for Moderna. The patient had an allergy to polysorbate and could not receive several vaccines. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter’s Comments: The benefit -risk relationship of product is not affected by this report.

Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Patient’s past medical history included: Hemangioma, Splenectomy, Migraines Patient’s concurrent condition included: Anaphylactic reaction due to food additives, subsequent encounter, Allergic urticaria, Allergy to milk products, Allergy to seafood, Allergy to other foods,Allergy to carrageenan, Allergy to Polysorbate 80,Hemangioma of right eyelid,Cavernoma in hypothalamus, Environmental allergies, Allergy to birch, Allergy to Timothy grass,Allergy to red Oak, Allergy to hickory,Allergy to red cedar tree, Allergy to Johnson grass, Allergy to dogs, Allergy to cats, Allergy to mice,Oral allergy syndrome,Allergy to Sulfa, Allergy to Penicillin, Headaches. Patient’s concomitant medication included: pneumonia vaccine, Meningitis vaccine, PNEUMOVAX,ZYRTEC [CETIRIZINE HYDROCHLORIDE], Allegra, Pepcid, PROPRANOLOL,TYLENOL,IBUPROFEN, Polysorbate 80. The patient’s past medical history included Hemangioma, Anaphylactic shock due to food additives, Eyelid hemangioma, Cavernoma, Headache and Splenectomy. Concurrent medical conditions included Migraine, Allergic urticaria, Seafood allergy, Environmental allergy, Oral allergy syndrome, Penicillin allergy, Allergy to plants (Allergy to red Oak), Allergy to animals (Allergy to dogs), Food allergy (Allergy to other foods), Sulfonamide allergy, Grass allergy (Allergy to Timothy grass), Drug allergy (Allergy to Polysorbate 80), Allergy to animals (Allergy to cats), Allergy to animals (Allergy to mice), Grass allergy (Allergy to Johnson grass), Allergy to plants (Allergy to birch), Allergy to plants (Allergy to red cedar tree), Allergy to plants (Allergy to hickory), Food allergy (allergic to carrageenan) and Hives. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, POLYSORBATE 80, Pneumococcal vaccine polysacch 23v (PNEUMOVAX), PROPRANOLOL, Paracetamol (TYLENOL) and IBUPROFEN for an unknown indication. In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. On -NOV-2023, patient started therapy with Moderna COVID vaccine. Patient stated that she went to get the 2023 Moderna COVID vaccine at Pharmacy and the Polysorbate 80 within the vaccine gave her hives. Patient stated that she took Benadryl, and the hives resolved about 2 days later. This case was linked to US-MODERNATX, INC.-MOD-2025-781748 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2025: Live Follow-up – No New Information accepted; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781748:case for everybody

gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix); she is 43 and I gave her a Dtap Polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 13-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Boostrix. On 13-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix)) and inappropriate age at vaccine administration (Verbatim: she is 43 and I gave her a Dtap Polio). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JAN-2025 The nurse gave a Dtap Polio (Kinrix) instead of a Tdap (Boostrix) to adult patient, she was 43 which led to wrong vaccine administered and inappropriate age at vaccine administration. The nurse was told to call GlaxoSmithKline and get your recommendations on revaccination. The Vaccine Administration Facility was the same as Primary Reporter.

tinnitus; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. In DEC-2024, 2 months after receiving Shingrix, the patient experienced tinnitus (Verbatim: tinnitus). The outcome of the tinnitus was unknown. It was unknown if the reporter considered the tinnitus to be related to Shingrix. It was unknown if the company considered the tinnitus to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 Patient DOB (date of birth) and initials were not available. The patient developed tinnitus 2 months after receiving the Shingrix.

Fatigue; Headache; not feeling too good; Extreme dizziness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5J959, expiry date 25-OCT-2025) for prophylaxis. On 27-DEC-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headache), feeling bad (Verbatim: not feeling too good) and dizziness (Verbatim: Extreme dizziness). The outcome of the fatigue, headache, feeling bad and dizziness were not resolved. It was unknown if the reporter considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy. It was unknown if the company considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy. Additional Information: GSK Receipt Date: 03-JAN-2025 Pharmacist reported that he/she had a patient here who received the Arexvy vaccine a week ago from today, last Friday. They did experienced some side effects like fatigue, headache and not feeling too good, extremely dizzy and they were still experienced those side effects on the day of reporting. Consented to follow up.

Maladministration of Engerix-B after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-month-old male patient who received HBV (Engerix B Junior) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis. On 03-JAN-2025, the patient received Engerix B Junior. On 03-JAN-2025, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B after the expiration date). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JAN-2025 Certified medical assistant called to report the maladministration of an expired dose of an Engerix-B 10 micrograms dose to a patient just a few days after the expiration date, which led to an expired vaccine used. The reporter needs an advice on what to do with the patient. The vaccine administration facility was the same as primary reporter.

Patient received the first dose on December 19th 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old male patient who received HAV (Havrix) (batch number C24B9, expiry date 06-MAY-2026) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX). On 02-JAN-2025, the patient received Havrix. On 02-JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received the first dose on December 19th 2024). The outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 03-JAN-2025 Reporter stated that a patient were not transferred to the system and patient ended up receiving a dose of Pediarix, Priorix, Hiberix and Havrix on 02-JAN-2024. Later patient’s mother provided the immunization records and it was realized that extra doses were administered. Patient received the first dose on 19-DEC-2024. Male patient, 2 years and 2 months old. Patient received booster dose within a month which led to shortening of vaccination schedule. For another vaccines received by patient please refer US2025000647, US2025000645 and US2025000650.; Sender’s Comments: US-GSK-US2025000647:Same patient US-GSK-US2025000645:Same patient US-GSK-US2025000650:Same patient

received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. Previously administered products included Arexvy (received 1st dose in 2023). On 26-DEC-2024, the patient received the 2nd dose of Arexvy. On 26-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 03-JAN-2025 The patient received Arexvy twice, which led to an extra dose administered.