headaches; brain fog; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headaches) and BRAIN FOG (brain fog) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (headaches) (seriousness criterion medically significant) and BRAIN FOG (brain fog) (seriousness criterion medically significant). At the time of the report, HEADACHE (headaches) and BRAIN FOG (brain fog) had not resolved. No concomitant medications were reported. It was reported that patient had received the covid vaccine when it came out, the first dose was fine then a month later, received the 2nd shot. It was from a different batch. Patient developed headaches, a terrible brain fog. Patient stated that mid-April will be the 4th year that have suffered with this. Patient would like to know if Moderna would be able to help, or if something to reverse the shot. It also stated that patient was permanently disabled from the Moderna shot and would like to get this head out that Moderna and that vaccine did a job to the patient. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.; Reporter’s Comments: Company comment: The benefit-risk relationship of product is not affected by this report.

slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain; There’s just a slight discomfort when I lift my arm a certain way; I couldn’t move my arm; Arm redness; The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain), LIMB DISCOMFORT (There’s just a slight discomfort when I lift my arm a certain way), HYPOKINESIA (I couldn’t move my arm), ERYTHEMA (Arm redness) and RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080803) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient’s past medical history included COVID-19 in July 2024 and Muscle pain. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Patient received 6 shots since 2019) in September 2023; for Muscle pain: Lipitor. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine and Lipitor. On 05-Jan-2025, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 05-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain). In January 2025, the patient experienced LIMB DISCOMFORT (There’s just a slight discomfort when I lift my arm a certain way), HYPOKINESIA (I couldn’t move my arm), ERYTHEMA (Arm redness), RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) and MYALGIA (muscle pain). In January 2025, ERYTHEMA (Arm redness) and RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) had resolved. At the time of the report, PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain) outcome was unknown, LIMB DISCOMFORT (There’s just a slight discomfort when I lift my arm a certain way) and MYALGIA (muscle pain) had not resolved and HYPOKINESIA (I couldn’t move my arm) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient had slight arm pain would happen within the 24 hour period, but the pain was really intense. The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half. Patient couldn’t move her arm. When lifted it, had excruciating pain. Normally when patient get the shot, move her arm around. Patient didn’t have anything like that with the other 6 shots that received since 2019. And the redness got worse within the weeks’ time. Then it started going down and patient could move the arm little bit. Patient still have a little bit of more like muscle pain. It wasn’t like the injection pain. It was a muscle pain. It was the same kind of pain patient experienced when she was on Lipitor and they increased dosage, the muscle pain, that kind of pain. There’s just a slight discomfort when patient lift up the arm a certain way, but the redness was gone. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-781695 (E2B Linked Report).; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781695:male case

new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,; Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) and ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) in a 46-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Immunisation. Co-suspect products included non-company products Influenza vaccine for Immunisation and Dupilumab (Dupixent) solution for injection for Asthma and Eczema. Concurrent medical conditions included Eczema and Asthma. On 26-Sep-2023, the patient started Dupilumab (Dupixent) (Subcutaneous use) 600 milligram once a day. On 10-Oct-2023, Dupilumab (Dupixent) (Subcutaneous use) dosage was changed to 300 milligram. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2023, the patient experienced BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic). On an unknown date, the patient experienced ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,). In 2023, BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) had resolved. At the time of the report, ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that eczema related symptoms were as severe over the past week just as they were prior to therapy. Physician was aware of it. These severe symptoms continued to be the same since the start of therapy with no reported adverse event. It was unknown if physician was aware of it. The bronchitis was resolved with taking antibiotics. Physician was aware of it.

expired Havrix vaccine was administered; 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 8-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis. On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). 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: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004475, reported by the same reporter.; Sender’s Comments: US-GSK-US2025004475:Same reporter/Different patient

given a PRIORIX dose intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 39-year-old female patient who received MMR (Priorix) (batch number 43G92, expiry date 01-MAY-2025) for prophylaxis. On 03-JAN-2025, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: given a PRIORIX dose intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route 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 The Healthcare professional reported that a female patient was given a Priorix dose intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route.

Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.

large knot on my arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced local swelling (Verbatim: large knot on my arm). The outcome of the local swelling was not reported. It was unknown if the reporter considered the local swelling to be related to Shingles vaccine. It was unknown if the company considered the local swelling to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2025 The reporter self-reported this case for himself/herself. The reporter need to know after getting a shingle shot it has left a large knot on my arm. The reporter asked was this normal

Suspected vaccination failure; Shingles again in 2020; I have been diagnosed with Shingles yesterday; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient’s past medical history included shingles. On an unknown date, the patient received Shingrix. On 01-JAN-2025, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: I have been diagnosed with Shingles yesterday). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles again in 2020). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JAN-2025 The patient had received Shingrix vaccine in 2017. She had been diagnosed with Shingles the day before reporting. She had Shingles again in 2020 as well. The patient enquired if the drug was not effective for some people. The patient wonder if there is a booster that would be effective. The patient symptoms were treated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.

Mesenteric vein thrombosis; Mesenteric venous occlusion; This serious case was reported by a consumer via other manufacturer and described the occurrence of mesenteric vein thrombosis in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y) for prophylaxis. Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MF014A) for covid-19 immunization. Previously administered products included Boostrix (First dose received on an unknown date.), Boostrix (Second dose received on an unknown date.) and Boostrix (Third dose received on an unknown date.). Concurrent medical conditions included hepatic disease and drug allergy (Allergy to codeine and erythromycin). Concomitant products included azathioprine, prednisone, furosemide (Lasix) and spironolactone. On 01-OCT-2024, the patient received the 4th dose of Boostrix (intramuscular) and the 4th dose of NOVAVAX COVID-19 VACCINE (intramuscular). On 02-DEC-2024, 62 days after receiving Boostrix, the patient experienced mesenteric vein thrombosis (Verbatim: Mesenteric vein thrombosis) (serious criteria disability and GSK medically significant) and occlusion mesenteric vein (Verbatim: Mesenteric venous occlusion) (serious criteria disability). The outcome of the mesenteric vein thrombosis and occlusion mesenteric vein were not resolved. It was unknown if the reporter considered the mesenteric vein thrombosis and occlusion mesenteric vein to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the mesenteric vein thrombosis and occlusion mesenteric vein to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 13-JAN-2025 On 01-Oct-2024, the patient received dose 4 of Boostrix and dose 4 of Novavax. It was reported as the patient was not sure if she had the right kind of Tdap listed. her chart showed Tdap-adol/adult-Lot # X449Y. The reaction she believed was to the COVID vaccine. she received imaging several times a year to monitor her liver disease. On 26 September 2024, the ultrasound report showed color doppler imaging demonstrated no portal vein thrombus. Then when she went to visit another clinic on 02 December 2024, the CT scan revealed complete occlusion of the cephalic end of the superior mesenteric vein. For the portal vein thrombosis to go from small to non existent to total clot in the superior mesenteric vein in not even 3 months time did not seem to be a coincidence. The reporter’s causality assessment between the Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula), and events mesenteric vein thrombosis and mesenteric venous occlusion was captured as possible.; Sender’s Comments: Mesenteric vein thrombosis and Mesenteric venous occlusion are unlisted events which are considered unrelated to GSK vaccine Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE.

No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient’s medical history, concurrent conditions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 22-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/series, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength and route of administration was not provided) inadvertently after suffering from a temperature excursion (Product storage error). Varicella virus vaccine live (oka/merck) (VARIVAX) reached -11.6 degree Celsius but previous excursions for 3 hours 5 minutes. But previous excursions could not be confirmed. No symptomatic adverse events were reported. Lot# and expiration date of the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) were unknown. No additional AE (No adverse event).