had a reaction with Dupixent and the second COVID vaccine / headaches; This is a spontaneous report received from a Consumer or other non HCP from License Party. An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Lot number: 4F483A, Expiration Date: 31Aug2026) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg qow (every other week; strength: 3000mg/2ml)) subcutaneous for dermatitis atopic. The patient’s relevant medical history included: “Arthritis” (ongoing); “Osteoporosis” (ongoing); “D.farinae mite extract” (unspecified if ongoing); “illness” (unspecified if ongoing). Concomitant medication(s) included: PROLIA; METHOTREXATE; ATORVASTATIN CALCIUM; PAXLOVID taken for covid-19 treatment; ALBUTEROL SULFATE HFA; KETOCONAZOLE; INCRUSE ELLIPTA; METOPROLOL SUCCINATE; METHYLPREDNISOLONE. Past drug history included: Bupropion hcl, reaction(s): “Drug allergies: Bupropion”; Wellbutrin sr, reaction(s): “allergic to Wellbutrin SR”. Vaccination history included: Covid-19 vaccine (dose 1; unknown manufacturer), for covid-19 immunization. The following information was reported: HEADACHE (hospitalization), outcome “unknown”, described as “had a reaction with Dupixent and the second COVID vaccine / headaches”. The action taken for dupilumab was unknown. Clinical course: On an unknown date, the patient started taking dupilumab solution for injection at a dose of 300 mg QOW (every other week) subcutaneously with strength of 3000mg/2ml delivered via prefilled pen for dermatitis atopic. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur. Reportedly, patient had a reaction with DUPIXENT and the second covid vaccine that put her in the hospital (adverse drug reaction; onset and latency: unknown). She had an injection of methylprednisone yesterday and she was aware that there’s drug interactions between that and the Prolia. She was also prescribed methotrexate and it’s concerned about drug interaction as well. Patient Prolia therapy stated she did not want to take anymore. Stated she was not fully informed by her doctor of the side effects of the Prolia also concerned with drug interactions she has read online about. Stated the Prolia caused joint pain, and she already had arthritis. Also believed there is a contraindication to using Prolia with a methylprednisone injection she received last week and her methotrexate. Upon follow-up, patient reported arthritis and headaches (headache; onset date and latency: unknown) (batch number: 4F483A and expiry date on 31Aug2026) no additional details. SUSPECT PRODUCT is under agreement with BIONTECH SE.

severe vertigo; dizzy; couldn’t walk; couldn’t see, vision was really blurry; Rear occipital stroke; This is a spontaneous report received from an Other HCP. A 33-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 25Mar2023, outcome “recovering”, described as “Rear occipital stroke”; VISION BLURRED (non-serious) with onset Jun2023, outcome “recovering”, described as “couldn’t see, vision was really blurry”; GAIT DISTURBANCE (non-serious) with onset Jun2023, outcome “recovering”, described as “couldn’t walk”; DIZZINESS (non-serious) with onset Jun2023, outcome “recovering”, described as “dizzy”; VERTIGO (non-serious) with onset Jun2023, outcome “recovering”, described as “severe vertigo”. The patient underwent the following laboratory tests and procedures: numerous tests and studies: Unknown results. Clinical course: Patient initially suffered two cryptogenic strokes back in April, caller then checked and clarified and confirmed the two strokes were rear occipital strokes. First stroke occurred 25Mar2023, second stroke occurred 05Jun2023. Called to report, has gone through numerous tests and studies, doctors cannot figure out what caused. With first stroke, fainted, lost consciousness, was out for over a minute. With second stroke had severe vertigo, became dizzy, was dizzy for about three weeks nonstop, couldn’t walk, was in bed two and a half weeks, couldn’t see, vision was really blurry, wasn’t stable, couldn’t focus on anything for about a month. Would say disabling as well, hard to say whether life threatening, hard to say if life threatening, any time you have a stroke is life threatening. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender’s Comments: The association between the event rear occipital stroke with BNT162b2 NOS can not be fully excluded based on the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

COVID-19; COVID-19; This is a spontaneous report received from a Physician. A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient’s relevant medical history included: “aortic dissection”, start date: 23Dec2015 (unspecified if ongoing), notes: was medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient; “memory issues”, start date: Mar2016 (unspecified if ongoing), notes: became more progressive, right now patient is stable; “head scan”, start date: Sep2015 (unspecified if ongoing), notes: helped with diagnosis of memory issues. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER)), for Covid-19 immunization; Moderna bvln bstr (DOSE 5 (BOOSTER)), for Covid-19 immunization; Spikevax 12 plus (DOSE 6 (BOOSTER)), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome “unknown” and all described as “COVID-19”. The clinical course was reported as follows: It was reported that the patient had gotten COVID three times, and twice patient had to be hospitalized, confirmed admitted into hospital, either for two nights or for four nights. Third time patient had to be in the emergency room about seven hours, and then patient seemed fine. The reporter could take patient home or leave her there, thought with patient’s memory issues, the patient was probably better at home, but he stated should had left her there. Whenever patient got, was more problematic than when other people were getting it, so had gone ahead and given patient next booster. The patient’s husband thought patient had had eight doses now (got other dose in either Sep2024 or Oct2024). The patient shifted over to Pfizer because patient’s first doses were Moderna. The patient got Comirnaty 12 plus on 03Jul2024, the reporter thought the dose patient got of Comirnaty 12 plus must have been Pfizer, but unable to confirm.; Sender’s Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.

intermittent palpitations; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2025 as dose 1, single (Batch/Lot number: unknown) for immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset 15Jan2025, outcome “unknown”, described as “intermittent palpitations”. Additional information: It was reported via email that last Tuesday (14Jan2025), they administered Abrysvo and Prevnar (reporter confirmed the email only listed as Prevnar, unable to clarify which Prevnar) to the patient and the patient came in today, 20Jan2025, to let know the following day after getting the vaccine (15Jan2025), the patient had intermittent palpitations after receiving the vaccine. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.

I started losing hair; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (I started losing hair) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043501) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced ALOPECIA (I started losing hair). At the time of the report, ALOPECIA (I started losing hair) outcome was unknown. No concomitant medication was reported. Within 2 weeks after receiving vaccine patient started losing hair and it didn’t seem to be letting up. There was no change in his medicine, diet, or water intake. He did read that this was a rare side effect, and it should be improved in 3 to 6 months. No treatment medication was reported. Reporter did not allow further contact

sore throat; fatigue; redness which had been climbing up my throat into my mouth; it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth), ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient’s past medical history included COVID-19 in July 2024. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Patient received 6 shots since 2019) in September 2023. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine. On 05-Jan-2025, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 06-Jan-2025, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). In January 2025, the patient experienced ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth) and ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth), ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).) and FATIGUE (fatigue) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Patient got the 1st two shots when they first came out. Then got the boosters. Then had over 4 boosters since. Patient did not receive vaccines within the past 4 weeks, and no medical conditions has reported. No concomitant medication was reported. On January 6th, at the end of the day, patient developed a sore throat and fatigue. It lasted longer than patient would have thought. Patient went to primary care doctor, and he gave me a swab for the throat to rule out Strep, it was not the strep. He said it could be a passing sore throat, which they could get, although it’s already been at that point 10 or 11 days. Or could be possibly associated with the vaccine. Patient waited another 6 days and the redness which had been climbing up the throat into mouth, his wife looked in and it looked more like a little bit like a rash almost (the redness in throat converted to a rash appearance). Patient made an appointment for Friday to see doctor again. Patient was concerned about, something that will spread or that was a rash. It was not like typical of a viral sore throat because it just didn’t go away, and it was not progressing and getting worse. It was just changing in nature. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-781696 (E2B Linked Report).; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781696:Female case

she had COVID attack last year; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (she had COVID attack last year) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. In June 2024, the patient experienced COVID-19 (she had COVID attack last year). At the time of the report, COVID-19 (she had COVID attack last year) had resolved. No concomitant medication was reported. The patient also mentioned that she had to take the vaccination before travelling to avoid getting sick or COVID. She mentioned that she had COVID attack last year in late June as she did not take the Booster shot. No treatment information was reported. Reporter did not allow further contact

severe back pain (middle to upper); This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (severe back pain (middle to upper)) in a 90-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In January 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced BACK PAIN (severe back pain (middle to upper)). The patient was treated with Diclofenac sodium (Voltaren) at an unspecified dose and frequency. At the time of the report, BACK PAIN (severe back pain (middle to upper)) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. Patient did not receive vaccines within the past 4 weeks. No concomitant medication was reported. The patient did not experience any additional symptoms or events. This case was linked to US-MODERNATX, INC.-MOD-2025-781607 (E2B Linked Report).; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781607:Invalid case

While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand; Occasionally experienced numbness of her arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Patient had been receiving Spikevax vaccine, and there had been no problem previously. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms). At the time of the report, MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) had not resolved. Concomitant medication use information was not provided by reporter. The reaction had been going on for months. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.

COVID19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 07-Jan-2025, the patient experienced COVID-19 (COVID19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. In January 2025, COVID-19 (COVID19) had resolved. No concomitant medication was reported. He had received five doses of the Moderna covid-19 vaccine since 2021 and was recently diagnosed with covid-19 this month, with detection on 7-Jan-2025. He reports having taken Paxlovid for five days and currently felt well, stating, no problem right now, no coughed, nothing right now. He was feeling very well right now. He believes he was fully recovered right now and had not received a covid-19 vaccine for the 2024-2025 season. No treatment medication was reported.