Left Psoas tightness; lower back pain; buttock pain; difficulty walking; hip pain; This is a spontaneous report received from a Nurse. A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Jan2025 as dose 1, single (Lot number: LJ5283) at the age of 61 years, in right deltoid for immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2025 as dose number unknown, single (Lot number: 8080803), in left arm for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 19Jan2025 at 06:00, outcome “not recovered”, described as “Left Psoas tightness”; MUSCULOSKELETAL PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome “not recovered”, described as “buttock pain”; GAIT DISTURBANCE (non-serious) with onset 19Jan2025 at 06:00, outcome “not recovered”, described as “difficulty walking”; ARTHRALGIA (non-serious) with onset 19Jan2025 at 06:00, outcome “not recovered”, described as “hip pain”; BACK PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome “not recovered”, described as “lower back pain”. Therapeutic measures were taken as a result of muscle tightness, back pain, musculoskeletal pain, gait disturbance, arthralgia. Additional information: On 18Jan2025 received co-suspect Moderna 2024-2025 covid vaccine. Unknown if patient took any other medications within 2 weeks of the event starting. All symptoms associated with Left Psoas tightness including lower back pain, hip pain, buttock pain, difficulty walking, no prolonged hospitalization due to it. When asked what treatment received for the adverse event? So far, the pain was still existing as of this date.

large rash, itchy and still spreading and slightly swollen; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 at 15:48 as dose number unknown, 0.5ml single (Lot number: LJ5283, Expiration Date: 31May2026) at the age of 60 years intramuscular, in left deltoid for immunisation; influenza vaccine inact split 3v (FLULAVAL), on 21Jan2025 as dose number unknown, single (Lot number: 9H5J5, Expiration Date: 30Jun2025) for immunisation. The patient’s relevant medical history was not reported. The patient took concomitant medications. The following information was reported: RASH PRURITIC (non-serious) with onset 26Jan2025, outcome “not recovered”, described as “large rash, itchy and still spreading and slightly swollen”. Therapeutic measures were taken as a result of rash pruritic. Additional information: Reporter (Medical assistant) was calling from a doctor’s office, because they have a patient who had an adverse reaction to the Prevnar 20. The doctor was asking if there was anything else, she was using hydrocortisone cream (Treatment) and the doctor was recommending Benadryl for the adverse reaction (Treatment). Reporter stated that the patient was having a large rash, itchy and still spreading and slightly swollen. The patient was on several medications, Not on reporting day. Reporter stated, she still experiencing the reaction.

Red, itchy arm; Red, itchy arm; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient’s relevant medical history included: “Hypertension” (unspecified if ongoing); “Allergies: Penicillin” (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 14Jan2025 as dose number unknown, single; SECTRAL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 21Jan2025 at 16:00, outcome “not recovered” and all described as “Red, itchy arm”. Therapeutic measures were not taken as a result of erythema, pruritus. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.

it has been 1 week , 6 days of injection site pain/when he moved arm the muscle was hurting.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 68-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in left arm for immunisation. The patient’s relevant medical history included: “COVID-19”, start date: Dec2024 (not ongoing); “Valley fever”, start date: 2023 (ongoing); “Afib” (ongoing); “BPH” (ongoing); “Cholesterol” (ongoing). Concomitant medication(s) included: DIFLUCAN oral taken for coccidioidomycosis, start date: Dec2023 (ongoing); DABIGATRAN oral taken for atrial fibrillation; DILTIAZEM oral taken for atrial fibrillation, start date: Dec2023 (ongoing); TERAZOSIN oral taken for benign prostatic hyperplasia (ongoing); ROSUVASTATIN oral taken for blood cholesterol abnormal (ongoing). Past drug history included: Simvastatin for Cholesterol, notes: Probably started originally 10 -15 years ago and doesn’t recall when switched. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Jan2025, outcome “not recovered”, described as “it has been 1 week , 6 days of injection site pain/when he moved arm the muscle was hurting.”. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient stated that he had injection site pain that was lasted 6 days now, almost a week. He was really just calling to see if it is normal. He talked to a nurse and she had no idea. He wanted to see what timeline would be for that kind of pain. He does want to mention he was not 100% sure but he thought that the pain for him only lasted about 2 days and from what he remember pain was gone and yesterday, 26Jan2025, he noticed it hurting, not horrible, when he moved arm the muscle was hurting. He does not know if it really went away, it seemed like went away and came back but he may not have noticed. States the pain was also when he pushed on it. outcome: well when it started right after he had it and next day it was about the same as that and when it restarted he guesses it’s about the same. pain – there was the pain of the actual needle going in but the injection site pain was probably pretty soon after, within a couple hours. Like 1-2 hours later. Indication: because someone talked him into it finally. They kept asking him about it for several years and he finally saw a doctor and he said he really should based on his age. States that and he was not wanting to get pneumonia. Additional information on relevant medical history, It was reported that, the patient had Covid a month ago and recovered. He took Paxlovid for that, not within the 2 weeks of injection site pain, it was a month before. Valley fever did test positive Valley Fever but doesn’t know if he was still positive. Had not been retested yet. Concomitant Medications: Dabigatran states that a little over year ago when he started valley fever, he had really bad symptoms. Had symptoms of AFib which he had never had before. He only had 2 little episodes when in the throws of valley fever but must be on this the rest of his life. Additional Information for Other medicines Rosuvastatin: used to be different many years ago and changed from simvastatin to this. Probably started originally 10 -15 years ago and doesn’t recall when switched to this. Additional Information for Other medicines Terazosin: started taking about 6 months ago. Additional Information for Other medicines Diflucan: Has ongoing valley fever. He had Valley Fever a year ago and he tested positive again. Original start date Dec2023 and was on for 3 months. Was off Diflucan and back on about a month ago, 13Dec2024. The patient felt pretty confident it is normal. He hasn’t had a vaccine last this long or go away and come back. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

the bone in my left arm is killing me/pain when i lift my arm; the bone in my left arm is killing me/pain when i lift my arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); alprazolam (XANAX). The patient’s relevant medical history included: “copd” (unspecified if ongoing). The patient’s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for covid-19 immunization. The following information was reported: BONE PAIN (hospitalization, life threatening), JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening), outcome “unknown” and all described as “the bone in my left arm is killing me/pain when i lift my arm”. The event “the bone in my left arm is killing me/pain when i lift my arm” required emergency room visit. The action taken for fluticasone furoate, umeclidinium bromide, vilanterol trifenatate and alprazolam was unknown. Clinical course: When asked if the adverse reaction required her to go to the emergency room, the patient said, “yes because the bone in my left arm is killing me”. Patient can feel pain in her bone and cannot lift up her arm and definitely need more than an x-ray because it would not show in the x-ray. This happens for doing the right thing, getting a booster shot for covid which she received 2 years ago (in 2023). She has pain when she lifts her arm. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.

She had Covid twice; She also has a blood cancer diagnosis; This serious initial Spontaneous safety report was received by Novavax on 23-Jan-2025 from a Consumer or other non-health professional via Novavax Medical Information (Case No. NOV25-00044). A 72-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula) (Intramuscular) (Lot number was not provided in the report) on an unspecified date. No medical history was reported. No concomitant medications were reported. On an unspecified date after vaccination the patient experienced She also has a blood cancer diagnosis (PT: Haematological malignancy) (Serious: Other Medically Important Condition) and on an unspecified date after vaccination the patient experienced She had Covid twice (PT: COVID-19). At the time of reporting, the event outcome of Haematological malignancy was Unknown and COVID-19 was Unknown.; Sender’s Comments: This 72-year-old Female experienced Haematological malignancy and COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula). The event Haematological malignancy was assessed as serious. The event COVID-19 was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula) and Haematological malignancy and COVID-19 is considered Possible.

Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 1 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as “32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781834, US-MODERNATX, INC.-MOD-2025-781835, US-MODERNATX, INC.-MOD-2025-781838, US-MODERNATX, INC.-MOD-2025-781839, US-MODERNATX, INC.-MOD-2025-781841, US-MODERNATX, INC.-MOD-2025-781791, US-MODERNATX, INC.-MOD-2025-781842, US-MODERNATX, INC.-MOD-2025-781844, US-MODERNATX, INC.-MOD-2025-781847, US-MODERNATX, INC.-MOD-2025-781848, US-MODERNATX, INC.-MOD-2025-781849, US-MODERNATX, INC.-MOD-2025-781851, US-MODERNATX, INC.-MOD-2025-781850, US-MODERNATX, INC.-MOD-2025-781846, US-MODERNATX, INC.-MOD-2025-781853, US-MODERNATX, INC.-MOD-2025-781854, US-MODERNATX, INC.-MOD-2025-781845, US-MODERNATX, INC.-MOD-2025-781856, US-MODERNATX, INC.-MOD-2025-781855, US-MODERNATX, INC.-MOD-2025-781858, US-MODERNATX, INC.-MOD-2025-781843, US-MODERNATX, INC.-MOD-2025-781859, US-MODERNATX, INC.-MOD-2025-781860, US-MODERNATX, INC.-MOD-2025-781864, US-MODERNATX, INC.-MOD-2025-781865, US-MODERNATX, INC.-MOD-2025-781866, US-MODERNATX, INC.-MOD-2025-781863, US-MODERNATX, INC.-MOD-2025-781867, US-MODERNATX, INC.-MOD-2025-781868, US-MODERNATX, INC.-MOD-2025-781869, US-MODERNATX, INC.-MOD-2025-781874, US-MODERNATX, INC.-MOD-2025-781878 (E2B Linked Report). Reporter did not allow further contact; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781834:Patient 12 US-MODERNATX, INC.-MOD-2025-781839:Patient 23 US-MODERNATX, INC.-MOD-2025-781844:Patient 15 US-MODERNATX, INC.-MOD-2025-781854:Patient 5 US-MODERNATX, INC.-MOD-2025-781835:Invalid Case For moderna and Pfizer product US-MODERNATX, INC.-MOD-2025-781838:Patient 13 US-MODERNATX, INC.-MOD-2025-781847:Patient 3 US-MODERNATX, INC.-MOD-2025-781842:Patient 2 US-MODERNATX, INC.-MOD-2025-781848:Patient 32 US-MODERNATX, INC.-MOD-2025-781853:Patient 25 US-MODERNATX, INC.-MOD-2025-781846:Patient 31 US-MODERNATX, INC.-MOD-2025-781850:Patient 16 US-MODERNATX, INC.-MOD-2025-781791:Patient 23 US-MODERNATX, INC.-MOD-2025-781845:Patient 30 US-MODERNATX, INC.-MOD-2025-781849:Patient 24 US-MODERNATX, INC.-MOD-2025-781851:Patient 4 US-MODERNATX, INC.-MOD-2025-781841:Patient 14 US-MODERNATX, INC.-MOD-2025-781855:Patient 17 US-MODERNATX, INC.-MOD-2025-781856:Patient 26 US-MODERNATX, INC.-MOD-2025-781859:Patient 27 US-MODERNATX, INC.-MOD-2025-781843:Patient 29 US-MODERNATX, INC.-MOD-2025-781858:Patient 6 US-MODERNATX, INC.-MOD-2025-781864:Patient 8 US-MODERNATX, INC.-MOD-2025-781867:Patient 11 US-MODERNATX, INC.-MOD-2025-781868:Patient 19 US-MODERNATX, INC.-MOD-2025-781863:Patient 18 US-MODERNATX, INC.-MOD-2025-781865:Patient 9 US-MODERNATX, INC.-MOD-2025-781866:Patient 10 US-MODERNATX, INC.-MOD-2025-781874:Patient 21 US-MODERNATX, INC.-MOD-2025-781860:Patient 7 US-MODERNATX, INC.-MOD-2025-781869:Patient 20 US-MODERNATX, INC.-MOD-2025-781878:master case (patient 22); Reported Cause(s) of Death: Death unexplained

Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 7 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as “32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender’s Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 7; Reported Cause(s) of Death: Death unexplained

Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 6 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as ” 32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender’s Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as ” 32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 6; Reported Cause(s) of Death: Death unexplained

Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece’s baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 26 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as ” 32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender’s Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as ” 32 people of her family were killed because of the vaccine”), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient’s demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 26; Reported Cause(s) of Death: Death unexplained