once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe; needle broke off the diluent syringe; This is a spontaneous report received from an Other HCP from product quality group, Program ID: A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome “unknown”, described as “once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe”; NEEDLE ISSUE (non-serious), outcome “unknown”, described as “needle broke off the diluent syringe”. Causality for “once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe” and “needle broke off the diluent syringe” was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Has a caller on the line who is a pharmacy intern calling about Abrysvo vaccine and stated that once the pharmacy tried to reconstitute it, it broke. She is reporting that and requests replacement product. The presentation is the diluent and the lyophilized antigen component. She is not fully aware what happened regarding it breaking but the pharmacist told her that while trying to reconstitute it, the needle broke off the diluent syringe and she has no manufacturer name or lot number to provide for the needle. Caller clarified she is now not sure if the needle broke or if something went wrong with the component of the diluent syringe. Carton/box: lot number KC7884, expiry date Sep2025, NDC 0069034401; Antigen vial: lot number KC7884, expiry date Oct2025, NDC 0069020701, and it says lyophilized antigen component. Diluent syringe: lot number HM8389, expiry date Sep2025, NDC 0069025001. Vial adaptor: Asks is that the white portion and she sees the connector piece on the diluent and antigen vial. Confirmed no patient involvement.

he got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he got COVID) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient’s past medical history included Stroke (25 years ago). Concurrent medical conditions included Disability. On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In May 2024, the patient experienced COVID-19 (he got COVID). At the time of the report, COVID-19 (he got COVID) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was reported that patient was supposed to get a second dose of the 2023 booster which he had never heard about. On May-2024, patient got COVID and it lasted about a week. There was lots of coughing , and his mucus was abnormal, it was clear and bubbly. He could breathe okay but he knew something was wrong. He stated he self-isolated for 5 days after he returned from his trip.He could not self-test as he is disabled and that he could only use one arm. Treatment information was not provided.

suffered paralysis in her arms and legs; This literature-non-study case was reported in a literature article and describes the occurrence of QUADRIPLEGIA (suffered paralysis in her arms and legs) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced QUADRIPLEGIA (suffered paralysis in her arms and legs) (seriousness criterion medically significant). At the time of the report, QUADRIPLEGIA (suffered paralysis in her arms and legs) 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. Concomitant and treatment medications were not reported. This report concerns a patient who, after being vaccinated with the defendant’s vaccine, suffered paralysis in her arms and legs, while a stroke was diagnostically ruled out. This case was linked to DE-MODERNATX, INC.-MOD-2023-694649 (E2B Linked Report).; Reporter’s Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender’s Comments: DE-MODERNATX, INC.-MOD-2023-694649:Master patient case

he felt “flu-ish” for a day or two; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt “flu-ish” for a day or two) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he felt “flu-ish” for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (he felt “flu-ish” for a day or two) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-467516 (E2B Linked Report).; Sender’s Comments: US-MODERNATX, INC.-MOD-2022-467516:Reporter’s case

deadly vaccine; This spontaneous report received from a lawyer concerned a patient of unspecified age and sex. Document was received in the form Legal Summons and Complaint and EZ report. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347799. This report was non-serious.

DEADLY VACCINE; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. after taking COVID-19 shot. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347802. Investigation Results: Undetermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.

deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid 19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347801. Investigation Results: Undermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.

Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series:1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with a product quality complaint: Product Complaint 90000347797. Investigation Results: Undetermined-Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. This report was non-serious.

Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with product quality complaints: Product Complaint 90000347798; 90000347962. Investigation Results: Undetermined, Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time. This report was non-serious.

deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deadly vaccine. After taking COVID-19 shot. (dose series is 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of deadly vaccine was not reported. This report was associated with product quality complaints: Product Complaint 90000347962; 90000347798. Investigation Results: Undetermined. Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time. This report was non-serious.