Resident recieved vaccine 12/5/24. Came sick and tested positive for RSV on 12/27/24 Resident was on the mend feeling better, came off of isolation. Resident had sudden decline, sudden death. Was unable to got her to ER to be evaluated by ER before she declined. I was leaving the dining room from passing lunch meds I was passing by residents room when I heard resident yell help. Went into residents room resident had c/o SOB. Resident did not have O2 on. I reapplied O2. Resident also said that she had to go to thebathroom. CNA was walking by the room. I yelled out for CNA to take resident to the bathroom. I parked med cart in med room grabbed plus ox and glucometer. Another CNA grabbed v/s cart. Resident kept saying I don’t feel good. I can’t breath. BS was not low. SPO2 was not low. Resident was slurring her words. I did stroke assessment, it was WNL. I called supervisor RN and stated what was going on and that I was going to send to ER. CNAs and other nurse put resident on gurney as I printed off paperwork. I took resident down to ER. Resident passed in the elevator as we exited into ER. TOD was 1257. Notified Dr @ 1310. @1315 pronounced. @ 1415 Funeral home picked up. Resident coughing productively thick brown sputum. lung sounds rhonchi. o2 sat 85% room air. I have placed on o2@2lpm.nc. Chest x-ray results pending. Dr notified of resident condition and of chest x-ray results. new orders for levaquin 500 mg one daily x 5 days and decadron 8 mg IM daily x 1 dose. Family notified. Resident continues to have cough/congestion/sinus drainage. Lung sounds diminished. she is coughing productively yellow sputum. T 97.9 P 103 R 28 b/p 121/70 o2 sat 92% room air. I spoke with RN. new order received for chest x-ray today. Family notified. Resident coughing productively light yellow sputum, lung sounds diminished bases and rhonchi upper airway. T 97.9 P 96 R 32 b/p 103/59 o2 96% I have administered prn cough syrup and tylenol. results pcr fo follow. allergies: promethazine. Dr. notified new orders received for cefdinir 300 mg one bid x 5 days, decadron 8 mg IM x 1 injection, mupirocin ointment to bilateral nares bid x 5 days. Family notified.

Patient felt so sick, a little bit fever/it’s still looks like she had a cold/weak/very sick/COVID.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient felt so sick, a little bit fever/it’s still looks like she had a cold/weak/very sick/COVID.) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient’s past medical history included Lung disorder NOS (problems with lungs). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 30-Dec-2024, the patient experienced COVID-19 (Patient felt so sick, a little bit fever/it’s still looks like she had a cold/weak/very sick/COVID.). At the time of the report, COVID-19 (Patient felt so sick, a little bit fever/it’s still looks like she had a cold/weak/very sick/COVID.) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: COVID. On an unknown date, X-ray: X-ray was fine. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant product use was not provided by the reporter. Patient never ever thought that she was gonna get the COVID because she was very careful. She was using the mask because she had a problem with lungs before. About 3 weeks ago, she felt so sick, a little bit fever, she think she got the COVID. When she got to the emergency room front door they came and they had that kind of the test for the COVID and inside of her nose and everything they did and they said go and sit in the waiting room. Now it was from the 30-Dec-2024, she went to the emergency room and they said, she got the COVID, but they took the X-ray from her lungs to be sure everything was fine with her lungs and they said, yes, the X-ray was fine, but she had the COVID and she had to go home and did not go with anybody around her because she was gonna spread the COVID to other people. She called her physician for lungs because she had a problem with her lungs before. Patient asked to quarantine for 4 weeks. From the 30-Dec-2024 she take the lots of the vitamin C and had lots of rest, and she was going to get better. She was a little bit better, but it still was going on with her. She was very, very weak, and she had a cold. When she was in a hospital in the emergency room, she heard that there was a medication that was gonna give it to the patient and stop the COVID. it was about 6-7 days ago. They said, usually we’re gonna give that kind of the medication to the patient for the 3rd day of this COVID and it was too late for her and she could not be prescribe that kind of the medication for you. At the time of reporting patient was suffering so much and she was very, very sick. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. Reporter did not allow further contact

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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure 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 to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a consumer via interactive digital media. The patient had received Shingles vaccine and still got shingles. 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.; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.

Parent reported fever night after vac.Patient was seen in UCC 3 days after vaccination for complaint of fever and ear pain, dx with otitis media and prescribed antibiotics. On the way home, pt developed right sided tonic clonic seizure activity and taken to ED. Admitted and treated with antiseizure medication and antibiotics. Patient continued seizure and fever on anti-seizure meds and antibiotics. LP with 50 WBCs, <1 RBCs, protein 19, glucose 60. Transfered to Hospital for persistent seizure activity. symptoms improved after IVIG. No infectious etiology identified - some labs still pending. Autoimmune encephalitis panel pending. Planning discharge. Will need Neurology follow-up

pregnant patient received Menquadfi with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age female patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient received Menquadfi with no reported adverse event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unkown previous pregnancy/ies. On an unknown date, the patient received unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization with no adverse event (exposure during pregnancy) (Latency same day). There was no information related to Relevant prenatal testing after exposure. Reportedly, Nurse called on behalf of a physician. They said that the physician administered Menactra to a pregnant patient.informed the nurse that Menactra has been discontinued.The nurse clarified that they meant MENQUADFI instead of Menactra. Information on the batch number could not be requested corresponding to the one at time of event occurrence Additionally, at time of reporting, the outcome of the pregnancy is unknown.

2nd dose FLUZONE HD was admisntered instead of Prevnar 20 with no reported adverse event; 2nd dose FLUZONE HD was admisntered instead of Prevnar 20 with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 90 years old male patient who received 2nd dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] was admisntered instead of PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2024, the patient received 0.5 ml of 1 and dose 2 (on 22-Jan-2025) of suspect, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT8470CA and expiry 30-JUN-2025) via intramuscular route in the left deltoid for Influenza instead of prevnar 20 with no reported adverse event (wrong product administered) (extra dose administered) (latency same day). Reportedly: Once they realized their mistake, they went ahead and gave the patient Prevnar 20. Medical assistant is asking if there would be safety concerns with regards to the situation. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

inappropriate use due to administration of expired MENQUADFI to patient with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old female patient to whom inappropriate use due to administration of expired Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] to patient with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine (Fluzone). On 23-Jan-2025, the patient received a expired 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, expiry date: 31-Dec-2024 and lot U7540BD) via unknown route in the left arm as Immunization (expired product administered) (latency: same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

inappropriate use due to administration of expired MENQUADFI to patient with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case linked to US-SA-2025SA024785 (cluster) This case involves a 11 years old male patient who had inappropriate use due to administration of expired Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel); Influenza vaccine (Fluzone) and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for Immunisation. On 23-Jan-2025, inappropriate use due to administration of expired dose (0.5 ml) of Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot U7540BD; expiry date: 31-Dec-2024) via unknown route in the left arm for Immunisation with no reported adverse event (expired product administered) (latency: same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender’s Comments: US-SA-2025SA024785:02386845

pregnant patient received a second dose of ADACEL in error with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19-year-old pregnant female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] second dose in error with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient received a second dose of ADACEL in error with no reported adverse event occurred at unknown gestation period The date of last menstrual period was not reported. The estimated due date was not reported. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Jan-2025, the pregnant patient received a 0.5 ml dose (dose 2) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot number: U8274AA and expiry date: 31-Aug-2026 via intramuscular route in the left deltoid in error also received dose 1 on 06-Dec-2024 with no reported adverse event (extra dose administered) (latency: on same day of 2nd dose). Reportedly, The patient is aware of the mistake and has not reported any reactions so far. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

patient who was due to get a shot of PENTACEL but the provider only administered the diluent part of the product with no reported adverse event; Patient was administered with 2 doses of the diluents back to back with about a 5 minute interval; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 months old male patient who was administered with the diluent part of the diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and patient was administered with 2 doses of the diluents back to back with about a 5 minute interval with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jan-2025, the patient received the diluent part of the diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection with standard strength (expiry date, lot number and dose not reported) via unknown route in unknown administration site as Immunization (single component of a two-component product administered) and was administered with 2 doses of the diluents back to back with about a 5 minute interval (extra dose administered) (same day latency). Reportedly, caller asked on the dosing for the patient’s next dose, since the patient was supposed to get it at 18 months, they wanted to know if the patient should only be given with Hib since the patient already got 2 doses of the DTAP-IPV. Information on the batch number was requested corresponding to the one at time of event occurrence. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.