The infant was born via SVD at 40 weeks gestation with no complications. She was given HepB vaccine (IM, right thigh) prior to discharge. On 10/23, she received the RSV monoclonal antibody (IM in left thigh). No report of immediate adverse reaction from mother. That evening, the infant was placed supine in an unsafe sleep environment (bedsharing with two adults and soft bedding) at approximately 11:30 pm and found at approximately 3:30 am not breathing and asystolic upon arrival of EMS. Pronounced deceased at 4:45 am on 10/24/2024 Reporting for temporal association, not causation

Within 8 hrs development severe headaches photophobia myalgia chills fatigue and sore throat. Unable to get out of bed.

Shingrix shivering, headache, severe muscle pain- even my buttocks hurt after and arm injection. Liw BP 80/67. Hr 91

RVS vaccine, Arexvy 05ml, left arm, on Friday, 01/17/2025 at Pharmacy. I had a painful red area, oval shaped, about size of a hard ball strike, at injection site that lasted for three days [through Monday].

During flu season, we administer many flu vaccinations. However, in this isolated event, during administration of Fluarix Flu Vaccine, with lure lock needle there was a product defect. When I was screwing on the needle, I felt a click, so I visually made sure that the needle was threaded correctly. The needle was on the syringe correct and was in a snug positing. When I went to administer the vaccine into the right deltoid, the liquid vaccine leaked down the arm of the patient. None or a very minimal amount actually got injected through the needle into the muscle. I disposed of the needle properly. I reached out to pharmacy to see how I should proceed. The manufacturer of the Fluarix vaccine was contacted, as well.

Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Patient does not have any records in database systems as far as vaccine administration. Patient has records on January 19, 2021 for care-coordination with clinic (which I do not have access to receive medical records for). Other Relevant HX: ANAPHYLAXIS

Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX:

Reported Symptoms: 10016025:FACE EDEMA; Narrative: Other Relevant HX: Other: EDEMA OF FACE

Reported Symptoms: 10037844:RASH; Narrative: Patient received the Spikevax vaccine on 9/24/24. Patient called on 10/9/24 complaining of a pruritic rash x2-3 days. He stated that he forgot that this had happened the last time he had received a Covid vaccine on 1/26/22. Patient was seen by a local urgent care following the 1/26/22 reaction and there are no records of this in the electronic record. Patient stated that he was treated with steroids in 2022. Patient was called back on 10/10/24 and he stated that he self treated with steroids that he had at his house and diphenhydramine and was doing so much better. He was instructed to not receive the Covid vaccine again, patient said he will still continue to get the annual Covid vaccine again, patient said he will still continue to get the annual Covid vaccine despite having the reaction. Other Relevant HX: Other: RASH

Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Patient presented to the urgent care on 10/21/24 with cold and flu symptoms following strep throat exposure. While being in urgent care the patient was given a covid and influenza vaccine. Patient presented to her local emergency department on 10/21/24 with angina and feeling like her heart was racing. EKG showed narrow complex tachycardia with maximum heart rate of 211. Patient was given adenosine with no resolution so she was started on heparin and diltiazem continuous infusions for atrial flutter with RVR. Troponin inreased to 170 from 51 showing demand ischemia. Patient was transferred to a highter acuity facility and the patient spontaneously converted to a normal sinus rhythm . Patient was transitioned to metoprolol and apixaban on discharge. Patient was discharged on 10/23/24. Follow-up ECG from 12/4/24 showed normal function of the left ventricle. Facility physician suspected the cause of this event was the Covid vaccine. Patient had no previous cardiac diagnoses. Patient has no other vaccine reactions listed. Other Relevant HX; Other: TACHYCARDIA