Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac disorder, Ear congestion, Electrocardiogram abnormal, Electrocardiogram ambulatory, Malaise
Clinical narrative: heart was pausing/ heart started to act up; has been fighting RSV since then and still has RSV; has been fighting RSV since then and still has RSV; This is a spontaneous report received from a Nurse from product quality group.  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in right upper arm for immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2012 (unspecified if ongoing); "Fibromyalgia" (ongoing), notes: Diagnosed twenty years ago at least; "Hypothyroidism" (ongoing), notes: Diagnosed in the past ten years. Is taking medication for that.; "Covid", start date: 2023 (unspecified if ongoing), notes: had COVID last year and that was just a bad cold. COVID was nothing even close to this RSV.; "Weight about 257lbs, which is too much" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lyrica for Fibromyalgia; Pregabalin for Fibromyalgia, reaction(s): "gained a lot of weight on that". The following information was reported: VACCINATION FAILURE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset 26Dec2023, outcome "not recovered" and all described as "has been fighting RSV since then and still has RSV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart was pausing/ heart started to act up". The events "has been fighting rsv since then and still has rsv" and "heart was pausing/ heart started to act up" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: 5ft 6 inches, notes: she's down to 5ft 6 inches now; 5ft 7in, notes: Used to be; Electrocardiogram: Heart was pausing; looked normal; Weight: about 257lbs. Therapeutic measures were taken as a result of vaccination failure, respiratory syncytial virus infection, cardiac disorder. Clinical course:  Patient was diagnosed Fibromyalgia twenty years ago at least. This is why she is taking Pregabalin. It was Pfizer's product. It was Lyrica when she was taking it originally. Now they have a generic that just came out last year. Clarified she is taking Pregabalin now. Hypothyroidism was diagnosed in the past ten years, and is taking medication for that. Patient's weight was about 257lbs, stated "which is too much". She's also on pregabalin and had gained a lot of weight on that. Height used to be 5ft 7in, she's down to 5ft 6 inches now. Patient was a licensed Practical Nurse. A person from a pharmacy came to the senior center to administer the Abrysvo vaccines. It was administered into her right arm because they can't do anything on her left arm because she had breast cancer. The person who administered it put the dosage and what the name of it was on that paper and the pharmacy where she came from. Patient thought there might have been a sticker on there that showed possibly the lot number and everything, but she can't be sure. And she doesn't remember the dosage of it or anything. As of 26Dec2023 she has been fighting RSV since then and still has RSV. She got it even though got the vaccine. She was so sick for a while that the doctor wanted to put her in the hospital to get antibiotics intravenously. The antibiotics he put her on to start with wasn't working. So far she's taken 4 packs of Medrol, started out on Cefdinir as an antibiotics, but that wasn't working. Then put on Levofloxacin, she was on that previously. Now is back on Cefdinir. Patient had a nebulizer and was wearing a heart monitor because her heart started to act up. They didn't know whether it was from the vaccine or what's going on, but she is wearing a heart monitor for 7 days. Patient had been in touch with Dr. (withheld), and had gone to see Dr. several times during this. Dr. took an EKG and said her heart was pausing and was very concerned about that. Sent patient to her cardiologist the day after who took another EKG, and it looked normal. When the cardiologist looked at Dr. report, she saw where the pause was and put a heart monitor on caller for 7 days. Just wanted Pfizer to know even though she got the vaccine, she still got RSV, it is one awful illness. Patinet had never been this sick and hopes she's getting over it. Could't seem to get rid of the congestion that's in her head and ear and believes that Dr. still heard the congestion in her chest. She's got a nebulizer at home and all that kind of stuff. She started showing symptoms of RSV on 26Dec2023 symptoms. Initially thought she had a sinus infection but it went to a lower respiratory thing and Dr. told her she has RSV and that caller is one sick person. It was almost to the point Dr. wanted to put her in the hospital, but patient didn't want to go. She would rather try and fight it at home where she's comfortable. Clarified Medrol as Methylprednisolone (Manufacturer: Blue point), patient has 4 packs, Dose: 4mg; all 4 packs are the same dosage. It was done so on the first day she would take like 6 pills, then down to 5 pills. She had 2 packs at a time she was taking. Clarified one day would take all 6 pills spread out and then next would take another 6 pills spread out. Then reduce down her dose to where she was down to 1 tablet in both packs. Then she was administered 2 more packs. Previous Cefdinir (Manufacturer: Blue Point), Dose/Formulation: Provides 300mg,This dosage was completed. Current Cefdinir (Manufacturer: Blue point): Dose/Formulation: Provides 300mg, She has 1.5 more days left until this dosage is completed. Levofloxacin (Manufacturer: Viona Pharmacy), Dose/Formulation: Provides 500mg, She completed this dosage. NDC/LOT/EXP not queried as confirmed non-Pfizer Product. As for Investigations, stated doesn't really have the lab work, going in for lab work tomorrow that was ordered by Dr. (withheld). Patient reiterated she has never been this sick before. She's had the typical. Even had COVID last year and that was just a bad cold. COVID was nothing even close to this RSV.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The assocaiton between the event lack of effect (RSV infection) with ABRYSVO can not be fully excluded.