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1,929,324 reports(850 ms)
5 minutes after administering immunization patient father discover a rash on patient's back. Dr check on patient and spoke with parents. She doesn't think rash was related to vaccines. Injection site was no red, swollen or warm. After making sure patient was o…
Pain that MD states was from injection going into bursa sac in right shoulder. MD prescribed meloxicam 7.5mg twice daily
Vaccine given in right deltoid at 1415. When activating the safety of the needle while in the arm it began bleeding requiring a bandaid change. Patient did not report any other effects at that time. Shortly before 1530 patient reports feeling nauseous and bega…
Pt weight was 115lb and attempted to use 1 inch needle tip. Pt had very little muscle mass upon sticking her so I removed the needle and replaced it with a 5/8 in needle to make pt more comfortable. Pt was double stuck but vaccine only administered once.
No additional AE; HCP called to report that a patient in their office received only half of the dose of GARDASIL-9 due to mishandling. The caller stated that the patient tensed the arm muscle which caused the nurse to pulled out the needle.; Patient received o…
No adverse event; HCP called to report that a patient missed/delayed her second dose of GARDASIL 9. HCP was made aware of the missed/delayed dose today, 08/26/2025, when the patient arrived at the pharmacy to receive her second dose. The patient was 12 years o…
a TE for ROTATEQ; no additional AE; This spontaneous report was received from an other health professional on 05-Sep-2025, referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions w…
No additional AE reported; HCP calling to state MMR II and VARIVAX were not mixed with the STERILE DILUENT instead they believe it was inadvertently mix with FLU-LAVAL; This spontaneous report was received from a Nurse and refers to a 12-month-old patient of u…
No additional AE; 1st dose of ROTATEQ was given to a 7 month old patient.; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies w…
fatigue; headache; This spontaneous report was received from a patient refers to herself (64-year-old female patient). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Sep-2025, the patient was vaccinate…
she had blisters and a circle around her left lower leg above the ankle; Pain in ears radiating down neck; Pain in ears radiating down neck; Pain in ears radiating down neck; sudden stabbing pain in her heart; This serious case was reported by a nurse via oth…
Atrial Fibrillation; This 64-year-old female subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 13-JUL-2021, for prophylaxis. Co-suspect products included losartan potassium f…
New onset of atrial fibrillation; This 64-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 21-JUL-2021, for prophylaxis. Concurrent medical conditions included…
Sinus Pause; atrial fibrillation; This 71-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 22-MAR-2021, for prophylaxis. Concurrent medical conditio…
Worsening of A-Fib; This 62-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 09-SEP-2021, for prophylaxis. Concurrent medical conditions included hypertension…
Atrial Fibrillation; This 63-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 15-APR-2021, for prophylaxis. Concurrent medical conditions included hyp…
Supraventricular Tachycardia; This 61-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular) on 7th July 2021, for prophylaxis. Concurrent medical conditions included sleep apnea, atria…
SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE; This 74-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 19-JUL-2021, for prophylaxis. The subject…
Atrial Fibrillation; This 73-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 04-NOV-2021, for prophylaxis. The subject's past medical history included coronar…
Atrial Fibrillation; COVID 19; This 80-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 11-OCT-2021, for prophylaxis. The subject's past medical history includ…