Search and filter adverse-event reports.
1,929,324 reports(825 ms)
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they hav…
Allergy to pneumovax; This spontaneous report was received from a consumer referring to an 80-year-old female patient. The patient's Historical drugs included Phenoxymethylpenicillin potassium (PENICILLIN VK), Influenza vaccine rHA 3v (baculovirus) (FLUBLOK),…
HPV infection; This spontaneous report was received from a Physician and refers to an Adult (late 20s or 30s) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were no…
No additional AE; Fridge dropped below freezing over the weekend while office was closed; This spontaneous report has been received from a healthcare professional regarding a 11-year-old female patient. The patient's medical history, concurrent conditions, and…
Missed dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered…
Expired product used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-month-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry dat…
Red spot at injection site, raised knot, sore arm for 4 days, hot at touch. 3 weeks later- migraine & nausea, 4 weeks later- unexplained seizures, dizziness, loss of consciousness, brain fog, headache, still lasting after 6 days.
Bronchiolitis; This 16-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-JUL-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscula…
fever; Rhinovirus; This 2-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 24th September 2018, for prophylaxis. Co-suspect produc…
Viral Gastroenteritis; This 12-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 5th March 2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular)…
SERUM SICKINESS; This 13-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-APR-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramus…
Respiratory failure with hypoxia; This 3-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-AUG-2022, for prophylaxis. The subject received the 1st dose of Hiberix…
Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10012703: DIAPHORESIS; 10013573: DIZZINESS; 10037087: PRURITUS; Narrative: 62 yo male with idiopathic angioedema and many medication allergies experienced allergic reaction to RSV vaccine mi…
Reported Symptoms: 10067481:NO ADVERSE DRUG REACTION; Narrative: at approximately 1430 on 12/5, patient's son contacted PACT team by phone. He had questions as to if the patient had received a flu shot. he stated his father came home with a band-aid on his ar…
injection site stinging; This spontaneous report was received from an Other health professional via a company representative and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions we…
POTS/autoimmune, autonomic, and neurological, injuries; Gardasil-induced autoimmune disorder; autoimmune, autonomic, and neurological injuries; Information has been received from a lawyer and refers to a female patient of 14-year-old. The patient's medical h…
Nurse calling to report that a 15 month old patient was inadvertently administered the adult formulation of VAQTA. No symptoms reported. Caller declined to report the AE at this time. No additional AE/No PQC.; No additional AE; This spontaneous report was rec…
Acute Bronchitis Due to Respiratory Syncytial Virus; This 4-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular, right thigh) on 01-FEB-2019, for prophylaxis. The subject received the 2…
also began having fatigue so severe; Muscle pain; Shivering; Upset stomach; Runny nose; Nasal congestion; Headache; couldn't get out of bed; she began feeling feverish,of 101.5 degrees Fahrenheit.; This non-serious case was reported by a consumer via call cent…
I have a 2 inch diamter red swollen area at the injection site. Very sore, soemwhat itchy.; Injection site itchy; Injection site red; Very sore; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 63-ye…