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1,929,324 reports(906 ms)
CARDIAC ARREST; RESUSCITATION; Information has been received from Food and Drug Administration (agency number not provided) on 16-JUN-2025. This spontaneous report refers to a 33-month-old male patient. The patient's medical history, concurrent conditions and…
Felt Terrible; feels warm; Loss of work; Loopy and Spacey; Voice alteration; Light sensitivity; Sound sensitivity/ voice sounds like a frog; Fever; Chills; Exhaustion; Headache; Nauseous stomach/ her stomach feels nauseous; Flu symptoms; This non-serious case…
heavy fatigue; painful raised welt approx 2 x 4 inches centered on left deltoid injection site with 1 inch diameter rash; painful raised welt approx 2 x 4 inches centered on left deltoid injection site; This spontaneous report was received from a Patient on 02…
injection site reaction over L deltoid - 8 cm erythema, warmth, pruritis, pain
Consumer calling to report that prior to getting MMR II vaccine, they had the negative titer test. Once vaccine was received, there was no change in negative titer results. Consumer did not report any side effect. Permission to contact HCP was not gi; This spo…
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Whole upper arm was swollen an…
headaches; abdominal pain/ gastrointestinal issues; loss of appetite/ gastrointestinal issues; vomiting/ gastrointestinal issues; pelvic discomfort; prolonged menstrual cycles; tested positive for elevated testosterone level; tested positive for elevated infla…
Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously a…
swelling/pain at sites; swelling/pain at sites; asked if the vaccine he had in the syringe was Novavax. He nodded "yes."/was told I was given Pfizer.; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provid…
a dose of ACTHIB was reconstituted with a sterile diluent and administered to a patient with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. Thi…
expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, ex…
Menveo, it was administered subcutaneously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 23-year-old fema…
Double dose on same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ZK9P4) for prophylaxis. Co-…
expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 3…
no additional AE; Second dose on 3/31/2025, and Third dose administered today, 6/25/2025; This spontaneous report was received from a Pharmacist and refers to a 37-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and…
They had a 9 year old patient who had severe warts on his entire body, they explained it as the worst they had seen. After being vaccinated with 3 doses of GARDASIL 9 his symptoms resolved completely.; This spontaneous report was received from a nurse and refe…
Confirmed no symptomatic adverse events; Inbound call from nurse calling to report administration of expired GARDASIL-9 to a patient on 18-MAR-2025. Caller states that they discovered that the dose was administered expired after the patient came in recently f…
POTS-like symptoms, rapid heart beat, chronic&daily fatigue, abnormal perspiration without exercise&excessive sweating,dizziness,abdominal bloating,autonomic&neurological injuries,excessive daytime sleepiness,daily pain,muscle fatigue; inhaler which she used f…
Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; Sustained Autoimmune Disease and Other Serious Autoimmune Autonomic and Neurological injuries; POTS, weight loss and loss of appetite, headaches, rapid heart rate, a…
Extra Dose Administered; Gave HEPLISAV-B Series Two Doses 28 Days Apart, Rechecked Titer and He is Non-Reactive; Initial report received on 07-Jul-2025. A nurse reported that a 33-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepa…