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1,929,324 reports(787 ms)
Red, hard lump, redness around the injection site
Mother called clinic approximately 40 hours post vaccination to report a reddened area 2.5-3 cm in length noted to outer thigh area of left leg noted yesterday (12/16/2025) am upon patient waking in am. Area not raised or warm to touch. Patient has not had an…
Patient reports developing alopecia 6 months after vaccine and believes it linked to the HPV vaccine
Brain encephalopathy with seizures like, respiratory symptoms, severe metabolic acidosis, lactic acidosis, elevated CK levels.
edema, erythema, pain. relatively immediately after administration. this was due to poor placement - ~ 8cm inferior to deltoid
a 0.25 ml dose was given instead of 0.50 ml
As per mother her baby developed rash in her neck right away after receiving the first dose of hepatitis B vaccine which spread to her whole body except her back. The rash was not raised. Her baby didn't develop any symptoms such at itchiness, shortness of bre…
After receiving vaccination, pt developed respiratory distress with hyperventilation and drowsiness
None
After a week, lots of pain, couldn't move left arm. Tried heat/ice therapy, nothing worked. took lots of tylenol/ibuprofen, didn't seem to help much. went to the doctor, who gave cortisone injection left arm (3months after the vaccine). helped a little bit. b…
This patient was administered the final Bexsero dose a few days too early
Left EYE became very blurry, Eye specialist could not figure it out. said eye vessel were clotting, steroids were issued twice , also received steroid shot in left eye.
Patient reported that after she got the COVID shot in 2024 she had a ringing in her ears that prompted her to seek attention from MD and was subsequently placed on a prescription nose spray that she still uses to this day. She did not inform me but also receiv…
no adverse event; Caller is 30 years old and received PROQUAD; This spontaneous report was received from a 30-year-old female patient who was referring to herself. The blood test showed that her levels of antibodies for measles, mumps, rubella and varicella we…
Nurse practitioner reported that a patient received a first dose of GARDASIL 9 in 10/2023 when the patient was 13 years old and did not get the second dose yet.; No additional AE; This spontaneous report was received from a nurse and refers to a 13-year-old pa…
Email received to Inbox on 01DEC2025 at 4:28pm with subject "FW: 12/1/25 Pharmacovigilance-sanofi/Rotateg & Pedvaxhib-2025SA315865 & Varicella Vaccine-2024SA156882/ 493850332" containing a scanned document sent from Sanofi r; Email received to Inbox on 01DEC20…
No Additional AE; HCP called to report TE where patient received product after it was improperly stored.; This spontaneous report was received from a medical assistant and refers to 1-year-old patient of unknown gender. The patient's medical history, concurren…
INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE WARMTH; INJECTION SITE REACTION; Information has been received from Foods and Drug Administration (FDA) (2853963) on 10-DEC-2025. The patient's pertinent medical history, concurrent conditions,…
No additional AE; improper vaccine storage; Rotateq dose 0.5 ml; This Spontaneous report was received from medical assistant and referred to a 2-month-old patient of unknown gender. The patient's medical history was not reported. The patient's past medication…
No additional AE/No PQC; Medical Assistant reported administration of improperly stored vaccines to multiple patients beginning on 10/2/2025; This Spontaneous report was received from Other health professional and referred to a 4 months patient of unknown gend…