Firm, painful swelling at the injection site, notably warm to the touch. Noticed within the first 48 hours after receiving the vaccine. Slowly enlarged in size until approximately 1.5 cm in diameter. It has been 20 days since the vaccination was administered. Both the size of the swelling and the pain level have decreased, but are still present.

After patient was vaccinated it was realized that pt had just been vaccinated with just the diluent. the shingrix vaccine was never reconstituted

Patient presented to the clinic for 12 month well child exam. After the exam she was given the first two vaccines (Hep A and Prevnar.) She immediately started crying and appeared to have a breath holding spell. MOm picked her up off of the exam table when she would not catch her breath and then the patient started seizing. The patient had generalized tonic clonic movements for about 15 minutes after the vaccines. An ambulance was called but the infant stopped seizing without medication by the time that paramedics arrived. She was transferred to a local emergency room for evaluation. She had a normal CT scan and tested positive for rhinovirus. She will be evaluated by Neurology as an outpatient. She was sent home with Diastat in the case that she has more seizure activity.

Patient stated that her arm swelled up with a lump like a golf ball. Did not seek medical treatment.

Hives on opposite arm a couple hours after injection, followed by outbreak of hives and swelling in forehead that have lasted more than 24 hours.

had lightheadedness on way out of clinic and had vasovagal event

the pt did not have an adverse event, however, this medication was given a dose that was not indicated or considered necessary. Pt received an Arexvy vaccine on 01/27/2025, however, the pt had received a previous Arexvy vaccine on 11/14/2023 as well.

Headache, fever, sore throat, sneezing, runny nose, tiredness, overall feeling bad.

Patient incorrectly received HIB in place of ordered Menveo vaccine. No adverse outcome noted. Patient remains stable with no medical intervention required.

Diagnosed with flu; Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024; Fever; Aches and pains; Fatigue; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a male patient of unknown age. Concomitant Medications: Unknown Medical History: Unknown Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: 0.5 ml, route of administration and anatomical location: not reported. Lot number: not reported but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Jan-2025, the patient experienced Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024 (Medically Significant, outcome: Unknown). On 19-Jan-2025, the patient experienced Diagnosed with flu (Medically Significant, outcome: Unknown). Associated symptoms included: Fever, Aches and pains, Fatigue. The patient reported that had tested positive for the flu on Sunday 19-Jan-2025. He received a Flucelvax vaccine on 29-Oct-2024. Side effects he had had were fever, aches and pains and fatigue. Patient reported that he was diagnosed with flu (influenza) after taking Flucelvax. Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter’s Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.