Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Allergic reaction; Itching in the left arm where she received the vaccine/itching at the injection site; Large hives on the same arm about 5 inches in diameter/ Injection site hives; Itching [at the injecon site that became and] then it spread to the chest and left arm; Arm was also swollen; This is a spontaneous case, reported by other non-health professional (consumer) to VAERS and initially received on 14-Jan-2019, concerning a 53-year-old adult female patient.  The patient historical condition included allergic reactions NOS. The patient had alpha gal allergy. The patient did not receive any concomitant medications.  On 12-Jan-2019, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252684 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On 13-Jan-2019, at 20:30 hours (the next day around 12 hours later), 1 day 20 hours 30 minutes after vaccination, the patient developed an allergic reaction. It started with itching in the left arm where patient received the vaccine. Then, the patient developed large hives on the same arm about 5 inches in diameter. The hives were raised and had definition along the edges. On the same day, itching was spread to the chest and left arm and the arm was swollen. The patient took 2, 25 mg tablets of Benadryl (diphenhydramine hydrochloride) as treatment and felt asleep at 21:30 hours. On the same day (reported as this morning) there was no itching or hives but had just red dots that looked like broken blood vessels. On the same night, symptoms reverted.  The patient recovered from the events on 13-Jan-2019.  The reporter assessed the case as non-serious.  Follow-up received from the reporter on 21-Mar-2019: The reporter's name, address (including state, city, postal code, county), phone number and email address was updated in the general tab. The patient's address (including state, city, postal code, county), phone number and email address was updated in the patient tab. Start date (13-Jan-2019) of the Benadryl was updated in the product tab. Start date of the events was updated (from 12-Jan-2019, 20:30 to 13-Jan-2019). The events peripheral swelling and generalized itching were added in the event tab. Stop date (13-Jan-2019) of the events were updated in the event tab. Med Info Number (SEQ19-01033) was added in additional information tab. It was reported that, the patient contacted her pharmacist that she was aware of her allergy to anything from mammalians (Alpha-Gal Allergy), but the pharmacist thought this was an egg-based vaccine and patient also reported that the package insert was not very clear about that. The narrative and case comment was amended accordingly.  Non-significant follow up received from other non-health professional (consumer) on 11-Apr-2019: The reporter confirmed that, the stop date of the event was 13-Jan-2019, since symptoms were reverted in that same night. No changes were made in narrative.; Reporter's Comments: A 53-year-old female patient experienced allergic reaction which started with itching, hives on the injection site, swollen arm and generalised itching, 1 day 20 hours 30 minutes after administration of Flucelvax QIVc. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine.