Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Injection site pain, Injection site swelling
Clinical narrative: ANAPHYLACTIC REACTION; PAIN ON LEFT ARM AT SITE OF INJECTION; MINOR SWELLING OF LEFT ARM AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic reactions to Penicillin and erythromycin, tetracycline, Streptomycin, sulfa, salmon, eggs, sensitivity to nuts, orange juice, anaphylaxis, non smoker, and non alcohol user and asthma other pre-existing medical conditions included: The Patient did not had history of drug abuse/illicit drug use. Patient not on any other medication at the time the adverse event started. Patient did not had illness at the time of vaccination and adverse event after any previous vaccination. Patient did not had pre-existing acute illness 30 days prior to vaccination, history of hospitalization in last 30 days, with cause. Patient did not had family history of any disease (relevant to vaccination) and allergy. Patient was not pregnant at time of vaccination and currently was not breastfeeding. The patient experienced achiness and tired when they received covid-19 vaccine ad26.cov2.s (Series 1) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Series 2 Booster dose) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, frequency one total, administered at left arm, on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021 within 5 minutes of received the booster, the patient experienced anaphylactic reaction and pain on left arm site of injection and minor swelling on left arm site of injection .The patient experienced coughing non stop, it was more a reaction and not exposure to something therefore the patient took a dose of rescue inhaler pro air and did not tell the pharmacy staff as the patient did not want to give epi-pen or the ambulance to be called. The patient waited in the pharmacy for 15 minutes then went to a store and realized that face felt hot, as prone to allergic reactions and anaphylaxis so went home and took liquid Benadryl (4 doses). The patient experienced swollen face red and hot and had a post nasal type drip type reaction (difficulty breathing). The patient was much better and it was about an hour and 10 minutes. The patient only had a little achiness and felt tired after the original dose, patient received (Series 1) on 11-MAR-2021, lot number was 1802072 and it was also administered on left arm. Treatment medications included: salbutamol sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from anaphylactic reaction ,Pain on left arm at site of injection, and minor swelling of left arm at site of injection. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211122735.; Sender's Comments: V0: 20211106318-covid-19 vaccine ad26.cov2.s-anaphylactic reaction. This event(s) is labeled per regulatory authority and is therefore considered potentially related.