Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Heart rate, Heart rate increased, Injection site pain
Clinical narrative: FEELING OVERHEATED; INCREASED HEART RATE; BACK HURT; FEELING CLAMMY; KNEE HURT; BAD HEADACHE; FATIGUE; FEVER; SORE ARM; INJECTION SITE BURNING; ANAPHYLACTIC REACTION; LITTLE BRAIN FOG; LOSS OF APPETITE; DIARRHOEA; BODYACHE; CHILLS; This spontaneous report received from a patient concerned a 59 year old white and not Hispanic or Latino male. Initial information was processed with the additional information received on 07-JUN-2021. The patient's height, and weight were not reported. The patient's past medical history included immunotherapy, and concurrent conditions included has pacemaker, seizure, and Crohn's disease. The patient was on an unspecified anti-seizure medication. The patient had an anaphylactic reaction to an unspecified anaesthetic drug. The patient experienced anaphylactic shock when treated with amoxicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient had an anaphylactic reaction to Janssen COVID vaccine. The patient started to experience throat tightening 2 minutes after getting vaccine, also started to experience sweating as well. The patient was given Epipen at the pharmacy, which seemed to reduce severity of the symptoms. The patient took Benadryl at home about 15 minutes after coming home and felt some relief after taking Benadryl, but was using oxygen currently at home as was still having some difficulty breathing after the vaccination. Treatment medications included: oxygen, diphenhydramine hydrochloride, and epinephrine. It was reported that the patient had not gone to emergency room (ER) as of yet. The patient's arm was burning at the injection site when was injected and was experiencing sore arm after the vaccination. The patient asked what could he take to alleviate symptoms but was advised to speak to their family MD or community pharmacist regarding that. On 05-JUN-2021, the patient also experienced loss of appetite, had bad headache, diarrhea, fatigue, body aches and fever of 101 F with chills the day after receiving vaccine, which worsened into the night. The fever lasted half the day but was resolved by that evening without any medication. The patient also checked oxygen and it dropped to 90 percent (O2 saturation) on same day, it usually ran around 95. It was reported that the patient no longer had headache, it lasted only Saturday, but still had diarrhea, lack of appetite, and a little bit of brain fog. On 05-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, and Oxygen saturation (NR: not provided) 90 percent. On 06-JUN-2021, the following evening Sunday was more severe, particularly the patient's knees and back were hurting. The patient woke up several times throughout night to apply Bengay. Treatment medications included: menthol/methyl salicylate. On the Sunday evening the patient started feeling clammy. The patient woke up in the morning on the reporting day and was feeling overheated and was sweating although took temperature at 97 F, had no fever. On 07-JUN-2021, during call, the patient checked oxygen saturation was at 91 percent. It was reported that the patient's heart rate was supposed to 85 beats per minute (bpm) due to pacemaker, but currently was at 128 bpm. On 07-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97 F, Oxygen saturation (NR: not provided) 91 percent and Heart rate (NR: not provided) 128 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headache, and fever on 05-JUN-2021, had not recovered from anaphylactic reaction, loss of appetite, diarrhoea, bodyache, and little brain fog, and the outcome of sore arm, injection site burning, fatigue, back hurt, feeling clammy, feeling overheated, knee hurt, increased heart rate and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210613072-COVID-19 VACCINE AD26.COV2.S-Anaphylactic Reaction. This event is labeled per RSI and is therefore considered potentially related.