Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Headache, Hyperhidrosis, Insomnia
Clinical narrative: CHILLS, TEETH CHATTERING,SHAKING; HEADACHE; SENSITIVE SKIN; PAINFUL KNEES; SEIZURE (MUSCLE CONTRACTIONS); FEBRILE,SKIN ON FIRE RED AND HOT; SKIN HURT TO TOUCH; ACID REFLUX; RASPY VOICE; DRY MOUTH; NO SLEEP; SWEATS; BODY ACHE; EXHAUSTION; This spontaneous report received from a pharmacist concerned a 58 year old white male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiatal hernia, high cholesterol, and penicillin allergy, patient medical history included injury at work and finger injury and other pre-existing medical conditions included in the past 30 days no other illness, no other vaccines received. patient had no history of prior seizures and never had covid19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 17-APR-2021) dose was not reported, administered on 20-MAR-2021 16:00 on left arm for prophylactic vaccination. Concomitant medications included omeprazole for hiatal hernia, fenofibrate for high cholesterol, cyanocobalamin, ergocalciferol, folic acid, krill oil, nicotinic acid, and testosterone.  On 20-MAR-2021 after receiving vaccine patient was feeling fine and did not report anything unusual. On 21-MAR-2021at 12:15am patient experienced full body chills, teeth chattering and shaking and took Publix generic Tylenol 1000mg at 12:20am. It was stated that severe shaking and chills to seizures multiple episodes realized this looks like febrile seizure. Temperature was measured on 21-MAR-2021 at 98F when Tylenol was given at 12:20am, temperature continued to increase, 99.7F 45 min later and 100.2F about an hour after Tylenol was given. It was stated that seizure episodes stopped after about 1.5 hours and temperature was measured at 100.6F and episodes of muscle spasm of the jaw, neck, shoulder and back of quads occurred 7-10 times on and off and would last about 5-10 seconds per episode. The muscle aches and spasms were strong and distorted his face during the time when the muscles in his jaw were seizing and also his mouth change shape when the seizure started. Skin was red and hot on patients back, neck, forehead and both arms. It was also mentioned that spacing of the contractions, interval between episodes was long enough. patient had severe headache starting when seizures began and also after seizure episodes that lasted until 5am 21-MAR-21. Headache was described by patient as worse than a migraine. And seizure reaction stopped after 1.5 hours after dose of Tylenol that was given at 12:20am on 21-MAR-2021. Body sweats began after seizure episodes ended and lasted until 5am on 21-MAR-2021. Patient was exhausted and in pain afterward and also complained knees were painful and mouth was dry. Patient complained of stomach pain and acid reflux in middle of the night 21-MAR-2021. Gaviscon 10ml liquid was given by reporter after seizure stopped at 3:30am 21-MAR-21.  Patient had no sleep at all, had sweats and complained about being hot. Fever broke 5am on 21-MAR-21 and after that patient started to feel better. Skin hurt from touch, whole body was achy sore and started generic Aleeve 220mg every 12 hours alternating with generic Tylenol 1000mg q8h. Reporter gave patient Benedryl 25mg for sleep 21-MAR-21 at 1:30pm and patient slept until 6pm. On 22-MAR-2021, patient experienced sensitive skin, it was reported knees were still hurt and voice started sounding like getting a cold, raspy. Laboratory data included: Body temperature (NR: not provided) 99.7 F, 100.2 F, 100.6 F. Treatment medications included: alginic acid/aluminium hydroxide gel, dried/magnesium trisilicate/sodium alginate/sodium bicarbonate, diphenhydramine hydrochloride, and paracetamol. On 21-MAR-2021 12:15, Laboratory data included: Body temperature (NR: not provided) 98 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (muscle contractions) on 21-MAR-2021 03:30, acid reflux, raspy voice, and sweats on 21-MAR-2021, was recovering from headache, painful knees, skin hurt to touch, and and the outcome of dry mouth, no sleep, febrile, skin on fire red and hot, chills, teeth chattering, shaking and sensitive skin, body ache ,exhaustion was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 22-MAR-2021. Upon review, the following information was amended:  medical history updated,(seizure (muscle contraction)  and febrile, skin on fire red and hot) upgraded as serious, addition of non serious events (chills, teeth chattering ,shaking, sensitive skin, body aches and exhaustion), events deleted(muscle spasm of the jaw, neck, shoulder and back of quads, stomach pain,  Muscle pain and ache, Skin on fire red and hot as subsumed), concomitant medications (Vitamin B12 and D2); Sender's Comments: v1: Version created to upgrade events (seizure (muscle contraction)  and febrile, skin on fire red and hot) upgraded as serious, addition of non serious events (chills, teeth chattering ,shaking, sensitive skin, bodyaches and exhaustion), events deleted(muscle spasm of the jaw, neck, shoulder and back of quads,stomach pain,  Muscle pain and ache, Skin on fire red and hot as subsumed), concomitant medications (Vitamin B12 and D2) and medical history. 20210342262-COVID-19 VACCINE AD26.COV2.s-Febrile/ Skin on fire red and hot. This event(s) is labeled per RSI and is therefore considered potentially related.  20210342262-COVID-19 VACCINE AD26.COV2.s-Seizure (muscle contraction). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s