Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: JOINT PAIN IN ELBOW; HARD TO MOVE; NECK STIFFNESS; SENSITIVITY TO LIGHT; HEADACHE; FEVER; MUSCLE ACHE; CHILLS; INJECTION ARM WENT NUMB; NUMBNESS/ LOST FEELING IN FINGERS; DIZZINESS; TINGLING IN HAND AND ARM; ANAPHYLAXIS; ARRHYTHMIA; SHOOTING PAIN DOWN ARM THROUGH FINGERS AND UP NECK; RACING HEART; UNABLE TO GET OUT OF BED, UNABLE TO WORK; COMA LIKE; LEGS BUCKLED OUT FROM UNDER ME WHEN I TRIED TO WALK; CONCUSSION LIKE SYMPTOMS; INJECTION ARM TINGLY OFF AND ON; BRAIN  SWELLING FROM TOXIN EXPOSURE; This spontaneous report received from a patient via a company representative and concerned a female of unspecified age, ethnic origin and race. The patient's height, and weight were not reported. The patient's past medical history included ruptured quadriceps. The patient's concurrent conditions included severe migrane, methylene tetrahydrofolate reductase (mthfr) gene mutation, headache, fatigue, and muscle ache, and  patient did not have food allergy. The patient experienced anaphylaxis when treated with doxycycline, and brain swelling, high temperature (108) and grand mal seizures when treated with diphtheria vaccine toxoid/pertussis vaccine/tetanus vaccine toxoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included calcium levomefolate. On 14-MAR-2021, about 2-3 minutes after the injection, patient got shooting pain down my arm through my fingers and up my neck (only in the injection arm). On 14-MAR-2021, about 20 minutes after injection, the subject developed anaphylaxis while onsite when her throat and tongue swelling started. The patient was treated on unspecified antihistamine. The patient was told she may be drowsy from antihistamine. On 14-MAR-2021, the patient stated about a half hour to an hour after the vaccine injection her wrist went limp and was hard to move. On 14-MAR-2021 in the afternoon, patient was feverish at 99.1. The patient's baseline temperature was 96.5-97.1.  On 14-MAR-2021, patient experienced racing heart and arrhythmia that afternoon, several times at night, and over the next couple days. That night temperature went to 104.8 and severe chills and fever all night. In MAR-2021, patient's injection arm went numb and tingly off and on, and lost feeling in my fingers several times. The patient had stabbing pain in the right side back (kidney height) that radiated through my whole back and down through my glutes. Patient figured that was just the muscle aches. The pain got so bad patient was doubled over when she tried to stand and hurt to lay down. The patient's legs also buckled out from under her when she tried to walk, lost balance and felt dizzy. The patient had been drinking a lot of water through the night to stay hydrated so it didn't seem to be from dehydration and was still urinating. The patient took ibuprofen when she realized   temperature was that high. The patient was concerned with her temperature spiking. On 15-MAR-2021, next day, when patient's mother came to check on her and tried to get her up, the patient could not open her eyes (although heard her) and was not able to get out of bed (PT of Loss of personal independence in daily activities). The patient usually gets up with no problem, even if she is exhausted. The patient felt like she could not move. The patient's mom came back in 4 hours. The patient only got up long enough to use the bathroom and get some water and she barely made it to the couch and was out again. Patient told her mom that this felt like way more than fatigue. Normally, the patient can handle jet lag without falling asleep and (although not good) have still been able to function after two all-nighters in a row working on research deadlines (and with migraine).  The patient noted this was a new feeling for her. Even with taking ibuprofen several times a day/night, it would temporarily bring my temperature down but temperature remained around 102.1 for going on the 5th day, in MAR-2021.  On unspecified date in MAR-2021, patient saw her doctor yesterday and told him she can hardly remember anything from the time she got home from the vaccine through now, and it did not feel like normal sleep. The patient said the only thing she could think of to describe it is coma-like (PT of Coma). The patient had been writing symptoms down as she experience them and look back. The patient experienced headache, neck stiffness, sensitivity to light further described she would not even turn the bathroom light on at night and have been staying in a dark room. The patient was not able to work remotely (PT of Loss of personal independence in daily activities). Patient further described as she could hold her phone in hand if she tried really hard a maximum of 5-10 minutes before it would drop out of her hand and had to close her eyes. She reported it felt hard to write, read and speak the first three days after the vaccine injection. It was a bit better, but still takes a lot of effort. When patient went to see her physician, physician said it was brain swelling from toxin exposure. The patient consulted with neurologist who said it sounded like brain swelling and impact to brain stem and mid brain. On an unspecified date in MAR-2021, last night was the first night patient did not take ibuprofen because she was trying to clear it from her system and see if the fever will stay down. The patient's temperature was 102 again today, on MAR-2021.  The numbness and tingling in my hand and arm subsided yesterday, in MAR-2021. The patient had no rash and no nausea or vomiting, but all other symptoms such as joint pain in my elbow and wrist run the injection arm were there worst and the pain in that arm was severe if anything touched it. On unspecified date, the patient consulted several physicians and one wrote back that symptoms were most like concussion and to treat it like that. Laboratory data (dates unspecified) included: Blood test was normal. The body temperature in MAR-2021 104.8, 102.1, 102. The endocrine test was normal and Magnetic resonance imaging was normal.  Treatment medications (dates unspecified, in MAR-2021) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness/ lost feeling in fingers, and tingling in hand and arm on MAR-2021, had not recovered from joint pain in elbow, and the outcome of brain swelling from toxin exposure, shooting pain down arm through fingers and up neck, fever, racing heart, arrhythmia, chills, muscle ache, dizziness, hard to move, injection arm went numb, injection arm tingly off and on, headache, neck stiffness, sensitivity to light, anaphylaxis, legs buckled out from under me when i tried to walk, unable to get out of bed, unable to work, concussion like symptoms and coma like was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 A female patient of unspecified age with the past medical history of "anaphylaxis" when treated with doxycycline, and seizures, "brain swelling" and hyperpyrexia when vaccinated with DPT, experienced a shooting pain down arm through fingers and up neck 2-3 minutes after being vaccinated with Janssen COVID-19 Vaccine Ad26.COV2.S. Approximately 20 minutes after injection, she developed "anaphylaxis" while onsite when her throat and tongue swelling started and was treated with antihistamine. On the same day, about a half hour to an hour after the vaccine injection her wrist went limp and was hard to move and, in the afternoon, she was feverish at 99.1. Later in the afternoon she experienced racing heart and arrhythmia, at night she had chills with a maximum temperature of 104.8. On unspecified date patient's injection arm went numb and tingly off and on, and she lost feeling in her fingers several times. She had stabbing pain in the right side back. Her legs also buckled out from under her when she tried to walk, lost balance and felt dizzy. The next day, the patient could not open her eyes and was not able to get out of bed. On unspecified date she saw her doctor and told him she can hardly remember anything from the time she got home from the vaccine through now, and it did not feel like normal sleep. The patient experienced headache, neck stiffness, sensitivity to light. Her physician said it was "brain swelling from toxin exposure". On unspecified date, she consulted several physicians and one wrote back that symptoms were most like concussion. Blood test, dates unspecified, was normal. The endocrine test and magnetic resonance imaging were normal. Although the information presented by the patient is unusual and complicated, based on the subject's medical history and compatible temporal relationship the causality for the events has been assessed possibly related to Janssen COVID-19 Vaccine.