Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Joint stiffness, Limb discomfort, Muscular weakness
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SEVERE MUSCLE WEAKNESS; SEVERE JOINT PAIN; SEVERE BURNING; LITTLE NUMBNESS ON FACE; PAINFUL HANDS; LEGS FEEL LIKE LED WEIGHT; HANDS AND JOINTS ARE STIFF; TROUBLE WALKING; COULD NOT SLEEP FOR HOURS; SPONTANEOUS BRUISING/GIANT BRUISE ON HER BUTTOCKS/BRUISE ON INNER THIGH; CHEST PAIN; HEADACHE; WEAKNESS; HIGH FEVER; BODY ACHES; SWELLING; HEART RATE DROPPED TO 40; LOW PLATELET COUNT; BLISTERS ON THE ROOF OF MOUTH; This spontaneous report received from a patient concerned a female of unspecified age and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient used to have slight histamine reaction sometimes, just if she is having a bit of alcohol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, 1 total, first dose administered on 11-AUG-2021 at left arm for covid-19 prophylaxis. No concomitant medications were reported.  On 11-Aug-2021, right after patient received the vaccine, experienced swelling for which she took a dose of inhaler and she was ok. On the same day, 3 hours after the vaccination, she had high fever, body aches, and weakness. She took the next 2 days off of work. And went to the ER (emergency room) to get checked out. Her platelets were low and her heart rate dropped to 40. They started her on Eliquis and Prednisone. She took 2 rounds of steroids (4 weeks each, so 8 weeks total). In Aug-2021, she also developed a giant bruise on her buttocks (captured as spontaneous bruising/giant bruise on her buttocks/bruise on inner thigh). She ended up being completely out of for 2.5 weeks (no work) but the total recovery time was 11 weeks. She also had severe muscle weakness and joint pain. In Aug-2021, about 10 days after vaccination, she developed blisters on the roof of her mouth. On an unspecified date, 3 months later, she tested positive for covid-19 which led to confirmed vaccination failure and had symptoms again that affected her joints (pain and severe burning) and muscle weakness. No lungs issues however. On 02-Aug-2022, symptoms of muscle weakness and headaches restarted suddenly. On 08-Aug-2022, she also had chest pain in night. On 09-Aug-2022, legs feel like led weight, little numbness on face, hands and joints are waking her up at night (hands and joints are stiff). She was having trouble walking again and couldn't sleep for hours. She had bruise on inner thigh. She felt like she was having a re-flare of her post-vaccination symptoms but milder. She had a doctor appointment scheduled. Her GP (general physician) was aware of her post-vaccination reactions (saw her after vaccination 2-3 times). Laboratory data included: COVID-19 virus test Negative (She was tested negative twice on an unspecified date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 40, swelling, body aches, low platelet count, weakness, and high fever on OCT-2021, and severe burning, had not recovered from confirmed covid-19 infection, and the outcome of severe joint pain, blisters on the roof of mouth, severe muscle weakness, chest pain, legs feel like led weight, little numbness on face, painful hands, hands and joints are stiff, trouble walking, could not sleep for hours, spontaneous bruising/giant bruise on her buttocks/bruise on inner thigh, confirmed clinical vaccination failure and headache was not reported. This report was associated with product quality complaint 90000245780. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220818843-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20220818843-covid-19 vaccine ad26.cov2.s-heart rate dropped to 40. 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). Therefore, this event(s) is considered unassessable.