Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, X-ray
Clinical narrative: COVID-19 PNEUMONIA; ALLERGY TO VACCINE; STOOLS HARD; STOMACH SWELL UP; MUSCLE SPASMS/ CRAMPS; BREAST SWELLING; PAIN FROM BACK OF SPINE TO TOP OF THE HEAD; NUMBNESS IN THE FINGERS; ABDOMINAL TENDERNESS; BLANKED OUT; RINGING IN THE EAR; FACIAL SWELLING; PAINFUL BLISTER; DIFFICULTY EATING; This spontaneous report received from a patient concerned a 48 year old (Indian or Native/aboriginal) female. The patient's weight was 272 pounds, and height was 66 inches.  The patient's past medical history included partial tubal ligation, and part of colon removed, and concurrent conditions included asthma, bronchitis, bleeding disorder (irregular period), cyst on ovary, gerd, high blood pressure, adhd, dysmenorrhea, tingling of extremities, asa allergy, narcotics allergy, soap residue allergy, lactose intolerance, tramadol allergy, sulfa antibiotics allergy, strawberry extract allergy, penicillin allergy, metronidazole allergy, nalbuphine allergy, oxybutynin allergy, bees wax allergy, haloperidol allergy, fluoxetine allergy, medroxy progesterone allergy, gabapentin allergy, and latex allergy. The patient had a blood test with her MD prior to and was told did not have Covid and could get the shot. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered to right arm on 16-MAR-2021, around 16:00 for prophylactic vaccination. No concomitant medications were reported. The patient was treated with injections to prevent blood clots (they did injection in the stomach area).  On 16-MAR-2021, around 09:00 PM, patient experienced facial swelling and blister on the right side of her lip was burst and formed a scab and that made it difficult to eat. On next morning, 17-MAR-2021, patient had excruciating pain from top of her head to nostrils, it caused being weak and blanked out. On the day after, 18-MAR-2021, patient had a different taste and a different smell, also had ringing in the ear and was nauseous. On the 5th day, 20-MAR-2021, patient's stomach was swelled and was really tender and breast was also swelled. The patient had a lot of headache, cramps, muscle spasms, body ache and was cold and hot. The patient had diarrhoea and had to lay down and had to crawl to bathroom with throwing up. The patient had high fever and could not keep anything down. On 20-MAR-2021, the patient experienced pain from back of spine to top of the head, numbness in the fingers. On 22-APR-2021, the patient experienced hard stools. On 27-MAR-2021, patient was hospitalized as she was coughing blood. On an unknown date, patient had patches on the x-ray and was diagnosed with pneumonia and her Covid (unknown) test was positive. Patient reported that she was given injections to prevent blood clots in the stomach area. The patient had pain back from spine to top of the head, was weak, had numbness in the fingers. She had headache, had lost appetite. The patient reported that as per her healthcare providers, was allergic to the vaccine as they noted shortness of breath, nausea and diarrhea. Laboratory data included: Body temperature (NR: not provided) High. On 27-MAR-2021, COVID-19 virus test positive (NR: not provided) positive, and X-ray (NR: not provided) blood patched, pneumonia. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, and ringing in the ear, was recovering from facial swelling, painful blister, difficulty eating, stomach swell up, muscle spasms/ cramps, blanked out, and abdominal tenderness, had not recovered from pain from back of spine to top of the head, numbness in the fingers, and stools hard, and the outcome of allergy to vaccine and breast swelling was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210507603-covid-19 vaccine ad26.cov2.s -covid-19 pneumonia. This event(s) is considered not related. 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: UNDERLYING DISEASE