Johnson & Johnson

Severe headache started within 6 hrs. of injection. Had a slight rise in temperature to 99.9. Very sleepy and tired. Muscle aches in legs and buttocks. Slight nausea. Took extra strength Tylenol. Slept off and on for next 24 hours. Had severe sweats and chills. All symptoms were just like I had had early December, 2020 when I had COVID, as per verified by a COVID nasal test done at local hospital.

LEFT ARM WAS EXTREMELY SORE. BODY ACHES ALL OVER, LOW GRADE FEVER, NO APPETITE, FATIGUE FOR 24 HOURS,

Extreme fatigue from 3/11/21 to3/19/21; Severe headache from 3/12/21 to 3/18/21; light-headed sensation 3/12/21 to 3/20/21; fainted 3/17/21; gastrointestinal issues and severe cramping the evening of 3/15/21 to 3/17/21; gastrointestinal issues (constipation followed with diarrhea without cramping).Colo

Patient reported feeling dizzy, nauseated and lightheaded Patient provided with water and seen by medical team Patient stated symptoms resolved, refused medical transport and signed AMA form Patient?s family drove him back home

"Janssen COVID-19 Vaccine EUA" Dizziness, ringing in ears, nausea (used Sea Bands for nausea, situation was resolved in 12 hours.

Patient received the vaccine on 4-9-2021, on 4-10-21 patient felt "blah," on 4-11-21 patient got up and around and was ok, on 4-13-21 patient was not feeling real great, but was tolerable, on 4-14-21, patient was feeling worse with blurred vision, throwing up, aches, doesn't want to eat, dizziness. Recommended that patient contact their primary care doctor for further treatment. On 4-13-21 pt went to ER and was admitted for one night, on 4-14-21 pt was dismissed from hospital, and is feeling improved.

WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

patients left neck , jaw, is exremely swollen and hurts to swallow. Recommended for patient to go to urgent care and I followed up with her primary care doctor within a hour of her reporting.

This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.

Chills (no fever) within 24 hours of the Janssen vaccination, lethargic, no appetite. Very dizzy and lightheaded on day 5 and day 6 after the Janssen vaccination with continued lethargy and loss of appetite for approximately 3 weeks. Heavy nosebleed in left side of nostril with large blood clots for 1.5 hours approximately 3 weeks after the Janssen vaccination

the day after the vaccine I got a headache that became a terrible Migraine that lasted for 4 day, subsided and then returned. It was bad and I did call and spoke to the nurse and doctor. I vomited for 4 days. I am a little better but this is day 6 and I am still dizzy and have a slight headache

The same night after the vaccine I had shaking violent chills, my teeth were chattering as well. I also was vomiting a lot , I had lots of chills that I could not get warm this went on all night long. The next day I did experience some bad body aches like the flu. The next day after that I slept all day long and tried to hydrate myself back together. Over the next few weeks I noticed how I was running out of breath so fast. I am now suffering from shortness of breath.

ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

MENTAL DECLINE; COGNITIVE IMPAIRMENT; CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY; EQUINE SYNDROME; CONSIDERABLE WEIGHT LOSS; VISION DISTURBANCES; DIARRHEA ON AND OFF; This spontaneous report received from a consumer concerned a 76 year old female. The patient's weight was 159 pounds, and height was not reported. The patient's concurrent conditions included eggs yolk allergy, shellfish allergy (nausea/vomiting), irritable bowel syndrome, essential hypertension, hypomagnesemia, dysphagia, severe protein calorie malnutrition, muscle weakness, and hypothyroid. The patient was not pregnant at the report time. The patient experienced rash when treated with liothyronine sodium, and sertraline, and paralysis when treated with suxamethonium, and hives when treated with penicillin NOS (not otherwise specified), sulfadiazine, and passed out when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1016022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included alendronate sodium for drug used for unknown indication, amlodipine for drug used for unknown indication, amlodipine besilate for drug used for unknown indication, bupropion for drug used for unknown indication, buspirone for drug used for unknown indication, buspirone hydrochloride for drug used for unknown indication, celecoxib for drug used for unknown indication, citalopram hydrobromide for drug used for unknown indication, dicycloverine for drug used for unknown indication, dicycloverine hydrochloride for drug used for unknown indication, ergocalciferol for drug used for unknown indication, levothyroxine for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, naloxone for drug used for unknown indication, ondansetron for drug used for unknown indication, pantoprazole sodium sesquihydrate for drug used for unknown indication, paracetamol for drug used for unknown indication, prochlorperazine for drug used for unknown indication, propranolol for drug used for unknown indication, bupropion hydrochloride, citalopram, colecalciferol, diphenhydramine, docusate/senna alexandrina, heparin, loperamide hydrochloride, macrogol, magnesium oxide, pantoprazole, prednisone, salbutamol, sodium chloride, loperidine and tramadol. The patient's diarrhea started on 08-MAY-2021 and was on and off for several days. The patient had vision disturbance started around 13-MAY-2021 or 14-MAY-2021. The eyes could not focus, and patient could not use cell phone due to vision disturbance. The patient's other problems started around 14-MAY-2021. The patient had been having nerve issues complications (Equine Syndrome). The patient was able to use upper body fine, but lower body had difficulty to mobilize. The patient was moved into a nursing facility and then had issues after that. The patient was having issues swallowing, tremors in face, problems with hands shaking and her fingers were almost bent in a weird position. On 19-MAY-2021, the patient was sent to emergency room (ER). The patient got infusion treatments of IVIG (intravenous immunoglobulin) and other steroids. The issues progressed to the point that she could not use her hands. The patient was in hospital for 6 days. The patient was progressively getting worse and had challenges of choosing correct words when talking to daughter. The rehab facility then sent her back to ER, where she was admitted ever since. The patient could not have foods that were not pureed. The diagnosis was chronic inflammatory demyelinating polyneuropathy and cognitive impairment. On 25-MAY-2021, the patient experienced mental decline. The goal was to give IVIG and prednisone infusions monthly, but unsure if it would help her. As on report time, the patient could use hands and swallow better again. The patient's mental/cognitive decline had been very recent and had not resolved. The patient's daughter had been unsuccessful to get hospital to give her a computerized tomogram scan again. Since MAR-2021, the patient had gone from 220 pounds to 159 pounds now (considerable weight loss). On 20-MAY-2021, the patient was 186 pounds. The rehab facility was giving doses of gabapentin 400 mg thrice daily. When patient refused to take it, they refused to help her, so she started taking it again. The patient was no longer on gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision disturbances on 17-MAY-2021, and diarrhea on and off on an unspecified date, was recovering from chronic inflammatory demyelinating polyneuropathy, and equine syndrome, had not recovered from cognitive impairment, and mental decline, and the outcome of considerable weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a consumer concerns a 76-year-old white female who was diagnosed with chronic inflammatory demyelinating polyneuropathy and cognitive impairment; with symptoms of "vision disturbance", "nerve issue complications" with lower body difficult mobility, issues swallowing, tremors in face, problems with hands shaking and her fingers were almost bent in a weird position approximately 8 days after receiving Janssen Covid-19 vaccine. Concurrent illness includes irritable bowel syndrome, essential hypertension, hypomagnesemia, dysphagia, severe protein calorie malnutrition, muscle weakness, and hypothyroidism. The patient complained of diarrhea 2 days after vaccination. On 13th post-vaccination day (PVD), the patient was brought to the emergency room, IVIG and unspecified steroids were given; the patient was subsequently hospitalized for 6 days. On 19th PVD, the patient presented with "mental decline; and >25kg weight loss in 2 months prior to hospitalization was reported. The patient recovered from vision disturbances and diarrhea; recovering chronic inflammatory demyelinating polyneuropathy, and equine syndrome; not recovered from cognitive impairment, and mental decline; the outcome of outcome of considerable weight loss was not reported. No other details reported. Based on the diagnosis of chronic inflammatory demyelinating polyneuropathy, the latency of 8 days from the vaccination does not suggest a plausible explanation. There is an increased risk of cuada equina in the elderly due to vertebral canal stenosis. The advanced age also increases the risk for mental decline and cognitive impairment. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

ASSESSMENT AND PLAN: 1. Palpitations (Primary) Assessment & Plan: Next step would be to take 1/2 dose metoprolol for any Bp <100/70 but pt doesn't want to do that at this time. Will cont asprin prophylaxis and will check tsh given concurrent fatigue. Will call with results. If normal thyroid, will f/u in 6 months or sooner should condition worsen Orders: - TSH, Reflex Free T4; Future - aspirin 81 mg EC tablet; Take 1 tablet by mouth Daily. Dispense: 90 tablet; Refill: 3 2. Essential hypertension Assessment & Plan: Well controlled at present. Limited by palpitations t hat are controlled by metoprolol but when controlled with metoprolol also occasionally cause some low bp and fatigue of unknown etiology. Will cont for now but may need to decrease metoprolol to 1/2 dose for any Bp <100/70 inf uture. Orders: - metoprolol tartrate (LOPRESSOR) 25 mg tablet; Take 1 tablet by mouth 2 times daily. Dispense: 180 tablet; Refill: 3 3. Fatigue after COVID-19 vaccination Comments: suspect much of fatigue is related to covid 19 vaccination. will monitor 4. Gastroesophageal reflux disease without esophagitis - omeprazole (PRILOSEC) 20 mg capsule; Take 1 capsule by mouth Daily 1 tablet before breakfast . Dispense: 90 capsule; Refill: 2 5. Seborrhea Comments: refilled chronic medications Orders: - desonide (DESOWEN) 0.05 % lotion; Apply 1 Application topically Daily as needed (itch) Apply once daily to prevent ear seborrhea. . Dispense: 59 mL; Refill: 3 - triamcinolone (KENALOG) 0.1% lotion; Apply small amount to affected area(s) two to four times daily as needed: avoid face and groin areas. Dispense: 60 mL; Refill: 3

Pt began experiencing aches, dizziness while walking, chills, and headache on 03/11/2021 at bedtime. Pt began experiencing nausea on 03/12/2021 morning. Pt took Tylenol for symptoms, but received mild relief. Pt was advised to continue taking Tylenol as directed, and if the symptoms worsen or do not resolve in 1-2 days to seek medical care. SPI was consulted and Dr. was notified.

Janssen COVID-19 Vaccine EUA: Adverse effects were nausea, vertigo, headache, body aches, chills, cold sweats for 6 days total. Took Bonine for Vertigo and Nauzene for Nausea.

At 11PM on 4/8/21, I had sharp, stabbing LEFT UPPER QUADRANT PAIN under the rib cage. For the 1st 15 minutes, they came EVERY 30 SECONDS. For the next 15 minutes, the pain came EVERY 30 SECONDS. For the following 30 minutes, the pain came intermittently for 5 more times until midnight. On 4/9/21, at 1PM my LEFT HAND FELT LIKE IT WAS ON FIRE until 12 noon. Since then, no other problems.

headache, abdominal pain, severely swollen right ankle and severe lower right leg pain, swollen left ankle and left lower leg pain, eyesight also was affected

UNABLE TO EAT OR DRINK; PAIN IN THE BODY (NECK & RIGHT ARM/SHOULDER); DIZZINESS; SICK; FEELING LOUSY; DIDN'T WANT TO GET OUT OF BED; WANTED TO SLEEP; FEVER; NAUSEA; FELT WEAK; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 07-APR-2021, the subject experienced unable to eat or drink. On 07-APR-2021, the subject experienced pain in the body (neck & right arm/shoulder). On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced lousy. On 07-APR-2021, the subject experienced didn't want to get out of bed. On 07-APR-2021, the subject experienced wanted to sleep. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced felt weak. On 08-APR-2021 18:50, Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the body (neck & right arm/shoulder), fever, nausea, dizziness, sick, lousy, felt weak, didn't want to get out of bed, unable to eat or drink and wanted to sleep was not reported. This report was non-serious.

NECK HURTS BY HER SHOULDERS; ARMS BOTHERING; TIREDNESS; HEADACHE; NAUSEA; MUSCLE ACHES; INJECTION SITE PAIN; FEVER; PAIN IN RIGHT ARM; SEVERE NECK SWELLING; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronavirus infection, and concurrent conditions included tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe neck swelling. On APR-2021, the subject experienced pain in right arm. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.6 F, 99.9 F, 101.5 F. On 07-APR-2021, the subject experienced neck hurts by her shoulders. On 07-APR-2021, the subject experienced arms bothering. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and injection site pain on APR-2021, had not recovered from tiredness, nausea, muscle aches, fever, arms bothering, and neck hurts by her shoulders, and the outcome of pain in right arm and severe neck swelling was not reported. This report was non-serious.

BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious

After receiving the J&J vaccine 6 weeks ago and started getting stomach cramps that lasted a week, after that it subsided but has never stopped, now I can hardly eat anything. I went to the ER two weeks ago but there was no concern because there were no blood clots. Now my bowel is restricted and I've had auto-immune issue about a year and a half ago. Now just cramps and bloating. I also have a tooth that's come loose and I have a strange taste in my mouth since having the vaccine. I saw the doctor and they just called and the doctor stated that I've continue to have problems I should consider having an ultrasound of my stomach. Also, in the past, I went to Hospital.

June 4 onset of diarrhea around 1pm. Took OTC Kaeopectate to stop diarrhea. Stools turned to nothing but blood. Fatigue, abdominal pain, nausea. Same symptoms as my daughter (she has filed a report). Saw Dr. at PCP office on Monday, June 7th. Blood tests requested. Stool Sample requested. Awaiting results. Since my daughter and myself both came down with same symptoms within 24 hours of each other we were instructed to complete this form and we have been discussing possibility of food poisoning with our PCPs. Still have nausea, chills, abdominal pain. Bloody stools have stopped for me.

:Took vaccine at 1:15pm March 9 then 12 hours later at 1:15 am March she started shivering and threw up once. Felt lousy. Headache No rashes, injection site clear. No fever Took Tylenol 9:30 am for headache

INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 638H8, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced intense diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea. This report was non-serious.

DIARRHEA; HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered to the left deltoid, on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, headache, and pain at injection site on 08-APR-2021. This report was non-serious.

with several days of receiving the shot the following symptoms occurred: severe headache backache severe pain in your abdomen or stomach pain in your chest leg pains joint pains shortness of breath

NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.

FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great. Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.

Sores in mouth and within 3 days it traveled to throat and esophagus. She had trouble eating and elevated blood pressure. She now suffers from severe memory loss.

Extreme pain in stomach with continued diarrhea 4/15/21-5/1/21. Visited Dr. 4/26/21 who ordered CT scan. Visited DR. 4/28/21. Dr. admitted me to Hospitalon 4/28/21. Dr. performed Colonoscopy with Biopsy and Endoscopy on4/30/21. Diagnosis with Enteritis inflammation of the small intestine.

Received vaccination March 29th, 2021, I started getting COVID symptoms headache, fever, body aches, extreme fatigue, Diarrhea, May 9th, 2021. I Called my PCP and they directed to go to the Urgent Care to get checked out. They did a physical Exam, COVID test, and Influenza A-B tests, both came out negative. ER determined that I was diagnosed with "Acute Upper Respiratory Infection - Encounter for Screening COVID-19," nothing too bad. My PCP just wanted to check that I did not have COVID and to check out all the basis. I was in the ER for about an hour and then went home. I self isolated for 2 weeks, symptoms lasted for about a week.

Extreme fatigue April 17-18 (slept all weekend). May 13 vomited dinner. Had chills followed by fever and constant sleeping, which continued until I went to the ER on May 17th. I was given a CT scan, told I had a virus and sent home. On May 21 the chills and fever returned and I was unable to function. I was admitted to the hospital on the night of May 21st and given chest xrays, CT scan, hooked up to heart monitor, etc. and was told I had a liver abscess. I had none of the symptoms of liver problems (i.e., chest or abdomen pain) but went through the drainage process. I am still wearing a drain, which emits very little fluids. I had been unable to eat any solid food since May 14th to May 27th.

SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.

Fever, headache, stomach cramps, rectal bleeding when I tried to go to bathroom. Bleeding lasted 3 days

within a few hours of receiving J&J vaccine, she started having nausea, vomiting and diarrhea. She then started having increased arthralgias with myalgias. She was unable to tolerate foods or liquids for 36 hours. She required IV hydration. 5 large whelps present to back with scattered fine rash to entire body (no itching or irritation). Denied fever, but did complain of chills.

This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event 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.

Tiredness, pain in right side of the body stopped at knee, dizziness, unbalance, loss of appetite, symptoms continued about a week, pain in back, burning effect, takes Tylenol every 8 hours

Mild shivers, then intense dry heaves for about 10 minutes (?) (was in bed sleeping), complete loss of bladder control (never before) when stood up Slept through much of the morning. Was OK after.

79 y.o. female who presents to ED on 3/16/2021 with body aches, headache and nausea/vomiting. Patient's daughter reports patient received the Johnson & Johnson single-dose Covid vaccine 4 days ago (on 03/13/2021 at about 3 PM.) prior to ED visit. The next morning woke up not feeling well. Has had generalized body aches and headache. Has also had nausea and vomiting. Patient is able to tolerate some fluids, but anytime eats anything will vomit. Reports has had some loose stools. Denies blood in the stool or vomit. Reports aching pain to the abdomen, not worse in any particular area. Has pain to the right side of the chest that has been constant for the last 3 days. Chest pain is worse with movement and standing, but not worse with exertion. Denies difficulty breathing, cough, fever, sore throat or congestion.

Flu-like Illness started Day 2 at waking up. 2 nights of Weird , confusing dreams, chills, Nausea, fatigue - tiredness, some quick headaches, NO fever, lasted through day 5

This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included suffers from sciatia nerve pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cyanocobalamin/pyridoxine hydrochloride/thiamine hydrochloride for pain, and tramadol for sciatic nerve pain. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced achiness. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on 03-APR-2021, and cough on 05-APR-2021, and was recovering from headache, sore arm, and achiness. This report was non-serious.

bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting

2 days after vaccination, patient started having vertigo, nausea and headaches. That day she tried to notify her doctor unsuccessfully. 2 days after that patient's headache became extreme and she lost her vision in one eye. Family doctor prescribed migraine medication and referred her to her eye doctor for the next day. The eye doctor told her he believes she had a stroke after a full exam. Stroke confirmed with MRI per family doctor. The stroke was in the occipital area. Referred to neurologist at present time. Vision loss persists. Patient is starting physical therapy and following up with neurologist, eye doctor and cardiologist.

FELT NAUSEOUS; This spontaneous report received from a consumer concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced felt nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt nauseous on 07-APR-2021. This report was non-serious.

SWELLING IN CALF; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, joint pain, macrobid iv dye allergy, and bowel impacting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included oxybutynin for bowel impacting. On 30-MAR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced swelling in calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, and had not recovered from swelling in calf, and nausea. This report was non-serious.

EXTREME DIZZINESS; HIGH BLOOD PRESSURE; VOMITED 3 TIMES; FOUR BOWEL MOVEMENTS; HYPERGLYCEMIA; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 65.5 kilograms, and height was 157.48 centimeters. The patient's concurrent conditions included high blood pressure, elevated cholesterol, non-smoker, alcohol user, hyperlipidemia, and hypertension, and other pre-existing medical conditions included patient had no drug abuse. The patient was previously treated with codeine, and acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included nebivolol hydrochloride for high blood pressure. On 13-MAR-2021, the subject experienced extreme dizziness. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced vomited 3 times. On 13-MAR-2021, the subject experienced four bowel movements. On 13-MAR-2021, the subject experienced hyperglycemia. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Alanine aminotransferase (NR: not provided) 52 IU/L, Alkaline phosphatase (NR: not provided) 80 IU/L, Aspartate aminotransferase (NR: not provided) 42 IU/L, Bilirubin total (NR: not provided) 1.2 mg/dL, Blood test (NR: not provided) Normal, Body temperature (NR: not provided) 34.4 F, Brain natriuretic peptide (NR: not provided) 34 pg/mL, Chest X-ray (NR: not provided) Normal, Diastolic blood pressure (NR: not provided) 99, 88, 68, 59, 43, 67, 57 mmHg, Heart rate (NR: not provided) 70bpm, 65 bpm, High sensitive troponin I (NR: not provided) <0.003 ng/mL, Oxygen saturation (NR: not provided) 92, 91, 93, 91 %, Respiratory rate (NR: not provided), Systolic blood pressure (NR: not provided) 250, 160, 130, 96, 103, 150, 130 mmHg, and Urinalysis (NR: not provided) Normal. On 13-MAR-2021 11:38, Laboratory data included: Pulse rate (NR: not provided) 62 pm. Treatment medications (dates unspecified) included: hydrochlorothiazide/triamterene, valsartan, omega-3 triglycerides, oyster shell, diclofenac, celecoxib, potassium chloride, ubidecarenone, xantofyl/zeaxanthin, simvastatin, and ascorbic acid/betacarotene/biotin/calcium/chlorine/chromium/copper/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/iodine/magnesium/manganese/molybdenum/nickel/nicotinamide/pantothenic acid/phosphorus/phytomenadione/potassium/pyridoxine hydrochloride/retinol/riboflavin/selenium/silicon/thiamine/vanadium/vitamin d nos/xantofyl/zinc. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme dizziness, high blood pressure, vomited 3 times, and nausea on 16-MAR-2021, and the outcome of four bowel movements and hyperglycemia was not reported. This report was non-serious.

Receive vaccination on 4/7/21, on 4/17/21 evening minor chest pain simulating heartburn started, on 4/19/21 progressed to severe pain, went to Emergency Room, where she was admitted the FIRST TIME, several test were done and they could not locate source of pain, Just treated with Morphine for pain; my mother was discharged on 4/21/21 with NO answer to the cause for SEVERE pain, just chest ray showed a SMALL amount of fluid. Upon release my mother continued with mild pain, Until it was unbearable on 4-30-21 Admitted for the SECOND TIME until this present, This time alot of fluid was found outside her lungs, then moved to around her heart causing cardiac unrest AND STILL IN HOSPITAL....A biopsy of the fluid was done before her cardiac unrest and hospital is still waiting for results of Fluid Biopsy.

30 min after vaccination patient felt nausea and started vomiting, chest tightness, trouble breathing, "funky" feeling at chest, sudden movements cause dizziness . pt notified us on 05/11 and symptoms have resolved, pt instructed to monitor for continue symptoms especially related to chest symptoms tightness, SOB, etc and to go to ER if symptoms arose again

after getting the vaccine in morning, later that same evening patient felt sluggish, nauseaus, tired. Daughter finally convinced patient to see a doctor. Md prescribed her a cough medication. She still felt bad for another 2-3 weeks, so she finally went to the emergency room where she diagnosed with blood clots in the legs and the lungs. She staying in hospital approx. 4-5 days before being released.

ABDOMINAL PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced flu-like symptoms. On 28-JUN-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and the outcome of abdominal pain was not reported. This report was non-serious.

HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

day 1 (Thurs) terrible chills, headache and violent burping and diarrhea (drank plenty of fluids) day 2: (Fri) diarrhea (lots of fluid and took Imodium) nausea every time I ate anything, no matter how small. day 3: (Sat) more violent burps and nausea and vomiting Saturday night (around 8 pm) and diarrhea (began feeling so sick) with no control. Constant diarrhea. Still vomiting day 4 (Sunday) could no longer keep fluid down, ALL DAY horrible vomiting, involuntary vomiting of something that looked like it came from the bowel and not stomach. Horrible smelling. so severe I went to hospital ER at 11pm. And dry heaves Completely dehydrated and diagnosed with severe gastroenteritis. Had IV fluids, zofran,

2 pm (1 hr after vaccination...felt strange feeling in the brain ... my son did, too on his shot.) 8 pm Shook so much and teeth chattered; didn't want my teeth to chip. Jumped in a hot shower for 15 minutes and that went away. I thought maybe my blood pressure had dropped too low; had same reaction when first put on too much blood pressure lowering medication. Or sometimes allergy makes the blood pressure drop. For 24 hours after that I was on the couch or in bed lying down; brain hurt(BAD headache), stiff neck, a big effort to lift my head off the pillow so I didn't unless I had to go to the bathroom. I laid back down asap due to slight nausea. No appetite. Whites of eyes were uniformly pink, eyes glassy. 3/23 Sore spot to the touch on left temple just above the eyebrow.

Jansen COVID-19 Vaccine EUA Chills - lasting about 2 hrs, fever 99.1, stiff neck, overall blah feeling, loss of appetite. Lasted about 12 hours, sleepy

Patient reports severe headache, nausea and vomiting starting about 6 hours after vaccine. Sometime during the night a fever of 104 which went away with Advil. Nausea/Vomiting/Headache still occurring 14 hours later.

INDIGESTION; FELT LIKE SHE SWALLOWED A ROCK AND IT IS IN HER CHEST; HAS NOT EATEN MUCH TODAY; CHILLS; HEADACHE; TEMPERATURE 101.6; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.6 F. On 04-APR-2021 01:30, the subject experienced chills. On 04-APR-2021 01:30, the subject experienced headache. On 04-APR-2021 01:30, the subject experienced temperature 101.6. On 06-APR-2021, the subject experienced indigestion. On 06-APR-2021, the subject experienced felt like she swallowed a rock and it is in her chest. On 06-APR-2021, the subject experienced has not eaten much today. Laboratory data included: Blood pressure (NR: not provided) 136/81 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.6, chills, headache, indigestion, has not eaten much today and felt like she swallowed a rock and it is in her chest was not reported. This report was non-serious.

DRY HEAVES; COUGH; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced dry heaves. On 11-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry heaves, and cough. This report was non-serious.

LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.

About a week after her vaccine she went to rehab and exercised which she then developed leg pain, she said it only lasted that day and has since gone away. She believes that was from the exercise. A few days later she experienced diarrhea without having any cramping or feeling ill, just out of the blue for about 6 hours and then it went away. She has been tired/ fatigued the entire time.

Patient had received the vaccine day prior to coming to ED. Presented to ED with family due to n/v/chills with shaking. She was able to dress self into gown and answer history questions. Then when she laid supine she became cold/clammy with loss of pulse. CPR was started with eventual decision by family to cease.

80y.o. female with past medical history of COPD on 3L O2 at home, Asthma, Arthritis, B12 deficiency, Depression, GERD, Achalasia, HTN and Hypothyroidism presented with a chief complaint of cough and weakness. Patient states that she had the Johnson & Johnson vaccine on March 11th 2021 and believes she got sick from it. Since getting the vaccine, whenever she eats something she begins vomiting for the next 2 days. This has happened to the patient before, as she has a history of esophageal dysmotility/achalasia. Patient began developing a cough and SOB over the last 2 weeks that are getting worse. Patient states that she has no appetite at all and is feeling very weak due to the lack of eating.

4/13/2021 heartburn like symptoms started. 4/20/2021 admitted to emergency room, received diagnosis of 3 blood clots in the heart, 4/27/2021 died as a result of blood clots in heart

Patient threw up 10mins after vaccination, twice, EMS was called. They advised to take her to hospital, she refused against medical advice

severe cramps, lst in the calve of my right leg every night for a week, then 2 days later severe cramps in the bottom of my feet for a week, then 2 days later cramps in my big toes for a week, this last week had severe cramps in my abdoman area and back that lasted for 3 days. went to chiropracter for adjustment thinking it was my back (did not help) Called and made an appointment to see a Dr. for Monday June21, 2021 to check out severe abdominal pain and back pain.

CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.

FEELING OF "DID NOT WANT TO BE ALONE"; FEELING KIND OF WEAK; GENERAL TIREDNESS; DIFFICULTY BREATHING; SWEATINESS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, tetracycline allergy, and vancomycin allergy. The patient experienced drug allergy when treated with promethazine, carbamazepine, and topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1802068 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced difficulty breathing. On 24-MAR-2021, the subject experienced sweatiness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 25-MAR-2021, the subject experienced feeling of "did not want to be alone". On 25-MAR-2021, the subject experienced feeling kind of weak. On 25-MAR-2021, the subject experienced general tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, sweatiness, feeling of "did not want to be alone", feeling kind of weak, fever, headache, nausea, and general tiredness on 26-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Pt states nausea, aches, general malaise, dry mouth since the day after her shot and continuing as of today 04/09/21

NAUSEA; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune, prediabetic, cholesterol, tricuspid valve leek, and severe osteoporosis, and other pre-existing medical conditions included patient is allergic to simvastatin and aspirin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. Concomitant medications included pravastatin for cholesterol, and furosemide for tricuspid valve leak. On 15-MAR-2021, the subject experienced flu like symptoms. On an unspecified date, the subject experienced nausea, and headache. Laboratory data (dates unspecified) included: Laboratory test normal (NR: not provided) NEGATIVE (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, and flu like symptoms. This report was non-serious.

DIZZINESS; LOOSE STOOL; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced loose stool. On 02-APR-2021, the subject experienced weakness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, loose stool, weakness, chills, and fever on 03-APR-2021. This report was non-serious.

Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke.

Family member stated that pt experienced headache the afternoon she received the vaccination then complained to home health nurse that she did not feel well the next day. Patient was admitted on 04/19/2021 with diarrhea and possible pneumonia.

DIARRHEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-APR-2021. This report was non-serious.

Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)

Pt w/significant cardiac hx p/w from LTC facility w/increasing confusion, decreased appetite, weakness over 4-5 days. No reported hx of cough, SOB, N/V, fever, or URI symptoms. CXR findings were clear. Ther was concern for dehydration due to worsening renal function. Pt tested positive for COVID-19 (4/24) despite Janssen vaccine (4/7) and pt stating they had COVID in December 2020. Pt admitted for additional management of COVID-19 infection w/acute metabolic encephalopathy, acute on chronic CHF, & AKI. Treated w/dexamethasone & remdesivir. Ultimately discharged 5 days later (4/28).

Awoke 3rd day after vaccination with severe positional vertigo or similar disorder - felt when I simply turned my head on pillow. It was as if I was falling in space, especially my head. Could not sit up without feeling terrible. Lessened somewhat during day but could not move head without feeling vertigo/dizziness. Unable to eat without nausea and vomiting. That was 04/09/21. On 04/10 and 04/11 it was difficult to arise from bed without feeling very dizzy. But after getting up very slowly without moving head, I could move slowly to use bathroom, get a little food, etc. Today, 04/12, still had to arise from bed very slowly, trying not to move head to avoid weird dizzy type feeling. Have been able to eat, get dressed and leave the house carefully. Try not to move head too much and move rather slowly.

Nausea, vomiting, body aches, episodic low-grade fevers, frequent chills, mild dyspnea on exertion, and sensation of being slightly short of breath, pain in legs, intermittent blurry vision, feeling jumpy.

SHORTNESS OF BREATH; SHARP PAIN IN LEFT ABDOMEN; SHARP PAIN IN UPPER THIGH; HARDNESS AT INJECTION SITE; TENDER ARM; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, fibromyalgia, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced hardness at injection site. On 29-MAR-2021, the subject experienced tender arm. On APR-2021, the subject experienced sharp pain in left abdomen. On APR-2021, the subject experienced sharp pain in upper thigh. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in left abdomen, and sharp pain in upper thigh on 15-APR-2021, and had not recovered from tender arm, hardness at injection site, and shortness of breath. This report was non-serious.

DIARRHEA; UPSET STOMACH; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on MAY-2021, and the outcome of upset stomach was not reported. This report was non-serious.

EXTREME NAUSEA; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastroparesis, non smoker, non alcohol user, and sulfa allergy, and patient had no known drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the patient experienced nausea and have had extreme nausea every day. Patients doctor (Gastroenterologist) was aware of the adverse effect. Patient was currently taking ondansetron for nausea but it was not working. Patients husband described her as deathly sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case was assessed as non serious.

around 7pm I had had a cup of coffee and a brownie and I suddenly felt tight in the chest and abdomen. tums did not help but didnt resolve. the next day I still had issues and was light headed. It did go away eventually. I have a history of indigestion/gas issues.

I got the shot on Wednesday and on Friday I was shivering so bad I thought my chest was going to pop out and so nausea. I called my neighbor and took me to the ER . They ran Blood test and urine test and everything was ok. They told me i was a side effect for the vaccine and sent me home. I went to bed and didn't feel good, the next day I still didn't feel good. I got so chilled again and nausea and went back to the ER and say the same Dr. and took my Blood work again and said my blood work was better than the night before. I also had a fever and they told me to take Tylenol and it was just a side effect. I feel so weak and sick at my stomach still.

Patient after taking a nap and applying ice to swollen cheek. Also c/o red swollen tongue and swelling of Rt cheek last night at 2 am. The tongue is no longer swollen but it is still red and her cheek swelling has decreased. She also has a hoarse voice. No Benadryl in the house. Patient urged to go to ED immediately to be evaluated.

fever, pancreatic pain, rapid heart rate and breathing. (pancreatic pain was the main symptom that resulted in the patient going to and staying overnight in the hospital)

On Saturday, 4/10/21, approximately 2 hours post vaccination, patient noted a knot on her left lower leg. No pain, redness or swelling noted to left lower leg. Patient took it easy the rest of the day. On Sunday, 4/11/21, patient began to have N/V, diarrhea and fatigue. No fever noted at this time or up to time of this report. As of 4/13/21, at 12:00pm the knot still remains present on left lower leg, along with fatigue and nausea. Patient was instructed to call PCP. Patient has an appointment with PCP on 4/14/21 at 1030am.

SWEATY; LOSS OF TASTE; WEAK; FEELING OF RASH UNDER SKIN; TIRED; INCREASED TEMPERATURE 98.1F; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, on left arm, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced loss of taste. On 14-MAR-2021, the subject experienced weak. On 14-MAR-2021, the subject experienced feeling of rash under skin. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced increased temperature 98.1f. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle aches, and nausea on 14-MAR-2021, and had not recovered from sweaty, tired, weak, increased temperature 98.1f, feeling of rash under skin, and loss of taste. This report was non-serious.

Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.

Severe reflux within two days of vaccine; Severe abdominal pain and probable gastric bleed within 6 days of vaccine; Daily heart palpitations within two weeks of vaccine; Two acute strokes within a month of vaccine and a third stroke event after the first two acute strokes causing paralysis on right side and noticeable cognitive dysfunction.

The hospital gave my mom the Johnson shot on May 18,21.( I was not informed about it until my my told me on May 20th ) she said she had a headache and stomach, My mom was scheduled for an angiogram that day but they couldn't do it then because the doctor had an emergency. So they schedule it for Saturday but they couldn't do it because my mom had an upset stomach. They then schedule it for the 24th but they couldn't do it because her vitamin k and plasma level's were off. So they gave her vitamin k and plasma in the morning of the 25th and said they could do the angiogram. When she came back to the room her blood pressure was extremely low and she was very bloated. I was told they couldn't do the procedure because she had blood clots in her leg. And the bloating was due to fluids they gave her to flush out the heparin they gave her. Later that evening she passed away

Patient sitting in chair passed out sternal run performed lowered to floor sternal rub performed again responsive breathing shallow lost bowels pulse weak ammonia salts used and EMS called

found my mother lying on the floor Monday morning covered in feces...she had been extremely tired after shot. Her Blood sugar was extremely elevated ...and she was dehydrated

April 9- mild headache and 2 dizzy spells 2 to 3 minutes each April 21- severe dizzy spell, 10 minutes long April 21- Dr. examination followed by blood work and brain CAT scan. All tests came back normal. April 23- severe migraine, feeling very sick, no appetite April 24- present- lite headed dizziness, unsteadiness

Patient previously had a Moderna (dose #1) vaccine on 1/15/21. Patient had difficulty swallowing, tingling on tongue, and got the jitters about 10-15 mins post dose. She was recommended by her PCP to try the Johnson and Johnson vaccine because of this allergy. We had discussion with an ID specialist and pharmacy manager to go ahead and give the vaccine after weight the risks/benefits. A pharmacist was there to monitor the patient and about 15 minutes post dose, patient had difficulty swallowing and noted that this was a very similar onset to when she received the Moderna vaccine. A code blue was called, patient was sent up on stretcher to the ER. Patient received steroids (methylprednisolone) , famotidine, and Benadryl while in the ER. Currently being monitored in the ER.

Patient reported right side of face red, hot and swollen beginning evening of 03/11/21. Ear aching. Pain and aching all over the body. Fatigue, nausea, dizziness and loss of appetite.

PATIENT WOKE UP AT 12 AM THROWING UP BLOOD AND FEELINGS OF PASSING OUT, 911 WAS CALLED AND AMBULANCE TOOK HER TO HOSPITAL, WHERE THEY DETERMINED IT WAS A STROKE AND MOVED HER TO ANOTHER HOSPITAL, WHERE CURRENTLEY BEING TREATED DETERMINED BLOOD CLOT IN BRAIN. MOST LIKELEY DUE TO VACCINE SHOT.

vomiting, shortness of breath, hospitalized, chart shows she suffered from blood clot, hospital has extensive records from tests

Pt reports fever; BLE edema; H/A - on & off with dizziness; Abdominal cramping; looses stools w/ offensive odor; fatigue started on 4/6/21

DIARRHEA; STOMACH PAIN; BACK PAIN; COUGH; SHORTNESS OF BREATH; RUNNY NOSE; CHILLS; FEELING TIRED/ FATIGUE; FEVER; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcers, blood count are always high, allergies to pain medication, and cigarette smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 23-JUN-2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced back pain. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling tired/ fatigue. On 15-APR-2021, the subject experienced diarrhea. On 15-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 15-APR-2021, was recovering from feeling tired/ fatigue, diarrhea, stomach pain, back pain, cough, shortness of breath, and runny nose, and the outcome of fever was not reported. This report was non-serious.

SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. This event is considered unassessable. The event 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.

DIARRHEA; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for drug use for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAY-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from diarrhea. This report was non-serious.

86 yo Female, in wheelchair, accompanied by granddaughters,had Janssen Covid19 Vax in Larm 10:28am.10:30 adverse reaction of feeling tired,weak/nauseous. Not diaphoretic. 10:32 V/S HR73,BP120/65,RR26/02%97%. Shallow breathing. 1034 EMS called as Attendee still symptomatic. 10:39am V/S HR77,BP130,RR16,02%99%.Attendee stated she felt better. 10:48am EMS arrive took V/S HR68,BP153/83,RR16,02%97%.Monitored Attendee.EMs offered to take Attendee to ER. Attendee refused. EMS left 10:57am. Attendee sat, rested. Had snacks and drinks offered by grandaughters.11:09am V/S HR66,BP150/70,RR19,02%99.Attendee and grandchildren educated on home discharge/adverse reason instructions.Discharge to home at 11:15am with granddaughters.

Pt states she got her COVID vaccine on Wednesday 3/17 and has been having nausea, vomiting, hoarseness, and fever since.

Patient was admitted to the hospital 12 days (3/24/21) after vaccine dose administration (3/12/21) sent in for refractory abdominal pain, nausea and vomiting. On admission, a CT Abdomen/Pelvis with contrast was largely unremarkable including reported demonstration of patent portal vein. During the course of the hospitalization the patient developed a portal vein thrombosis visualized on 3/26 by ultrasound. She also received Heparin SQ from 3/27/21 through 4/2/21 but not sent home on anticoagulation. Her course was also complicated by a seizure and Bacteroides bacteremia. MR Brain did not demonstrate thrombosis

Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Severe, Additional Details: shot 4:23pm, pt complained of seeing stars, being nausous, weak, was going in and out of concsiousness for 30 -45 seconds. Had patient elevate legs a while seated and took bp at 4:30pm was115/36 pulse 52. pt tried to vomit but nothing came up.Took 2nd bp at 4:44pm 137/91 pulse 75. Moved patient inside pharmacy had her lay down flat with legs elevated for 8 minutes. complained of tingliness in both arms up to elbows. 3rd bp at 4:50pm was 127/80 pulse 65, 4th bp 125/82 pulse 77, left at 5pm

BOWEL MOVEMENT; NOT ABLE TO SLEEP; DIARRHEA; NO APPETITE; This spontaneous report received from a patient concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at around 12:00 noon for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced no appetite. On 10-MAR-2021, the subject experienced not able to sleep. On 11-MAR-2021, the subject experienced bowel movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and no appetite, and the outcome of not able to sleep and bowel movement was not reported. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

DIARRHEA; This spontaneous report received from a consumer concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Patient received J&J covid injection 4/1/21. From 4/1-4/7 patient felt very fatigued/lethargic. 4/10-4/13 patient was having intense stomach pains and an intense headache, she felt off and states it was like nothing she's felt before. She thought she was going to have a stroke. Pt took her B/P on 4/11 it was 182/104, pt took an Aspirin and a half. An hour later it came down to 133/90. Pt states she wasn't thinking straight, she went to sleep. 5 lb recent weight loss d/t loss of appetite from not feeling well, 4/9 172 lbs, 4/13 167 lbs

89 yo female received J&J COVID-19 vaccination on 3/9/21. Patient with history of SMA thrombosis presenting with 1 month history of abdominal pain, nausea, and vomiting, found to have SMA stent thrombosis. Stopped antiplatelet therapy several months prior to admission without consulting vascular team. Admitted and stable on heparin drip. GI was consulted, as her symptoms are not a classic presentation of mesenteric ischemia. On 4/21 she underwent EGD. EGD was read as normal stomach and duodenum, Schatzki ring (widely patent) and regular Z-line. After this patient was able to resume PO intake in increasing volumes without nausea, vomiting or abdominal pain. Pt discharged on 4/23 with prescription for apixaban.

SORE THROAT; LEFT SIDE OF NECK PAIN; PAINFUL SWALLOWING; LOT OF PHLEGM; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, gout in left foot, split nails issue, seasonal allergies, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included biotin for split nails issue. On 18-MAR-2021, the subject experienced sore throat. On 18-MAR-2021, the subject experienced left side of neck pain. On 18-MAR-2021, the subject experienced painful swallowing. On 18-MAR-2021, the subject experienced lot of phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, left side of neck pain, painful swallowing, and lot of phlegm. This report was non-serious.

4/12 3pm patient went to get up from recliner, body was very stiff and had severe muscle spasms and cramps from back, stomach, pelvis, thighs and legs down to feet. Legs swollen (enlarged veins) patient said. Patient slumped over and went down to floor. crawled to bathroom and applied Hemp Vana every few hours until some relief. 4/13 moring took 2 tylenol -muscles from hips down burning, stinging and sore. Called doctors. 4/14 patient continued applying Hemp Vana but then switch to Arnicare pain relief. Patient mentioned diarrhea and nausea with headache(she did not mention before) seemed little better(on and off) 4/16 up at 8am diarrhea and throwing up -muscles very sore -spent day exhausted and resting 4/17 patient used warm wet towels and arnicare. 4/18 diarrhea and nausea stopped 4/19 muscles beginning to relax. leg and thigh swelling going down 4/20 Saw dermatologist for other issue. He lower back and thighs and recommended patient to see ultrasound vascular surgeon for pelvic ingestion syndrome and recommended doctor.

7/15/2021: Patient presented to the ER due to persistence of COVID symptoms after testing positive on 7/11/2021 with no oxygen requirement & discharged home. Patient developed nausea, was unable to keep anything down, had bitter taste associated with loss of smell. 7/18/2021: Patient medically cleared for discharge, saturating well on room air and tolerating diet with no episodes of nausea or vomiting. 7.26.21: as of today, discharge cleared, awaiting placement. Note: Patient received J&J COVID-19 vaccine in May 2021.