Johnson & Johnson

malaise, aches and pains, feels "like a cold" Caller states that she got the first vaccine ons saturday the 13th and within a couple of days starting having runny nose and sniffles, mild headache, shaking to body/hands/arms (shivering) but no fever. Memory loss. hypertension (pre-existing medical condition she takes medication for) and confusion. she has alternated with APAP, ASA, ALKA-SELTZER. she says she always gets sick from the flu vaccine. s/s have been on/off staff adv to f/u w/pcp. adv s/s reported may be ameliorated with OTC analgesics taken as directed on label as well as antihistamines. adv to call back if any questions. someone will follow up to check on her.

FEELS BAD; Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban. On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.; Sender's Comments: V0 A 76-year-old female patient reported feeling bad next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. The patient's concurrent conditions included pulmonary arterial hypertension. concomitant medications, and details of the event were not reported. On an unspecified date the patient was hospitalized. This case has insufficient information to make a meaningful medical assessment.

Patient reported having dizziness and lightheaded ness and nervousness Provided water and seen by medical team Patient refused medical transport and signed AMA form, Symptoms resolved Patient will be driven home by spouse

8 hours later bad chills then fever of 101. It was over within 12 hours Three days later had a strange like feeling of flittering near heart area...has happened 3 times since Blood pressure has increased at least 20 points or more since vaccine Swelling in fingers and toes

On 3/11/21, patient had a CVA, resulting in hospitalization. Testing during admission indicated a need for a carotidectomy. Pt had the procedure on 3/17/21, when a second CVA occurred. Pt has returned home, but requires assistance with ADL's. Family notes that patient had an ultrasound of arteries completed January of 2021, results were "normal".

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.

PAIN ALL OVER THE BODY; TINGLING ALL OVER THE BODY; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included caller states she has no medical problems and takes no medications., and other pre-existing medical conditions included the patient had no medical problems and took no medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced pain all over the body. On 15-APR-2021, the subject experienced tingling all over the body. On 15-APR-2021, the subject experienced couldn't sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over the body, and tingling all over the body, and the outcome of couldn't sleep was not reported. This report was non-serious.

SLEEP EXCESSIVE; MALAISE; TIREDNESS/FATIGUE; SORENESS IN THE ARM; MILD HEADACHE; 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 09-MAR-2021, the subject experienced soreness in the arm. On 09-MAR-2021, the subject experienced mild headache. On 10-MAR-2021, the subject experienced sleep excessive. On 10-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep excessive, malaise, and tiredness/fatigue on 11-MAR-2021, soreness in the arm on 23-MAR-2021, and mild headache on 10-MAR-2021. This report was non-serious.

CONFUSION STATE AS CLOSED TO SUFFERING OF DEMENTIA; PAIN IN BOTH EARS; INJECTION SITE PAIN; HIGH FEVER; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 145 pounds, and height was 162 centimeters. The patient's past medical history included covid 19, and concurrent conditions included fibromyalgia, contrast dye allergy, kiwi allergy, raw shellfish anaphylaxis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206AZIA, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced confusion state as closed to suffering of dementia. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced high fever. On 30-APR-2021, the subject experienced pain in both ears. Laboratory data included: Body temperature (NR: not provided) 104 F. On 01-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 104 F, 103 F. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from confusion state as closed to suffering of dementia, injection site pain, high fever, and pain in both ears on 02-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

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.

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.

Immediate feeling of "oddness" then loss of consciousness. Awoke to consciousness of being surrounded by EMT personnel, oxygen mask in place, IV line in right arm, heart monitoring electrodes on chest. Hearing someone asking questions from a great distance but being unable to answer. Hearing snatches of conversation from EMTs. "Was unresponsive," "heartrate is 30," "BP is extremely low," "Heartrate begins to come up then falls back to 30." Finally was able to speak at first in a faint mumble, then more normally. Heart rate is still in 30s. Was taken by ambulance to hospital.

She got the vaccine, no symptoms until about 10 days later on Tuesday 4/6/21 in the early morning she woke up around 3:00 AM and felt like she had been in a bar fight, had painful arm around vaccine site. She could not go back to sleep that night. The next night she went to sleep and everything was fine, no reactions. She slept on both sides of the arm up until the 10th day, and had no problems. The following night again got up to go to the bathroom and felt a pain in the left arm, but still had painful arm during the next day, ache going up through the top part of the arm where injection was, going across her shoulder area and into her back. The pain comes and goes as a dull ache during the day. The pain mainly occurs at night on the shoulder that she got the injection. Last night the same thing happened again and she slept a couple of hours, still having sensations there. When she got up had the big pain again, and filled a hot water bottle which seemed to help. Right now, 4/12/21 she still has an ache in the arm, but during the night it feels like somebody is punching the arm, which has been going on for 5-6 days. Deep breathing also radiates the pain to the shoulder area as well. Did not take anything for the symptoms other than the hot water bottle.

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.

This is a possible breakthrough COVID case. The patient had right-sided weakness for two weeks prior to 4/20/21. She then developed weakness and confusion in the few days leading up to hospitalization on 4/20/21. The patient tested positive for COVID on 4/20/21. The patient was also previously COVID positive on 11/6/2020.

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

This patient is 77 years old, and had a menstrual cycle that began 5/15/2021 and lasted until 5/18/2021. She has not menstruated in over 30 years. She experienced cramps, low back pain, and irritability.

: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

Chills throughout Thursday nite 3/4, Fever Friday AM 3/5 102.4F, slept most of day, Fever blisters occurred on top and bottom lips as well as blisters in roof of mouth. Fatigue. Tylenol, topical applications for blisters as well as salt water oral gargle several days.

My mother reported feeling numbness/tingling in her left fingers/hand on the drive home approximately 30 minutes after receiving the vaccine. She wanted to go straight home. When we got home she reported that the numbness had been felt in her head and tongue and it was a very weird feeling. She was numb on her entire left side. It seemed to resolve after a while. She is still very tired and has a low heart rate, but normal blood oxygenation. There is no visible swelling or reaction at the vaccine site. She still has some slight numbness on the left side. She may call the doctor tomorrow if there is still some concern.

3/11/21- pt was feeling fine. She stood up got dizzy and seamed to have a seizure. when she came to she did not know that it had happened. about 5 hours later she stood up again got dizzy and seamed to have had another seizure. her husband called 911. EMTs took her vitals but did not detect anything to be wrong at the time and was advised to see PCP. Next day 3/12/21 she went to her PCP. She had blood work which showed high enzymes for heart failure so was sent to hospital to be admitted. Pt had blood work, chest xray which showed blood clots in both lungs. She was administered blood thinner. MRI of head was clear. Echocardiogram was clear. Pt stayed about 4 days. Enzymes for heart failure was clearing up. Pt was released and had a FU appt w/ PCP on 3/22/21. Pt found out that she also had bilateral deep vein thrombosis in both legs while she was in the hospital. Pt is improving and is almost back to normal.

Patient at first felt "weird", as described by the patient. About 5 minutes after vaccine, patient complained of a tingling sensation in her nose and around her mouth. After 20 minutes, patient complained of a numb tongue. At this point, EMS was called to assist her and she went to the hospital for further treatment.

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.

At 8:05 am on 05/12/2021 temperature of 102.8 was noted and Tylenol was given. The nurse did not did not document any other symptoms and stated that the patient denied any pain and felt fine. CBC, CMP, Flu swab, chest x-ray and UA with culture were obtained. The resident had a low grade temperature of 99.9 at 2:04 pm on 05/12/2021 and no other symptoms were documented. On 05/13/2021 at 12:15 pm, Nurse noted that resident wasn't 'acting like herself'. Nurse obtained a rectal temperature of 99.6 from resident and the resident had a blood pressure of 159/80, pulse of 66, respiration of 18, and an O2 sat of 95% on room air. Nurse noted that the resident was trying to speak but could not get

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.

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.

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

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

recurrent acute embolic stroke noted on MRI brain. Received vaccine on 4/10. Seen in ER 4/11 with confusion. CT head negative and discharged home. Admitted 4/13 with worsening L weakness and fall at night. Acute stroke noted on MRI imaging.

Patient had been working all day in her flower gardens. At 4:30 p.m. she felt like she had double vision and difficulty talking. She does not remember much of what happened after that, but her husband said she had sudden onset of right arm weakness, leg weakness and drooping of the right side of her face. Denies having numbness. He immediately called 911 and EMS took her the Hospital. She had a CT scan of the head that was negative. When she arrived at the emergency room her symptoms had resolved, but she had recurrent episode of her symptoms in the emergency room with an NIH score of 5 scoring a point for level of consciousness, best language, and dysarthria and 2 points for facial droop. She was given tPA and her symptoms resolved. A CT angio of her head and neck did not show any large thrombus. She was transferred for ongoing care and neurology evaluation. Neuro deficits resolved. Patient was discharged the second day after the event on Aspirin, Plavix and Lipitor. Hospitalist (Dr) asked me to file VAERS report given recent Janssen vaccine administration.

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.

Eleven days after getting the shot, my mother in law was experiencing severe back pain and was not able to get comfortable or sleep at night. Before we could take her to see a doctor, she fell while trying to get out of bed at 7am the next morning. She had trouble getting up and exerted a lot of energy trying on her own. She called for my husband and I to help her get up. I grabbed her around the waist and my husband held her walker for her as support. Upon rising (mostly of her own ability) she was so exhausted that we had her sit on her walker and rest a moment. My husband went to check on her twice over the next 15-20 minutes, but when he returned again she was showing classic stroke signs and EMS was called. They arrived quickly and agreed. She was taken immediately to the ER, where they also agreed that it looked like a stroke. She was admitted as they continued to run tests, but she continued to decline more and more each day at the hospital losing motor skills and ability to speak. She was not able to move her right side at all and the left side was fidgety and had uncontrollably flailing that left her bruises on her arm and leg. She was also excessively sleepy. After loads of testings and images, the MRIs finally showed that the brain stem was extremely inflamed and it was an auto-immune response. By this time, she was already a vegetable in the ICU ward under incubation, IVs and a feeding tube. They continued to run more tests and brought in infectious diseases, but they ultimately said her body was fighting an infection that she did not have. They attempted a hemoglobin treatment with an oncologist to shut down her immune system but never consulted with her renal doctor, even through they were very concerned about renal failure. She could not complete the treatment and only received 4 out of the 5 doses they wanted to give her because of her kidney counts. They said that the auto-immune attack was very aggressive and they could not shut it down. In the early morning of 4/28/21, they finally contacted her kidney doctor and she was put on dialysis as a last effort to try to save her, but it was too late and all her organs were failing. She passed at 1:56 pm. Patient was homebound during the pandemic and did not leave the house unless she was visiting her doctor's office. My husband and I have limited contact at our jobs, as we work in small offices, and our children (that also lived with her) were being schooled virtually. There is nothing that I know that could have caused her immune system to go into overdrive, except for the vaccine that was administered less than 2 weeks (which is considered the time frame for vaccine immunity) prior to her symptoms.

Caller is an 80 YOF that received the Janssen Vaccine. Just today she noted that the site was bruised. she is a retired RN and had them do the Z track method to admin medication. she does not report pain to site but does say the bruise is noticeable. She has also noted some memory lapses where she forgets something she just read and this is not typical for her. adv to continue to monitor site. may apply warm compresses to site. if pain, take OTC analgesics. adv tof/u w/PCP if s/s persist/worsen.

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.

She was Janssen COVID19 vaccine on 3/8/21. She came in on 4/14/21 reporting that starting around 4/6/21 the injection arm started hurting. The pain was not localized to injection site and varied from the shoulder to the wrist and was on and off. Could sometimes keep her up at night. She was advised per guidelines to contact her PCP.

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.

COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; 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 ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength 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.

FEELING TIRED; MEMORY LAPSES; REAL BAD BODY ACHES; MUSCLE TIGHTNING AS SHE WALKS; SEVERE POST PARTUM SHINGLES PAIN ACTIVATED; This spontaneous pregnancy report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe post partum shingles pain activated. On 26-APR-2021, the subject experienced muscle tightning as she walks. On 28-APR-2021, the subject experienced memory lapses. On 28-APR-2021, the subject experienced real bad body aches. On an unspecified date, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from real bad body aches, had not recovered from muscle tightning as she walks, severe post partum shingles pain activated, and memory lapses, and the outcome of feeling tired was not reported. This report was non-serious.

pt told me she had the Johnson and Johnson one covid shot and slept for 3 days afterwards and then had to be hospitalized for a blood clot

pt says she felt very strange like she was having some type of reaction and like something was wrong with her. She wants to sleep all the time and stay asleep. She says she has never been so tired and she is scared to even drive. She reported this to her pharmacist. She cant keep her balance and has never been so tired in her entire life, saying she could sleep night and day if she could and has felt bad since the day she took the vax. She also has some brain fog. She had to put her husband in a Rehab because he needs her care and she was not able to take care of him since she was so sick. (she wanted me to take note of these numbers)

WOKE UP FROM SLEEP DUE TO PAIN; RIGHT ARM PAIN; RIGHT SHOULDER PAIN; This spontaneous report received from a consumer 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced woke up from sleep due to pain. On 05-JUN-2021, the subject experienced right arm pain. On 05-JUN-2021, the subject experienced right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, right shoulder pain, and woke up from sleep due to pain. This report was non-serious.

Patient stated that she was very week. Patient stated that she could hardly walk. Patient stated that she felt like she had the flu. She kept her self hydrated. Patient stated she gets tired easily and can not continue her everyday lifestyle.

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.

4/2/2021 - pain in right arm starting at injection site. Over next 18 hours pain ran along arm to shoulder to upper back. Pain starts as sharp, then burning. Patient had difficulty sleeping. Started on ibuprofen (1000mg) at 8am on 4/3/2021 and heating pad. Pain dulled a bit. Additional info: on 3/27/2021 Patient woke up with a droopy eyelid that was diagnosed as Horner?s Syndrome on 3/31/2021 . Sent to ER at Hospital for MRI/MRA/CT, scans showed nothing conclusive - no evidence of stroke, aneurysm, clot, cancer, or anything pressing on optical nerve. Have followup with Dr at Hospital Neurology. Blood work ordered to check for evidence of other conditions that could deteriorate the myelin sheath.

WORRIED; CHILLS; HEADACHES; 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 past medical history included colon cancer, and concurrent conditions included codeine allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headaches. On 13-APR-2021, the subject experienced worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headaches on 14-MAR-2021, and the outcome of worried was not reported. This report was non-serious.

SHAKY FEELING; SCARED; 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 asthma, high blood pressure, penicillin allergy, allergic to dairy products, perfume allergy, dust allergy, pollen allergy, mold allergy, allergy to cats, peanuts allergy / cashews allergy, and live vaccines allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had a history of unknown cold medicine caused her to go to the hospital and get a shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced scared. On 13-APR-2021, the subject experienced shaky feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaky feeling, and the outcome of scared was not reported. This report was non-serious.

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

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).

At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21. Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion of the left shoulder with sensation of swelling in the arm on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain. She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21 where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy. An MRI was recommended.

TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; 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 (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.

on 3/22/2021 pt developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was administered 65 mg IVPB alteplase 3/22 1245 with last known well 3/22 1000. Received Covid vaccine 3/18/21. Pt was usual state of health prior to stroke with no illnesses. initial NIH score was 18. post tpa NIH of 12 am of 3/23.

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.

UPPER LEFT ARM PAIN/SORE/ACHES; CAN NOT SLEEP; 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 chronic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced can not sleep. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced upper left arm pain/sore/aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper left arm pain/sore/aches, and the outcome of can not sleep was not reported. This report was non-serious.

Paraphrase from provider discharge to swing bed note: 83 y/o female brought to ED for fall and left shoulder pain. Baseline dementia, poor historian, early onset Parkinson's Disease. Fully vaccinated for COVID-19, showing no obvious symptoms of COVID. Cough, no dyspnea per review of systems. Problem list includes: Anterior shoulder dislocation, reduction. COVID-19. Essential Hypertension, Acute confusion, baseline dementia, urine + for nitrite and bacteria, started on macrobid. Depression. Unable to enter required fields for Q.#21, Hospitalization. Currently Hospitalized

3/13/21 ER HPI: 83 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. The patient comes in because her blood pressure at home has been very high. It is actually not reading on her cuff. She has a very dull headache on the left side of her head, but states it is very mild. No chest pain. She might be a little bit short of breath, but not much more than normal. She denies any current neck pain. She states a few hours ago she had a little bit of pain in the left side of her neck that was just brief and then way. On my initial evaluation her systolic blood pressure was around 240. The patient does have a history of anxiety. She states she has had typical anxiety, but nothing new. 3/15 office followup note: Subjective: Patient is 83 y.o. year old female that is here for ER follow up. 2 ER visits over the weekend. BP was elevated into the systolic 200s. Has ringing in ears when BP was elevated On Saturday: Left side of throat dry Left side of face "doesn't feel right", hard for patient to describe When she woke up on Saturday, couldn't see out of left eye, this has improved Says her voice doesn't sound the same, "gravely" She did not tell the ER doctor on Saturday about the neurologic symptoms. In her 1st ER visit she had a chest x-ray which showed no acute disease. Cardiac enzymes were negative. ER doctor increased her losartan dose and gave her p.r.n. clonidine. In the early morning hours on Sunday, she returned to the ER. Blood pressure was elevated again at 208/85. Patient was given sublingual nitro and a Norvasc 5 mg tablet. After the sublingual nitro, blood pressure was 144/84. ER doctor discharge patient with follow-up today.

ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; 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 past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. 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). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. 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: MEDICAL HISTORY of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

CONFUSION; AMNESIA; This spontaneous report received from a consumer concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included previous heart attack, and concurrent conditions included diabetes, high blood pressure, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient do not have any known drug allergies nor drug abuse or illicit drug usage. 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 19-MAR-2021 15:19 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021 03:00, the subject experienced confusion. On 20-MAR-2021 03:00, the subject experienced amnesia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confusion, and amnesia on 20-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

I was walking in the airport and I just fell for no reason. I went down slow. I was able to get up on my own, but I have no idea what made me fall. I went to my daughter's house and I was trying to climb the stairs to get to her place, but I couldn't even bring my leg up to step on the first step. I had to physically pull myself up the stairs by my arms. I felt like I lost my strength. I lost control of my bladder. I went to the doctor to have a urinalysis done and there was not an infection. I also lost my balance and would often have chills. Anytime I would start walking it would feel like I was drunk with how I couldn't walk straight. I felt fatigued during this time as well. During time that I would try to speak, I would say something in a sentence that had nothing to do with the topic of conversation. I was thinking I may have had a stroke, but when I went to the doctor and had a CT scan, a brain MRI and blood work done, everything came back normal. All of this lasted three weeks and then just all went away. My doctor diagnosed me with post COVID viral illness, but I never had COVID. She said it's similar to a viral meningitis.

On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient

New embolic strokes requiring hospitalization and mechanical ventilation due to mental status. New lower and upper DVT, unable to anticoagulated due to new strokes. Symptoms started acutely on day of admission, 4 days after vaccination

CAN'T GET OUT OF BED; DOES NOT SEEM LIKE HERSELF; This spontaneous report received from a patient concerned an 84 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced can't get out of bed. On 2021, the subject experienced does not seem like herself. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't get out of bed and does not seem like herself was not reported. This report was non-serious.

Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems. This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.

CAT SCAN HEAD - SOMETHING IN HEAD; FEELING LIKE A BLOOD CLOT ON INNER UPPER THIGH OF RIGHT LEG; DIFFICULTY BREATHING; CALCIFICATION OF LUNGS; NUMBNESS IN BOTH FEET AND TOES; DIZZINESS; OFF BALANCE; RIGHT LEG TINGLING/FEELS LIKE WATER RUSHING; FELT LIKE BUGS RUNNING IN HEAD; ELECTRICAL SHOCK LIKE BUGS IN HAIR; SQUEEZING IN FACE; WHOLE BLOOD WAS DROPPING OUT OF BODY; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 230 pounds, and height was 66 inches. The patient's past medical history included stroke, and concurrent conditions included atrial fibrillation, allergy to medications, non-smoker, and non-alcohol user. The patient was not pregnant at the time of reporting and the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride for atrial fibrillation, and warfarin sodium for stroke. On 01-MAR-2021, the patient's laboratory data included Doppler scan and results were normal. On 04-APR-2021, the patient got dizzy right after the vaccination and off balance which exasperated everything. On the same day, the patient experienced tingling in right leg, felt like water rushing, both feet toes were numb, on right side felt like a blood clot on inner right thigh, difficulty breathing, calcification of lungs, felt like bugs running in her head, electrical shock, like bugs in her hair and squeezing in her face. The patient felt like her whole blood was dropping out of her body. The patient described everything comes and goes and one day it was there and another day it was not, then it came back. It was reported that, the patient visited her physician for the tenderness in her leg for possible blood clot issue and she did not know the results. On 29-JUN-2021, the patient's laboratory data included computerised tomogram (CAT scan) of brain and lungs which was abnormal, showed calcification on the lungs and that something was in her head. The patient had visited an ear, nose, throat (ENT) physician, internist, pulmonary physician, and cardiologist and it was made aware that all the side effects were from the vaccination. The patient had scheduled upcoming appointment with gastroenterologist physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 04-APR-2021, had not recovered from right leg tingling/feels like water rushing, numbness in both feet and toes, feeling like a blood clot on inner upper thigh of right leg, difficulty breathing, calcification of lungs, felt like bugs running in head, squeezing in face, electrical shock like bugs in hair, and whole blood was dropping out of body, and the outcome of off balance and CAT scan head - something in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728298-covid-19 vaccine ad26.cov2.s -this case concerns a 84 year old female-feeling like a blood clot on inner upper thigh of right leg. 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).

From 10 p.m. to 1:30 a.m. my heart beat was about 140/ min. then returned to near normal. I could not fall asleep until about 4 a.m. even tho I usually sleep through the entire night. When I finally fell asleep I had weird dreams like when one has a fever; however I had no fever. I experienced chills all night. By noon today (3/21/21) I have no more symptoms and feel back to normal.

Friday 3/19 Confusion, did not know her granddaughter, which grandchild she was kept confusing family names. That was very unusual for her. Saturday 3/20 didn't feel good that day, Sunday 3/21 around 3am got up to go to the restroom got very light headed and fell/fainted hitting her head on the night stand and falling to the floor. When EMS arrived she was in A-fib. That had never happened before. No known heart problems.

A week following my mothers vaccination, she became increasing fatigued. On day 10 following her vaccination she went to bed and had to be helped to her room, this was unusual. She remained in bed for 19-20 hours a day for three days. I called all of her doctors, all of whom she had just been seen by, routine CT scans performed, blood work done, and visit with her neurologist. Her oncologist suggested we seek a hospice evaluation, even though her CT scans showed that her cancer had only slight growth, nothing to be concerned about. Her primary care office ordered the hospice evaluation and it was performed on Thursday, 3/18. They said ?she may just be having a bad week following her vaccination? and ?lets revisit this the following week?. her condition continued to deteriorate significantly over the next few days, so much that she began sleeping 21?23 hours a day. On the following Tuesday, 3/23, she was admitted into the hospice system. Now, four weeks later, we are in the final weeks of her life. She refuses food and water now, and her nurse says that it won?t be much longer. She went from a relatively healthily, senior woman, with underlying health issues, none of which presented her imminent demise, to dying at home within weeks of receiving her J&J vaccine. I have no idea if he demise is in anyway related to her vaccine, but thought it was important to report her symptoms.

Feeling quite ill. Did not sleep night before trip to hospital. Terrible taste in mouth. Taken to hospital emergency room morning of April 18, 2021. Admitted to hospital by ER physician. Reason: blood c lots in both lungs.

J&J vaccine was administered to patient. Consent form states that patient will be receiving J&J vaccine today. Pt is confused per medical baseline. Notified facility nurse, RN that I will be given J&J to patient and was okay with giving. After vaccine was given a second facility nurse, RN confirmed that pt was supposed to received second dose of Pfizer vaccine today. Pt was closely monitored in area for 30 minutes, facility Dr was notified. No acute distress noted, vital sign stable, no reactions noted, no active bleeding noted during 30 minutes of observation. Pt was taken back to her room and 15 minutes after observation at around 09:35AM, facility staff notified pt was desatting, was placed on oxygen and ambulance was called and taken to emergency room.

FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; 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 steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. 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.

86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8. Patient's last known well was at 10 AM on 4/8. GCS on arrival 15. NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria). In the EMS blood glucose was 122, no meds were given. Patient is not on any anticoagulation. Patient's blood pressure was elevated at 233/78. Patient denying any headaches, nausea, vomiting. Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit. Neurology contacted in the ED for stroke code. Patient outside of TPA window. CT head was negative. CT head negative for acute intracranial infarction. Chest x-ray negative for any acute cardiopulmonary findings. Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off. CBC showed mild leukocytosis (14.8) likely reactive. CMP unremarkable. PT/INR was also obtained. After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke. After discussion with family and the physicians the patient refused admission. Upon reexamination no further worsening of her initial symptoms, blood pressure controlled. Patient was discharged in a stable condition. She was discharged AMA. Patient was thoroughly explained the risks and benefits of leaving AMA. Patient said she understood and was advised to come back if the symptoms worsen. Patient was discharged with aspirin, Plavix and atorvastatin. Recommended to follow-up with the PCP tomorrow soon as possible. Also advised to return to the ED if any of the symptoms return.

FLU LIKE SYMPTOMS; INSOMNIA; PAINS IN LEGS; HEADACHE; This spontaneous report received from a consumer concerned an 86 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, start therapy date were 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 flu like symptoms, insomnia, pains in legs, and headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) not reported, and Doppler scan (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, headache, pains in legs and insomnia was not reported. This report was non-serious.

FEVER; NIGHTMARE; DIZZINESS; DROWSINESS; NIGHT SWEATS; FATIGUE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced nightmare. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced drowsiness. On 06-MAR-2021, the subject experienced night sweats. On 06-MAR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmare, dizziness, drowsiness, and night sweats on 20-MAR-2021, and fever on APR-2021, and was recovering from fatigue. 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.

Patient received 1 shot of the J&J vaccine on 4/9/2021 at 1155 by Fire department paramedic. The patient was identified as a homebound resident in our community and met screening requirements for in home vaccination. Patient was very lucid and verbal prior to the shot, but showed some mild confusion afterwards. Upon calling her son, FD learned that the patient has been experiencing some confusion lately. FD also learned from son that the patient had already completed her series of COVID19 Vaccine with Moderna. Her Moderna 2nd shot was completed on 3/8/21. The patient's registration resulted from a contact list forwarded to the Fire Dept with the patient's phone number. The patient was registered through phone for the J&J vaccination homebound vaccinations on 4/9. J&J was notified with anonymous patient info. Follow up with the son was provided by, PharmD BCGP, who consulted with CDC recommendations: ?The patient may experience the same local and systemic adverse reactions as either mRNA/VV vaccine. Furthermore the patient may experience a higher rate of adverse reactions which should be monitored closely. The patient/family should notify the patient?s health care provider about the case. No additional COVID-19 vaccines should be provided to this patient.? FD will be following up with the patient and son tomorrow (day after the injection).

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

pt had her J & J vaccine at medical center- on april 8th ... on the 20th , she developed arm pain, in the same arm, lower than where the shot went in. she also said it "burned" when she got the shot. she has had extreme pain, hasn't slept in 6 nights. went to ER on 21st, and did telemedicine with NP on 24th. xray was negative.

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

FATIGUE; RESTLESSNESS; TINGLING IN HANDS AND FINGERS; ITCHY RASH ON BOTH ARMS; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and concurrent conditions included hypertension, and other pre-existing medical conditions included statins allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180898, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced restlessness. On 09-APR-2021, the subject experienced tingling in hands and fingers. On 09-APR-2021, the subject experienced itchy rash on both arms. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restlessness, tingling in hands and fingers, and itchy rash on both arms on 10-APR-2021, and had not recovered from fatigue. This report was non-serious.

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.

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

Pt had Her Johnson and Johnson COVID shot on April 1. three days after this have coughing, and this was followed by a steady decline in her mental status and functioning. She was walking , talking , feeding self prior to time she go the shot. She could shortly not do any of these.

Patient presented to the ED 5/18/21 with voice slurring, headache, leg swelling. Patient with symptoms starting on Friday 5/14/21. Patient with profound weakness of her lower extremities, unable to ambulate around the house which is new. Patient also reporting she feels "different/wrong." While here in the Emergency department, patient fell onto her rear while at ultrasound, did not hit her head. Unable to stand on her own after. Patient was found to have an acute left lower extremity DVT on 5/17/21: Acute deep venous thrombosis throughout the left lower extremity with most proximal extension of thrombus into the common femoral vein noting that the external iliac vein could not be visualized

Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.

As per Daughter of PT, PT is in the hospital. Daughter of PT states that that on 04-07-2021 after receiving the J&J vaccine her mother developed severe right leg pain and is hard for her to mover leg, her right leg gets stiff and has difficulty to ambulate. Daughter of PT also states that her mother?s memory started to be off since receiving the J&J vaccine and that her doctors at the hospital placed her on Parkinson?s medication because the doctors think she displays symptoms of Parkinson?s disease. Daughter is at the hospital due to a fall injury and should be coming home soon. Due to the fall injury she has had lab work, x-rays, CT scan and lab work. Daughter of PT since the J&J vaccine she has had more frequent headaches on a daily basis than before.

Janssen COVID-19 Vaccine EUA Patient was found on the ground in home and admitted for observation on 6/24/21, reported frequent fals. Patient was provided J&J COVID Vaccine on 6/25/2021. On 6/26/2021 at 8:14 pm patient was noted to have left sided facial droop. Pt alert, confused. Can lift arms and legs for full 10 seconds. No weakness noted. Pt unable to tell when touching her left arm with her eyes closed x 3 attempts. Denies tingling/numbness in this arm. Not present in face/left cheek or left leg. 14 MRI brain showed small right MCA infarction on the background of considerable chronic microvascular changes. MRA head and neck showed diffuse intracranial and atherosclerosis without significant. stenoses or occlusion.