Johnson & Johnson

Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%

Fever,headache,cold/hot sweats,bad muscle aches,no appetite,dizzy ,stiff neck ,stinky major sweat , uncomfortable no sleep felt like i had the Corona virus...

For 24 hours had fatigue, fever, nausea, diarrhea, lost of appetite, soreness in shot arm, and dizziness

COVID infection post vaccination 1 day following vaccination, patient experienced fatigue, myalgia and low grade fever. RA test positive. That evening, patient with increasing SOB and increasing oxygen requirement and was admitted for hypoxia + LE swelling. Although SNF where vaccination took place denied symptoms at time of vaccination, per H&P, increasing oxygen requirements were noted 3 days prior to vaccination. See H&P below He is currently residing in a rehab facility following a hospitalization detailed below, but essentially he noted some shortness of breath about 4-5 days ago. They checked his oxygen saturation and noted that he was hypoxic, so started him on oxygen (reportedly 4L NC?). He reports a worsened productive cough; sputum is dark but not bloody in color. He has been fatigued and chilled; he thinks he's been intermittently febrile. No nausea, vomiting, or constipation. He endorses twice daily diarrhea, but he associates this with his bowel regimen. He also has a fair amount of lower extremity swelling which is bothersome to him; he says this has been ongoing since his MVA in January.[KE.4] He was recently seen in Nephrology clinic, where he was started on lasix 40mg daily and started on a low sodium diet[KE.3]. He is unsure if the lasix is helping his swelling, but does have robust urine output after he takes it

Day of vaccine: No symptoms. Next day: Slightly achy, occasional mild nausea, occasional mild light-headedness. Day 2: Headache, muscle aches, bone aches, more prevalent nausea. Feel "feverish", though no elevated temperature present.

abdominal aches and cramps gradually increasing in severity; walking and other core body movement provided temporary cessation of increasing severe pain; the peak of severe pain was accompanied by a bowel movement, followed within about 5 minutes by body temperature increase, sweating, and profuse salivation such that saliva was swallowed every 2-3 seconds for a few minutes. Treatment was a focus on breathing while practicing the turtle yoga position (forehead on floor with knees folded under abdomen) and then laying flat on back with one or both knees bent. After 10-15 minutes of this treatment the symptoms (abdominal pain, high temp, profuse salivation) subsided.

Immediately following the injection, felt "spacey." He went home to rest and developed a headache. Symptoms seemed to subside until the evening of April 1. He woke up from a nap with chills and had a 100.9 fever. The fever has subsided but for 6 days he has had a headache, body aches, fatigue and nausea. The morning of April 8, he has vomited.

Received shot at 11am. Around 9:30pm that evening started having the chills and a slight headache. Around 1:30am woke up with severe chills and a very bad headache where even my eyes were hurting. Also my arm was hurting from my upper shoulder down to my elbow and was warm. Around 2:00 am I started to throw up and had dry heaves for about 30 minutes. Once that stopped I took 2 Tylenol and fell back to sleep about an hour later. Woke up around 6am with a slight headache, took 2 more Tylenol and by noon time I felt completely fine and not even tired

Local rash (5-10 cm), pain at injection site x 4 days, Fever and chills x 36 hours, muscle aches x 36 hours, nausea, headache

9/10 MAR: Fatigue, chills. 11 MAR: Diadiarrhea. 20/21 MAR: sharp pain between shoulder blades, pain in back of upper arms, back of thighs and legs. 22-Present Mar: Numbness in face, toungue, nose, &Total Pelvis area waist down to upper thigh. 24 - present MAR: Lower back pain. Unable to sleep well due to pain. 26-Present MAR: Severe numbness in fingers, toes & Feet. 3 Days in Hospital: 20-22 MAR. hospital CSF cell count was normal. Protein 60 glucose 105. CSF culture normal. CSF VDRL negative. Serum ACE HIV Sjogren's antibodies and Lyme antibodies were negative.

Effects started approximately 24 hours after injection with a mild headache. Within 2 hours of the onset of the headache queasiness and vomiting occurred.

After vaccination that night he was nauseated, chills, fever and days followed he had persistent fatigue and pain in both arms. He went into a Hemolytic Elliptocytosis crisis following injection.

Deceased complained of abdominal pain and was taking aspirin for a headache. He died within less than a day of initial complaints.

3/31/2021: 6-7 HOURS S/P VACCINATION: HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021: UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021: ABOVE SYMPTOMS CONTINUED . 4/4/2021: STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER . WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021: DEVELOPED A RASH ON BACK.

HEADACHE; PAIN DURING INJECTION ON RIGHT ARM; PAIN DOWN RIGHT ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included triple bypass, back surgeries, and neck surgery.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stomach pain. On 31-MAR-2021, the subject experienced pain during injection on right arm. On 31-MAR-2021, the subject experienced pain down right arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from pain during injection on right arm, stomach pain, and pain down right arm. This report was non-serious.

WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.

Abdominal pain that lasted about an hour. Did not feel well, went to sleep, the pain was gone when I awoke.

BODY ACHE; CHILLS; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, once a total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-MAR-2021, was recovering from body ache, and had not recovered from fever, and diarrhea. This report was non-serious.

LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. 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

In the beginning a very strong pain arms whole body after the stomach started the back and everything got worse for 4 days going to and from the emergency room and then still hospitalized all due to problems after the vaccine in the last exam the variant was positive for guillen barrer before discovering this he lost his sight for two hours he cannot walk he lost the strength of his limbs and his pressure shot up he has dysphacia and is still hospitalized with physical therapy

Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Vomiting-Mild

pt woke up with an extreme severe headache and nausea. Vision was blurred, he had joint point, body aches and pains. He used ice pack for headache. These symptoms lasted about 24 hours. On 5/13/21 Pt still has blurry vision but other symptoms have subsided.

Patient developed paresthesia/sensory changes and lower back and abdominal pain. Found to have likely Guillain Barre syndrome. No motor involvement and discharged home.

Presented to emergency department on 5/12/21 with productive cough what onset a week and half prior to presentation. Also had complaints of diarrhea, nausea, dizziness, and shortness of breath when standing. Patient had cardiac stent placed approximately 5 weeks earlier. Was found to be COVID-19 positive and was admitted for further management. He was admitted for 2 days.

SORE ARM; 103 FEVER; NAUSEA; BRUISING ON RIGHT FOREARM; This spontaneous report received from a patient concerned a 60 year old male. 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: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced bruising on right forearm. On 04-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced 103 fever. On 04-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, 103 fever, and nausea on 04-MAY-2021, and had not recovered from bruising on right forearm. This report was non-serious.

Patient had sweating , snoring, dizziness, shaking , throwing up .we called 911, before the paramedic came in, he started to talk and be more aware about everything around. they checked his blood sugar was 152, blood pressure was above the normal. the paramedic kept talking to him and he was responding good. Patient refused to go to the hospital

Dryness in mouth when eating anything would cause an abrasion, was rough and sensitive. When opening mouth all the way feels as though rubber bands holding him back. Thought it was something that would go away, but continues to feel the same way. Attributed it to mouth disease, physician says it is not a mouth disease, he should get a biopsy.

I was having arm , shoulder and stomach pain. I have been suffering with leg pain since the vaccine. I am now going to see a spinal surgeon. I have cyst on my nerves and I also have thyroid issues.

Patient had a stroke on June 4. Developed unusual headache evening of June 3. Went to see doctor on June 4 . Bp remained elevated even after taking bp medicine . Doctors office sent him to ER. First it was said he had a aneurysm in heart which was ruled out . Then it was advised to us he had a brain stem stroke . Patient still in icu. Still in hospital as of today .06/16/2021. Patient will be going to pt therapy snd of therapy . Has dysphagia unable to eat and left side weakness . Peg tube inserted . Want to establish if Johnson and Johnson vaccination was linked to him having stroke . Patient current illness was maintained and under control until this event happened suddenly .

07/04/2021 at approx. 3:00 AM I woke up with severe chills . At approx. 6:00 AM I experienced abdominal pain and diarrhea. The diarrhea persisted for approx. 2 hours. I was very weak for the rest of the day . At approx. 7:00pm diarrhea persisted. 07/05/2021 approx. 8:00 PM abdominal pain and diarrhea started again.

Hospitalization Case began symptoms on 06/25/2021 consisting of productive cough, diarrhea, syncope, chest pain, and chills - reports pneumonia, diabetes mellitus, cardiovascular disease, and chronic liver disease as pre-existing medical conditions - case was transported to hospital via EMS, admitted 06/25/2021-06/28/2021

COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.

DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 year old male. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.

first night high fever 103, bad chills, muscle pain. Next night tinnitus. I have existing tinnitus that is not that noticable. This increased the volume 3 times. lost weight, 3 pounds not since injection. stomach pain 3rd night.

Had suddenly didn?t feel good. Passed out was out for five minutes, Had a strange reaction when he came to, His vision was blurred, he has vomited 6-7 themes. I contacted the pharmacy where the sot was given and the clinic. He refused to go to E R The have taken notes to this. He sat in his recliner and took a nap. Took temp he does not have a fever. If his symptoms get worse I will call for ambulance.

Event free for 1 week then last night (1/23/21) experienced painful full body ache (no position could relieve discomfort so could not sleep) Felt queasy but not to point of throwing up Felt some acid reflux

Fever/Chills/Headache/Muscle Aches/Fatigue following day; acid reflux appeared on second day after vaccine and fatigue continued and has continued since vaccination; daily medication doubled for acid reflux but has not gotten it under control; continue to wake up with acid reflux and fatigue daily.

FLU LIKE SYMPTOMS; CHILLS; SHIVERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced shivering. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, shivering, nausea, and headache on 22-MAR-2021. This report was non-serious.

While calling to follow up on patients who had received the Janssen vaccine, the patient reported to RN Case Manager that he has been experiencing abdominal pain x 1 week. Pt denied any other signs or symptoms at this time. Reported that he had received a Janssen vaccine on 03/31/2021. Pt was advised to go to ER for further evaluation, but declined to go. Pt stated he was going to "wait it out".

Two separate events, approximately 1 week after injection and 2 weeks after injection. Symptoms; vomiting and diarrhea, unable to keep food down for a period of 2 &1/2 days each event. At the moment I am symptom free. I am seeing a physician for an issue with similar symptoms that have been under control for months using Creon DR. The speed at which the symptoms progressed and the dissimilarity in what I typically experience is what is prompting my VAERS notification. I cannot say with certainty that the symptoms experienced were wholly or remotely caused by the vaccine.

COVID19 Janssen after injection on 3/22/21 started with upset stomach, heartburn and diarrhea on 4/13/2021 to present 4/15/2021

BODY ACHES; LIGHT HEADEDNESS; STOMACH ACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medication allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, light headedness, stomach ache, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, body aches, light headedness and stomach ache was not reported. This report was non-serious.

CHILLS; NAUSEA; HOT FLASHES; FEELING HOT AND COLD; This spontaneous report received from a patient concerned a 61 year old male. 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 and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced hot flashes. On 05-APR-2021, the subject experienced feeling hot and cold. On 05-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, chills, nausea, and feeling hot and cold. This report was non-serious. This case, from the same reporter is linked to 20210424684.

MELT DOWN; SHIRT WRINGING WET; ALLERGIC REACTION; BODY CHILLS ON/OFF; BURNING/CHERRY RED LEGS AND WHOLE BODY BURNING; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 61 year old male. 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: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning/cherry red legs and whole body burning. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced body chills on/off. Laboratory data included: Audiogram (NR: not provided) Negative, and Blood test (NR: not provided) Everything came back negative. On 09-APR-2021 17:00, the subject experienced allergic reaction. On 15-APR-2021, the subject experienced melt down. On 15-APR-2021, the subject experienced shirt wringing wet. On 17-APR-2021, treatment medications included: pregabalin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from allergic reaction, burning/cherry red legs and whole body burning, body chills on/off, abdominal pain, melt down, and shirt wringing wet. This report was non-serious.

This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious. Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.

Dizzy spells (room spinning, nausea) for first 2 weeks. Now only having light headed and nausea spells no dizziness. Does seem to be getting less severe as time goes by but still having spells. Had an MRI done on 04/26/2021 of my head and everything came back normal.

HE CALLED ME ON MAY 6, 2021 REPORTED THAT HE IS HAVING SEVERE NAUSEA, MUSCLE ACHES, THROWING UP. NO DIZZINESS. BECUASE OF MUSCLE ACHES I ASKED HIM TO STOP TAKING ATORVASTATIN NEED TO CONTACT MD ABOUT THE FURTHER CHECKUP AND EVALUATION.

Five minutes after receiving the Janssen vaccine, this patient was observed to be diaphoretic sitting in the post vaccination observation area by this nurse. Patient was alert and oriented x 3. Patient reported that he felt nauseous and felt like "passing out". Vital signs were assessed by this nurse and paramedic. Patient's vital signs were normal. Symptoms resolved shortly after vital sign assessment and 5 minutes after first reported. Diaphoresis resolved. Nausea resolved. Patient denied "feeling like passing out". Family escorted and drove patient home after he completed his 30 minute observation. Patient encouraged to call 911 or his PCP if symptoms reoccur.

Saturday evening May 1 I met with nine friends (all vaccinated) and ate a lot of food, drank moderately, and then did not sleep well. Approximately noon the next afternoon (Sunday, May2) while driving I noticed a developing dry-cough, chest congestion, and general fatigue. While camping that night I had some chills, thought I might have a bit of a fever, and had little appetite. I arrived home Tuesday, May 4 coughing a lot and very fatigued. Wednesday morning I went in for a Covid test. My cough and fatigue continued to increase along with muscle pain and headache. Wednesday night my fever topped out near 104. It broke and I felt much better but for the next few days (until around May 11) it fluctuated between normal and around 100-102. The Covid test came back negative but I went back for another just in case. It too came back negative. My temperature has now stabilized, the cough and congestion are mostly gone. I'm still a bit tired but feeling much better. It seemed like a case of Covid without the Covid. I am glad I got vaccinated but that was rough.

For the first two weeks, there was only mild headache and fatigue. But on day 12 (or 13) following the shot, my husband had severe abdominal pain and black, tarry poop. He passed out on the toilet in the middle of the night and hit his head, woke up in a puddle of blood (from hitting his head) . He was severely lightheaded, short of breath, could not walk. He had to crawl back to bed. He continued to have severe lightheadedness, shortness of breath, muscle aches, abdominal pain, and also ringing in his ears. He called me early Saturday morning and told me what happened and that he called out from work. (We do not live together. He is 280 miles away because of his job.) That man has called out sick only one time since I've met him in 1998; so when he told me he did not go to work, I knew it had to be really bad. I drove up there ASAP the same day, and I took the pulse oximeter with me. His oxygen levels were all over the place. They were usually better (like high 70s to low 80s) while he was lying down. When he would sit up or stand up, the number would plummet, reading so low I thought he was going to die. One time his finger was so cold that it took me 4 tries to get a reading. It read at 55, but I realize that might be because his finger was too cold.

Chills at 12 hours after shot. Abdominal aches around the rib cage and gut starting 48 hours after shot. Aches were severe for 14 days, moderate for 12 additional days, mild for 10 additional days. Treated abdominal pain with Advil. Shortness of breath after mild exertion - like walking the dogs around the block. Shortness of breath still persists today after 5 weeks. I am concerned the shortness of breath may be due to a PE blood clot.

Wasn?t able to stand up at all... nausea fainting dizziness etc... had to take rescue twice within 5 days... was in the ICCU unit at one point.. diagnosed with orthostatic hypotension

Pt became nauseated, lightheaded, and dizzy about 3 minutes post vaccination (Janssen). Pt was laid down on the floor and feet propped up on chair. BP 112/74. Vomited x3. Symptoms began improving after vomiting. Repeat BP 116/80. Pt sat up and was observed for 15 minutes. Pt has history of similar reactions post blood draws. Pt left after 15-minute observation period with symptoms resolved.

VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.

Patient received vaccine on Thursday evening. He began to feel very tired Monday and Tuesday. Wednesday he woke up in alot of abdominal pain. We went to healthcare facility at 4:30pm. He was diagnosed with Acute Pancreatitis. He was sent home at 10:30pm We went back to ED at 1:30 am Thursday. He was admitted during the day. In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive. His heart stopped and they did compressions for 8-9 minutes. He was put into ICU. By 3am we were told he may not survive. By 5 am we were told his organs were shutting down. He passed around 7:45am. In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas. We believe he died as a result of the reaction to the vaccine and his body and organs could not fight.

DIARRHEA; SORE ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included no known allergies and patient does not abuse drug or have illicit drug usage. 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 25-JUN-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 25-JUN-2021, the subject experienced sore arm. On 26-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and sore arm. This report was non-serious.

Nausea with diarrhea shortly after receiving the vaccine. Low level nausea continues to be present constantly. Periodic diarrhea (approximately 2-3 times per week) with symptoms suggestive of irritable bowel syndrome. No prior history of GI disorder or irritable bowel syndrome. OTC treatments partially effective.

5/23 chills,headache, sore throat, diarheah, vomiting, cough, low energy 5/24 Seen doctor given steriod and antibiotic injections, prescribed prednisone and antibiotics. Condition improved for a few days but never went away. Then condition started to worsen as energy and breathining became worse. condition continued to decline as breathing becomes more labored and energy level dropped more. had to stop working as condition worsend. couldnt walk 20 feet without having to stop and rest. i was out of breath and struggling. decided to see doctor again. 6/17 seen doctor and given steriod and antibiotic injections again. given new scripts for prednisone and antibiootics. condition did not improve. more to add

diarrhea started 7 days after vaccination and is still continuing to have the symptoms. not everyday, but most days.

Sudden onset of severe headache, chest pain, difficulty breathing, fatigue and nausea, ~72 hours post vaccination. After 16 hours of bad symptoms that got worse, I took my husband to the ER, as he was having difficulty breathing and moving. (He is normally very fit, active and healthy). In hospital, they ran a battery of tests and found signs of inflammation in chest and lymph nodes. They gave him fluids, and intravenous pain meds (acetaminophen, Toradol), which helped slightly. Symptoms diminished slowly over next 24 hours, and he was feeling 90% better by Saturday afternoon.

On Monday March 8th I went to the Pharmacy to get the Johnson & Johnson Covid vaccine under the new 1b guidelines. I am a 62 year old white male with type 1 diabetes, insulin dependent for the past 49 years. I filled out the question form I was presented by the staff and then was given a dose of the J&J vaccine. This vaccine was administered at approx. 1:30 p.m. I was asked to wait 15 minutes to see if I had and acute reaction, following none, I was told I could leave. There rest of the day I was fine. I went to bed at 11:00 p.m. and within 15 minutes I was cold, shaking and sick on my stomach. I took my temp and it was 100.2 F My O2 sat was 95% and heart rate was 120 with feelings of palpitations from time to time. I went to the bathroom and stayed there the rest of the night with frequent vomiting and loose stool. Stomach cramps all night long. Several BGL were taken and even with an insulin pump I was not able to lower my 299 level for over the next 24 hours of repeated bolus. I was finally able to stop dry heaves and fall asleep for moments at a time around 5:00 a.m. My temp finally broke around 11:00 a.m. the next day Tuesday. I had a headache this entire time. I called hospital ( Ask a Nurse ) on Tuesday morning around 8:00 a.m.and enquired about side effects for this vaccine and effects on a type 1, they basically told me to go to the ER or Clinic and be seen by a Physician. I choose not to do either, but to monitor myself and see how the rest of the day went. The first time, other than a headache and complete body soreness my vitals and BGL, were WNL, was late Tuesday evening around 7:00 p.m. This was a horrible set of side effects. Onset was within 11 hours from injection. No warning for type 1 people to be careful for the possibilities of increased BGL. Today is Wednesday March 10th, and my vitals have remained WNL, but I still have a mild headache and body soreness, some maybe from the vaccine but I believe mostly from the throwing up. Today is March 11th, my vitals are still WNL and BGL is in target. BGL control is responsive to pump therapy now. The past 2 nights I have awoken in a cold soaking sweat that cannot be tied to a low BGL. My body is somewhat still soreness.

6 hours after shot, severe headache and chills. 10 hours after shot vomiting every 1/2 hour for over two hours. 12 hours after shot went to ER . could not hold down fluids. was given IV and anti-nausha medicine. headache lasted two days.

went to bed, got chills for half the night then got hot and was uncomfortable most of the night with stomach ache and little or no sleep

Janssen COVID-19 Vaccine EUA 2 1/2 days of severe flu symptoms. Nausea, Fever, Chills, weakness,no sleep. The next days nausea and light headedness Day 7 (today 3/20/2021) nausea, weakness, and fainting spells. Fainting spells include vision impairment (everything looks fuzzy like a bad tv reception).

High fever, dizziness, weakness, sore joints, headache, diarrhea. Started approx. 8 hours after injection, worsened over the night, lasted into the next day.

Warm feeling followed by fainting and slight convulsions. Nausea, gas, feeling faint, and usability to drive a vehicke for approximately 75 minutes. Slept for several hours, faint feelings subsided after 15 hours.

On 04/12/21 I had just eaten and sat down at the computer. I started feeling disoriented, light headed and my vision started to become affected. I could not focus my vision and tried to vomit also also but immediately went to bed. Throughout the day/night when i got up I was unable to walk/see as normal and required my hand on the wall for balance. I also felt nauseated and could not eat anything during this time. I was able to sleep mostly and as of this submittal(04/13/21 7:51 pm CT) i have been symptom free for several hours. No medical treatment was sought due to no health insurance. All symptoms indicate stroke .

Patient experienced nausea. Also her irregular heartbeat kicked in. Patient had shakes for about 15 minutes. Eventually we decided because of heart and weakness to transfer to hospital for follow up. Patient as of 6pm 4/13/2021 is fine.

Severe lower bottom left of the abdomen on March 26 at around 7am. Difficulty in walking. Pain around hip and middle and upper back.

Patient received the Janssen vaccine on 3/17/21 at 4:42 pm. Beginning at 2:30 am on 3/18/21 the patient began to experience dizziness, vertigo, shaking, tremors, nausea, and vomiting. The shaking and tremors occurs all over but is most significant in the hands and arms leaving the patient unable to do simple daily tasks or return to work. These symptoms began 3/17 and have persisted every day since in varying severity. Sometimes the tremors last for more than 20 minutes straight. The patient was seen in the emergency department on 3/26/21 but the hospital notes are unavailable to the pharmacy at this time. Per patient, he had an MRI and no other tests and was given a prescription for ondansetron for nausea and discharged. The patient believes he was not adequately assessed and is still suffering from symptoms. He has a follow up with a primary physician 5/28/21 which is the soonest he was able to be referred.

Patient was diagnosed with a DVT. Also had symptoms of nausea and vomiting which preceded the vaccine.

WHOLE BODY ACHES; DRY COUGH; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight was 205 pounds, and height was 69 inches. The patient's concurrent conditions included elevated cholesterol, arthritis, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced whole body aches. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, was recovering from whole body aches, dry cough, and headache, and the outcome of nausea was not reported. This report was non-serious.

-Nausea, Vomiting, Memory loss, headache, seizure - 4/12/2021 at 4 am -Seen in ED on 4/12/2021 and had a negative non-contrast brain CT -MRI 4/15/2021 showed a Nonpygenic thrombosis of intracranial venous system

DIZZINESS WITH MOVEMENT; MUSCLE ACHES ALL OVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and dental numbing, and other pre-existing medical conditions included the patient had no known allergies. The patient experienced drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 16:00, the subject experienced dizziness with movement. On 08-MAR-2021 16:00, the subject experienced muscle aches all over. On 08-MAR-2021 16:00, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches all over, dizziness with movement, and slight nausea. This report was non-serious.

BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

4/9 thru 4/12, body aches, chills. 4/12 0400 throwing up stomach pain from dry heaving throughout the day, confusion starting at 6pm on 4/12. Seizure on 4/12 at 8 pm. 911, ambulance. to Hospital Seizure so severe caused a Fracture in the Right Scapula. MRI on 4/15 showed a venous thrombosis partial occlusion in the brain.

Patient states he received J&J vaccine on 4/1; on 4/10 he had nonradiating persistent low back pain. A few days after that (on 4/13) he felt numbness and pain in his legs, in addition to ?decreased sensation in his inner thighs. These sensations were migratory and intermittent. Also noted in his upper extremities as well. He also had issues with temperature sensation in his lower extremities. On 4/14 he had slight haziness in vision while driving which resolved after 30-60min and has not recurred. He also had slight difficulty walking. On 4/15 he had an appointment with his PMD; had L-spine XR which revealed moderate lower lumbar facet arthritis, and was thought that change in sensation was likely d/t radiculopathy - was prescribed ibuprofen, muscle relaxant, oxycodone (took oxy x1, ibuprofen for a few days). Since then he has also had intermittent stabbing pains in various parts of his body which resolved spontaneously. On 4/17-4/18 his back pain resolved. On 4/18 at 4:30am he woke up with R-sided facial weakness. He has not had focal weakness aside from the face. Was seen in ED that morning for this R-sided facial droop involving the forehead, diagnosed with Bell's palsy and given prednisone/valacyclovir. Yesterday 4/19 around mid-day he started having L-sided facial weakness and slurred speech. This has progressed since yesterday. Reports ability to swallow, though a little difficult d/t cheek weakness. Low back pain has returned as well. Does report constipation and possible poor bladder emptying for the last few days. He was seen by a Doctor and referred to ED to rule out AIDP and other diseases after J&J vaccine.

BLOOD IN STOOL; TENDER LUMP ABOVE HIS LEFT EYEBROW; FACIAL CONTUSION; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Human immunodeficiency (HIV) infection, seasonal allergy, medical marijuana, alcohol use (glass of wine with dinner), non smoker, and bleeding issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AV1A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 19:30 to right arm for prophylactic vaccination. Concomitant medications included atazanavir sulfate for antiviral, emtricitabine/tenofovir alafenamide fumarate for antiviral, cetirizine hydrochloride for seasonal allergies, amlodipine besilate, and topiramate. He stopped his antivirals medications two days prior to this report and three days after vaccination. On APR-2021, the patient experienced injection site pain. On 10-APR-2021, around noon he noticed a lump above left eyebrow/facial contusion, described as a raised portion the size of a pea, with a red portion an inch by and half. It was tender. It was still present at the time of this report but improved. On 11-APR-2021, after a bowel movement, he noticed fresh blood in the stool around the faeces and afterwards he wiped. On 13-APR-2021, he contacted his healthcare professional (HCP) and they did a coagulation test (NR: not provided) and it was within normal range. He mentioned that the bleeding was a little worse but his HCP was going to retest in a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from tender lump above his left eyebrow, and facial contusion, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210431872-Covid-19 vaccine ad26.cov2.s-Blood in stool. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY

PAIN AND BODY ACHES; ABDOMINAL DISCOMFORT; LITTLE SORE ARM; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced pain and body aches. On 13-MAR-2021, the subject experienced abdominal discomfort. On 13-MAR-2021, the subject experienced little sore arm. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little sore arm on 15-MAR-2021, was recovering from pain and body aches, abdominal discomfort, and nausea, and had not recovered from fatigue. This report was non-serious.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling was only located in fingers and hands. Patients Blood Pressure after event was recorded at 106/58. Patient states he naturally runs lower blood pressure and heart rate. Also mentioned that he has a fear of needles.. Patient is now responsive and feeling better.

Started at 430 am on the 13th of April, my stomach started hurting. It does not matter if or what I eat, it still hurts. I got headaches, those have also continued since the 13th. The following week my mouth began to hurt, I started coughing more than normal. First a dry cough, now I'm coughing up phlegm with specks of blood. And I can not stop itching, and I'm getting tired of taking benadryl for it. I contacted my doctor, all I got was these are normal reactions to the vaccine. They last 2 to 4 weeks. I already get migraines, my gut is picky since that shot. I used to eat hot peppers, now if I use pepper on my dinner my stomach is in pain. These side effects should be gone by now. I am one pissed off person.

Janssen COVID-19 Vaccine EUA. Severe headache in the night of Vaccine followed by vomiting. Sleepiness and disorientation the next two days. Hospital ER and discovery of bleeding in the brain and admission to the NICU

Pt watching TV, experienced sweating, chills, extreme nausea, and shakiness. Patient went to Emergency dept. BP was 187/71 and all tests were clear. Patient was kept for approx 5 hours and released with no further symptoms.

Right after receiving the vaccination I immediately became drowsy. I became very dizzy could not keep any food down including water. The duration was about 24 hours. I also experienced Vertigo and could not stand up. My head also was spinning like a merry go round.

INDIGESTION; UPSET STOMACH; This spontaneous report received from a patient concerned a 62 year old male. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced indigestion. On 05-JUN-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from indigestion, and upset stomach. This report was non-serious.

LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.

abdominal pain fatigue leg cramps and severe head pain and shortness of breath i now have full blown stage 4 lung cancer that has spead to neck and lymph nodes on left and right sides i was perfectly healthy before the vaccine i blame all of this on the vaccine

About three days after I got the shot, I started having strong gut pain, extreme gas, some nausea and distended stomach. It felt much like a Celiac fair after eating gluten, but I had not eaten any gluten. This continued for about a week. Since that time, my gut has felt like it was always on the verge having the above symptoms. The symptoms will flair up easily and stay longer than normal.

On March 24 I began experiencing severe pain in my right arm. The er thought it might have been a pinched nerve or something along those line. March 28, noticed a lack of muscle control on the right side of my lips while drinking from a straw. This time I was admitted as a possible stroke. Two different MRI sessions revealed no stroke. They performed a lumbar puncture and discovered that I had extremely high protein levels. After having been admitted, for the next couple of days my face slowly lost the ability to close my eyes fully and a complete lack of control of my lips (total paralysis on my face). I also began to experience bouts of stabbing pain throughout my body and weakness in my limbs. After the after th

Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.

wife's report "He said he was nauseated all night. at 5am this morning (3/10) he was vomiting and said his stomach felt bloated like it 'needed to pop'. He had a 100.8 temp this am, back pain. he took tylenol at 12:30p and now his temp is at 100."

3/16/2021 1330 Injection. No immediate adverse reaction. 1350 Discharged. 2100 Chills begin. 2200 Very mild nausea. 2230 Fever 98.9. (I usually run between 97.8 and 98.3). Also, mild joint and muscle aches (knees and shoulders). 3/17/2021 0100 - 0300 Nausea, retching, dry heaves, chills, sweats. Fever 99.7. 0300 - 0400 Unable to sleep. Would awaken with spasm of nausea upon nodding off. 0400 - 0430 Got to sleep, but woke with muscle cramps in both ankles. 0500 - 1000 Fitful sleep. 1000 - 2400 General muscle aches and low grade headache all day. 3/18/2021 0000 - 0500 Fitful sleep. 0500 - 0900 Restful sleep. 0900 Woke with just mild muscle aches. 1600 Side effects gone. No medical treatment sought. One night of discomfort worth it for protection against COVID.

I experienced acute vertigo and nausea three days after vaccine. I was treated at the ER at Hospital on Wed. 3/17/21, and discharged on 3/19/21. The diagnosis was Unilateral Vestibular Hypofunction; it was the same side I got the shot on (left). I was treated with meclizine and given outpatient eye-hand exercises to do. The symptoms have faded, but not disappeared as of today, 3/20/21.

COVID LIKE SYMPTOMS, RUNNY NOSE, LOSS OF TASE AND SMELL, SHORTNESS OF BREATH, NAUSEA/VOMITING, STOMACH HURTS

Hot flashes and excessive sweating, dizziness and nausea, fatigue and achiness. Started at approximately 3:30 am Sunday, March 28th. Symptoms greatly subsided by that evening. Mild nausea Monday morning.

Started feeling ill a few hours after vaccination. Became increasingly ill over the next few days with nausea and vomiting, severe diarrhea, leg cramps that progressed to where he was not able to ambulate, flushed, confused.

Sx: Perfuse sweating, loss of consciousness, vomiting, inability to answer questions, decrease in HR, loss of color to face. Txt: HR, observation, patient remained seated as they were seated when they lost consciousness and were vomiting concurrently, 911 called, BP, HR taken Outcome: Post emesis patient regained consciousness within 2 minutes regained normal color and was alert and oriented

VOMITING/ THREW UP FOR AT LEAST 6 TIMES; ACHES ALL OVER BODY; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10808978, and batch number: 10808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced vomiting/ threw up for at least 6 times. On 02-APR-2021, the subject experienced aches all over body. On 02-APR-2021, the subject experienced feeling weak. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 106 F. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/ threw up for at least 6 times on APR-2021, and had not recovered from fever, aches all over body, and feeling weak. This report was non-serious.

Flu Symptoms 13 hours after J&J Vaccine on Wed April 7th @ 10am - Started Vomiting 11pm-1am and then was on the Toilet from 2am - 8am and Dull Headache and Bodyache until Friday April 9th @ 10am. It was like a Colonoscophy Cleanse that started in my upper digerstive and then my lower digestive system. Feel Back to Normal Friday April 9th @ 3pm

Severe head ache began approx. 2- 3 hours after injection. Followed by fever of102 degrees. Day two fever persisted, nauseous, weakness. Spent entire week with high fever, averaging 101-102 degrees. Day 4 severe diarrhea and vomited. Fever finally broke on 4/11. Currently have heavy chest, cough and weakness. Have spent entire week in bed using Tylenol only.

Janssen COVID-19 Vaccine EUA 6 Hours after injection I became violently ill. Severe Sweats Severe Vomiting Severe Headache Severe Dizziness (could not stand with out falling) Severe Diarrhea

3/17 Vaccination By 6PM, stiff shoulder, stiff neck. Got progressively worse thru night. The diarrhea went away within 24 hours. The floaters in L eye appeared that first night. It started to increase, swatting at 'flies'. 3/18 It got worse; floaters. I made appt with eye doctor. 3/30 Saw Dr. She stated was a lot of floaters in L eye. It is still a few every couple of minutes. Has improved but still ongoing.

Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record). I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS.

Feeling tired, muscle aches, nausea, vomiting, difficulty breathing, dizziness, weakness, heartburn Medications given: NaCl 0.9 %, ondansetron (ZOFRAN) Rx for ZOFRAN ODT

Pt received the J&J vaccine on Monday 4/12 around 10 am. Reports onset of diarrhea mon night, frequent episodes. Then Tuesday 4/13 developed dysuria, fever/chills, headache, nausea, vomiting. Presented to ED 4/14 and admitted to hospital medicine with acute kidney injury.

Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand. I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears. I recommended him to go to the ER now, he said he had called his PCP and was told the same thing. He stated he is single and lives alone and does not drive. I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him. I offered to call his daughter for him and he declined. Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.

I started getting a headache about an hour along with pain in the back of my neck and a mild headache after my shot (maybe an hour or so). Around 1100 hours, about the time I got back from the Facility, I began to feel a tightness in my throat and got a little raspy. When I drank water and ate a little, it hurt similar a hangover as if dehydrated, but went away after a minute or so. About 1400 hours began to develop chills, causing me to get into bed, and then the chills, overall muscular pains, very tired, moderate headache and some nausea ensued as well along with an initial low grade fever. Fever went up to 102.1 degrees and had fever till about 2130 hours and broken only after I took two (1) Tylenols. Still had a very low grade fever till about 2300 hours or so (99-100), but finally went away. I awoke next day (13 APR) about 0800 feeling a bit better, but with a moderate headache and touch of diarrhea. Headache lasted all day. This prompted me to contact my treatment facility and a telecall was conducted giving them my symptoms. They recommended Rizatriptan should my headache continue and Tylenol not enough to relieve. I cannot take any analgesics due to my liver disease and Thrombocytopenia. Finally my headache went away (with a slight hint it might come back), but no more fever, chills etc. On 14 APR, no more headache but still felt a little tired. From 15 APR through today (16 APR), no further symptoms and feel great, but prepared to report anything that may develop laer.

Patient reported on 04/21/21 that he has experienced severe headache for 10 days, increase in blood pressure (189/82, 171/82 vs regular values for him of 150/77), increased blood glucose ( afternoon reading of 289 vs usual 140), abdominal pain, leg pain, all of this for about 10 days. Patient is reporting that he is feeling better and has seen the doctor today.

3/16 - 3/23 : fewer ( 100 -101 F), headache. used Tylenol 3/24 : fewer, headache, nausea, vomiting. used Tylenol 3/25 : fewer, headache, watery eye. stayed in ER. diagnosed sinus infection. treated with Amox/clav 875mg-125mg; claritin; Tylenol 3/26 - 3/28: fewer, serious headache, double vision. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg; waiting for schedule MRI. 3/29 - 3/31: fewer, serious headache, double vision. stayed in hospital. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg.

Today it has been 12 days since the patient got vaccinated. Patient called today to report that ever since he got the vaccine he has been with generalized pain all over his body, sick to his stomach, a real bad headache that does not go away and feeling warm to the touch. Patient reported not having any fever. Patient said he was feeling fine before having the vaccine and not having any health issues on the day he received the vaccine. Patient is going to see his primary doctor tomorrow to discuss the situation.

SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 year old male. 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: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

ABDOMINAL PAIN; DIARRHEA; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021, the subject experienced abdominal pain. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, and had not recovered from severe chills, diarrhea, and abdominal pain. This report was non-serious.

Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen). Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea. Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms. MRI of the abdomen shows left portal vein thrombosis/which is an unusual site. Patient has no liver cirrhosis or metastatic cancer. Is being investigated for idiopathic or acquired thrombophilia

One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.

DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. 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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. 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).

Patient presented to hospital emergency department on 5/19/2021 with complaints of headache, myalgia, nausea, vomiting with hematemesis and severe abdominal pain (rated 8/10) that began on the 5/16. Patient started on argatroban for treatment of mesenteric vein thrombosis. Treatment course pending.

Severe vomiting, severe diarrhea, weakness, spasms in legs. Could barely get out of bed for 36 hours.

Yesterday felt dizziness and queasy and deep pain in the venter of my chest, about 1am it was exacerbated and felt it was symptoms of a heart attack and I took a baby aspirin.

DIFFICULTY BREATHING; LOSS OF APPETITE; DIFFICULTY SLEEPING; UNABLE TO TAKE KIDNEY MEDICATIONS; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 180 pounds, and height was 75 inches. The patient's concurrent conditions included kidney failure, dialysis, non smoker, and marijuana drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 882A286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced difficulty sleeping. On MAY-2021, the subject experienced unable to take kidney medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, difficulty breathing, difficulty sleeping and unable to take kidney medications was not reported. This report was non-serious.

I got the J&J vaccine on 4/6/21. Afterward, I felt fine for about 6 days and then started suffering from head aches, muscle pain, stiffness and nausea. I also suffer from some seasonal allergies so the addition of soar throat a week or so later could have been from that. I had the symptoms for about 4 weeks before they went away.

SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.

The patient had symptoms start 5 minutes after the vaccine was administered. The patient was diaphoretic, his blood pressure dropped 20 systolic, he stated he was weak, he was dry heaving and having difficulty breathing. He was administered an Epi-pen by the nurse. The patient stayed in the office for 45 minutes and was evaluated by the physician. After waiting 45 minutes the patient stated he felt good and wanted to go home.

HEADACHES, SOMETIMES BLURRED VISION, AND SLITHG PAIN IN THE STOMACH, ALONG WITH SOMETIMES LIGHTHEADED (DIZZINESS) C.HEST PAINS

8 hours of receiving the vaccine my temperature begin to increase by 8PM it was 99 degrees Fahrenheit my body could not take liquid or food continued diarrhea. The temperature continued all the night and the diarrehea I only took a pair of aspirin the next day the same no thirst or hunger and reluctance with body, muscular and bone pain. Around 4PM all symptoms began to gradually lessen, by night I had thirst and hunger. The next day I was almost normal with only reluctance and heavy legs. This was all I experience after the vaccination.

Diarrea 4-5 times a day still on July 7th Diarrea 3 times a day. Even with Imodium being taken 3 days.

Tightening of chest Difficulty breathing Nausea Pain at injection site for over 7 days Fever Tired needing to rest

Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital.

Could taste vaccine immediately. Mouth and throat are raw and sore. Bottom lip is very red and swollen. Difficulty swallowing and have no taste buds. Arm is sore but minor issue compared to mouth and throat

Chills, fever 100.1 deg F, headache, stiff neck, loss of appetite, joint and bone pain, sciatica, throbbing kidneys, unable to sleep

I felt like i had to throw up. Took off from work went home I was running fever 101.3 . Took two Tylenol. I felt my joint hurt , my left arm was the sorest from any shot I ever had and is still very sore. I went to bed slept 12 hours. I still feel weak but no fever yet

very bad sore arm at the injection site. sore throat, diarrhea, fatigue, headache, chill (no fever yet)

Very severe diahrrea on the day of the vaccination starting about 6:00 PM lasting for about 14 hours

Janssen COVID-19 Vaccine EUA , Accelerated Heart Rate of 115 / 120, Acclerated Respirations, Fever with temp of 101.6 lasting for 23 hrs, Extreme body aches, headache, feeling very tired, minor dizziness, minor nausea

6 hour after shot; Bloating, burping with foul taste, diarrhea, nausea 8 hours after shot; Vomiting, diarrhea, nausea, weakness 8-30 hours; Discomfort, nausea, weakness 36 hour; Feeling fine again. Fyi,

HOSPITAL COURSE: Patient is a 64 y.o. man admitted on 4/8/2021 with hx of HTN, HLD, tobacco use, Hypothyroidism, and OSA who presented with acute right facial droop in setting of 8 days of headaches and paresthesias, found to have acute ischemic stroke. New slurred speech and worsening of facial droop 4/9 AM, but no new findings on repeat MRI. .

03/22/2021, severe right back pain. 03/23/2021 visited Urgent Care (severe right back pain). 03/26/2021 visited Emergency Care (severe lower right side pain).

PAIN; DRY HEAVING CONTINUOUSLY; BACK DISCOMFORT; DISCOMFORT IN SCAR TISSUE FROM HIS PRIOR SURGERIES; CHILLS; FEVER; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A 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 vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced pain, dry heaving continuously, back discomfort, and discomfort in scar tissue from his prior surgeries. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea, had not recovered from dry heaving continuously, and the outcome of chills, fever, pain, back discomfort and discomfort in scar tissue from his prior surgeries was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

1. metallic taste in mouth lasting about one day on day of injection march 25 2. body aches and pains, severe headache, fatigue, stomach distress nausea March 26-28 3. April 5-7 another incidence of fatigue including fever and shaking 4. April 9 a mini-flu type illness including vomiting and shaking/constipation/diarrhea 5. today April 25, metallic taste in mouth again

Pt complained 4 days after vaccination of headaches, abdominal pain, and diarrhea. No reaction at time of vaccination. Dr was notified on 04/12/2021 when pt complained.

Roughly 20 to 30 minutes after the patient received the vaccine, the patient experienced nausea and vomiting. No other symptoms were reported.

BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients 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: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient experienced migraines, fever, abdominal pain, sweating and felt stabbing pains for 7 & 1/2 hours.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium

SWEATING; STOMACH ACHE; STING ON THE RIGHT SIDE OF FACE; NAUSEA PREVENTED FROM EATING ANYTHING; NAUSEA; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aches every day due to history of arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced sweating. On 01-JUL-2021, the subject experienced stomach ache. On 01-JUL-2021, the subject experienced sting on the right side of face. On 01-JUL-2021, the subject experienced nausea prevented from eating anything. On 01-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting on the right side of face on 01-JUL-2021, was recovering from sweating, nausea, and stomach ache, and the outcome of nausea prevented from eating anything was not reported. This report was non-serious.

Minor discomfort following Shot at first Following with pain at injection point. I took it more it was cause by person giving shot as it was central to the injection site. Was given by a Pharmacist On May 24th 2021 went for quarterly Dr visit and was put on Jardiance 10mg Tab my weight was 388. I started to get a loss of apatite and abdominal pain. On June 8th it became severe Contacted PCP. PCP ordered a ultra sound ended up going to Went to ER on June 19th. had a cat scan run to look at intestinal and found swelling

Patient admitted to the hospital 7/21/21 through the ED and tested positive for Covid19 via rapid molecular test. Patient states he was vaccinated "months ago" and received one dose. He complained of fever, diarrhea, and fatigue. His Chest XR consistent with patchy airspace opacities. He was found to have orthostatic hypotension and hyponatremia attributed to dehydration.

Slight dizziness and mild nausea occurring the day following the immunization (3/5) and continuing through present. No treatment as of yet has been administered.

shivers/chills/fatigue 10-12 hours after vaccine, spent 36 hours in bed with fatigue, headache, muscle aches, nausea, didn't eat or drink anything for past 24 hours, lost 5 lbs in the last 2 days, today I'm partially improved

Slight fever, chills, shivering, weakness, headache, severe heartburn. Duration from 6:30 in evening to noon the next day. Flu like symptoms without nausea and without tingle in sinuses. More runny nose than usual.

almost 24 hours to the minute after receiving the vaccination i had fever, chills, extreme nausea, headache, muscle pain , weakness. even touching my eyebrows hurt. it lasted 10 hours during which time I did not take any medications, eat or drink anything. I did not seek treatment and by morning I was wiped out but all symptoms had resolved.

Headache, achy and dizzy on evening of March 26 (about 6 hours after). This continued morning of March 27. Then suddenly mid-day (about 24 hours after the vaccine) fever (over 100), chills, shaking, dizzy, nausea set in (could not function) and lasted for 14 hours. March 28, still achy, dizzy and feeling of light headedness and exhaustion.

Pt received Janssen vaccine, pt waited 30 minutes post vaccine administration due to his allergies. Pt reported throat pressure and difficulty swallowing approx 30 minutes post vaccine. Pt alert and no difficulty with speaking. EMS activated and patient transported to ER for evaluation

Fever 101.9 degrees, dizziness, Elevated pulse 105 bpm. (Normal pulse rate ranges between 75-78.) Elevated BP 175/100. (Normal BP in the 125/78 range. Nausea. Severe headache. Fever, headache and nausea subsided after 5 days. Heart rate and BP still elevated, Pulse will "race." I contacted my family physician . He suggested I keep close check on BP and go to ER if major symptoms persist after 4 days.

The day after the shot, I felt real tired for at least a half day. My hands tingled on and off, which felt strange and kind of went up my arms slightly. I also felt slightly nausea on and off through the day. I had a slight headache most of the day, which seemed to make my head feel a little warm. About 22 hours after the shot, I felt norm

Strong abdominal contractions started roughly 48 hours after injection. These contractions were about 20 minutes apart and lasted for 24 hours.

Severe Bloody nose, with quarter size blood clots that took more than 45 minutes to stop. Never had a bloody nose in his life. They told us it was from our dry house, but we had not not had the heat on. It stopped bleeding and we went home. Had bad headache for two days following.

Shopping, climbed a single level stairway, became winded, nauseous, got bad heartburn feeling, felt flush and started getting dizzy. Took Tums, no help went to Emergency Room and was told that there was an enzyme in my blood which showed I had a heart attack

Pt states that he had some stomach pain as well as slight leg pain. I instructed him to call his doctor and let them know because it might be signs of a clot and out of caution the doctor might want to see him.

I spoke to patient by phone on Saturday morning around 9:20am. He was concerned about the fatigue, nausea, headache, chills, and muscle aches he had the night before. He felt better when I spoke to him. He wanted to know when those side effects would go away finally. Since I had the Moderna vaccine I said 24 to 36 hours. But I didn't know about the J&J vaccine. We disconnect the call at 9:40am Saturday morning. After the call at some point he fixed lunch or dinner and stopped eating before finishing his meal. He had left the food on the table and in the pans he fixed it in. Very unusual for him. The patient then went to his room where is was found Monday 3/22/21 around noon in his bed laying on his chest (he hated to lie on his chest) by the police and the HR officer from his work. The HR officer had called my other brother around 11:15am on 3/22 /21 to ask if we had heard from the patient because he had not reported to work or phoned in. He has passed sometime between noon on Saturday till Sunday evening alone at his residence. He had towels and a trash can beside his bed when he was found. The coroner call it death by natural causes and would not do an autopsy when even asked by his PCP.

DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

1.stiffness in joints, 2. achy 3. coughing 4.runny nose 5. feeling tired 6. nauseous 7. blurred vision

Per pt's wife - reported to pharmacy - 2 days after receiving vaccine - pt experienced shortness of breath, coughing, nausea. Patient was not feeling well in general. 2 days after this (so about 5 days after receiving the vaccine) - pt was COVID positive - and is at the moment in the ER.

Patient began having fever, chills, rash, and vomiting night of the vaccine (03/31). Patients symptoms have continued for almost 4 weeks (03/31-4/26)and have worsened. Unable to keep down any food other than saltine crackers and some ginger ale. Patient now has a cough, shortness of breath, and lower left abdominal pain. Patient has not been able to follow up with primary care doctor or lung specialist. Encouraged the caretaker to take patient to PCP, urgent care, or ER. Symptoms typically resolve within first week (fever, chills, and fatigue). Symptoms, especially, fever persisting with treatment of Tylenol and Motrin should be assessed ASAP. Waiting to hear back from doctor follow up and if there were any underlying causes for symptoms.

pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated.

2 weeks ago on April 17th, I woke up feeling very dizzy and nauseous. The room was spinning. My left ear was ringing, My balance was off. Every time I bent over it was worse. I vomited after I ate. Spent the day and the next day in bed. On Monday I called my doctors office and explained how I was feeling and a tele visit was scheduled later in the day. During the tele visit, the doctor diagnosed my symptoms as vertigo. I never had vertigo in the past. She couldn't tell me if it was from the vaccine or not. She did mention she had patients complaining of vertigo after getting the covid vaccine. Medication and exercises were given to me. A few days later, my big toe on my right foot was aching terribly. Each day it seems to be worse and I am at the point where I can barely walk. Today I did some research online and saw that it could be gout. I never had gout n the past. I read vaccines can cause gout. So here I am 2 weeks since my symptoms began and I am still dizzy and have the toe pain. Exercises and medication is not helping.

About three weeks after the vaccine, I started to experience an inability to concentrate. I had Diarrhea and a low grade fever for one day and I couldn't concentrate. I started to have symptoms of depression that I do not normally have. I felt restless and I had trouble sleeping. I was very aggravated, and I was having repetitive thoughts. I had trouble working and my brain was a little. It went on for two weeks. I have had a few more episodes since then but it is much better.

About a month after i received my shot I had a headache and nausea, stomach ache, headache would not subside. Contacted at the Clinic.

VOMITING; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levetiracetam for seizures. On 21-MAY-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.

On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m.

Day after shot patient was tired, he was not feeling well, & he never fully recovered. He went to work on Monday, May 10th & worked until 6:00pm. Returned home eat a little & went to bed. Tuesday, May 11th he worked at home, Wednesday, May 12th we had coffee, laughed & joked around & he went back to work at home. I went to check on him about five minutes later & he was sitting up sleeping. He would usually wake up & say I took a power nap but he was not breathing. I started mouth 2 mouth but he did not respond. My sister told my nephew to call 911 & they told us to lay him on the floor & start CPR until the paramedics arrived. Once they arrived & took over they tried to get him to breathe & restart his heart. The paramedics worked on him for a long time giving us updates on what they were trying to do. Patient never regained consciousness. They indicated probably a heart attack.

Acute Ischemic Multifocal Posterior Circulation strokes resulting in L sided weakness, L facial droop and dysphagia. Hospital course complicated by respiratory failure. Patient had placement of tracheostomy en g-tube given failure to wean off the ventilator and prolonged dysphagia with poor mental status to aid in swallowing

On May 14 I received the covid vaccine. On June 18 I started to experience persistent diarrhea which has continued to this date. I rarely experience diarrhea and when I do it usually lasts only 1-3 days. So on June 25 I contacted my primary care NP who ordered blood and stool labs. the diarrhea was watery, no cramping, no unusual odor or visible blood in the stool. the labs however reported trace blood in the stool. The frequency of stool was 1-2 times daily. I followed the diet suggested by my NP .Have there been any similar reports like mine regarding the J&J vaccine? Please contact me by email.

cold, shivering as if with a fever yet no fever present along with sore leg muscles, a long hot shower relieved the symptoms temporarily but they lasted till approx. 3AM. Then waves of oversensitivity with knee and foot joints hurting as if arthritis, and this lasted most of the night. I also experienced strange hallucinations in the night as if I had a high fever but I don't believe I had a fever, and I also had a migraine and neck pain. The arm where the vaccine was applied is fine and not sore at all. I also have a slight soreness in my stomach as if I had been coughing for a while, which was not the case. It is now 11:34 AM the following day and I believe I'm getting back to my normal self but it sure was a rough night and I though you should be aware.

Body chills. In going to bed I had heavy clothing, bathrobe and multiple blankets to offset the chills. During the night I woke up overheated and bathed in sweat. Got up to go to the bathroom for BM but was nauseous, feeling need to vomit at the same time. After BM I stood and still felt need to do one or the other or both when I passed out. Wife came upstairs and found me sitting up against the corner wall. She was able to shake me awake while calling 911. I was groggy but aware I was still nauseous and stayed down next to toilet until stomach settled. I came downstairs and EMTs arrived. Took blood pressure. Result was it was low. Took EKG and that was normal. Second blood pressure test showed that I rebounded. When offered I felt it unnecessary to go to hospital.

#1 I had reaction to Moderna first (Jan 22) and 3 MDs told me to get J&J as second A few hours following shot developed dry cough, which persisted 4 days. Within 3 hours developed moderate headache which lasted 4 days. After 7 hours became EXTREMELY cold. Had to stay in bed w 7 blankets for 2 days. By 3 days still chilly but relenting. Mild to sometimes moderate nausea developed first day, lessening over 3 days. Fatigue severe starting 8 hours post vaccine, resolving over 4 days. Tiny bit of injection site pain.

Severe vertigo started on 15 Mar 2021. Symptoms include: vomiting; dizziness; unable to walk without falling; etc.

DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 year old male. 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: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.

2 days after shot, fatigued, minor muscle ache, dizziness, blurry weak vision. Some nausea in a.m., then today, 7 a.m. nausea and weakness, chilly and extreme fatigue, in bed all day so far. Feeling like not enough air all week since shot.

Patient came to the ED complaining of abdominal pain which he states began a few hours after receiving the vaccine. Evaluated by GI and will follow up on colitits

pt says on 4/8/21 he got chills and dry cough. On 4/9/21 day he got body aches and pain w/chills. He had loss of appetite and had no taste. On 4/10 he developed night sweats. By 4/11/21 he was not able to control his bladder. On 4/12/21 he had diarhea. He went to Urgent Care. They did Covid Test, blood work and X-ray w/ negative. He was given a shot of penicillin. He was prescribed Cefuroxime Axetil 200mg. He feels like he is getting better but still has no taste. Pt says he has never felt like this bad in his life.

By 10:00 pm that evening I got Chills, fever, muscle aches, headache, nausea and low back pain. Stayed home from work for 1 or 2 days. Felt better in all ways except my low back got very, very painful. I asked my wife to buy me a walker to take to work because I had difficulty walking the distance from the parking lot to inside my office. Also used the walker at work. My boss said to go home, it looks like you're in pain. Saw Dr. on Monday March 15 because the low back was getting worse. He prescribed muscle relaxors and anti-inflammatory medicine. Called the next day asked for something stronger for pain because worse. Nurse responded to continue on existing meds. Went to Chiropractor on both March 16 and 18 without back pain relief. On March 19 went to urgent care, got X-ray and pain meds. MRI done 2 days later on March 21st which revealed a spinal abcess. Admitted to Hospital, surgery done to remove spinal abcess on March 22. Bacteremia, laminectomies in L3,4,5 S1 to relive spinal cord pressure. Puss had the filled spinal epidural cavity, cultured out as Strep bacteria. Remained hospitalized until April 2nd. Sent home for 1 night then returned to hospital via ambulence the next day April 3rd with 103 degree fever. Discharged April 8th. Readmitted to hospital for 3rd time on April 17 where I remain today with Kidney and liver function problems likely reactions to meds. Continue to have excruciating low back back which is why continues to be hospitalized at the time of this report.

STOMACH UPSET; SLIGHT HEADACHE; SLIGHT PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach issue, and concurrent conditions included high blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, on left arm administered on 07-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slight pain. On 08-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced stomach upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 08-MAR-2021, had not recovered from stomach upset, and the outcome of slight pain was not reported. This report was non-serious.

DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site. His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. 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, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. 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).

Fever, delirium, unable to control body temperature, searing headache, pervasive, unrelenting nausea,

PAROXYSMAL ATRIAL FIBRILLATION; FEELING OR SENSATION OF DRAINAGE IN LEFT NOSTRIL; OCCASIONAL PRESSURE IN BOTH EARS; SLIGHT BURNING SENSATION IN JUST LOWER LIP WITH SMALL, TINY PROTRUSIONS; LOCALIZED BACK PAIN BILATERALLY INFERIOR TO THE POSTERIOR RIB CAGE BUT MOSTLY ON LEFT SIDE; SLIGHTLY HIGH PITCH SOUND IN LEFT EAR; HEADACHE; FATIGUE; SMALL AMOUNT BLOOD IN STOOL; NODULE IN CUBITAL FOSSA AREA ON MEDIAL SIDE OF ARM; SMALL AMOUNTS OF BLOOD IN PHLEGM; IRREGULAR, LESS FREQUENT AND MORE SOLID BOWEL MOVEMENTS; INCREASED URINATION LASTED 2-3 WEEKS; OCCASIONAL LOCALIZED PRESSURE AND HEADACHES IN OCCIPITAL, FRONTAL, AND TEMPORAL AREAS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (experienced all the typical symptoms, but waited 13 days to get tested) and concurrent conditions included paroxysmal atrial fibrillation (last time he had an episode until after he received the vaccine). He did not have any recent episodes of atrial fibrillation The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced occasional localized pressure and headaches in occipital, frontal, and temporal areas which were intermittent and pulsating in nature. On APR-2021, the patient experienced small amount of blood in stool and had irregular, less frequent and more solid bowel movements about 2-3 weeks post vaccination. He mentioned around the same time he was urinating more (increased urination lasted 2-3 weeks), and then his bowel movements and urinations became regular again. He also experienced a nodule that appeared in the cubital fossa area on medial side of his arm two weeks after the vaccination and then gradually resolved over 2.5 weeks after it appeared and small amounts of blood in his phlegm which appeared 1.5 weeks post vaccination and he continued to experience this on week 2, week5 post-vaccination and then resolved. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative, Complete blood count (NR: not provided) unknown, and Platelet count (NR: not provided) Normal. He reported experiencing 5 episodes of atrial fibrillation within the 7 weeks after vaccination, a diagnosis of paroxysmal atrial fibrillation was confirmed by his cardiologist. He also experienced fatigue about 5-6 weeks after vaccination. He had intermittent waves had fatigue throughout the day which lasts for an hour and then came back later in the day, with no consistency and stated this was still unresolved. (Later on he stated he had no fatigue spells lately and considered this resolved). On an unspecified date, he experienced feeling or sensation of drainage in left nostril, (even though had no excess blood or fluid) which started a few weeks after received the vaccine and then lasted for several months but now resolved and occasional pressure in both ears (opening and closing his mouth did not relieve the pressure) and slight high pitched sound in the his left ear. His ear side effects came and gone and considered them to be resolving but not fully resolved. He noticed a few weeks after vaccination he had slight burning sensation in just his lower lip with small, tiny protrusions (He initially said this was unresolved, but then later said this was resolved). He also experienced localized back pain bilaterally inferior to the posterior rib cage but mostly on the left side. He mentioned he have a checkup next week and will discuss his concerns since this side effect was still unresolved and headache. The patient stated he did not experience any of these side effects before receiving the vaccine. He was generally healthy and tried not to take medication if possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paroxysmal atrial fibrillation, nodule in cubital fossa area on medial side of arm, feeling or sensation of drainage in left nostril, slight burning sensation in just lower lip with small, tiny protrusions, and fatigue, and small amount blood in stool, small amounts of blood in phlegm, irregular, less frequent and more solid bowel movements, and increased urination lasted 2-3 weeks on APR-2021, was recovering from occasional pressure in both ears, and slightly high pitch sound in left ear, and had not recovered from headache, localized back pain bilaterally inferior to the posterior rib cage but mostly on left side, and occasional localized pressure and headaches in occipital, frontal, and temporal areas. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667239-COVID-19 VACCINE AD26.COV2.S. Paroxysmal atrial fibrillation. This event is considered not related. The event 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 than the drug. Specifically: UNDERLYING DISEASE 20210667239-COVID-19 VACCINE AD26.COV2.S. Small amount blood in stool. 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 complaining of shooting , neuropathic type pain from top of head radiating down. Patient complaining of increased saliva production, difficulty swallowing.

COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. 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, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor. On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. 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, UNDERLYING DISEASE.

About 7pm I started feeling terrible chills and headache. by 10pm I had extreme body aches, bones , muscles, etc. Headache was very intense,eyeballs ached ,face etc. I was dizzy, jaw was stiff but mostly terrible pain. had some wheezing by it went away when I coughed up mucus. Had a 101.5 degree temperature all night which went down to 100 in the morning and back up to 101.2 later on the 14th. I had nausea and extreme pain all over my body and restlessness. it got a little better the next day but still feels like I have the flu. I had covid back in march of 2020 and was tested for the antibodies at the end of August. There is a horrific dearth of research on people who have had covid and whether they should get the vaccines. It is disgraceful, and the next time I will listen to my gut which told me NOT to get vaccinated!

Death on 3/23/2021 at 9 AM. Home Health Nurse who gave immunization on 3/19/21 verbalized pt was fine after injection, stayed in home for 1 hour after injection was given. Wife verbalized pt was very tired the following day and through out the weekend. Pt stopped eating one day prior to death. Respirations changed on the morning of 3/23/2021 and wife called EMS, pt died at home.

Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again.

Nursing Home resident given Janssen COVID-19 vaccine during On-Site clinic and Rehab. Sponsor consented to resident receiving vaccine and resident/facility denied resident receiving any prior dose of COVID-19 vaccine. After vaccination completed upon reporting it was noted that a dose of Janssen COVID-19 was given at a Dialysis clinic the week prior. Pharmacy reported to facility to verify accuracy. Facility nor sponsor were aware or notified about a prior dose of COVID-19 vaccine. Dialysis clinic verified dose was given. Doctor notified. Resident had mild nausea the day after vaccine, but resolved and no other side effects noted.

The day after vaccination date patient began to have increased SOB and a headache (Pain Score of 6). Spouse checked BP which was WNL for patient. O2 sat was as low as 88% on room air. Patient then applied O2 at 2LPM via nasal cannula. O2 sats have maintained in the low 90's with home intermittent/on demand O2 in place. Has required O2 24/7 since day after vaccination. Headache has remained persistent with a pain score of 6 - unrelieved with routine scheduled pain medication, along with taking PRN Tylenol and Ibuprofen. Patient verbalizes more fatigue than usual for himself. Has had decreased appetite.

Increasing chest pain and colon discomfort. I went to hospital on Friday April 9th because of this. Troponin levels were normal. Symptoms have been coming and going and are still present. At times I feel like I am going to black out. I feel generally unwell and the chest pain is concerning.

FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.

POOR APPETITE; WEAKNESS; FEVER; COUGHING; This spontaneous report received from a consumer concerned a 67 year old male. 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 administration not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, 97.7 F. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced poor appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from weakness, coughing, and poor appetite. 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.

Nauseous, vomiting, headache, light headed, disorientation, vision changes, jaw pain, lymph node inflammation, lethargy, mental confusion, sense of hopelessness, 15 days taper Prednisone, ibuprofen, acetaminophen, still currently experiencing symptoms today

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

On 5/2/21 patient presented to Emergency Room with Rt upper chest pain that is worse after meals and associated with vague nausea and some sob. Reported that pain was constant and burning in nature. Pt was admitted to hospital with mildly elevated troponin. D-dimer was greater than 20. Pt had a VQ lung scan which confirmed the diagnosis of pulmonary emobolus. Pt was given Enoxaparin 100 mg subcutaneously every 12 hours from 5/2-5/7. Then patient was started on Apixaban 10 mg po bid x 7 days which will transition to 5 mg po bid. Pt improved and will be discharged today 5/7/21.

Patient developed acute onset bilateral anterior thigh pain that radiated to the lower back and buttocks, as well as in the posterior hamstrings. The pain was 10/10 and started suddenly over 1/2 days, described as sharp and stabbing in nature. He was able to ambulate but had extreme pain with hip flexion. Associated with this had unintentional weight loss of 10 lbs over 3 weeks, loss of appetite, drenching night sweats for 4 days prior to admission. He presented to the ED on 4/16 with negative work up and was discharged. He re-presented on 4/24 with the same symptoms and was admitted until 5/3. His pain was managed with oxycodone and extensive work up was pursued given concern for systemic inflammation with leukocytosis, elevated CRP, ESR, but normal CK. Eventually pursued thigh muscle biopsy which showed ". At last point of contact at 5/7, he described having two more episodes of bilateral thigh pain after discharge that lasted 30 min in the mornings, but had not had any symptoms the day prior to the call.

Pain in top of head, blurred vision, weak, tired, diarrhea, confused; lasted about 10 days; symptoms came on about 45 minutes after injection.

Increased fatigue, lightheadedness, nausea, intermittent left arm pain and underarm pain and swelling. Left sided chest discomfort - pain worse with breathing and coughing non productive cough

PULSE RATE; HEADACHE(COMING AND GOING); NAUSEA; FEVER; This spontaneous report received from a patient concerned a 67 year old male. 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: 207821A, expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced pulse rate. On 03-JUL-2021, the subject experienced headache (coming and going). On 03-JUL-2021, the subject experienced nausea. On 03-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, Body temperature decrease (NR: not provided) 97.1 F, and Pulse rate (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUL-2021, had not recovered from headache(coming and going), and the outcome of nausea and pulse rate was not reported. This report was non-serious.

Headache, dizziness, vomiting over 3x in a 7 hour time period, pressure in neck up to the back of head, tightness in the back of head, faint feeling.

I didn't have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn't kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication. I've had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn't give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.

Patient was unresponsive initially, slow breathing , pallid color, called 911, patient came too and felt nauseous and needed to use the bathroom, Paramedics check him out and he left with his wife (did not go to the hospital)

The patient called the pharmacy on 4/7/2021 and said that he had vomited and had been experiencing an excruciating headache that he said was worse than any headache he had ever had and was concerned about how he was feeling since he had just had his Covid vaccine on Monday. I told him that headaches were a very common adverse reaction and that many people had experienced headaches after vaccination. I told him that from my experience it usually didn't last more than a day for others and I assured him that it should go away soon. I later talked to him and found out that he had went to the Emergency room that Wednesday evening (4/7/2021) because the headache was so bad. He was seen in the ER, observed overnight, released the next morning, and then had a follow up appointment with his primary care physician on 4/15/2021. He also had a very high blood pressure reading he told me in the Emergency room that evening he was evaluated.

1 bout of Violent diarrhea that occurred on 4/9/21 or 4/10/21- passed out on the bed after the episode, exhausted. Nausea followed the diarrhea. Comes and goes. Still happening. Experienced heart palpitations at night on 4/12/2021, never experienced before. Got EKG the next day- normal. Back ache began on 4/15/21 to 4/16/21. Not experienced this before. The ache comes and goes. Fatigue and weakness in the whole body. Comes and goes. Better after food.

fever, shortness of breath, shivering, loose stools, loss of appetite, muscle aches, headache, extreme fatigue.

SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. 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.

severe headache, abdominal pain, or shortness of breath and patient states they were consistent for 2 weeks and now they have passed

Facial pain or headache becomes more severe, drowsiness or confusion , swelling of the forehead or eyelids, vision problems including blurred and double vision, seizure, dry mounth nausea tiredness constipation, double vision Diplopia, one aye is affected, vertigo, speech or walking

The following evening after the shot, he had severe pains in his back and shoulders, headache, nausea (vomited). 2 days later, felt severe pain in his stomach, along with pain in his shoulders and back, with a headache, also vomited.

LOWER INTESTINAL DISCOMFORT; FOGGY THINKING; FORGETTING THINGS; DIARRHEA; HOT EAR; COULD NOT SLEEP; NAUSEA; HEADACHES; INJECTION SITE PAIN; INCORRECT PRODUCT ADMINISTERED; ARM PAIN; FELT LIKE POSTICTAL PHASE OF EPILEPSY; DISORIENTATION; DAZE/FEELING WONKY; ITCHING; OVER-SENSITIVE SKIN; FACE FEELING "SUNBURNED"; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included polycythemia year diagnosed, and concurrent conditions included frontal lob partial focal epilepsy, recovering alcoholic, nicotine free, vegetarian, anaphylactic shock to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no any 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: 042A21A, and UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included oxcarbazepine for frontal lob partial focal epilepsy. On 06-APR-2021, the subject experienced felt like postictal phase of epilepsy. On 06-APR-2021, the subject experienced disorientation. On 06-APR-2021, the subject experienced daze/feeling wonky. On 06-APR-2021, the subject experienced itching. On 06-APR-2021, the subject experienced over-sensitive skin. On 06-APR-2021, the subject experienced face feeling "sunburned". On 06-APR-2021, the subject experienced incorrect product administered. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hot ear. On 13-APR-2021, the subject experienced could not sleep. On 16-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced foggy thinking. On 18-APR-2021, the subject experienced forgetting things. On 19-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 111/70 mmHg, and Body temperature (NR: not provided) 96.7 F. On 20-APR-2021, the subject experienced lower intestinal discomfort. Treatment medications (dates unspecified) included: ibuprofen, cortisone, hydrocortisone, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 19-APR-2021, arm pain on 06-APR-2021, and headaches on APR-2021, was recovering from face feeling sunburned", had not recovered from nausea, and the outcome of injection site pain, disorientation, daze/feeling wonky, felt like postictal phase of epilepsy, over-sensitive skin, diarrhea, foggy thinking, forgetting things, hot ear, lower intestinal discomfort, could not sleep and incorrect product administered was not reported. This report was non-serious.; Sender's Comments: MAC comment: V0; Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.

day after vaccination had violent headache. chills, extreme muscular, joint pain, nausea., eyes glossed over, disorientation, dizziness . had weakness in left arm [site of vaccination and left leg .didn't take anything. only ate 2 dry english muffins. day 2. same with marginal relief. day 3 woke up at 4 am with sweats. clothes soaked with sweat. violent diarrhea . at 9 am. still have some disorientation, glossy eyes. afraid to eat because of diarrhea. had 2 , 2 liters of room temperature coke for previous 2 days. now 6 hours later somewhat better feeling.

BLOOD IN THE URINE; SHINGLES; RASH LOOKING LIKE SHINGLES; FATIGUE/FEELING TIRED; BAD HEADACHE; LOSS OF APPETITE; FOOD DOES NOT TASTE QUITE WELL; NUMB AREA; ITCHING; FELT LIKE ELECTRIC CURRENT GOING THROUGH; PAIN 24/7; BUMP AND IT SPREAD TO SHOULDER AND IT SEEMED TO AFFECT THE NERVE; DISCHARGE FROM RASH; This spontaneous report received from a patient concerned a 68 year old white, not Hispanic or Latino male. Initial information was processed along with the additional information received on 10-MAY-2021. The patient's height, and weight were not reported. The patient's past medical history included ruptured pancreas for which he had a major surgery, eczema, femoral by pass of the right leg to increase blood flow, and blood in urine (which had occurred due to unspecified medical conditions and was cured), and concurrent conditions included prostate cancer, home bound (got vaccinated at home), and the patient was on foley catheter. The other pre-existing medical conditions included the patient had no known allergies, no history of mumps or chickenpox when he was a child and had not been in contact with anyone having chickenpox. 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, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination. Concomitant medications included triamcinolone for eczema. On an unspecified date in 2020, 6 months ago at the time of reporting, laboratory data included: Blood cholesterol (NR: not provided) unknown, and Lipids (NR: not provided) unknown. On 06-APR-2021, after vaccination the patient experienced bad headache for a couple of days, fatigue/feeling tired, loss of appetite that was still lingering. Per patient the food wasn't tasting quite well. on an unspecified date the patient experienced rash like shingles. On 27-APR-2021, the nurse said that the patient experienced a kind of rash that looked like shingles on left shoulder and left neck and had dark colored urine which indicated blood in urine (patient was on foley catheter). On an unspecified date in 2021, the patient experienced a small bump ( injection site lump) at the site of shot on the left arm which spread to the shoulder and it seemed to affect the nerve, the area was generally numb, itching and electric current going through (electric shock sensation), the pain was 24/7 and discharge from rash. The bumps ruptured easily and the patient was advised not to spread the discharge from rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headache on 08-APR-2021, was recovering from fatigue/feeling tired, had not recovered from rash looking like shingles on left shoulder and left neck, loss of appetite, blood in the urine, and pain 24/7, and the outcome of numb area, food does not taste quite well, injection site bump spreading to shoulder and affecting the nerve, itching, discharge from rash and felt like electric current going through was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516869-COVID-19 VACCINE AD26.COV2.S-Blood in the urine . 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

VOMITING; NAUSEA; FATIGUE; SURGE OF ENERGY; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 4 prostate cancer, and sulfonamide allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced surge of energy. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from surge of energy on 16-MAY-2021, and had not recovered from nausea, vomiting, and fatigue. This report was non-serious.

4/15/2021: Severe headache, hip/joint pains, Nausea & vomiting. Mobility & balance issues, unable to walk or stand, tinnitus & extreme fatigue, change is mental status. *tinnitus, fatigue, nauseous feeling and balance problem & sudden depressed feeling continuous for weeks. 5/20/2021: severe neck pain and neck stiffness. Fatigue, nausea, tinnitus, confusion & mood changes

DRY HEAVING; NAUSEA; HIGH FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and had no history of 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced flu like symptoms. On 19-MAY-2021, the subject experienced high fever. Laboratory data included: Blood glucose (NR: not provided) Not Reported, and Body temperature (NR: not provided) up to 101.9. Treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced dry heaving. On 20-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) up to 102.9. Treatment medications included: prochlorperazine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, dry heaving, and nausea, and had not recovered from high fever. This report was non-serious.

FLU LIKE SYMPTOMS; EPISODES OF DIARRHEA EVERY 1 WEEK; WEAKNESS WITH UNCERTAIN CAUSE; ABDOMINAL PAIN; ABDOMINAL BLOATING; ANXIETY REACTION; DEPRESSION; FEELS LIKE DYING/FEELS LIKE SHIT INSIDE; POSSIBLE DEHYDRATION; VERY FRUSTRATED; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, thyroid disease, all grass allergy, trees allergy, non alcohol user, and non smoker. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination into left arm. The batch number was not reported and has been requested. The patient was under 6 to 7 other medications which are not related to these symptoms. On 07-APR-2021, the patient had begun experiencing diarrhea which lasted approximately a couple of days and then it went away, and the patient had begun feeling fatigued, weakness with uncertain cause, nausea. Every once a week the patient had claimed having a diarrhea episode. In Apr-2021. the patient had abdominal pain, abdominal bloating and it has been consistent. The patient rates abdominal pain a 9/10 on a scale of 1-10, 10 being the worst. The patient felt like these are flu like symptoms. The patient had about 7-8 emergency room (ER) visits because of these symptoms. The patient does not remember the exact dates. In 2021, the patient stated he felt like shit inside, developed depression, possible dehydration, felt like dying, anxiety reaction and very frustrated. On an unspecified date, the patient was hospitalized for diarrhea, abdominal pain, abdominal bloating, weakness for uncertain cause, fatigue and nausea. The patient narrated he has hospital records. The patient was prescribed with an unspecified anti-emetic medication and it has not been effective. The patient had a planned follow up with his primary health care professional (HCP) on 06-JUN-2021. The patient was even looking into palliative hospice care might be into a mental health ward. The patient was very concerned that his symptoms have now lasted approximately two months. The patient stated they took his vitals, electrocardiogram (EKG), computerized tomogram (CT) scan and did testing on him and they could not find nothing wrong with him and they cleared him. The patient had stated that a rehab nurse would be coming out to his house to do some blood work, a physical on him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, abdominal bloating, weakness with uncertain cause, flu like symptoms, episodes of diarrhea every 1 week, depression, anxiety reaction, feels like dying/feels like shit inside, possible dehydration, and very frustrated. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210604777-covid-19 vaccine ad26.cov2.s-abdominal pain, abdominal bloating, flu like symptoms, episodes of diarrhea every 1 week. 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: 20210604777-covid-19 vaccine ad26.cov2.s-weakness with uncertain cause. This event(s) is labeled per and is therefore considered potentially related.

The individual tested positive for COVID-19 on 6/23 with a PCR test that was done at Medical Center, when the case arrived because he was experiencing nausea and vomiting and there was blood in his vomit. He vomited twice and the first time the blood was lighter, and the second time it was darker, so he decided to seek emergency medical treatment at the hospital. The patient continues to be currently hospitalized (today is 6/25/21). His primary care doctor. And the Hospital Doctor seeing him is a GI specialist.

2 days after shot (4/4/3021) experienced severe stomach pain and diarrhea that lasted 2 days. Had to go to hospital and get pain med to handle pain.

Onset severe headache that went away, dizziness that diminished when he lay down, two previous nights of stomach cramps

PTS WIFE NSTATES NPT REFUSED TO GO TO HOSPITAL AFTER DEVELOPING CHILLS, LOW BODY TEMP @ 95, VOMITING, FATIGUE, WEAKNESS, AND LOSS OF APPETITE. SHE FED HIM CHICKEN NOODLE SOUP, PENTY OF BLANKETS, AND GATORADE. ITS BEEN 1 WEEK AND HE IS STILL ILL AND STILL REFUSING MEDICAL ATTENTION

Strong headache lasting about 2 weeks, nausea, red raised sores up to half inch diameter clearing some after 12 days on face and scalp

Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.

initially had mild headache and diarrhea but this resolved after a few days. Then around 4/25, developed atraumatic bruising and swelling and pain to the left biceps region (opposite side from vaccine). denied current headache/visual symptoms/abdominal pain or other bleeding/bruising.

On March 30th the patient had loss of appetite and headache. On March 31st the patient collapsed and was taken to the ER, the patient's oxygen was low. Patient's blood pressure had dropped and you could not wake him up all afternoon. The Ambulance took him to the hospital on April 1st where he had shortness of breath and blood clots in lungs. On April 1-2 the patient was leaking blood but the hospital staff could not find where so they gave him 3 units of blood. Patient also received 3 antibiotics for a rare pneumonia.

Patient describes frequent bouts of diarrhea with associated weakness and lightheadedness, symptoms started 05/08/21, he had received the Jand J vaccine 05/05/21

PAIN ALL OVER BODY, FROM ANKLES UP TO HEAD (WORST BACK, CHEST NOT GOOD); SLEEPLESSNESS; FEELING LIKE DYING, NOT MAKING IT; SHORTNESS OF BREATH; NOT EATEN ANYTHING IN DAYS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's past medical history included horrible accident, right femur replaced, both ankles replaced, both knees replaced, and fuse lower back, and concurrent conditions included artificial hip, blurry vision, ptds (post traumatic demoralization syndrome), and panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced pain all over body, from ankles up to head (worst back, chest not good). On MAY-2021, the subject experienced sleeplessness. On MAY-2021, the subject experienced feeling like dying, not making it. On MAY-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced not eaten anything in days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over body, from ankles up to head (worst back, chest not good), and the outcome of sleeplessness, feeling like dying, not making it, shortness of breath and not eaten anything in days was not reported. This report was non-serious.

Injection Site soreness, by bedtime, slight fever, chills (all night), overall aches (like the Flu), terrible headache upon waking. No appetite, symptoms continued for 3 days. Back to somewhat normal on day #4.

I was kinda weak, not feeling real well. I went to see my cardiologist and let him know that I had discovered blood in my stool. They ordered blood work and my hemoglobin and rbc was so low the told me to go straight to the hospital. They gave me 3 units of blood. They did a colonoscopy and endoscopy, and have not determined the cause of the bleeding. I was admitted in the Hospital for 3 days.

SUDDEN ELEVATION OF TEMPERATURE= 102, NAUSEA, BLOOD SHOT EYES, GENERALIZED JOINT PAIN. TOOK TYLENOL/ASPIRIN. LESSENED THE EFFECTS.

DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 year old male. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.

fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash.

Severe Head ache on the day after, nausea, fever of 100 degrees, felt a lot better on March 13th. Woke up on the 14th with head ache and muscle pain all over especially in my chest area. Treated with Tylenol. During the night on the 15th I had a fever of 102.5 with severe headache and vomited. Tylenol has not worked. Call my PC and let him know my symptoms. It is now late in afternoon on the 15th, still have weakness and headaches and muscle aches. Fever is down to 100.0

Substantial weakness, muscle aches and fatigue, chills, fever, headache, neuropathies, additional digestive problems. Recovered slowly over 5 days.

Patient started to experience dizziness a couple seconds after the shot. Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10. 911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110. Nitroglycerin was given but it did not help with his chest pain and he began to have a headache. He was taken to the hospital. He stated that he was not feeling good a couple days before today. He felt better today and received his J&J vaccine. Fired his cardiologist and was looking for a new one.

All symptoms I had when I had Covid in March 2020 returned within 12 hours of receiving this vaccine. Had body aches, severe chills, nausea, and 102.5 fever along with fatigue. Symptoms lasted 36 hours and subsided only to return 12 hours later. with chills and fever of 101.7. Taking Advil and Tylenol alternating every 4 hours.

Having nausea, vomiting and unable to have bowel movement for 12 days. Symptoms for 12 days so far. having myalgias and fatigue. Excessive coughing

Flank chest pain (pain under right rib cage) and Dyspnea on exertion; woke pt up at 0300 on 4/9/21 Chest pain with deep breathing., fever, and nausea upon presentation to ED Pt denied recent travel or prolonged immobilization Patient diagnosed with bilateral pulmonary embolism per CTA

Abdominal Pain Narrative: Patient is a 70 year old male who received Janssen COVID-19 Vaccine (Lot# 1802070) on 3/9/21. Vaccine was administered with no complications and patient was advised to remain in facility for 15 minutes following administration. On 3/15/21 patient contacted hospital reporting that he has had diarrhea every day since his vaccination. Reported bowels on 3/15 turning pink and noted blood in stool with most recent BM. Patient also reports occasionally abdominal pain (4/10). States no improvement after taking Imodium. Patient was recommended to visit hospital for evaluation. Patient was admitted to hospital from 3/15 for observation with dx of leukocytosis, diarrhea and orthostatic hypotension. No complications during stay and diarrhea resolved resulting in discharge on 3/17.

Per my aunt (uncle's wife), my uncle complained of severe headache especially on the right temple area, nausea, and dizziness at around 6am on 4/11/2021. Soon afterward, she noted my uncle has left side weakness and drooling when drinking.

Patient experienced severe diarrhea, sore arm, achey joints, fatigue, depression, chest and lung pressure, injection site pain, leg pain. 2 to 3 weeks after the vaccine, patient experienced tinnitus and head pressure Patient noticed a blood pressure increase

Vaccination at 0830 am, reactions started at @ 0930 pm while at work, Worked till 0400 am. When I left work my feet felt like they were frostbitten, had chills and temp of 99.9. Went home took 2 Extra Strength Tylenol, went to bed with 100.8 temp. Got up the night of the 16th, chills were gone temp was 101.1. Took more Tylenol drank some fluids tried to eat but couldn't . Went back to bed 3 hrs later temp down to 99.9. got up today at 1130am fill fine ate and drank some, temp now is 99.5 but I fill fine.

Patient brought in by EMS due to 2 episodes of emesis, not eating for past week with on and off vomiting episodes, and altered mental status. Possible urinary tract infection, treated with antibiotics

Starting on 04/13/2021 noticed very easy bruising seems to be improving. Starting 04/16/2021 backache right side near kidney area, still on-going. Starting 04/18/2021 sore on tongue and right inside of mouth.

CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 71 year old male. 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 08-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 20-MAR-2021 05:00, the subject experienced chills. On 20-MAR-2021 05:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from chills, fever, and nausea. This report was non-serious.

FEELING WEAK; TIRED; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced weak. On 03-APR-2021, the subject experienced tired. On 22-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Treatment medications included: Z pack (azithromycin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, weak, and loss of appetite. This report was non-serious.

Patient developed cough, poor appetite, decreased po intake, altered mental status, failure to thrive, increased work of breathing, approximately three weeks after vaccine administration. He presented to the hospital where he was found to be covid-19 positive on admission. Patient is currently hospitalized (hospital day 1)

10 days after the injection (on 5/16) , husband had headache, lethargy, prolonged diarrhea (48+ hours), fever, chills, neck and body pain that lasted 4-5 days. (Wife with no injection on 5/21 got headache, nausea/bloating feeling and neck ache that lasted 4 days.) Husband resumed outdoor activities on 5/22 but began relapsing on 5/27 with headache, fatigue, neck and body pain that still persists as of date of this report (5/29). Item 21 is PENDING how this continues or hopefully resolves. It is still ongoing but your computer insists I must enter something...and you do not have a box indicating ongoing.

Patient had acute onset of low back pain 1.5 weeks prior to presentation on 6/3/2021. This pain and weakness progressed to complete bilateral lower extremity paralysis with loss of bowel and bladder function on 6/09/2021. Patient was seen emergently and found to have critical, bilateral lower extremity ischemia. imaging showed RIGHT RUNOFF: 1)There is abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging, small amount of contrast is seen within the severely stenotic popliteal artery and very small amount of contrast is seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. LEFT IMPRESSION: 2)Abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the LEFT common iliac arteries with propagation throughout the LEFT lower extremity down to the popliteal artery. 3)On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid calf level. Due to severity of the ischemic limb, patient was offered bilateral above the knee amputations. He declined and will discharge to hospice on 6/12/2021. He is going to die.

Four days after injection developed symptoms of labyrinthitus - slight nausea, light headedness, dizziness and vertigo. Started acutely then got better but continue now for 31 days. Took flu injection 14 days before the Covid-19 injection. Previous viral labyrinthitus years before with lingering symptoms for months. On receiving Covid injection healthy. More info on injection EVDS vac number VP4WNUAHLAJ9 Symptoms may be related or nonrelated to Covid injection. Symptoms getting better but still present. Use antihistamnine on occasion without real effect.

Right after the vaccine, I experienced no symptoms. I had stomach problems and I felt very woozy and had diarrhea, and I also fainted. I hit my head but not bad at all. I went to the ER. I was dehydrated and they gave me IV. They told me drink liquids and Gatorade. It did help with symptoms. They said that it could have been a virus that was going around or it was food poisoning, one or the other.

DIPLEGIA; ANAL INCONTINENCE; URINARY INCONTINENCE; ASTHENIA; ILIAC ARTERY EMBOLISM; ILIAC ARTERY OCCLUSION; PERIPHERAL ARTERY OCCLUSION; PERIPHERAL ARTERY STENOSIS; PERIPHERAL ARTERIAL OCCLUSIVE DISEASE; PERIPHERAL ARTERY THROMBOSIS; POOR PERIPHERAL CIRCULATION; ANGIOGRAM PERIPHERAL ABNORMAL; COMPUTERISED TOMOGRAM ABDOMEN; COMPUTERISED TOMOGRAM PELVIS ABNORMAL; BACK PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Report System) concerned a 71 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type II. The patient experienced drug allergy when treated with acetylsalicylic acid (aspirin), and ibuprofen. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered to left arm, on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals NOS/retinol/tocopheryl acetate/vitamin B NOS/vitamins NOS/zinc (centrum silver), fish oil, glipizide and lisinopril, all for unknown indications. Patient had acute onset of low back pain 1.5 weeks prior to presentation on 03-JUN-2021. On 09-JUN-2021, this pain and weakness (asthenia) progressed to complete bilateral lower extremity paralysis (diplegia) with loss of bowel function (anal incontinence) and bladder function (urinary incontinence). He was seen emergently and was found to have critical, bilateral lower extremity ischemia. Computerised Tomogram angiography of the abdomen and pelvis revealed: 1. Right runoff: abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging a small amount of contrast was seen within the severely stenotic popliteal artery and very small amount of contrast was seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. 2. Left impression: abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the left common iliac arteries (iliac artery embolism, iliac artery occlusion) with propagation throughout the left lower extremity down to the popliteal artery. 3. On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery (peripheral artery stenosis) identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid-calf level. Additional events were reported which occurred on an unspecified date in JUN-2021: peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation. The patient was hospitalized for 6 days. Due to severity of the ischemic limbs, he was offered bilateral above the knee amputations. He declined and would discharge from the hospital to hospice on 12-JUN-2021. Report stated "He is going to die." The patient had also visited Emergency Room (ER) for the events anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). Version created to amend previously reported information on 25/Jun/2021. Upon review, following information was amended: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.; Sender's Comments: V1 The follow up version updates the following information: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.The updated information does not change the causality of previously reported events. This case, received from VAERS, concerns a 71 year-old male patient with diabetes, who presented with back pain, weakness, lower extremity paralysis and bowel/bladder incontinence, and was found to have critical lower extremity ischemia, 83 days after receiving the Janssen COVID-19 vaccine. Angiography revealed occlusion of the left iliac and bilateral femoral and popliteal arteries. Events included iliac artery occlusion and embolism, and peripheral artery occlusion, stenosis and thrombosis. No platelet counts were provided. The patient was offered amputations but declined; the events did not resolve and he was discharged to hospice. The vessel stenosis is longstanding in nature and most likely related to his age and diabetes; the embolism/thrombosis may also be related to his chronic condition, and the latency between the events and the vaccine is long. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

STARTED TO FEEL LIKE SOMEONE IS STANDING ON MY STOMACH IN THE MORNING/HE THOUGHT HE WAS CONSTIPATED/ PAIN THEN STARTED TO MOVE FROM THE LEFT SIDE THEN IN HIS BACK; BLACK AND BLUE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included liver transplant, and concurrent conditions included diabetes, and spider bite. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced black and blue at the injection site. On 06-JUL-2021, the subject experienced started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue at the injection site on JUL-2021, and had not recovered from started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. This report was non-serious.

Diarrhea started 10:30am 3/7/21 Chills began 12 noon 3/7/21 Took Extra-Strength Tylenol 2 x 500mg at 12:30pm 3/7/21

About 4 days after receiving his vaccine he began to have difficulty with chewing, swallowing and speaking. He describes waking up in the morning with paresthesias of numbness from the nose down to his jaw. He is scared to eat due to fear of choking. He notes as he continues to chew or speak he gets fatigued. He denies any difficulty with breathing or generalized weakness. He does report coughing with secretions. He reports his symptoms have been ongoing for 2 weeks with no improvement. Patient ended up getting admitted to the hospital for IVIG treatment for the myasthenia gravis flare.

MUSCLE ACHES IN SHOULDER AND LEGS; TIREDNESS; FELT LIKE VOMITING; BODY ACHES; This spontaneous report received from a patient concerned an elderly male. 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: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced felt like vomiting. On 06-APR-2021 21:00, the subject experienced tiredness. On 07-APR-2021, the subject experienced muscle aches in shoulder and legs. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and muscle aches in shoulder and legs on 09-APR-2021, tiredness on 07-APR-2021, and felt like vomiting on 06-APR-2021. This report was non-serious.

Acute gastro intestinal cramps for 12-18 hours Joint pain in kidney, bank and left hip joints Both reactions were acute on the first day experienced then on more modest basis 2 days later

BACTERIAL INFECTION; DIFFICULTY SWALLOWING; DIFFICULTY CHEWING; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced difficulty in swallowing and chewing . He was diagnosed also with a bacterial infection of unknown origin. On 23-MAR-2021, the patient was hospitalized for 11 days in the ICU. The patient was recovered from the infection but continues to experience symptoms of myasthenia gravis. The patient was discharged from the hospital on 02-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bacterial infection on 02-APR-2021, and had not recovered from difficulty swallowing, and difficulty chewing. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422146-covid-19 vaccine ad26.cov2.s-bacterial infection. 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. 20210422146-covid-19 vaccine ad26.cov2.s-difficulty swallowing and difficulty chewing. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: UNDERLYING DISEASE

LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Shortly after vaccine, upper respiratory issue started. Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count. Had blood clot. Urinary Infection Possible sepsis. Still in hospital.

Patient presented to the ED on 6/7/21 with abdominal pain that had started earlier that day. CT abdomen, CXR, and urinalysis were done and all came back negative. Patient denied any respiratory symptoms. On physical exam, he was found to have severe swelling, erythema, and ecchymosis on his left leg extending into the upper thigh and knee. A lower extremity doppler was done and found extensive occlusive thrombosis within the left lower extremity beginning in the external iliac vein and extending into the common femoral, femoral, profunda, popliteal and visualized deep calf veins. No evidence of PE or DVT in the RLE was found. Vascular Surgery was consulted, who did not recommend any procedures, but patient was started on a heparin drip. Hematology later saw the patient and changed the heparin drip to rivaroxaban on 6/9/21. Infectious Diseases was also consulted for possible sepsis.

SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.

swelling began in feet and moved up legs to abdomen; 25 lb weight gain in two weeks between routine doctor exam and emergency visit leading to hospital admission for 6 days where an atrial flutter was detected that was not present in May 19th exam. Diuretics in the week since admission have pulled off over 35 lbs and vastly reduced swelling but heart damage remains.

NAUSEA; HEADACHE; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and herniated disc, and concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, headache, and general body aches on 04-APR-2021. This report was non-serious.

Headache and pain behind Rt. eye, developing into a low grade reaver and vomiting. By Tuesday the 11 I developed a rash on my face with pain shooting behind my eye to the back of the head. Tuesday at Emergency room eye was swollen closed, rt. side of face was broke out in scabs and sharp pains through the eye and scalp.

DIARRHEA; INCREASED PULSE; WEAKNESS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood in brain, and concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headaches. On 12-APR-2021, the subject experienced increased pulse. On 12-APR-2021, the subject experienced weakness. Laboratory data included: Pulse rate (NR: not provided) 110 (units unspecified). On 14-APR-2021, the subject experienced diarrhea. On 15-APR-2021 05:36, Laboratory data included: Pulse rate (NR: not provided) 87 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased pulse, and had not recovered from weakness, and diarrhea. This report was non-serious.

GAS IN THE STOMACH; STOMACH ACIDITY; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included depression, and concurrent conditions included anxiety, and hypertension. 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 07-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-APR-2021, the subject experienced gas in the stomach. On 07-APR-2021, the subject experienced stomach acidity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the gas in the stomach and stomach acidity was not reported. This report was non-serious.

73 y.o. male former smoker with PMH significant for coronary artery disease with history of CABG in 12/22/2020, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypertension, non proliferative diabetic retinopathy, sleep apnea presents to emergency room complaining of generalized fatigue and body aches ongoing for 2 weeks. Patient received Johnson and Johnson COVID-19 vaccine 2 weeks ago. Patient denies any fever or chills. Denies any chest pain or shortness of breath. No nausea or vomiting. Poor appetite. Patient had is the cardiac catheterization rehab post CABG, last session was 1 week ago. Denies any sick contacts. ED vitals stable, afebrile. Patient on room air. Labs remarkable for lymphocytes 15.3, monocytes 10.9, glucose 190, BUN 21, creatinine 1.3, sodium 133, potassium 5.3, chloride 97. Lactate normal at 1.6, troponin 14, Last A1c 6.7 from 12/19/2020. EKG no acute ST wave changes EKG changes. CTA chest no pulmonary embolism seen. Patchy airspace disease of the lungs suspicious for mild to moderate bronchopneumonia. Ultrasound Dopplers of the lower extremity right negative for DVT. COVID-19 positive. Patient received Rocephin, Zithromax in ED, ER asked to admit patient the hospital for observation due to ongoing fatigue and body aches from COVID-19 pneumonia.

73 year old male with PMHx of AFib, CAD, and HTN who presents with c/o dyspnea that started 4/6/21. Patient states it got to the point where he could not walk in his house without severe dyspnea. States he was diagnosed with COVID-19 one week prior. Per chart review he was in our ER 4/3/21 and diagnosed with COVID-19. At the time he was 95% on room air. His only other symptom has been diarrhea. He states he received the Johnson and Johnson vaccine one month ago. He denies any dizziness, chest pain, abdominal pain, n/v, weakness, or numbness. In ER patient was hypoxic and improved only with BiPAP. Per chart review patient had cardiac arrest on 11/2020 for 17 minutes. He has a significant cardiac history consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib post ablation 2017, V-tach. He was started on therapy with steroids, anticoagulation, and Remdesivir. He failed to improve and had increasing oxygen requirements. He was eventually intubated. Due to failure to improve patient was made DNR and eventually expired.

Father received vaccine on May 13, 2021. Complained of migraine headaches, feeling tired, and generally unwell. Migraines became more persistent. Father died on June 16, 2021 at home. Coughed up blood and vomited around time of death.

Two weeks to the day, high fever up to 103.5 for a week; tired slept for about a week, shaky, no appetite. Could barely function.

Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence.

Acute - Got Johnson & Johnson COVID-19 vaccine this past Thursday - Thursday night starting cramping with abdominal pain radiating to the back; remained quite bothersome through Friday, Saturday, Sunday - Had nausea but no vomiting; mild HA - Some episodes of loose stools but no blood - No fever and chills but some diaphoresis - Has been drinking water but not eating - Has been a little bit of SOB and dyspnea on exertion - No lightheadedness, syncope or near syncope; no palpitations or chest pain - No clear alleviating factors, worsens when he drinks too much water - no recent history of alcohol intake

My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021.

Severe diarrhea, blurry vision, inability to focus, inability to "have a normal conversation" (all started today, per patient report).

STOMACH FEELS FULL; NO BOWEL MOVEMENT FOR 2 DAYS; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's past medical history included left rotator cuff tear, and hip replacement, and concurrent conditions included type 2 diabetes, no alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included patient had no 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: 042a21a, expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced no bowel movement for 2 days. On an unspecified date, the subject experienced stomach feels full. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no bowel movement for 2 days, and the outcome of stomach feels full was not reported. This report was non-serious.

Headache, muscle aches, diarrhea the following day and one week later. Soreness and discoloration at injection site the following day to date.

Patient admitted to hospital due to hyperkalemia; called to come to hospital based on labs from hemodialysis session a day prior- 3/21/21. Patient also complaining of bright red blood with bowel movement and weakness. Patient reports non compliance with medications and diet. Hyperkalemia treated and resolved. Evaluated by cardiology for halter monitor- will follow-up as an outpatient.

Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing.

PAIN IN LOWER RIB CAGE; BODY ACHE; LOSS OF APPETITE; SLEEP WAS LIMITED; CHILLS; LACK OF ENERGY; HIP MUSCLE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included above average health and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 pain in lower rib cage, body ache, loss of appetite, sleep was limited, chills, lack of energy, hip muscle pain, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 and plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower rib cage, chills, hip muscle pain, and fever, and was recovering from body ache, headache, loss of appetite, lack of energy, and sleep was limited. This report was non-serious.

Had mild symptoms of headache, fatigue, nausea, light headedness for starting about 3 hrs. after shot given and lasting into evening of next nigh; No fever or shortness of breath experienced. Except for fatigue was generally OK for next 6 days. Then eyes started blurring down my vision, and started seeing double/triple vision... symptoms are intermittent; worse in evening when eyes are fatigued. Called medical center for info and course of action and was advised to report to medical center emergency Room. Will see what eyes are like in morning

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Pt reports intermittent brain fogginess since having the vaccine. It has not resolved in the 3 months since administration. He also reports increase nausea since the dose.

Initial Complaint of Constipation, admitted for altered mental status, respiratory failure, HTN, hypothyroidism. Information pulled from Report

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

Extreme vertigo, weakness, unable to walk, extremely unbalanced when attempting to stand up, severe Headaches, blurred vision.. Also with sinus type drainage. Extreme nausea and fatigue. Literally couldnt even hold his head up. All sypmtoms started within 48 hours of injection and came on with a vengance. He was so unsteady and unstable he fell with attempts to get up. Prior to the vaccine he was great! Strong and healthy for all of his underlying medical condtions. Completely Independant, driving , working around the house ect. Unfortunaley this is still going on. He is very weak, and still unsteady when he is up. Nausea continues. He is doing Vestibular therapy for the balance issues. Took a round of seroids.

Not feeling well, malaise, fatigue, intermittent upper stomach pain (sharp) beginning day after vaccine administration lasting 8 days resulting in death on 4/10/21

pt says a couple of days after taking the vax he woke up feeling woozy. He says his head hurt and he couldn't think straight. He felt like he was coming unglued. He had some confusion and trouble with his memory. He had burning in his stomach. On 3/12/21 he contacted his PCP for a tele-visit. He couldn't remember what the doctor told him after speaking with him because of his confusion. He was prescribed Raglan. He said the food going in his stomach does not come out. He saw his gastro Dr. regarding his stomach pain. He had a scope procedure and had bile pumped out of his stomach. He was prescribed famotidine, tenatoprazole, Amitiza, and Sucralfate. He is not taking the Amitiza or Sucralfate. It is 2 months later and he still has these symptoms and still doesn?t feel normal.

Patient received 1 dose of Janssen vaccine at pharmacy on 5/25/21. Patient visited hospital emergency department on 5/28/21 after experiencing new a syncopal episode with abdominal pain and vomiting, then acute left-sided chest and arm pain after with new atrial fibrillation diagnosis which was managed. Patient revisited same ED later on 6/1/21 for significant fatigue/weakness and diagnosed with STEMI.