Johnson & Johnson

3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. Transferred to Hospital, dx: pneumonia dt covid-19 virus

Paient was given vaccination on 3/26/2021 and he said he had fever, nausea and headache which lasted for two days. He took Tylenol OTC.

SON REPORTED THAT PATIENT WOKE UP 4/7/21 WITH FLU LIKE SYMPTOMS AND STAYED IN BED ALL DAY. PT DID NOT DRINK ANYTHING OR TAKE INSULIN ON 4/7/21. WHEN DAUGHTER ARRIVED AT PTS HOME THAT EVENING, PT WAS INCOHERENT. SHE CALLED 911 AND PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON 4/9/21.

Beginning 4/9/21 (4 days after vaccination) woke up feeling fatigued and with some dizzy spells. Lasted till around noon then felt better. Started again around 4-5 PM. BPs elevated 189/92. Subjective feeling ?weird". Felt disoriented, tired, and dizzy. No fever. No dyspnea,. No headaches. At 7 PM BP was 165/86. 8pm was same. Following day 4/10/21 continued with symptoms of weakness and a little disoriented. Still weak and a little disoriented. Had medium grade headache at night. Next day 4/11/21 had fatigue all day and intermittent disorientation. Continued with medium grade top posterior headache. The headache resolved on its own without medication by later in morning. Blood pressure has been in the 135/73 range. No fever. Subjective improvement from 2 days prior. Next day 4/12/21 had profound fatigue. It began to let up by the evening. Next day 4/13 fatigue was not as severe but still present.

Acute metabolic encephalopathy, BPH with urinary obstruction due to blood clot. Patient was vaccinated at a pharmacy with Janssen covid-19 vaccine and experienced headaches and dizziness. Then began to have urinary retention which was believed to be due to a large blood clot requiring 12x 100mL flushes. Patient went to ED at medical center on 3/30/21 and was admitted. He was discharged to nursing home on 4/11/21.

Severe headaches which I thought may have been sinus, however no relief Pain started within two weeks after vaccination. Pain is still present but comes and goes on a daily basis. Never had this prior until now.

Pt was seen in the emergency room on 4/1/2021 c/o cough, fever, chills, nausea and poor appetite. He tested positive for Covid 19 and was given ivf in the emergency and sent home for recovery and quarantine.

Patient starting feeling chills on Sunday, patient stayed home then had a seizure 4-12-21. They were admitted to the hospital on the evening/ night of 4-12-21 . Still in hospital as of 4-20-21.

With oin 10 hours I began to have extreme chills (no sweating) which lasted 8 hours, dizziness upon rising from bed, and a temperature of 103 degrees F that lasted 9 hours. I did not report these to my doctor, but I did cancel an appointment with a doctor who was going to review CT scan results with me.

Patient left the pharmacy area and when to check out his groceries. While in line, the patient became dizzy and started sweating profusely. The cashier got him a chair so he could sit down. She gave him a cold water and some candy. I came over and asked him about low blood sugar and if he had eaten since I knew he was a diabetic. He sat in the chair for about 20 to 25 minutes. after he drank the water and ate the candy, i did a blood pressure reading, a temperature reading, and a blood glucose reading. The patient was able to leave and drive home after eating the candy and drinking the water.

According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021. They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms. On Monday, May 17, he called one of his daughters, but she missed the call. The family tried to call him on May 18- and May 19, but they couldn't reach him. A welfare check was initiated on May 20; however, the police didn't enter the residence. He was found dead in his bed on May 21, 2021, with changes of decomposition.

Patient received Covid vaccine in March (unknown date). He subsequently developed a burning chest pain and cough. Diagnosed with Covid May 20,2021. Admitted to the hospital May 27th with new stroke symptoms and mycoarditis/NSTEMI

Patient came in to the Hospital with blood in the urine since July 3. Patient had been on Kleffx, and then called his own pcp. Pcp adviced he get blood work done at the urgent care. Urgent care was only able to do urine test. Kleffix was discontined and patient was then given Bactrium also Zofran. Patient was complaining of eating very little , denied chest pain, denies SOB. Complained of chills and shaking. No other complaints, Patient did have a chest x-ray. Found on x-ray ground glassin the perfary of right lower lobe. Diagnosis was , acute weakneess, phemonia, hematuria.

INJECTION SITE PAIN; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1138391 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, and tiredness on 11-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210425531.

SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. 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 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was non-serious.

FEELING LIKE SINUS INFECTION; HEADACHE; NIGHT SWEATS; PAIN IN LEFT EYE; BURNINIG IN BOTH EYES; PINK EYE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23/JUN/2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced night sweats. On 08-APR-2021, the subject experienced pain in left eye. On 08-APR-2021, the subject experienced burninig in both eyes. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced pink eye. On 09-APR-2021, the subject experienced feeling like sinus infection. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and muscle aches on 09-APR-2021, had not recovered from headache, and feeling like sinus infection, and the outcome of pain in left eye, burninig in both eyes, fever and pink eye was not reported. This report was non-serious.; Sender's Comments: v0- Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.

Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person. Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21.

EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.

FEELING SLIGHTLY TIRED; This spontaneous report received from a patient concerned a 77 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, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 16:00:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced feeling slightly tired. The action taken with covid-19 vaccine was not applicable. The outcome of feeling slightly tired was not reported. This report was non-serious.

SINUS INFECTION; RASH STARTED ON LEFT SIDE OF CHEST, UNDER THE ARMS AND BACK; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 250 pounds, and height was 69 inches. The patient's past medical history included prostate cancer survivor, and concurrent conditions included high cholesterol, tremor, high blood pressure, catheterized, chronic urinary tract infection, acid reflux, depression, wheezing, chest pain, erectile dysfunction, dizziness, muscle cramps, alcohol user, previous long term smoker, seasonal allergies, environmental allergies, sores on lips, sores on mouth, and seizure, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage (recreational drugs) and no hospitalizations in the month before his vaccination. The patient experienced bad dizziness, drug allergy and loss of balance when treated with primidone for control seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, mirabegron for bladder, acetylsalicylic acid for chest pain, atorvastatin for cholesterol, potassium for cramps, sertraline for depression, meclozine for dizziness, sildenafil for erectile dysfunction, paracetamol for fever, nifedipine for high blood pressure, methenamine hippurate for prevent urinary tract infection, triamterene for prevent urinary tract infection, nitrofurantoin for prevention of urinary tract infection, lysine for sores on lips, and sores on mouth, clonazepam for tremor, budesonide/formoterol fumarate for wheezing, fluticasone propionate/salmeterol xinafoate for wheezing, tocopheryl acetate, zinc, and . On 12-MAY-2021, the subject experienced rash started on left side of chest, under the arms and back. Laboratory data included: Body temperature (NR: not provided) 96.5 F, and Pulse rate (NR: not provided) 145/50. On 30-MAY-2021, the subject experienced sinus infection. Treatment medications included: dextromethorphan hydrobromide/guaifenesin. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, and the outcome of rash started on left side of chest, under the arms and back 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.

Caller stated that close to midnight his heart start beating very fast and he couldn't sleep. The next day his heart rate would speed up throughout the day. A few minor aches and pains around the neck and shoulder and more tired than normal.

LOSS OF APETITE; ACHES AROUND SHOULDERS; CHILLS; LEGS DO NOT WANT TO MOVE/SOME WEAKNESS IN THE LEG; TIREDNESS; PALPITATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included blood thinner, and hospitalisation, and concurrent conditions included weak heart, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergy and had no drug abuse or illicit drug use. The patient was previously treated with furosemide for weak heart, atorvastatin calcium for weak heart, and acetylsalicylic acid for weak heart. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Oxygen saturation (NR: not provided) 140 (unit was not provided), 68 (unit was not provided). On 15-JUN-2021, the subject experienced palpitation. On 15-JUN-2021, the subject experienced aches around shoulders. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced legs do not want to move/some weakness in the leg. On 15-JUN-2021, the subject experienced tiredness. On 16-JUN-2021, the subject experienced loss of apetite. Laboratory data (dates unspecified) included: Palpitation (NR: not provided) 74. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches around shoulders on 17-JUN-2021, and chills on 16-JUN-2021, and was recovering from palpitation, tiredness, loss of apetite, and legs do not want to move/some weakness in the leg. This report was non-serious.

Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation.

Fever 101.2 F, fatigue What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): *** I reviewed Q400, 401 and 408. I adv can try some APAP as desired if this is something that can safely be taken without issues, stay hydrated, and if fever >102.5 F with APAP use consider evaluation and please call back if any worsening/persisting issues. Provided phone number and PCC/Covid line will check back on them on Sunday

BODY ACHES; TIREDNESS; This spontaneous report received from a consumer concerned a 78 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210355363.

Patient states on Friday, 4/9, he went to the pharmacy to receive his J&J Covid-19 vaccine. He states on Saturday morning, his R nostril began to bleed, and continued to bleed until Monday. He states on Wednesday, 4/7, he noticed oral sores that at first were not painful, but large. He was worried about it interfering with his shot, but because he had waited so long to get it, he decided to proceed anyway. He denies any fever or chills, no frank diarrhea, but occasional loose stools, without blood seen. He denies HA, vision changes, or focal neuro deficits. On Sunday, 4/11, the patient ended up going to ED to evaluate his epistaxis, the MD attributed it to his elevated BP, the patient reports it being 160s/90s. They gave him new BP medications, which he took, but when he saw the Dr., he instructed the patient not to keep taking his BP meds. When asking the patient if anything correlates with foods he eats, the only thing he can pinpoint it to, would be pico de gallo. He states it has irritated his mouth before. He also reports recently taking his wife's supplement (unknown name) but thinks it is for cholesterol. He took that approximately 1 week ago. No new changes in food habits, mouthwash, or toothpaste. He states once his sores began to get a little painful, he went to buy a special mouthwash for oral sores (unsure name). His only reported allergy is to Lisinopril, which his reaction was a whole body rash. He states they did not pack his nose or do anything for his epistaxis at the ER, but eventually he let the nostril clot with blood. Now he feels fullness in the nare, but does not want to disturb the clot in fear that it will re-bleed. His wife also noticed a petechial rash that began on his BLE, he is unsure when that started. He presented to ED on 4/13, due to his PCP instructing him to be evaluated when he had outpatient labs done and revealed a PLT count of 4,000. In the ED, the patient had normal vital signs. He was transfused one unit of PLTs. He also had a negative head CT. He was also started on decadron 40mg PO daily by heme/onc. Patient tells me today his sores are less painful and feel smaller than usual. Heme/onc also ordered 2 IVIG 1,000 mg/kg/day x2 doses.

Patient developed shortness of breath, chest pain 'fuzzy head,' headache, rhinorrhea, diarrhea, and increased fatigue around 3/28/21 had clinic appointment 3/30/21, diagnosed with pneumonia. XR CHEST 2 VIEWS (PA AND LATERAL), TRANSTHORACIC ECHO (TTE) ADULT NON CONGENITAL, EKG 12-LEAD completed. given cefTRIAXone (ROCEPHIN-Equivalent) injection 1,000mg IM, and doxycycline monohydrate (MONODOX) 100 mg capsule PO. was evaluated in ED 4/5/21 CT Abdomen Pelvis with IV Contrast Final Result 1. Positive for extensive acute bilateral pulmonary emboli at the lung bases as detailed in the body of the report. DX Chest Portable 1 View Final Result Mild left ventricular prominence is noted. Small right pleural effusion is seen. Minimal discoid atelectatic changes in the left perihilar region and left lung base. Elevated right hemidiaphragm suggests eventration. Admitted to Hospital 4/5/21, per admission diagnosis: Acute pulmonary embolism (*) submassive likely secondary to covid 19 Per hospital course notes:Patient presented with acute hypoxic respiratory failure and was show to have submassive PE with severe pulmonary hypertension seen on TTE. He should be on lifelong therapy given 2nd VTE and severity. Iwould consider unprovoked (COVID in 11/20 wouldn't count I wouldn't think). He was started on eliquis 10 mg BID x 7 days than 5 mg bid. Given his severe pulm htn on TTE, left atrial pressure normal. We would have outpatient sleep study as well He will need VQ scan to assure no CTEPH. Will have outpatient follow up. We discontinued his aspirin on discharge as well.

Husband began expressing "I'm tired" which was out of the ordinary on May 1, 2021. Again on May 2 and 3. On May 4 he was really weak, moving much more slowly than normal, complaining of sinus headache above left eye, sleeping longer and more than normal, brain fog and confusion, not able to do normal activities. This impairment has continued through May 11 with no improvement from one day to the next. Visited his Dr to get checked on May 11 due to our concern over how long this was lasting. He has had no fever but some chills here and there. Dr checked everything she could think of and requested blood tests which we have not heard about yet. Extreme fatigue was the major symptom. Today, May 12, he feels better, moving around faster and doing some normal activities but still tires easily and must rest.

TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. 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 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.

One month after the vaccine I started to get Hot Flashes followed by pain. The pain lasted for six hours and then went away. The pain is all over my body The process returned after a week or so and it has continued intermittently since then. The cycle is always the same. I get a hot flash and then the pain starts. As time goes on it is happening more often and the pain lasts for longer. I get really hot and sweat for about 15 minutes and then the pain starts. It builds up to being a more severe pain which has been lasting up to 24 hours. It has been getting less often and for slightly shorter periods of pain. Just in the last two weeks I started to get pain at the injection site, and it is starting to affect my whole arm around the area. It is like a muscle pain. I have consulted my doctor and She prescribed Tramadol. It seems to help but over the counter medications don't seem to work.

Per Regulatory Authority it is to be reported if patient gets COVID if fully vaccinated. Per MD note 1. Acute hypoxemic respiratory failure: This is in a patient with COVID pneumonia. The patient was placed on supplemental oxygen. The plan is for the patient to use supplemental oxygen with oxygen by nasal cannula up to 6 L and if oxygen saturation falls below 90% on 6 L oxygen by nasal cannula, he will be transitioned to high-flow oxygen. However, if he is on maximal support with high-flow oxygen with oxygen saturation falling below 90%, the patient should be placed on BiPAP and transferred to the ICU. The patient is a full code. 2. COVID pneumonia: This in a patient who apparently received his Johnson and Johnson COVID vaccine 3 weeks ago. The patient started on treatment with remdesivir. He will get steroids. He is prescribed Tessalon Perles and Robitussin with codeine as needed for coughing. He may be considered for potentially other treatments in the setting of his COVID pneumonia, especially if his respiratory status deteriorates. We will closely follow up in the COVID unit after admission. 3. Alteration of mental status and encephalopathy: This in a patient who is hypoglycemic. However, part of his encephalopathy related to his COVID infection and volume depletion. He is being volume repleted and treated for his condition. He will have frequent neurologic checks done after admission. 4. Generalized weakness and deconditioning: This is in a volume depleted patient with COVID. His COVID will be appropriately treated and he will be volume repleted. He will need to work with physical and occupational therapy towards the end of the hospitalization. 5. Congestive heart failure, systolic plus diastolic dysfunction: The patient does not have any evidence of acute congestive heart failure at the moment. However, we will take care to prevent volume overload in this patient, who requires volume repletion in the setting of his volume depletion. 6. Volume depletion: The patient will get another liter of IV fluids after admission at 80 mL per hour as tolerated. The goal is to avoid excessive IV fluid administration in this patient with COVID pneumonia.

First night: flu symptoms. Next day: fatigue, drowsy, some flu symptoms. That night: halucinatory dreams, woke up and had difficulty with orientation - room spinning, difficulty walking came back to bed, bed spinning. Got up later room spinning vertically - took several minutes to settle down. This problem has gotten worse as the days go by. This morning, dizziness persists longer than before, feeling of strong nausea, near vomiting, cannot walk in a straight line. Fear of falling. These are symptoms of vertigo I believe. Should I go to a doctor? Feeling that this will get worse. Difficulty concentrating. Quite an unsettling and scary experience.

Shortness of breath, tired, elevated blood pressure, no appetite, upset stomach, nausiated, blood blister in groin area. soreness in groin area, overall feel bad.

4 days after vaccination, beginning at 3AM on Wed 04-15-21, began uncontrolled and unending concurrent watery diarrhea and vomiting and abdominal pain, and sweating. Taken to hospital by ambulance and admitted for 2 days. I was Administered IV fluids, IV zofran, oral vancoymcin, etc. Upon discharge, I was directed to continue oral Zofran and Vancomycin for 9 more days during which I continued to experience watery diarrhea, nausea, and abdominal cramps.

INCREASING HEADACHE, AND SHORTNESS OF BREATH. Previously frequent bloody nose on 03/30/21, pt is not currently taking any blood thinners, he recently went to the ER on 03/30/21, after the visit the nose bleeding stopped. Pt's wife C/o of edema of the ankles with SOB. C/o severe migraine headaches and back pain. Norco helps the patient with his migraines and pain w/o SEs. Patient has still has SOB on exertion, but it is stable, pt's wife states that he is getting worse, he will c/o of SOB after walking less than half a block. He continues to use 2 L oxygen nasal cannula supplement and his inhalers and nebulizer treatment up to 4-6x a day. No fever and chills. Pt only has occasional cough. When he uses his inhalers, his cough will subside. PATIENT HAS HX OF THROMBOCYTOPENIA, BUT THROMBOCYTOPENIA HAS GOTTEN WORSE AFTER VACCINE.

CHANGES IN VISION; HEADACHE; This spontaneous report received from a patient concerned an 80 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced changes in vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of changes in vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521409.

He got his vaccine and the next day had extreme fatigue and it did go away after a couple of days. Starting last night he has had diarrhea all night long, nausea and a runny nose that started yesterday. He is very tired, possibly due to the diarrhea. He has not called his doctor or taken anything for it.

The day after the vaccine, he noticed he didn't feel well. Tired, headache, stomach ache, and shortness of breath. This started out mild and as the week went on got worse. Symptoms were leg swelling, shortness of breath, persistent stomach pain, headache, and chestpain. On 6/24 at 3:30 am he went to the ER where they discovered a large (golf ball size) blood clot in his right lung. He also has been diagnosed with pancreatitis. We have talked to five different doctors and multiple other hospital staff who all say it is a direct impact of the covid vaccine.

patient initially devleoped joint pain, fever, chills, vomiting abd distention on 7/11/21 then on 7/14/21 awoke with diffuse maculopapular rash over entire body and came to ED.

Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him. He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea. This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure. This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered. The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.

Pt called Call center on 4/23/21 regarding concerns about his symptoms. Pt complains of vomiting/nausea once a week since 1 and 1/2 month ago after eating and sometimes runny nose. Pt mentioned coming back from a trip out of the country on 3/25/21 and getting Johnson and Johnson vaccine on 4/9/21 and had concerns about the symptoms. Vomiting and nausea started before getting the vaccine and frequency didn't change afterwards. No doctor appt within 24 hrs at the time of call. Advised pt to go to ED.

The patient presented to Emergency Department with lethargy, confusion, and hypoxia. Upon presentation to the ED, the patient tested positive for COVID-19 (04/29/21). The patient is currently being treated with dexamethasone and remdesivir.

Severe headaches and pain, right foehead, right side of head and neck and right side back of neck. Skin in hair on right side hurts to touch.

1 WEEK AFTER VACCINATION- EXPERIENCED HEAD ACHES , SORE THROAT AND EAR ACHES. AROUND 2 WEEKS- PATIENT. FELT DIZZY AND PASSED OUT. STILL HAS SOME BRUISING IN THE ARM NEAR BICEPS.

HEART ACHE; SORE THROAT; BODY ACHE; SNIFFLES; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, disabled, emphysema, and seasonal allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced injection site soreness. On 08-MAY-2021, the subject experienced sniffles. On 10-MAY-2021, the subject experienced body ache. On 11-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced heart ache. The action taken with covid-19 vaccine was not applicable. The patient was recovering from injection site soreness, and sniffles, and had not recovered from body ache, heart ache, and sore throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Patient received the COVID vaccine on 5/24/21. On 5/31/21, patient started to experience chills, fever, and cough, which continued to progress until 6/3/21, when patient presented to the ER. He tested positive for COVID in the ER and was noted to be short of breath and satting 88% on room air. Patient was admitted to the hospital on 6/3/21 for COVID treatment (remdesivir and dexamethasone).

Client developed mild cough, weakness, and extreme fatigue on 6/25. Tested with PCR on 6/25 and was positive for Covid

The patient began having flu-like symptoms the following day after the vaccine. Felt achy, fatigue and not wanting to get out of bed even on vacation. That lasted for 2 weeks and still not great even now. The patient's spouse reported trouble walking, stumbling, falling and gait. The patient developed a cough a few weeks ago and is currently being treated with antibiotics called in from the physician. The patient has not see a physician for diagnosis. I encouraged the patient to be evaluated as soon as possible

Ten days later woke up in severe pain in neck and shoulders; spread to other joints over the next few days -- some days so painful can hardly walk (hips, knees, elbow, ankle; most recently big toe...which joints varies from day to day but always in neck, hips and knees). Major fatigue; daytime sleepiness; unexplained and random diarrhea.

PATIENT WAS ADMINISTERED THE JANSSEN COVID VACCINE AT APPROXIMATELY 10:30AM. IMMEDIATELY FOLLOWING REMOVAL OF NEEDLE AFTER INJECTION, THE PATIENT APPEARED TO FAINT FALLING FORWARD IN HIS OWN LAP. AFTER ABOUT 15 TO 30 SECONDS, HE REGAINED CONSCIOUS. WE ASSESSED THE PATIENT TO ASK IF HE HAD EVER EXPERIENCED FAINTING BEFORE OR SPECIFICALLY DURING VACCINATION. HE HAD NO PREVIOUS EPISODES. WE QUICKLY OFFERED THE PATIENT SOME WATER AND CRACKERS WHILE HE REMAINED SEATED. THE PATIENT FELL FORWARD AGAIN AND APPEARED TO BE CONVULSING. ONCE HE STABILIZED, MY PARTNER STEPPED AWAY TO RETRIEVE WATER, AND THE PATIENT ONCE AGAIN FELL FORWARD AND BEGAN CONVULSING. ONCE HE STABILIZED, HE DRANK SOME WATER AND ATE SOME CRACKERS. HE MENTIONED THAT HE FELT EXTREMELY TIRED. WE INSISTED TO CALL THE PARAMEDICS FOR HELP,BUT HE DECLINED SAYING THAT HE WAS OK AND MAYBE THE NEEDLE TRIGGERED THE EVENT. AFTER WE OBSERVED THE PATIENT FOR 30 MINUTES AND HE ASSURED US HE WAS IN STABLE CONDITION, HE LEFT WITH HIS GIRLFRIEND. PATIENT WAS CALLED TWICE AFTER THE EVENT TO FOLLOW-UP BUT WE HAVE NOT HAD SUCCESS IN FOLLOW-UP.

June 4, Became largic, could not speak aloud, but understood. could not swallow hardy even water shock head to answer, only last day, very little response Prior to that, was feeding self, carried on good conversation and was enjoyable to visit with

Patient received shot around 2pm and developed symptoms overnight. Fever, sweats, body aches, cough and phantom pain on his amputated leg.

Janssen COVID-19 Vaccine EUA Patient received vaccine on 3/13/2021. Patient presented to physician office complaining of headache for over 3 weeks. Headache is worse when bending forward, and keeps patient awake and/or awakens him. Described as a constant pounding headache in the frontal and bitemporal area radiating towards his occiput. No nausea, emesis, vision changes, or personality changes. CT of Head demonstrates an acute left frontal subdural hematoma measuring 5 mm in maximum thickness. Patient's warfarin held, keppra started, vitamin K and PCC administered. Patient stabilized clinically and on CT and was discharged on 4/9/2021

Swollen shoulder, pain in shoulder in line with the injection site. Tiredness, fever for two nights.

DIZZINESS; COUGH; SNEEZING; SORE THROAT; SOME HOARSEN; This spontaneous report received from a patient concerned an 83 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced some hoarsen. On an unspecified date, the subject experienced dizziness, cough, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and the outcome of dizziness, cough, sneezing and some hoarsen was not reported. This report was non-serious.

PATIENT STATED THAT 1 WEEK AFTER THE VACCINE HE IS EXPERIENCING SEVERE FATIGUE AND SPENDS MOST OF THE DAY SLEEPING. HE ALSO HAS EXPERIENCED CONFUSION

Patient with advanced parkinson's, dysphagia, on G-tube feed received J&J vaccine on 6/9 per wife, developed fatigue/general weakness, developed fever, admitted to hospital for aspiration pneumonia/sepsis/acute respiratory failure.

vomiting, diarrhea, dizziness, unable to stand, weak starting the night of vaccine leading to dehydration did an ECHO next day by Dr and found blockages which were taken care of that day by MD, and then episodes of decreased blood pressure, severe headaches

After vaccination that day, patient was too tired to get out of bed to do his evening walking exercises. On 6/10/2021 3:00 am, patient unable to support himself on the commode and was put back to bed. Next couple of days patient was too weak to get out of bed. 6/14/21 1:00 am, patient became very congested and unable to remove fluid in his lungs, wife called medics and patient was admitted to hospital for 2 days with pneumonia. 6/16/21 7:00 pm, patient discharged from hospital. That night, patient became very congested despite continuous suctioning through the mouth, patient experienced respiratory distress and lungs congested with fluids, 2:30 am medics was called and paramedic performed invasive deep suctioning of lungs via his nose on way to the hospital, upon arrival at hospital they performed another deep suctioning of lungs before sending patient to the ICU. 6/21/21 4:00 pm, patient discharged from hospital in stable condition, doing physical therapy and occupational therapy at home.

BRAIN FOG; CAN HARDLY HOLD COFFEE CUP DUE TO SHAKING/ KNEES SHAKY; COULD HARDLY STAND UP; SLEEPING A LOT; LEGS RUBBERY; LEGS TINGLY; LEG GAVE OUT; TIREDNESS AND FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned an 83 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: 1805081, and batch number: 1805081 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, can hardly hold coffee cup due to shaking/ knees shaky, could hardly stand up, sleeping a lot, legs rubbery, legs tingly, leg gave out, tiredness and fatigue, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can hardly hold coffee cup due to shaking/ knees shaky, leg gave out, could hardly stand up, weakness, tiredness and fatigue, sleeping a lot, brain fog, legs rubbery and legs tingly was not reported. This report was non-serious.

ACHINESS FOR A WEEK ON AND OFF; TIREDNESS FOR A WEEK ON AND OFF; This spontaneous report received from a consumer concerned an 84 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achiness for a week on and off. On 11-MAR-2021, the subject experienced tiredness for a week on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness for a week on and off, and tiredness for a week on and off on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210403886.

SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.

He got his vaccine, he had chills that didn't last too long. Then two days later he could not move his left shoulder, and could not move his arm. If he moves it across his chest feels like somebody is stabbing him. His lower back is also in a lot of pain, the entire back. It now feels like a ball rolling from left to right, and sometimes it is both, and then perhaps one or the other. It has also affected his bowel movements as well, watery bowel movements. He now goes 3-4 times a day. When he relieves himself the pain subsides He still continues to have the pain. He went to his PCP and he gave him OTC medicines that helped some but did not get rid of the pain, especially in his lower back as it felt like somebody was stabbing him, as well as his left arm. His PCP sent him to pain management and that didn't work. He gave him 6 shots into his back, 3 on each side which did not relieve the pain. He went back to that doctor last week, and has a friend who is in charge of an x-ray company and got an x-ray. His lower back didn't show much of anything. He went back to pain management and told him to come back and went last week and told him that it could be arthritis and gave him some exercises, stretches, and he couldn't help him. He gave him some Tylenol with codeine for the pain, but has not taken them all. He is improving with his symptoms very slowly and is now able to move some and do exercises which are helping him. He was almost paralyzed before and now able to move some. He is waiting for the effects to just leave his body.

Narrative: VETERAN REPORTED THAT HE LOST CONTROL OF BLADDER, HAD SHAKING AND TREMORS IN HANDS LEGS AND BODY. FELT LIKE HE HAD SYNCOPE. LOST ALL STRENGTH. FELL WHEN TRYING TO PICK UP THINGS, COULDN'T GET BACK UP. HAD HA/FATIGUE AND MUSCLE ACHES.TEMPERATURE, GIVEN APAP. DRANK GATORADE. TEMP WAS 101.6, BP 141/68 AT 6AM.

RED BLOTCHES ITCHING ON CHEST, BLOTCHES ON STOMACH ON THIGHS AND ALL OVER TOPS OF FEET AND BOTH LEGS; SEVERE CHILLS; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attacks, and concurrent conditions included penicillin allergy, and tetracycline allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) Normal. On 23-MAR-2021, the subject experienced severe chills. On 27-MAR-2021, the subject experienced red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. Treatment medications (dates unspecified) included: cortisone, and paraffin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 24-MAR-2021, and had not recovered from red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. This report was non-serious. This case, from the same reporter is linked to 20210355358.

developed bilateral swelling and cough/subjective shortness of breath. Found to have bilateral DVT with likely several PEs (not confirmed). Patient started on SQ Lovenox.

Day after shot, end of all patient's fingers turned yellow then purple and were numb. Left hand was worse than right (had rec'd injection in left arm). Patient had chills for 2 hours. Purple fingers went away after the second day. Numbness lasted for 3 days then went away. Numbness continues to come back every few days and lasts 1 to 2 hours (worse in thumbs, mostly the left). No purpleness. Patient called his MD the day after the shot. MD told him to soak in a warm bath, which he said did help some.

Flu like symptoms for 3 days, then continue loss of appetite, weakness, so much so that on April 5, 2021, I was taken to the emergency room for immediate treatment. The hospital then discovered 2 pulmonary embolisms (blood clots), one in each lung and pneumonia. At this time, I was extremely weak and in major physical stress. NOTE: I do not have a history of ever having blood clots.

Daughter reported that on 4/13/21 pt had increased weakness and difficulty breathing, taken to ER for x-ray of lungs, small amount of fluid noted. On 5/11/21 Pt with weakness, shortness of breath, increased edema in lower extremities, taken to ER, admitted to the Hospital with Pneumonia. Pt now home on Hospice.

3 days after vaccination, patient was found down in his home. Admitted to ICU from the ER with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis. Patient deceased day after hospitalization.

BLOOD BEHIND THE RETINA; FATIGUE/FEELING TIRED; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, latex tape allergy, alcohol user (once in a while), and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. The consumer reported that after taking the vaccine, for the first week the patient had no side effect and felt fine. In APR-2021 (about 3 weeks after vaccination), the patient experienced fatigue and feeling tired and both eyes got blurry and cloudy (left eye more severe than the right eye). Further consumer stated that, the patient went to see an eye doctor because the blurry cloudy vision persisted. The eye doctor referred him to a more specialized eye doctor who diagnosed him with blood behind the retina and gave him shots in the eye to help the blood dissipate. The patient's right eye had been cleared but the blurriness in the left eye had not been resolved. The consumer was concerned that it could had been a blood clot that traveled to the eye because the patient never had any issues like that before. And also mentioned that it could had been some age related eye issue but he was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/feeling tired, and blood behind the retina. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626620-covid-19 vaccine ad26.cov2.s-blood behind the retina- 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

SLEEPY; This spontaneous report received from a consumer concerned an 87 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy. This report was non-serious.

Patient developed confusion four days after receipt of vaccine. At presentation to the hospital was confused, dehydrated. Neuroimaging negative, LP showed aseptic meningitis with 30 neutrophils, normal protein and glucose. Numerous tests for bacterial and viral pathogens were negative. Patient improved, and was discharged after a three day stay.

RUNDOWN; TIRED; This spontaneous report received from a consumer concerned an 87 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: Unknown) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rundown. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and rundown was not reported. This report was non-serious.

CHILLS; FEVER; This spontaneous report received from a patient concerned an 87 year old male. The patient's height, and weight were not reported. The patient's past medical history included copd, and concurrent conditions included streptomycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: 25-MAY-2021) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever. This report was non-serious.

Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on 5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit.

Vaccine administered 12 APR about 0830 hours and all fine that day. Next day (13 APR) my father awoke feeling tired, somewhat sluggish and experienced a little diarrhea. 14 APR, still a hint of diarrhea but now tired and with pain in the back of his neck and his body ached all over, but pain was mild and these conditions lasted through 15 APR 21. No fever or headache observed. Today he awoke and felt fine, no additional issues to report but will report anything else should it occur.

Pt developed a fever on 3/17. He received COVID test the same day which came back positive. His grandson who cares for him tested positive on 3/11 or 3/12.

Pt hospitalized for COVID19 on 6/20/21. Sick for about 1 week prior to hospitalization. Exposure to family member that was positive.

SLEPT A LOT; FEELING VERY TIRED; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height and weight were not reported. The patient's past medical history included artificial valve surgery, and pacemaker surgery, and concurrent conditions included non smoker, sepsis, cancer on shin bone and radiation burn 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: 206A21A and expiry: 23/JUN/2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included amoxicillin for sepsis. On APR-2021, the subject experienced slept a lot. On 13-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 15-APR-2021 and the outcome of slept a lot was not reported. This report was non-serious.

HEADACHE; ACHY ARM; This spontaneous report received from a patient concerned an 89 year old male. The patient's weight was 73.6 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary hypertension.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included selexipag for drug used for unknown indication, tadalafil non-company for drug used for unknown indication, and macitentan for pulmonary hypertension. On an unspecified date, the subject experienced headache, and achy arm. Laboratory data (dates unspecified) included: Pulmonary hypertension (NR: not provided) ICD-9 and ICD-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy arm was not reported. This report was non-serious.

Onset of extreme fatigue, diarrhea, and then swelling, pain, redness, heat, and hardness of the Left Leg and Ankle. Sharp pain in the leg and ankle developed over the next months with swelling, becoming severe enough to see an Orthopedist on June 15, and then a visit to the primary Dr. on June 22. EKG, Blood including d-dimer, and Chest xray done same day, then a Sonogram done on June 23. No signs of blood clot, but leg issues and diarrhea continue, with skin breakdown occuring at the ankle. Placed on Prednisone 10Mg x 5 days, Lasix 40mg x 30days, Klor-Con MEG 10mg x 30 days, Keflex 500mg x 10 days, Mupirocin 2%.skin cream 3x day. Some improvement of the diarrhea since this time, but leg continues to be swollen, red, painful, and hard.