Johnson & Johnson

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

FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.

FEVER; EXCRUCIATINGLY PAINFUL HEADACHE; INJECTION SITE REDNESS; INJECTION SITE SWELLING; TENDERNESS AT INJECTION SITE; MUSCLE PAIN; BODY ACHE; FEELING HOT AT INJECTION SITE; BLISTERS ON COVID ARM; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 16:30 to right deltoid, for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced feeling hot at injection site. On APR-2021, the subject experienced blisters on covid arm. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced tenderness at injection site. On APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 101.5. On 02-APR-2021 11:00, the subject experienced excruciatingly painful headache. On 02-APR-2021 12:30, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) I antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciatingly painful headache, and fever on 04-APR-2021, was recovering from body ache, had not recovered from injection site redness, feeling hot at injection site, blisters on covid arm, and tenderness at injection site, and the outcome of joint pain, injection site swelling and muscle pain was not reported. This report was non-serious.

JOINT ACHE; TIREDNESS; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and no known drug allergies. 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 14-MAR-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced tiredness. On 14-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, tiredness, and soreness on the injection site on MAR-2021. This report was non-serious.

Stiffness /Pain on left side of head from temple down to neck & shoulder. Painful to turn head to left. Sharp pain in temper/ear area down back of head. Painful at times to hold head up. Dull Headache. TREATMENT: 3/18/21 - Primary Care Physician administer Ibuprofen shot to right side of shoulder, Prescribed Muscle Relaxer, referred for X-Ray of Shoulder. 3/30/2021 - Primary Care Physician re-examined - Prescribed Antibiotics for 14 days - referred for CT Scan of Sinus area. 4/6/2021 - Primary Care Physician re-examined referred for CT Scan of Brain/Head. 4/13 - Primary Care Physician re-Examined - prescribed Methylprednis-Olone for 6 days and referral to Neurology. .

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

Pain at left side of head, neck and ear with tender lymph nodes and "throat feels funny", few days later "legs feel funny" with numbness sensation

No reaction at all until 14 days after vaccination. Worked all day came home really exhausted. Went to bed at 6:00 PM. Got up at 8:00 AM feeling exhausted. Came home from afternoon dentist appointment (cleaning) exhausted with aching joints, bones and a slight temperature. Went to bed at 6:00 PM and slept til 8:00 AM. It felt like the same reaction from the flu shots which is why I didn't want to get vaccinated. I started taking 1000 mags at 6 :00PM about every hour 7-9000 mg total and felt fine the next morning instead of in bed for 3 days with the flu shot and no Vit. C. Also, shortly after the shot, I got a tingling at the indent in the back of my neck near the hairline which doesn't quite hurt but I feel the need to press on it. I can't tell when it's going to come or what I've done to make it happen. It's still happening several times a day.

Kidney transplant on 4/11. Immediately after surgery severe R groin pain. Within 7 days, leg continued to swell, pain continued, and clots (DVT?s) were found via ultrasound in the R groin, R calf, L calf. Readmitted to the hospital where anticoagulant therapy found unsuccessful. Clots continued to grow. Pt was put on heparin. Pt has no history of blood clotting disorders.

FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.

Severe low back and both legs nerve and muscle pains every day especially upon standing in morning. Cramping, etc. everyday beginning a week and half post vaccination. Ongoing.

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

03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain lasting entire day and into evening, difficultly moving

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

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

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

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

Patient states 3 weeks after getting vaccine she got muscle weakness and got shingles for 4 weeks. She asked her md and he stated it was probably from the vaccine.

CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. 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, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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).

SHOOTING PAIN; PAIN IN LEFT SHOULDER THAT STARTS FROM END OF THE NECK AND GOES ALL THE WAY DOWN TO LEFT ARM AND ELBOW AND COMES BACK AND HARDLY COULD RAISE ARM UP; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included pain, and other pre-existing medical conditions included the patient had experienced something similar to the adverse event in past but that did not last long. The patient was previously treated with ibuprofen for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ1A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shooting pain. On MAY-2021, the subject experienced pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up. On 09-MAY-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up, and shooting pain. This report was non-serious.

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

Patient arrived at the pharmacy 7-19-21 reporting she began to experience left arm weakness between the shoulder and elbow on 7/3/21 .She was unable to move or use the arm for 3 days, at which time it resolved. She also reports a sharp, bone pain just above the injection site-she experiences the pain only when she touches the area, (began 7/3/21). She continues to experience this pain as of the time of this report. She also reports a feeling of compression/numbness on the on the outside of her lower left leg between the ankle and the knee, this started 7/3/21 it has improved but has not completely resolved. Patient states she has not reported this to her health care provider

78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery.

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

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

Started having muscle pain; I didn't have chills. I was very fatigued - in bed all day. I had a headache and the muscle pains went into my left side and into my left lung and every time I breathed I would get a sharp pain. It went into both of my breasts but worse on left side of breast. This lasted about three or four days. I went to the doctor on Thursday, the 15th. But now everything is cleared up and I feel good. Yesterday, the 22nd I started feeling myself again. Except, I have a tremor that won't go away - I had a slight tremor before the vaccine but now after the tremor it is much worse.

Patient was discharged from the hospital after massive PE. She went to the hospital at 2am last Saturday. Patient described unbelievable pain from shoulder neck and arms. She could hardly walk to her car. Went to ER. There they ran tests and found many blood clots in lungs. Blood clots had stopped the blood in that area. They were not definitive but said it sounded like that. Got a breathing apparatus after because it's been hard to breathe and she has been shaky. Her shot was administered 04/12 during chemo. Hospital April 24. She was discharged and given a blood thinner and pain medication - Oxycodone & Eliquis.

NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.

PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was not reported and height was 51.5 inches. The patient's concurrent conditions included hypertension, obesity, arthritis, panic attacks, borderline diabetes, mold allergy, tree allergy, cat allergy, dog allergy, cipro allergy, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced pain in shoulder. On 29-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in shoulder on 09-APR-2021. This report was non-serious.

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

BODY ACHES; SHORTNESS OF BREATH; SNEEZING; MUSCLE ACHE; FELT GENERAL TIREDNESS/EXTREME FATIGUE; COLD; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included right sided breast cancer, and torn meniscus surgery, and concurrent conditions included physical therapy. The patient experienced drug allergy when treated with clarithromycin, and cefuroxime axetil. 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold. On 17-MAY-2021, the subject experienced felt general tiredness/extreme fatigue. On 18-MAY-2021, the subject experienced body aches. On 18-MAY-2021, the subject experienced shortness of breath. On 18-MAY-2021, the subject experienced sneezing. On 18-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on MAY-2018, had not recovered from muscle ache, and body aches, and the outcome of shortness of breath, cold and felt general tiredness/extreme fatigue was not reported. This report was non-serious.

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

This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

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

1 day after vaccination, patient experienced pain in both arms from shoulder to elbows, headache, and overall felt sick causing patient to lay in bed for several days. Majority of symptoms resolved on 7/21/21. Patient does complain of lingering headache still today (7/22/21). Patient did not take any medications to treat symptoms

Janssen COVID-19 Vaccine EUA Patient had her Johnson and Johnson vaccine on March 10th. About 2 weeks after she started feeling achy all over like she over did something. She had diffuse arthralgias in both shoulders and also both knees, left knee worse. She also developed left groin/hip discomfort and arthralgias. Symptoms have been persistent. She denies any trauma or overuse. No DJD symptoms before onset as above.

After having an immediate reaction to the Moderna vaccine my doctor said I should have the J&J for my second dose. When we returned home and I got out of our vehicle, my left hip hurt. It continued to be painful when up and about for the rest of that day (Friday) and the following day (Saturday). By Sunday morning the pain was no longer present. My left arm had minor discomfort.

BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient felt some pain in ankle, which was slowly moving up to the calf (left leg). The patient was brought to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months. Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The 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).

RIGHT ARM WEAKNESS; RIGHT ARM PAIN; MUSCLE ACHES; HOT AND COLD; FLU-LIKE SYMPTOMS; FREEZING; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol consume, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced hot and cold. On 06-MAY-2021, the subject experienced flu-like symptoms. On 06-MAY-2021, the subject experienced freezing. On 06-MAY-2021, the subject experienced muscle aches. On 12-MAY-2021, the subject experienced right arm pain. On 14-MAY-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold, flu-like symptoms, freezing, and muscle aches on 07-MAY-2021, and was recovering from right arm pain, and right arm weakness. This report was non-serious.

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

I received the Johnson & Johnson Covid19 vaccine at 3:30 PM on June 30, 2021. At 5:30 PM I experienced muscle pain in my right lower thigh muscles right below my hip replacement scar that continued throughout the night. The next day the muscle pain was so sever I could not walk on my right leg and had to get down my walker from my surgery. The following day the pain was less severe. It has been 12 days now since the vaccination and my right thigh muscles are still sore but I can walk OK.

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

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

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

4 to 5 inch bruise to injection site, soreness to left arm starting from shoulder Patient has applied cold compress with no relief. Recommended applying heating pad to left shoulder and to takeTylenol as directed. If symptoms worsen advised to see primary provider.

I do not have vaccine details. Patient developed acute knee swelling and pain requiring drainage. She has subsequently developed L wrist inflammation with swelling and warmth. She also had acute neck and lumbar spine pain. These are acute polyarthritis sxs that are new for her.

Right hip pain causing difficulty walking which is new onset immediately following vaccination. Woke with symptoms next morning. Started with generalized weakness midnight after the vaccine.

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

My arm was in pain. I experienced back pain for two days. I had a fever, chills, neck & shoulder pain, and I felt cold. I took Tylenol and Icy Hot. I already had a prior appointment scheduled to see the doctor so I did not see the doctor for this adverse event. But I told my doctor about my fever and they said the vaccine may have caused it.

LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.

WOKE UP FROM SLEEP DUE TO PAIN; RIGHT ARM PAIN; RIGHT SHOULDER PAIN; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced woke up from sleep due to pain. On 05-JUN-2021, the subject experienced right arm pain. On 05-JUN-2021, the subject experienced right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, right shoulder pain, and woke up from sleep due to pain. This report was non-serious.

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

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

While waiting the 15 minutes after shot was given, noticed a tingling sensation that traveled from my left arm, across my left shoulder to the back of my neck. It subsided about 15 minutes later. April 22 - Started mild symptoms of stiff and sore neck; ache in lymph nodes below left ear; pimple at the hairline at the nape of my neck. Discomfort moved to different areas near my left ear. May 5 - Discomfort moved up above my left ear- all other symptoms remained. Became a full blown headache above my ear to my temple. Headache was a sharp, stabbing painwhich moved around on left side. At one point, I timed it at every 16 seconds. May 7- Went to emergency room. Had a full workup. All tests

Pt noted neck stiffness, and tingling around neck/throat area. Pt requested 30 minute observation. When time was up she reported the symptoms. Pulse ox checked by MA, 98%, verbalizing coherently. Given Benadryl 25mg po and discharged to neighbor for transportation home. Pt given ER precautions and she verbalized understanding.

Not feeling well, no temp, but had pain in back behind lungs thought maybe it was pneumonia but, tested for covid just to make sure. It was positive.

PAIN IN NECK; RUNNY NOSE; PAIN IN BOTH ARMS; This spontaneous report received from a patient concerned an 81 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, penicillin allergy, sulfa allergy, arthritis, incontinence, and cataracts, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain in neck. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced pain in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both arms, pain in neck, and runny nose. This report was non-serious.

CLIENT HURT HER ANKLE COMING OUT OF HER BED ON 4/10/21 AND DEVELOPED A BIG BRUISE, SWELLING, AND COOL TO TOUCH THAT DIDN'T HEAL AND REQUIRED A UREGENT CARE VISIT ON 4/21/21. SYMPTOMS HAVE STAYED THE SAME , NOT PROGRESSIVELY GETTING WORSE. CLIENT WENT TO SEE HER PRIMARY AND HE SAID IT WAS 'ANGRY' AND NEEDED A VISIT TO URGENT CARE FOR AN ULTRASOUND TO RULE OUT A BLOOD CLOT.

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

Presented to ER with weakness and tired last couple of days. Left side of neck pain and headache, shortness of breath.

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

She received the vaccine, no problems initially, no real arm soreness. The next morning when she woke up she could not walk, had to hold onto something to walk, and has a lot of pain, and has not improved even with taking pain medications. There has been no improvement from the pain. There are times that she feels just a little better, but then returns back to where it was. She went to the ER on 3/17/21, they said that she had arthritis which she had but she has not had this type of pain until the vaccination. They gave her some pain medicine which did not help at all. She again is taking some pain medication now but the pain is still there. She can stand on her leg and it doesn't hurt, but when she moves her leg is when it hurts. She is now using a walker which she did not have to use before the vaccine.

PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.

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

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

ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

WEAKNESS IN THE LEFT ARM; This spontaneous report received from a patient concerned an 83 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced weakness in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness in the left arm. This report was non-serious.

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

Pt presented to ED w/2 week hx of malaise, myalgias, weight loss associated w/dyspnea and dry cough. Found to be hypoxic, in which she responded well with 2L O2. Labs confirmed COVID-19 positive w/elevated inflammotory markers (lactic acid). Pt had received Janssen vaccine (3/31/21). Was admitted for additional management of her acute hypoxemic respiratory failure w/COVID-19 on 4/23/21. Was treated with dexamethasone, remdesivir and empiric antibiotics which were stopped early. Pt ultimately discharged 3 days later w/follow-up scheduled in 3-5 days.

SHOULDER SWELLING; SHOULDER PAIN; SHOT WAS EXTREMELY PAINFUL; FLUSHED FEELING; DIFFICULTY LIFTING THE ARM; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 100 pounds, and height was 157.48 centimeters. The patient's concurrent conditions included arthritis in left shoulder and mammals allergy. The patient had no illness at the time of vaccination. The patient had no past history of similar event. the patient had no adverse event after any previous vaccination(s). The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization or acute illness in last 30 days, with cause. The patient had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for left deltoid prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced flushed feeling. On MAR-2021, the patientexperienced difficulty lifting the arm. On 15-MAR-2021, the patient experienced shot was extremely painful. On 19-MAR-2021, the patient experienced shoulder swelling. On 19-MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder swelling, and the outcome of flushed feeling, difficulty lifting the arm and shot was extremely painful 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.

BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included 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, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes. On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.

84 y.o. female with PMH of coronary artery disease with prior RCA stent in 2019, atrial fibrillation s/p pacemaker, type 2 DM with diabetic nephropathy, and CKD 4 who was admitted on 4/23/2021 with chest pressure radiating to the arm.

Patient reports having pain and a lump in her inner elbow joint the night after getting the vaccine. She presents to the pharmacy today 5/11/21 stating it is still painful and there is still a lump. No other adverse effects. Advised her to report to he primary provider as soon as possible.

Presented with right hand/arm pain, numbness, and weakness since morning after receiving injection on ipsilateral side. Workup and imaging confirmed acute arterial thrombosis of the right upper extremity requiring surgery and thrombectomy.

PROVIDER HIT THE BONE/BONE HURTS; SORE ARM NEAR SHOULDER; PROVIDER HIT THE MUSCLE; INJECTION SITE PAIN STILL HURTS SINCE 4 WEEKS; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18050221 or 1805022) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced provider hit the bone/bone hurts. On 19-MAR-2021, the subject experienced sore arm near shoulder. On 19-MAR-2021, the subject experienced provider hit the muscle. On 19-MAR-2021, the subject experienced injection site pain still hurts since 4 weeks. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm near shoulder, injection site pain still hurts since 4 weeks, and provider hit the bone/bone hurts, and the outcome of provider hit the muscle was not reported. This report was non-serious.

BLOOD CLOTS IN BOTH LUNGS. SHORTNESS OF BREATH. UPPER BACK PAIN. WEAKNESS. SWEATING AND COLD. NO COLOR IN FACE -- GREY. LOSS OF EYE SIGHT -- STARTED WITH BLURRED VISION.

Patient is an 85-year-old female with a history of hypothyroidism, hypertension, and osteoarthritis who presented from home complaining of 4 days left shoulder pain that radiates into her left pectoral area. She states she was vaccinated with the Janssen Covid vaccine on 4/8/21 in her left shoulder and her pain started 4/23/21. She is not sure if these were related. It was initially intermittent, sharp, stabbing, however became fairly persistent. She has noted her blood pressure being elevated. On my evaluation her blood pressure is 185/64. Patient states she was recently started on lisinopril for hypertension. She has not taken her lisinopril yet today. Chest x-ray showed no obvious infiltrates. Clear lung fields. Normal cardiac dimensions. EKG shows sinus mechanism with normal axis, intervals, ST segments. Otherwise normal EKG. D dimer was elevated, and VQ scan was negative for PE. Patient was evaluated by Cardiology who recommended outpatient stress test. Echo showed LVEF 60-65%. Trace aortic valve regurgitation. Mild mitral regurgitation. Mild mitral leaflet calcification is visualized. Trace tricuspid regurgitation. The right ventricular systolic pressure is calculated at 28mmHg. Patient was found to have hyperlipidemia and was started on statin. Her pain resolved on the day of discharge. Her blood pressure was controlled with lisinopril and coreg. She is to follow up with Cardiology and her PCP.

Lethargic 4 days; headache, weak legs (knees buckled), odd pains various locations, tingling in hands and wrists, dizzyness, weakness, sore throat two weeks,

I RECEIVED THE JENSEN VACCINE ON JUNE 21ST. HAD NO REACTION FOR TWO DAYS. WHEN I WOKE UP ON THE THIRD DAY MY LOW BACK, BOTH HIPS, BOTH THIGHS, KNEES AND FEET HURT SO BAD I COULDN'T STAND ON THEM. I SPENT 3 DAYS IN BED AND SLOWLY BEGAN TO MOVE ABOUT. TODAY JULY 24TH I AM STILL HURTING WITH THE SAME PROBLEMS I DESCRIBED. MY DR. IS SEMI RETIRED AND LEFT NO ONE IN CHARGE OF HIS PATIENTS. HE HAS NOT BEEN INFORMED OF MY PAIN.

PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.

FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

SEVERE PAIN IN LUMBAR REGION OF SPINE; HEADACHE-3 DAYS; SEVERE SCIATIC NERVE PAIN IN LOWER LEFT LEG AND CONTINUING GOING DOWN THE KNEE WITH A LOT OF PAIN; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included herniated disk, non smoker, non-alcohol user, diabetic type 2, high blood pressure (HBP), arthritis spine, penicillin allergy, bee sting allergy, ragweed allergy, juniper allergy, strawberry allergy, grape allergy, asthma, and chronic pain, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was not ill at time of vaccination, had no previous history of similar events and had not experienced any adverse events after previous vaccinations. The patient did not have acute illness 30 days prior to vaccination and hospitalization in last 30 days. Patient had no family history of any disease or allergy related to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:15 upper left arm for prophylactic vaccination. Concomitant medications included nebivolol hydrochloride for high blood pressure, hydrocodone for pain, and metformin non-company for type 2 diabetes. On 09-MAR-2021, the subject experienced severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain. On 09-MAR-2021, the subject experienced headache-3 days. On 09-MAR-2021 21:00, the subject experienced severe pain in lumbar region of spine. On 10-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain, and severe pain in lumbar region of spine on 23-MAR-2021, and headache-3 days on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210322279.

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

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

SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold 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.

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

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

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

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

VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.