Johnson & Johnson

Later in evening after vaccine administration: fever, chills, headache, nausea/vomting, body aches, exhaustion, facial swelling, rash on face and head. Unaable to sleep all night

Developed dizziness in the afternoon after receiving the COVID-19 vaccine on 03/13/21. Developed myalgias & malaise on 03/14/15. On 03/15/15, he woke up with erythema and warmth of his ears. At 7 pm that evening, he developed facial swelling (forehead and cheeks) and erythema around his mouth.

LYMPH NODES UNDER RIGHT ARM WORSENING AND GETTING SPREADING; STIFFNESS; Nausea; FELT JUNK; SHOULDER SORE; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight was 170 pounds, and height was 71 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known allergies and non 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: Unknown) dose was not reported, administered on 07-APR-2021 for vaccination prophylactic. The batch number was not provided and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt junk. On 07-APR-2021, the subject experienced shoulder sore. On 07-APR-2021 15:30, the subject experienced stiffness. On 07-APR-2021 15:30, the subject experienced nausea. On 08-APR-2021, the subject experienced lymph nodes under right arm worsening and getting spreading. On 10-APR-2021, treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt junk, had not recovered from lymph nodes under right arm worsening and getting spreading, and the outcome of nausea, stiffness and shoulder sore was not reported. This report was non-serious.

Pt received the vaccine & was advised to sit near the pharmacy for 15 min but pt preferred to walk around the store instead. heard mom yelling to call 911 & went to the aisle. Pt fainted while walking in the cooler aisle. Per mom he hit his head against a shelf. He does not recall hitting his head but said his neck was hurting. Pt was alert. Per pt & per mom pt gets anxious w/shots. 911 was called, pt stayed laying on the floor until EMS came to evaluate pt. EMS did not advise pt to go to hospital.

Patient received Janssen COVID vaccination on April 6, 2021. Pt had no symptoms initially after vaccination. Pt started coughing up blood and having episodes of dyspnea on April 25, 2021. Pt went to Urgent Care earlier in the day on May 11, 2021 - no medications were given, told he was fine. Pt then went to Medical Center and was found to be pale, diaphoretic, and tachycardic in triage. Pt vitals were temp: 36.6; pulse: 128; respirations: 22; BP: 161/129; SpO2: 97. Hospital medications: carvedilol 6.25mg PO BID, enoxaparin sodium 40mg SQ Q24h, azithromycin 500mg/sodium chloride 250mLs @ 250 mLs/hr IV Q24h, ceftriaxone sodium 2gm/sodium chloride 50mLs @ 100mLs/hr IV Q24h, lisinopril 2.5mg tablet PO QD, metoprolol tartrate 5mg IV Q5MP prn tachycardia. ER disposition: consult for admission Dx: hypertensive urgency, tachycardia, suspected COVID virus infection, bilateral pneumonia

HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Temperature of 103.6 - Vomiting, Lower abdomen pain, Cold Sore outbreak on 7/27 at eyes, nose, mouth Complaint of ear ache. Cold sore eruption increase to around both eyes, under nose, bottom lip. Bottom lip swollen, eyes puffy

Puffy eyes and face, swollen, but no other symptoms. Vaccinated at 4;45 pm and had mild inflammation 3 hours later, woke up today at 1pm with eyes and face completely swollen

LEFT ARMPIT STARTED SWELLING; LEFT ARMPIT TURNED RED / REDNESS; RASH; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 195 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced rash. On 03-APR-2021, the subject experienced left armpit started swelling. On 03-APR-2021, the subject experienced left armpit turned red / redness. 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 left armpit started swelling, rash, and left armpit turned red / redness. This report was non-serious.

Pt sts shortly after receiving the vaccine she became lightheaded. She passed out before she knew she was going to and as a result she fell out of her chair hitting her head. She has a minor abrasion approx 8mm in diameter to the L forehead. Swelling is minor as well, there does appear to be a light contusion as well. Pt sts she has not passed out with needles or injections before. VS: HR 110, BP 122/58, RR 14, Sats 98%. PMSx4, skin signs normal. Pt went to first aid area and allowed vitals. She does have tenderness to the site of her abrasion on her forehead. Her lightheadedness resolves and she denies all further complaints. She does not complain of headache and does not want further treatment. She declines further assessment, including a second set of vitals. Risks of refusal given. Pt notified that VAERS will be completed. Pt instructed to follow up with her doctor.

HORRIBLE BACK PAIN (WITH A PAIN SCALE OF 7.5 OUT OF 10); SWOLLEN POUCH ON LEFT LOWER BACK APPROXIMATELY FOUR INCHES DIAMETER AND THREE INCHES HEIGHT DIAGNOSED AS LYMPHATIC ISSUE DUE TO VACCINE; FEVER OF MORE OR LESS 100 F; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight was 150 pounds, and height was 190 centimeters. The patient's pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced horrible back pain (with a pain scale of 7.5 out of 10). On 24-MAY-2021, the subject experienced swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine. On 24-MAY-2021, the subject experienced fever of more or less 100 f. Laboratory data included: Body temperature (NR: not provided) more or less 100 F. Treatment medications included: paracetamol. On 25-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine on MAY-2021, and was recovering from horrible back pain (with a pain scale of 7.5 out of 10), and fever of more or less 100 f. This report was non-serious. This case, from the same reporter is linked to 20210557778.

10pm after taking the vaccine started getting headaches and nausea he was in alot of pain from the headaches. 911 was called After the he experienced diarrhea and swollen lymph nodes in his neck

Acute pericarditis. 4 days of worsening substernal chest pain. Diffuse ST elevations on ECG. Large pericardial effusion on CT and ultrasound. Troponins negative. ESR and CRP elevated. No previous history of viral illness or autoimmune disease. Treated with course of Colchicine and Indomethacin with close Cardiology follow up outpatient. Patient otherwise afebrile and hemodynamically stable.

High respiratory rate with shallow breaths, Rash on chest, Tachycardia, Altered Mental Status . The Patient that was suspected to have an adverse reaction. EKG displayed no abnormalities, IV was placed in patients L Arm and provided 1,000 ML of Normal Saline, and administered supplemental O2 via simple mask. An Epinephrine Auto Injector 0.3mg was also injected into the patients L thigh. Determination to transport to local treatment center was made by provider. Patient arrived at Medical Center approx. at 2245 and further evaluated there. Patient was then transferred to Level 3 Trauma facility to Hospital around 0100, 17 March. Admitted to the ICU for further evaluation. Update- Patient will be admitted until 18 Mar 2021. It was noted by Hospital Patient had a sever anaphylactic reaction.

21 yo male presented to ED Face swelling, hives, facial pruritus, throat tightness starting approx. 30-40 minutes after J&J COVID shot. In ED vitals stable, pt not in distress. Good response w/ Epi pen and adjunct medications.

The adverse events that occurred after this vaccination include the following: Severe headache, vision issues (i.e., loss of clarity, focus), muscle aches/cramps, chills, stomach/abdominal discomfort, upset stomach, loss of taste, loss of smell, sore throat, swelling of lymph nodes (underarms, groin region, and behind the ears), tiredness / loss of energy, and nasal congestion. The most adverse event, a headache, led to some dizziness, loss of clarity/focus (vision), and pain behind the eyes. The only treatment taken to lessen the severity of these events were acetaminophen and ibuprofen. The adverse events still occurring today are (as of now 04/14) include: stomach discomfort, muscle aches/pains, and discomfort under the arms (armpit area) near lymph nodes.

21 y.o. male with no significant PMHx who received the Johnson and Johnson vaccine 4/10/21 found to have extensive LLE DVT (extending above inguinal ligament). Pt was transferred to OSF for catheter directed thrombolysis. He was given 10 mg Eliquis prior to transfer. Pt reports acute onset of LLE pain the evening of 4/16 with progressive pain over the weekend and development of LLE edema/redness 4/18. Left leg mildly more edematous than right. Foot pink/warm, sensorimotor intact. No skin discoloration. Pt denies recent surgery, prolonged immobility or known family history of clotting disorders.

Patient reported that he has a lump in his right armpit that started yesterday. This is the same arm that he received his J&J COVID vaccine on 5/13/2021. The lump is dime sized, red, appears to be filled with yellow exudate. Lump appears infected. Started Doxycycline 100mg PO BID x 5 days and instructed patient to notify medical if it becomes larger, or shows no improvement with the antibiotic.

The patient presented with neck swelling, right-sided neck rash, complaining of shortness of breath, and feeling lightheaded

FEVER; ANAPHYLACTIC REACTION (PASSING OUT/ COULD NOT BREATH/ SWOLLEN LIPS AND FACE); LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma (as a child), non-alcoholic, and cigarettes smoker. The patient experienced drug allergy when treated with Tamiflu (oseltamivir phosphate). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown, NDC number: 59676-0580-15) dose was not reported, 1 total administered on 14-MAY-2021 at 10:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, as soon as the patient got the shot (within the 15 minutes of wait at the pharmacy), he had an anaphylactic reaction. It was further reported that he could not breath, his lips and face started to swell and then he passed out. The patient was taken to ER (emergency room) and his doctor gave him EpiPen (epinephrine) shot, Medrol (methylprednisolone), Benadryl (diphenhydramine hydrochloride) and IV (intravenous) fluids. The patient's lips were drooping to the right side of his face even after taking the medications. The patient stayed at the ER for 6 or 7 hours then was sent back to home on the same day. On 15-APR-2021 (reported as Saturday), the patient had fever. On 16-MAY-2021 (reported as yesterday from the date of reporting), the patient was much better, and his drooping lips was there a little bit but not as bad. The reporter did not have patient's vaccination card (for lot number or expiration date). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction (passing out/ could not breath/ swollen lips and face) on MAY-2021, and was recovering from fever, and lips were drooping to the right side of face. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210532244-COVID-19 VACCINE AD26.COV2.S-ANAPHYLACTIC REACTION. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210532244-COVID-19 VACCINE AD26.COV2.S-LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE. 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).

pt mom reports on Tuesday morning. PT HAS FEVER, SWELLING OF LEGS, SHORTNESS OF BREATHE, NO BLOOD FLOW IN EXTREMETIES. PT REPORTS FEELING NUMBNESS IF EXTREMETIES. CANT SEE OUT OF HIS RIGHT EYE, REFERRED TO hospital.

Swollen leg possible blood clot, couldn't walk for days. got antibiotics and its coming along still swollen but able to walk again somehow

Angioedema; treated with and EpiPen, famotidine, and diphenhydramine; swelling and tingling are reducing

At roughly 6 days after vaccination my body developed Hives head to toe. Roughly 18 or so hours after initial hive development I sought treatment for a anaphylactic reaction in my throat and face area. I received a steroid and a Pepcid to calm it down, and was given an epi pen and sent on my way. The following now two plus weeks since then I've had episodes of dizziness, shortness of breath and headaches that seem to be constant. There has been almost no relief from these symptoms, however the rash has completely resided. I've taken an Aspirin in the mornings to deal with the headaches but strenuous activity seems to bring these on much more prominently.

Patient had an initial response 2 days after the vaccine, with general malaise, dry mouth, headache and itching hands as well as local discomfort at the injection site that seemed to resolve spontaneously. On April 3rd he had non-specific changes in his hands that he attributed to cold weather that led to discomfort when running them under warm water. By monday APril 5th he was having worsening sensitivity in his hands and feet to heat, touch and experienced numbness. he also began to have difficulty walking. He went to the ER April 6th and was discharged April 7th after undergoing MRI of the brain and spinal cord, labs and lumbar puncture, with a presumptive diagnosis of early Guillain-barre Syndrome. His symptoms continued to worse, loss of gait was more pronounced as well as loss of balance and new off sensations in his tongue. He was admitted to the hospital, continued to undergo diagnostic workout. Results from tests on APril 6th came back positive for Anti nuclear antibodies and high protein in his CSF. He was treated with 3 days of infused Immunoglobolin therapy and was discharged on April 11th with a diagnosis of likely GBS. His symptoms continue to worsen slightly, but with less day to day decline

Prior to receiving vaccine patient was normal healthy 24 year-old male, with no underlying health conditions. Pain and Swelling in Groin area/Testicular Pain (on 4/12/2021). Started as discomfort at 9:00 a.m. and gradually worsened during the day. By midnight pain was sever, no position would give relief. Pain intensified to causing loud painful screams. Took 600 mg of Ibuprofen waited 20 minutes with no relief. Taken to local hospital ER, Emergency Department, Upon release from ER- recommended to see Urology Specialist. As of 4/14/2021 patient is still taking Ibuprofen for discomfort. Pain has lessened and is not as intense but is still present.

Pt is a 24 year old male with hx of IBS and anxiety with reported swelling and pain to the left shin that just popped up prior to presenting to ER. Complained of pain on Lt shin that started while he was standing at the sink. Started stinging, looked down at shin, he stated it started swelling and stinging. Does not remember any injury, but is unsure. DX - Hematoma to the left lower extremity. BP 155/72 Temp-98.0 HR 77 R- 18

LIGHT HEADEDNESS, THEN SEIZURE FOR ABOUT 10 SECONDS. WE CAUGHT PATIENT AND LIED HIM ON THE FLOOR AND TURNED PATIENT ON A SIDE, ARM WAS SWELLING AND TURNED ORANGE. PATIENT WAS CONCIOUS, EMT ARRIVED AND TOOK HIM TO THE HOSPITAL.

After administration, pt went shopping with his wife and kid. While shopping within the store, pt reports he fainted, fell down to the ground on his forehead and sustained a deep cut injury right above his left eye. He was bleeding profusely, first aid was rendered and his wife drove him to the ER

Vaccinated workers on 7/12. Patient noted itching of hands on evening of 7/12. Woke the mornig of 7/13 with slightly swollen hands. On 7/14, woke with swelling of both hands and feet and severe itching of hands.

Thursday 4/8: 3:20pm: COVID injection given in right arm Friday 4/9: ~1:00 am: woke up shaking with chills and severely cold; had slight headache. Had insomnia all night. 6:00 am: woke up with bad headache, slight fever. 7:00 am: got out of bed and had vertigo and was running into walls trying to walk to my living room, along with the worst migraine I?ve ever had. Also had dizziness, nausea, chills, 100+degree fever, aches, skin sensitive to touch, and severe tinnitus. All of the veins were visibly popping out of my head. As the day went on, everything got worse. Any time I moved, my head would throb so bad that I thought I was going to have to go to the hospital. 3:45 pm: the headache started to finally go away. It would only hurt if I moved fast. At this point my fever was only slightly high, about 99 degrees. I was still unstable when I walked and dizzy. I went from being super cold, to being super hot and sweaty. And I was alternating between cold & hot and sweaty for the rest of the night. Was also having some memory issues, repeating things when I was having a conversation with someone over the phone. I was sweating all night when I was sleeping. Saturday 4/10: 7:00am: woke up with a slight headache; still out of it and dizzy. 8:00am: after being awake for about an hour or so, I looked in the mirror and my whole face (around the lips, cheeks, and jawline, and under the eyes) was really swollen and puffy. My face was even mis-colored. Under my eyes was purple and yellow, and my cheeks were white. Some confusion persisted throughout the day as well as dizziness.