Johnson & Johnson

Pt was 17.83 yrs of age at time of vaccine administration; not 18 years. Pt was choosen to prevent a wasted dose; pt also employee of pharmacy as a delivery driver. Pt's father also employee of pharmacy who had a heart transplant last year. Pt had nausea about 12 hours after shot; only lasted about 12 hours. By 24 hours after shot no remaining issues other than pain at injection site.

Janssen COVID-19 Vaccine EUA Awful headache, fever over 102, slow, weak, muscle aches, injection site hurts a lot.

flu symptoms. Pt received J&J vaccine this morning 0900. At 1400, started having a HA, chills, dizziness, chest pain cramps, and n/v. History: Pt had J&J COVID-19 vaccine this morning and after noon, pt started developing chills, non-thunderclap headache, felt light-headed like passing out while standing, having to sit down, sweating, with N/V x 2, here for eval. Also had muscle aches, in chest, thigh, and other parts of muscles, not isolated to chest. Felt not quite 100% when pt woke up this morning but otherwise didn't have any other symptoms before the vaccine and denies recent sick contact, recent travel, recent illness/surgery/procedures/abx use, diarrhea, rash, COVID-19 hotspot visit, sore throat, ear pain

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

The day the vaccine around 8pm Patient had chills and fever 100 degrees. Around midnight he started vomiting, had chills, fever 101, headache, body aches, extreme fatigue, racing heart 140 bpm. I called ER and told them symptoms. They said to bring him in. We arrived at ER at 1am. At ER they gave EKG, Tylenol, Toradol injection and IV fluids. They also gave him covid19 test. He started to feel better and he was sent home at 5am. Two days later he had rash going down his left arm where he received the vaccine. It was gone the next day.

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.

8 hrs after the vaccination my son experienced violent shaking and rigor, extreme discomfort because of the muscle cramps. Headache, high fever (102F), nasal congestion, nasal discharge and generalized body pain. He took multiple Tylenol and Motrin however the fever did not decrease for many hours and low grade fever (100F) continued into the next day. He had pain on the entire left side of the body. He felt increased sensitivity to touch and even the shower water was hurting. The fever and body pain stayed till the next day evening and needed round the clock Tylenols and Motrins to feel better. He inly felt better 2 days after the vaccination.

7 minutes after vaccine was administered pt started reporting severe nausea. Face was extremely red. Pt did not report nausea until 15 minutes after. Administered 50 mg of benadry PO. Patient also started drinking gingerale. An hour later pt is doing a lot better. Nausea subsided redness as well.

Within 4 hours of vaccine and lasting 12-24 hours: Injection site pain, then severe chills followed by fever (99.9 degrees F), nausea, vomiting, joint aches/pain, shivering, loss of appetite, difficulty sleeping, GI pain, headache, severe light and sound sensitivity, fatigue; At 24-48 hours, headache, joint aches, fatigue, light sensitivity, decreased appetite, increased pulse; 48-72 hours - 2 pound weight loss, joint aches in major joints, fatigue, unable to perform physical work >72 hours - feeling better, but tired

Janssen COVID-19 Vaccine EUA I had a fever, headaches, nausea, fatigue, soreness on injection site, and loss of appetite.

Client was encouraged to drink a full bottle of water as he came to the dispenser table. "I do this every time I get a shot or when my cast was taken off." He proceeded to lay on the floor and closed eyes. Noted bluish tint around his eyes L>R eye. VS at 0920: 98/40 BP-52 HR-12-96% on the oximeter. He was talking to his mother on the phone. Legs elevated on chair to increase BP. At 0928 am BP was 128/58 and starting to feel better. At 0933 am, BP: 126/60-64-14 and 98%. At 0938 am, BP was 126/80-77-98% on oximeter. BP 126/80-96%- 77 HR and regular. Patient released from observation at 0951 am.

After a few hours, developed a low grade headache and some soreness at the injection site. About two hours later I started getting extremely cold, despite the temperature in the mid-high 70s. I covered up under blankets. I began feeling very tired and a general sick feeling. After about an hour and a half of progressively worse chills and cold sweat, I began to get very very hot and removed all blankets and eventually clothes. I took my temperature, which was at 102 f. At this point I drank some water and Gatorade and waited for it to pass. I also noticed that my Apple Watch heart rate detection was saying my heart rate was in the high 90s to low 100s despite me just laying in bed. This was alarming because my typical resting heart rate is in the low 60s. About two hours later I felt well enough to at least brush my teeth, but upon standing up was greeted with an extreme feeling of weakness and dizziness and it was hard to keep myself up right. I eventually was able to fall asleep, and upon waking up, felt better, but still not great. My heart rate was more normal at this point, I no longer had chills or a fever, but still had a headache and soreness across my body, worst at the injection site.

Day 1 (March 7) 102.7 fever, severe body aches, headache. Resolved within 24 hours Day 6 (March 13) full body hives. Resolved with benadryl within 24 hours

This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, diarrhea, headache, chills, pressure in ears and injection site pain was not reported. This report was non-serious.

He has had the following symptoms from the 4/12/2021 till present time: constant headache and fatigue. Intermittent low fever (99F). On 4/21/2021, his primary care doctor recommended that we take him to Emergency Room because she was concerned about thrombosis as side effects from the vaccine. His legs had some red patches on the back of the ankles area. At ER, doctor did blood test for blood clot and result was negative. He got an IV injection less headache.

RED HANDS; CHILLS; FEELING WEAK; FEVER OF 103; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043821A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced red hands. On 30-APR-2021, the subject experienced chills. On 30-APR-2021, the subject experienced feeling weak. On 30-APR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red hands, chills, feeling weak, and fever of 103 on 02-MAY-2021. This report was non-serious.

11:00 AM PT RECEIVED VACCINE, moved to a chair on his own, 11;05 AM PATIENT WAS OBSERVED TO BE SLOUCHING IN CHAIR AND WAS ASKED IF NEEDED ASSISTANCE. WE GOT SOME WATER AND HELPED HIM TO PAY DOWN, PATIENT WAS ASHEN IN COLOR AND SAID HE FELT WOOZY.ABOUT 11;15 PATIENT STARTED TO RESPOND WITH EYES OPENED AND A SMILE. DECLINES EMS CALL. 11;20 SAT BACK UP IN CHAIR,REPORTED FEELING OK. KEPT PATIENT FOR ABOUT 30 MINUTES AND NO FURTHER INCIDENTS TO REPORT.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was given COVID vaccine and moved to another chair to be observed. Upon sitting in other chair, he almost immediately went stiff, began convulsing, and then went unconscious. Patient came to, 911 was called, and patient was transported to ER.

At 12:45, AM, my son got chilled and began shaking uncontrollably. He began running a 103 fever,. The fever, would drop to 101 with Tylenol, but would spike as soon as it would wear off. He was very tired and slept most of today. Today, the fever is gone, but his back hurts and so does the injection site.

as soon as needle went in patient's arm patient turned white and sweaty. never lost consciousness. pt said ears were ringing and that he couldnt see patient's mother wanted us to call squad. we did. they arrived shortly after. they determined it to be an allergic reaction and administered epi and gave pt IV fluids patient was stable enough to leave a little before 7 pm

Pt received vaccine at 5:55 pm At 6:00pm Pt had syncopal episode fell out of chair and hit head on concrete Pt had abrasion to right head right wrist and right knee Ot was able to answer questions A&Ox 4 No vomiting No blurred vision 911 called and ot was transported to hospital via Ambulance

While in observation after vaccine was given, 18 y/o male had a tension of body and fainted out of chair from sitting position. Head did hit the concreate floor. Male immediately jumped up once he hit the floor. Syncopal event occurred. HE was brought back into treatment area and placed on EKG along with vitals. Normal sinus rhythm, BP and HR stable. Small laceration to right side of temporal lobe about 1cm long, minimal depth, no stiches required, bleeding stopped immediately and ice pack placed. Neurological intact, pupils equal and reacted to light. AAOX4, No nausea, vomiting or dizziness. Male is stable condition with brother. Advised to seek further eval with x-ray of skull for precaution. He was in agreement and understood.

11:08 Text from client's mom: allergic reaction, throat swelling and hives all over. Client took Benadryl. Instructed to go to ER and ask them to complete a VAERS form. The mom texted back,: he took some Benadryl and it was about 30 minutes and he could feel things staring to go down and he feels a ton better, so I think we are OK. At 1:02 PM I texted her "How is he doing?" Her reply: "Much Better." At 5:11 PM Client's mom called and said patient was having chest congestion, swelling in his throat and sick to his stomach and nausea. I instructed her once again to get him to the ER . Client took Benadryl once again and also went to the ER. At 6:36 PM Client's mom let me know they were giving him an epinephrine shot and a steroid shot. she also texted: Dr. has never seen this kind of reaction. 6/3/2021 9:30 AM Client "so much better, thank goodness. 6/8/2021 Client himself stated he was fine. No additional problems

Within 12 hours- Severe chills for 2 hours, then turned into fever of 102. Took motrin at 4 am (four hours after effects started.) Headache and achy. Fever continued for 20 hours. Took Nyquil that night. 5th day at 11pm, developed itchy rash on forearms, spreading to torso and shoulders. Started down back. Took benedryl and used caladryl lotion on rash. Tired for 4 days.

On the location of the shot a big bump has popped up feels like its getting bigger, and theres a slight pain when i put pressure on it. Its been almost 3 months since i got the vaccine and i didnt notice the bump till this month.

LUMP AT INJECTION SITE ON LEFT ARM; HOT FLASHES; FEVER; FATIGUE/FEELING DRAINED; HEADACHE; This spontaneous report received from a patient concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced fatigue/feeling drained. On 03-APR-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced lump at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and fatigue/feeling drained on 05-APR-2021, and fever, and headache on 04-APR-2021, and had not recovered from lump at injection site on left arm. This report was non-serious.

Patient immediately reported the shot hurt more than usual shot and that he was feeling dizzy (he described it as "the spins"). He stated getting warm to the touch and started sweating profusely. About 4-5 minutes after the shot he said he was nauseous. About a minute later he threw up. He said that throwing up helped a little. RPh asked if he wanted some orange juice. He said he did and he took a few sips. He continued to feel warm to the touch and was sweating quite a bit. He also was quite pale. RPh continued to monitor him, providing cool compresses to forehead and back of neck and continued to have him sip on orange juice (drank about 20 ounces aver 30 minutes). He reported feeling better at 10:45am (about 30 minutes after shot.) RPh kept him for observation for another 15 minutes at which time he felt good enough to go home. Girlfriend drove him home. RPh called to check on patient at 6pm. Girlfriend reported he was doing ok and hadn't had any other reactions. He had just been sleeping all day.

bilateral axillary rashes 10 x 15 cm 2 days post vaccine, treated with Benadryl, evaluated at clinic. continue Benadryl as needed. to ER if any difficulty breathing or swallowing. appears stable

Patient reported running a fever last night after getting vaccinated yesterday afternoon. She did not have any rashes on her face till she threw up this afternoon and then she stated that she had rashes all over her face and it was itchy. I advised her to take some antihistamine and she had cetirizine 10mg at home and she took one tablet. And then I advised her to go to the ER.

At 1628, RRT was called for a 19 y/o M with c/o dizziness and lightheadness. At first appearance, he was diaphoretic, pale, shaky, cool, and clammy. Head-to-toe assessment completed and all WNL than what was previously mentioned. Vitals: BP: 110/58, HR: 72, RR: 20. Has asthma, NKA, no medications/herbal supplements/vitamins taken that day. This was his 1st dose of Pfizer. Response team gave him icepacks to put on his neck and arms and client stated he felt better. His mother arrived and client and response team informed her of situation. Client declined paramedic/EMT assistance. Over monitoring/evaluation period, client?s condition improved. Skin color returned, no more diaphoresis, skin was warm. Client left facility at 1640, accompanied by mother. Mother drove client home.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Additional Details: na

Almost immediately after Johnson & Johnson Covid Vaccine was injected into patient, he passed ouit. He was in chair and his head went backwards with his eyes rolling back. called for help and I responded. Patient was coming to but proceeded to pass out 2 more times. Epi Pen was ready to inject if needed, but did not appear to be an allergic reaction. 911 and a code white were called. Blood pressure was taken and was low. Patient was warm and clamy. Ice was placed on his neck. Paramedics arrived and checked his vitals. Blood pressure had come back up. Pulse ox 99. blood sugar was normal. Paramedics told patient to hydrate and eat. Water was given to patient after paramedics cleared it. Patient eating in store and then checking in with Pharmacist. Patient will be called tonight at closing time.

Pain in left arm just below site of injection. 101 degree fever with dehydration, severe lightheadedness, and headache that lasted till morning. General feeling of weakness and exhaustion that lasted till evening the next day.

Pt sat for 15 mins, got up started to walk felt dizzy and fell down, hit head on wall. bruise on head above left eye 1" x1/4" Pt stated this is a typical reaction to blood draw

Janssen COVID-19 Vaccine EUA. Last night I was very warm, had a terrible headache, felt tired/dissociated and my entire body ached. I went to bed around midnight and woke up at 5 with terrible chills, body aches and a headache and couldn't stop shaking and couldn't fall back asleep for about an hour. I woke up around 10 drenched in sweat and had a bad headache, body aches and a 101 fever. I took ibuprofen last night, around 8 this morning at 5 and this morning at 10 and felt slight symptom relief but still have a fever.

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.

Fever, headache, body aches, sharp lower back pain, redness in lower legs (from knee down) - the way a sunburn would appear, loss of sensation on lower legs for a couple of hours. This all happened within 24 hours of receiving the vaccine.

Janssen COVID-19 Vaccine, arms and legs were fully numb and cold, chest and back were hot, fever, headache, could not look to the edge of my vision, could not hold down food or water, intense pain in the lower back, bad balance, chills, aches,.

Low Fever 99.0-101.7 on going at 99.0 Chills/headache Arm Rash on the same arm others of where shot was injected Fatigue on going. Racing Heart.

Urticarial rash that appeared 4 day after vaccine, no respiratory/gastrointestinal symptoms, rash improved when seen in office, had fevers on day of vaccine, rash does not blister, no bleeding or bruising.

SKIN FEELS SENSITIVE/TINGLING; SKIN FEELS SENSITIVE/TINGLING; FEELS LIGHTHEADED; HEADACHE; FEVER 102 DEGREES; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non smoker, abstains from alcohol, and penicillin allergy, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced skin feels sensitive/tingling. On 08-APR-2021, the subject experienced feels lightheaded. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever 102 degrees. On 08-APR-2021, the subject experienced skin feels sensitive/tingling. Laboratory data included: Body temperature (NR: not provided) 102 deg, and COVID-19 virus test negative (NR: not provided) Negative. 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, skin feels sensitive/tingling, feels lightheaded, fever 102 degrees, and skin feels sensitive/tingling. This report was non-serious.

Lightheadedness and headache about 8 hours after vaccination, restless sleep during the night. Next morning before taking a shower felt lightheaded and sick to stomach. After my shower I fainted and had an ankle contusion due to fall.

Okay this is supposed to be for the Johnson and Johnson vaccine but I didn?t see an option for it, but I am reporting hives around the injection site that has been persistent for days now

initial arm soreness, followed by extreme fever of 103.9 on set hour 8 and lasting for 12+ hours. Roughly hour 28 extreme lung pressure, new bruising and patching red dots on palms of hands. A phone call was made to a Covid help line and determined an ER visit was needed ASAP. ER visit determined an extremely elevated INR, but chest xray was clear. Toradol injection given after it was determined it was an inflammatory response to the vaccine centered in the tissue/muscles between the ribs.

Started with a low fever 6 hours after vaccination, with slight muscle ache symptoms. About 4-5 hours later it evolved into a high fever (104 at peak), muscle aches on the whole body, and ringing in my right ear. The next day the symptoms were more mild, but still present (other than ringing in ear) with a lower fever, and the day after the symptoms were gone except for tenderness at injection site.

Patient received vaccination in their right arm. Patient looked at injection site and saw a drop of blood, then lost consciousness in the chair. They were held upright by the nurse who administered the vaccination. Patient regained consciousness after several seconds and was transferred to the cot. Ice pack applied to patient's head due to warm observation area. Patient declined VS, declined a snack, sat with girlfriend and requested to leave at 1420.

pt states getting J&J yesterday at 1500 and at 2300 felt fever and chills upon waking noticed hives on arms pt denies N/V/D pt denies change in soap, detergent.

Severe arm pain/low swelling in arm area. Nausea. Pain near liver area. General fatigue. Mental cloudiness. Random bouts of tinnitus in both ears, switching off, never both ears at once. The arm pain and swelling in shot area lasted about two days, but the nausea, ;over pain, and fatigue continued for the better part of 4 days after the shot. The tinnitus only happened a couple times about 1-3 hours after the vaccination then ceased. I did not get this verified by a doctor, but I suspect my liver pain was related to an inflammation in the liver associated with the vaccine, as in the past, pain around my liver area has been associated with inflammation of my liver during minor flare ups.

Client had a J&J vaccine at 1327. He reported that he was having trouble breathing around 1333. He reported that he felt hot and sweaty and lightheaded. He appeared distressed. We called 911, then we provided a client with a cold pack. His pulse was 47 bpm and his spO2 was 97%. He continued to state that he was lightheaded so we had him lay down on the ground and take deep breaths. EMS arrived they collected his vitals which were WNL. His blood glucose was 71. He was warm and moist to the touch. EMS stayed with the client until 1350 at which point he had sat up and sat in the chair. He said he was definitely not having trouble breathing anymore and was feeling better. Provided client with a juice box and water. Client stayed onsite until 1410 at which point he said he felt comfortable leaving. Client walked unassisted out of the clinic.

Immediately after sitting down in the waiting area after receiving the shot, the pt reported feeling a strange pressure in their arm. Following this, the patient described the sensation of "blanking out". The pt fell off their chair and lacked alert conconciousness for roughly five seconds. When the pt came to, they appeared confused and twitchy, with wide eyes and an overall appearance of shock. Pt remained in their state for roughly a minute, before stating that they felt completely better. The pt had developed a sweaty back but didn't state that they felt overally hot. They didn't mention being in any pain. The local injection site appeared a bit red but nothing of significant note. Pt did bump their head on the side wall behind the chair, receiving a minor bruise. Pt was given some water to drink and was monitored for 30 minutes. They pt stated they felt fine. They had no past history of fainting with vaccines, thought pt claimed to have passed out like this before but only after suffering a head injury. After their wait, the pt was allowed to leave and assured us that they felt completely fine.

patient fainted, fell off chair and hit head on wall we had him lie down on floor, took his blood pressure and put ice pack on bump on his head he eventually sat up and felt better

PAINFUL ARMPITS; REDNESS IN ARMPITS; RASH UNDER BOTH ARMPITS; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. patient took 180mg of otc allergy medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced painful armpits. On 21-MAY-2021, the subject experienced redness in armpits. On 21-MAY-2021, the subject experienced rash under both armpits. On 22-MAY-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful armpits, and had not recovered from rash under both armpits, and redness in armpits. This report was non-serious.

High temp fever (102.5), body aches, headache, possible loss of consciousness (momentarily- unverified - I wasn't there) temp responded to acetaminophen/cold compresses but lasted thru night. In AM temp down to <=101 for another 12 hours, slept all day After 18 hours, temp resolved (still achy for another 12 hours) NO chills, NO nausea, only mild injection site swelling Note - the pharmacy suggested I create this report because of the possible loss of consciousness (was non-responsive to sibling when arrived home)

Attendee received Johnson & Johnson vaccine at 13:49 in the left arm. Lot# 204A21A. Attendee was directed to observation area. At 13:52 voiced complaints of dizziness and lightheadedness. Attendee's skin was warm and dry. Skin pale 13:53 – Assisted to a wheelchair 13:55 - HR: 77 BP: 110/72 RR: 12 O2Sat%: 99 13:57 - Attendee stated he felt better, pale. Took a mint that mom had in her purse and a sip of water. HR: 75 BP: 110/80 RR: 12 O2Sat%: 96 14:01 -No voiced complaints- skin warm and dry. HR: 76 BP: 110/90 RR: 12 O2Sat%: 95 14:06 -No voiced complaints- skin warm and dry. No longer pale. HR: 88 BP: 112/90 RR: 10-12 O2Sat%: 96 14:10 -No voiced complaints- skin warm and dry. HR: 75 BP: 120/86 RR: 10-12 O2Sat%: 98 14:20 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his family. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.

High fever, extreme shaking and chills, nausea. I was pretty much immobile from 11pm-3am (until I was able to fall asleep) on the day of vaccination (3/8/21). This happened immediately after I showered with hot water. The next day (3/9/21) until around 8pm I had a high fever, chills (not as bad but still pretty bad), headache, nausea, fatigue, and extreme muscle/joint pain particularly in my back and arms. I was unable to work, go to school, or do homework the entire day. After 8pm, I was down to a 100.4 fever and slight chills with mild nausea and fatigue. Today (3/10/21), I have mild muscle pain in my back and near the injection site. I took 400mg of ibuprofen every 6-8 hours from 3:00pm 3/8/21 (day of injection) to present with mild effects on pain and fever levels. I?m an infrequent user of ibuprofen. If I didn?t have someone with me the first night after the vaccination (3/8/21) I would have gone to the hospital.

Red swelling spot on arm where vaccine was administered, after 2 days the size of the spot increased

In 15 minute observation area, Passed out, fell off chair, had some shaking, difficult to rouse, hit head on floor and got a small cut, was taken on stretcher to private area, vitals taken every 10 minutes, released in 30 minutes. He still feels off, several hours later. Incident wasn?t documented at site.

Patient was administered Janssen COVID vaccine. Patient was fine immediately post administration in the IMZ room but witness stated he fell sideways (within a few minutes of receiving the vaccine) out of post-administration observation chair (which is in front of the pharmacy). Technician called code white and patient was immediately met with management and the pharmacy team. Patient was laying on his stomach on the floor, supporting himself upward with both hands/forearms. Patient had blood dripping from forehead and nose. Gauze was applied to laceration on forehead to help with bleeding and once patient was able to roll over on his back, an ice pack was applied to his forehead/nose area. Patient said he felt "pain" after the injection and then he felt light-headed. He remembered blacking out for a few seconds. Patient stated he felt "ok", then later stated he felt better but just had a bad headache. Patient stated he felt "it starting to hurt" and that it triggered his anxiety. Dad was in the store and arrived a few minutes later; dad said son/patient has a "fear of needles" and "he hasn't had anything to eat today in quite awhile". EMS arrived to examine patient and asked him if he needed to go to the ER; dad felt going to the ER was for the best since they had a 3 hour car ride home. Paramedics then transported patient to the ER and said he would likely need a stitch for the cut above his eyebrow.

Patient was waiting in chair about 5 minutes after the vaccine when I heard him say he didn't feel too good. His skin color was pale and when I went up to see how he was he bent over and vomited. After he vomited he said he felt a lot better. I asked him to remain seated and asked for my tech in the pharmacy to call 911, but he then said no and that he was feeling better. He said he felt clammy just before he vomited. I asked him to stay seated and got him some cold water. He remained in the waiting area another 15 minutes after to make sure no further problems. After 15 minutes he was feeling fine and I reassessed and his color returned to his skin and I noticed some redness around inner portion of both thighs, but he said that was from his eczema and that it was there already. Allowed him to leave at 1:15pm and told him to seek medical attention right away if he felt any issues regarding trouble breathing. I called him an hour later to check up on him at 1:30pm and he was feeling fine. He thanked me over the phone.

SEVERE BODY ACHES TOO PAINFUL TO LAY DOWN ON BED; CHILLS; FEVER; VERY PAINFUL HEADACHE FELT LIKE BLOOD VESSELS IN HEAD WERE SQUEEZING HIS BRAIN; FATIGUE; PAIN AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe body aches too painful to lay down on bed. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very painful headache felt like blood vessels in head were squeezing his brain. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches too painful to lay down on bed, chills, fever, and very painful headache felt like blood vessels in head were squeezing his brain on 03-APR-2021, and was recovering from fatigue, and pain at injection site. This report was non-serious.

COVID VACCINE BY JANSSEN LOT# 1808982 EXP JUNE 23/2021 IN ADDITION TO REGULAR SIDE EFFECTS - PAIN AT INJECTION SITE, FEELING UNWELL, HOT AND COLD CHILDS, TIRED, NAUSEA - THE PTNT ALSO HAS CHEST PAIN AND VOMITING. PHARMACIST ADVISED PTNT TO GO TO ER - PTNT WAS RELEASED UNCER FATHER CARE. ADVERSE EFFECTS AND SYMTPONS IMPROVED AND WERE GONE BY DAY 5.

It is now the next day, and I feel significantly better. I have pain at the injection site, some muscle fatigue, a little bit of a depleted appetite, tiredness in my eyes and head (likely due to lack of quality sleep), and a bit of sweating, but my pain has reduced to maybe a 2/10 or 1/10 (i.e., not even uncomfortable). I did end up getting decent sleep between 2 AM and 12 PM with only a few interruptions of family members checking on me. The only notable pain that is worrying me is abnormal soreness in my right wrist that is not the result of overuse, overextension, etc., although I was able to take care of that pain with another 3 Advil pills. I am considering scheduling a doctor's appointment, as I know the J&J vaccine got recalled today for blood clots. My assumption is that because I am a healthy 20-year-old, my immune system overreacted to the vaccine, but I want to check to make sure that it doesn't cause any additional health problems.

The most severe headache I had ever experienced, as well as pain when I move my eyes around, lastly pain in the injection site for 4 days since

IN BY SELF --STARTED WITH A RASH ITCHY ARMS AND BACK AND STOMACH AREA TOO --TRIED BENADRYL --THEN SPREAD ALL OVER GOT BUMPY ALSO OINTMENT TRIED.. ? C... UNCERTAIN NAME--HELPED .. OF NOT HAD J&J VAC LAT WEEK . NOT BEEN OUT IN WOODS -NO KNOWN EXPOSURE TO POISON IVY ETC.. WORKS WITH MACHINES --DISC'D RISK - ZYRTEC PRN--OK 2 X A DAY X 3-5 DAYS

Patient reported light-headed and dizzy and collapsed in chair almost immediately following injection. EMS assessment and monitoring, recovered quickly. Reported numbness at injection site approximately 15min into monitoring which subsided before discharge. No treatment administered, patient was discharged from clinic completely recovered.

Fever of 103.3, chills, shakes, body pain, headache that lasted three days. On the 12th of april, itching over all of body. Doctor treated with Hydroxyzine.

Got chills, muscle aches, headache, hives on day shot administered. 12 days later started seeing defined red and purple splotches, started on hands and palms, spread over my entire body over the next 2 days. Splotches were dark purple. Went to clinic, they were unsure of the cause. Waited a day and then went to another clinic where they thought it might be Coxsackievirus, except there were no sores in the mouth and the splotches were on the palms and pads of the feet. The splotches faded over the next 2 weeks, the last place they were visible were on the upper arm, torso and thighs.

Janssen Covid 19 vaccine given at onsite employer vaccine clinic As documented on: 1025 client c/o bilateral itching upper arm and slight headache 5/10. Itchy and HA began after 15 min observation period. Denies SOB, no wheezing noted. no hives or rash noted. 1027 50mg of Benadryl administered for itching. BP 122/70 , HR 88 @ 1045 1058 142/72 RUA, HR 82. Continued to c/o itching, no hives or rash visible. Reports slight improvement in HA, rating 5/10 pain level. Reports slight drowsiness, A&Ox3. 1110 Continued intermittent itching. Reporting worsening HA 7/10 frontal area. states he is unsure if HA has worsened because he is thinking about not itching. Mild nausea reported. 1124 BP148/82 HR 86, Reports continued mild nausea, upper extremity itching. Patient went home at 1128am.

DIZZINESS (HEAD RUSH); BRAIN FOGGINESS; FELT HOT; FEVER; PULSING IN THE PLACE OF THE SHOT; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 08-APR-2021, treatment medications included: ibuprofen. On 08-APR-2021 18:00, the subject experienced dizziness (head rush). On 08-APR-2021 18:00, the subject experienced brain fogginess. On 08-APR-2021 18:00, the subject experienced felt hot. On 08-APR-2021 18:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness (head rush), pulsing in the place of the shot, brain fogginess, and felt hot. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Left arm pain onset following vaccination/injection, but persistent for 3 weeks. States pain to deltoid area with moving arm/shoulders, but no shoulder pain. Full rom to shoulder joint. No redness or swelling, no induration or pain to deltoid area with palpation

Severe thrombocytopenia (<2000) 8 days after vaccination resulting in widespread petechiae Hospitalized for IVIG and corticosteroid treatment with slow rise in platelets to 58,000 then discharged. Seen by me in clinic 4 days after discharge and repeat platelet count again <2000 and re-admitted. Bone marrow biopsy was reassuring and he was started on high dose prednisone (150mg/day) to be tapered over the next 6 weeks Discharged 5/1/2021 with follow up with me 5/5/2021 and follow up with hematology 5/7/2021

PT presents with n/v/d and "Acid reflux" x 1 day with onset of rash to R hip and L ribs. reports itching to site of rash. received JJ vaccine x 2 days ago. denies taking any medication today.

Fever of 102.4, chills, soreness at injection site, throwing up, nausea, head ache, uncontrollable shaking, stuffy nose.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient nodded off into a faint when I went to get him a snack, he remained in his chair but dropped his water. Patient said he was feeling sweaty and seeing black. He rested with head down & on the floor. Had some water and a snack. Side effects lasted 5-6 min, patient remained in pharmacy for an additional 15 min without any further events.

AFTER PATIENT RECEIVED THE JANSSEN VACCINE, PATIENT WENT TO GO SIT DOWN FOR 15 MINUTES. ABOUT 1 MINUTE LATER, PATIENT FELT DIZZY, BLACKED OUT AND FELL ONTO THE GROUND FROM THE CHAIR. PATIENTS BROTHER WAS WITH HIM AT THE TIME AND PATIENT REGAINED CONSCIOUSNESS A FEW SECONDS LATER. PATIENT WAS SWEATING AND FELT WARM TO THE TOUCH. WE HELPED HIM BACK TO THE CHAIR AND I ASKED SEVERAL TIMES IF I CAN CALL EMS FOR HIM, PATIENT REFUSED MULTIPLE TIMES AND STATED HE FEELS A LOT BETTER AND WILL HAVE HIS GIRLFRIEND DRIVE HIM HOME. I HAD PATIENT SIT DOWN FOR ANOTHER 20 MINUTES BEFORE LETTING HIM GO HOME. I ADVISED PATIENT IF HE FEELS ANY SYMPTOMS AT ALL, WHILE AT HOME, TO CALL EMS IMMEDIATELY. PATIENT AND HIS BROTHER UNDERSTOOD AND THEY LEFT.

Attendee received Johnson & Johnson vaccine at 13:49 in the left arm. Lot# 204A21A. Attendee was directed to observation area. At 13:52 voiced complaints of dizziness and lightheadedness. Attendee's skin was warm and dry. Skin pale 13:53 – Assisted to a wheelchair 13:55 - HR: 77 BP: 110/72 RR: 12 O2Sat%: 99 13:57 - Attendee stated he felt better, pale. Took a mint that mom had in her purse and a sip of water. HR: 75 BP: 110/80 RR: 12 O2Sat%: 96 14:01 -No voiced complaints- skin warm and dry. HR: 76 BP: 110/90 RR: 12 O2Sat%: 95 14:06 -No voiced complaints- skin warm and dry. No longer pale. HR: 88 BP: 112/90 RR: 10-12 O2Sat%: 96 14:10 -No voiced complaints- skin warm and dry. HR: 75 BP: 120/86 RR: 10-12 O2Sat%: 98 14:20 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his family. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.

Patient received Janssen vaccination in our shot room and was able to walk to the waiting area without assistance or complaint of feeling ill. Within 5 minutes the patient passed out as he tried to move to a chair closer to his father. He fell to the floor and lost consciousness. He almost immediately regained consciousness, however, was very confused and disoriented for a short time. 911 was called. I stayed with the patient, gave him water, and made sure he stayed on the floor until EMS arrived. They checked the patient out and concluded that he was ok to leave with his father. A trip to the hospital was not necessary. The patient has a small cut behind his left ear, but otherwise was ok.

When injected, felt the burn of the vaccine. A few minutes later started sweating, dizzy, blurred vision, ears ringing and sound start fading.

flu symptoms. Pt received Covid J&J vaccine at 0920. At 2100ish stared to have ha/blurry vision/body aches, cough, chills, nausea. History: pt received J&J COVID-19 vaccine this morning and after 2100 or so tonight, pt developed body ache, nausea, non-thunderclap headache, and cough, here for eval. Denies any symptoms prior to vaccination and went to the area once over the weekend in the past 2 weeks and no recent travel/COVID-19 hotspot visit, no sick contact, and denies also ear pain, sore throat, runny nose, SOB, focal abdominal pain, vomit/diarrhea, rash, prior co-morbidities, use of any meds.

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.

Experienced soreness at injection site, body aches, fever, headache, and nausea. By the next day all symptoms were gone besides soreness at injection site

Medium pain and soreness in left arm at injection site immediately after, 30 min later heavy soreness in entire left arm down past elbow -8 hours later moderate headache - 1 hour after above splitting headache - 20 minutes later extreme chills chittering teeth and coldness - then after 20 minutes heat feeling overtook body - splitting headache continues

Adverse event(s): Hives/red swollen skin(arms, legs, abdomen, back), fever, swelling of lips, fast heartbeat, high blood pressure, dizziness, weakness, headache Treatment: Prescribed Medrol (Pak) 4mg tablets, OTC antihistamine Zyrtec daily x 2 weeks, Benadryl at night Outcome: N/A. side effects have been reduced, occasional flare of hives.

Incredibly painful headaches which then turned into migraines. Chills Fever Dizziness Whole body aches Disorientation Stabbing pain at injection site

At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet elevated. Ice pack to back of neck. VS taken 98/60, HR 66 reg strong, rest 16 reg non labored, SpO2 99% no LOC, no SOB, no N/V. Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine. after 15 min pallor, dizziness, diaphoresis and nausea subsided. 2nd set of VS taken 110/72, HR 68 reg strong, resps 16 reg nonlabored. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel better" Ok'd to exit after 30 min.

Shortly after taking the Jassen COVID-19 vaccine (4 days), I started noticing sporadic bumps appearing on my skin starting on my hands and slowly spreading down my arms, followed by my chest, and finally spreading to my private area. These bumps slowly started developing into a rash with my chest being the main area that's affected. As this progressed I went to the doctor's office on April 5th to see what could be done. The doctor prescribed me 25mg of Banophen (Diphenhydramine) with instructions to take one pill every six hours to ease the pain. Unfortunately, the bumps have continued to spread sporadically throughout my body, the rash gets worse every night, and the itching is constant.

Recieved Jannsen vaccine at 11:15 AM on March 23rd. Rash on hands, arms, feet, and legs appeared at 5:00 PM on May 3rd. It itched and burned and was difficult to sleep. No medication was taken, but by morning the rash was nearly gone and by midday it seemed to be gone. Around 5:00 PM, it started back again. I took Diphenhydramine because it appeared to be an allergic reaction. This helped me get to sleep. It was gone in the morning again, but started back in the evening again. This happened repeatedly for a total of 5 days.

4/8/21: Vaccine Received - 6:oopm By 9:00pm, patient begins suffering from intense headache, hearing loss in both ears, and blurred vision. For the ears, it was as if someone had taken ear plugs and coated the ear drum with them, making it hard to hear. Headache was treated with an ice pack on the temple for immediate site relief. Began to feel tired and worn out while in bed, loss of vision begins to occur as well. Body aches begin. 4/9/21: Patient is woken up from intense body spams throughout the entire body. Once awake, the entire body was spasming, causing the patient to be unable to control his body, and all extremities. After sipping some water for about an hour, the spasms subsided in all areas of the body except for the legs and shoulders. 4:00pm patient begins to feel extremely nauseous, begins having increased bowel movements including rapid diarrhea, and extreme stomach cramping. Deep body aches and pain continue. 4/10/21: 10am: patients body begins to become covered in hives all across his skin, inside his mouth, under his feet, and in his hair. Hives continued to grow, with no reddening of the skin however. This was treated with Benadryl for the remainder of the day; hives subsiding around 6:15pm. Dehydration also occurred, and hospital treatment for IV saline bag was soon to be utilized had the patient not been able to rehydrate himself. Body aches continue

HEAD HURTS; FIRE SHOT DOWN ARM TO ELBOW WHEN RECEIVED THE VACCINE; SORE AND ACHY FEELING/ SORENESS EVERYWHERE; FEELS LIKE CRAP; SENSITIVE TO LIGHT; FEVER OF 102.5; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A2119 or 201A211A) dose was not reported, administered on 08-APR-2021 10:50 on right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore and achy feeling/ soreness everywhere. On 08-APR-2021, the subject experienced feels like crap. On 08-APR-2021, the subject experienced sensitive to light. On 08-APR-2021, the subject experienced fever of 102.5. On 08-APR-2021, the subject experienced fire shot down arm to elbow when received the vaccine. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 08-APR-2021 17:30, the subject experienced head hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fire shot down arm to elbow when received the vaccine, was recovering from fever of 102.5, and sensitive to light, and had not recovered from sore and achy feeling/ soreness everywhere, feels like crap, and head hurts. This report was non-serious.

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.

a number of minutes after receiving the vaccine, patient fainted while seated, fell backwards in his chair, and hit his head on the floor. as a result of the fall, the back of his head was cut. he remained on the floor and gauze was held against the cut to slow/stop the bleeding until the ambulance service arrived. Patient was taken to the hospital for treatment of the cut. Patient is currently in good health.

12 hours after vaccine I got chills, fever, nausea. Felt better next day with just fatigue and lightheadedness. Tuesday after the vaccine I got diarrhea with constipation along side the fatigue. Those symptoms lasted throughout Thursday. Friday night after the vaccine I got small haves around my head, neck, and upper back that would not away after an hour or two. That continued throughout Saturday and midday trough Sunday. Sunday I had shortness of breath after moving some water bottle cases around and lightheadedness along with the small hives at around 2pm I went to the ER to get checked out. Doctors said it was a reaction caused by the vaccine. They gave me Benadryl for the reaction and injected me with a "Steroid" to the my upper buttock. I don't remember the name of what they injected with me. It is now Monday April 19th a day after the ER and I feel much better. The Benadryl made the hives go away.

RESTLESS; LACK OF SLEEP; LACK OF MOTIVATION; FELT ROSY IN THE CHEEKS; FELT HOT; FEVER; BODY ACHES; DIZZINESS; WEAKNESS; INJECTION SITE PAIN; EXTREMELY FATIGUE AND TIRED, FELT REALLY WORN DOWN; FELT OFF; SENSITIVITY TO LIGHT; SENSITIVE TO SYMPTOMS OF A SEIZURE ONSET; CRAMPING STYLE PAIN THAT TRAVELLED UP AND INTO THE SHOULDER AND UP INTO THE NECK MUSCLE INTO THE BASE OF SKULL WRAPPING AROUND HEAD CAUSING A MIGRAINE; HARD AND HOT TO THE TOUCH GOLF BALL SIZES LUMP SLIGHTLY PROTRUDING; DISORIENTED; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensitive to symptoms of a seizure onset. On 10-APR-2021, the subject experienced cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine. On 10-APR-2021, the subject experienced hard and hot to the touch golf ball sizes lump slightly protruding. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced felt off. On 10-APR-2021, the subject experienced sensitivity to light. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced extremely fatigue and tired, felt really worn down. On 11-APR-2021, the subject experienced felt hot. On 11-APR-2021, the subject experienced restless. On 11-APR-2021, the subject experienced lack of sleep. On 11-APR-2021, the subject experienced lack of motivation. On 11-APR-2021, the subject experienced felt rosy in the cheeks. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, weakness, disoriented, fever, felt hot, felt off, sensitivity to light, and felt rosy in the cheeks, and had not recovered from injection site pain, cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine, extremely fatigue and tired, felt really worn down, body aches, restless, lack of sleep, lack of motivation, sensitive to symptoms of a seizure onset, and hard and hot to the touch golf ball sizes lump slightly protruding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

Approximately two minutes after receiving vaccination patient fainted. He came to consciousness within one minute of fainting where he was sweaty. He did not seem disoriented and stated that the injection site radiated and had pain for a moment prior to his fainting.

Pain in the arm of injection(at site and when moving arm), migraine/headache, forehead feels hot, exhaustion, runny nose.

Pt c/o rash with vesicles in three spots on face (R forehead, upper cheek, and lower cheek) Pt state he had the J&J vaccine on Tuesday and on Thursday the rash started to appear.

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.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild

Patient - received the Johnson & Johnson vaccination (Lot # 1808609) on 05/22/2021 at 1131 in the left arm. Upon walking to observation patient fell, it was observed that he hit the back of his head by nurse at nursing station #4, nurse immediately cradled patient?s head and turned patient on his side for safety. Patient was assessed for open wounds, hematoma and bleeding. Negative findings. EMS called by RN Patient assessed RN. Patient is a 21-year-old with no past medical history per patient?s grandfather. Patient is laying on the floor, with eyes wide open, not verbally responsive, and unable to follow commands. Patient was pale and diaphoretic. Patient is awake, but not oriented to time and place. Patient also does not recall having breakfast, but his grandfather stated that he did have eggs earlier this morning. Vital signs as follow: Time 1134: BP 147/78, pulse 43, 98% room air, temp 97.1 Time 1138: BP 147/82, pulse 47, 98% room air, patient started to become response asking questions. Patient denies any lightheadedness or dizziness, he only felt a burning sensation on the back of his head. Patient?s grandfather at his side. Patient?s wallet, vaccination card and glasses given to patient?s grandfather. Time 1142: BP 125/79, pulse 64, 98% room air Privacy screen in place for confidentiality from other patients. Awaiting EMS. Incident aware 1144 EMS arrived. 1146 Patient placed in wheelchair and left the building with EMS. Patient was awake and alert upon leaving the building.

Pt w/ hx of allergy to penicillins - swelling that required hospitalization. Pt presents w/ facial rash/hives, dizziness. p/t c/o tingling/numbness BLA LE, RUE. BP 164/92, HR 116, RR 16 -- > 160/94, 116, 16. 911 called and the patient was taken to the Emergency Room ~30mins post vaccination.

PAIN IN THE REAR OF THE RIGHT RIB CAGE; SHARP PAIN; SORE THROAT; NAUSEA; LIGHT RINGING ON THE RIGHT EAR; LEFT EYE DRYNESS; SLIGHT NECK STIFFNESS; BOTH EYES SENSITIVITY TO LIGHT; LEFT EYE IRRITATION; SLIGHT PRESSURE-LIKE FEELING ON THE NECK; SLIGHT PRESSURE-LIKE FEELING ON THE CHEST; DROWSINESS; HOT FLASH ON CHEST AND NECK; TOP LEFT OF THE ARM (AND SHOULDER AREA) FELT LIGHTLY NUMB; DIARRHEA; NERVOUSNESS; ANXIETY; SLIGHT LEFT SIDED CHEST PAIN; VERY SORE ARMS; LOSS OF APPETITE; ARMS AND LEGS FELT HOT TO THE TOUCH; HANDS WERE CLAMMY; SHORTNESS OF BREATH (UPON ACTIVITY - BUT WHENEVER LYING DOWN OR SITTING, THERE IS NO SHORTNESS OF BREATH); SMALL "HIVES" APPEARED ON HIS BODY; UPSET STOMACH; STOMACH PAIN; LIGHT HEADEDNESS; FATIGUE; HEADACHE; FEVER; CHILLS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A - VHC 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 trouble sleeping. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.4 deg. On 12-APR-2021, the subject experienced light headedness. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced upset stomach. On 13-APR-2021, the subject experienced stomach pain. On 16-APR-2021, the subject experienced small "hives" appeared on his body. On 18-APR-2021, the subject experienced shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath). Treatment medications included: dexamethasone, and diphenhydramine hydrochloride. On 19-APR-2021, the subject experienced arms and legs felt hot to the touch. On 19-APR-2021, the subject experienced hands were clammy. On 19-APR-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) negative for fever. Treatment medications included: paracetamol. On 20-APR-2021, the subject experienced very sore arms. On 21-APR-2021, the subject experienced anxiety. On 21-APR-2021, the subject experienced slight left sided chest pain. Laboratory data included: Blood test (NR: not provided) no abnormality, Chest X-ray (NR: not provided) no abnormality, and EKG (NR: not provided) no abnormality. On 22-APR-2021, the subject experienced top left of the arm (and shoulder area) felt lightly numb. On 22-APR-2021, the subject experienced diarrhea. On 22-APR-2021, the subject experienced nervousness. On 23-APR-2021, the subject experienced hot flash on chest and neck. On 26-APR-2021, the subject experienced drowsiness. On 28-APR-2021, Laboratory data included: Body temperature (NR: not provided) no fever. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the neck. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the chest. On 03-MAY-2021, the subject experienced left eye irritation. On 04-MAY-2021, the subject experienced both eyes sensitivity to light. On 08-MAY-2021, the subject experienced slight neck stiffness. On 09-MAY-2021, the subject experienced left eye dryness. On 14-MAY-2021, the subject experienced light ringing on the right ear. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced nausea. On 16-MAY-2021, treatment medications included: ibuprofen. On 17-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 18-MAY-2021, the subject experienced pain in the rear of the right rib cage; sharp pain. On 19-MAY-2021, treatment medications included: azelastine hydrochloride, cetirizine hydrochloride, and methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 12-APR-2021, headache on 18-MAY-2021, and nausea on MAY-2021, was recovering from loss of appetite, very sore arms, diarrhea, and sore throat, had not recovered from upset stomach, fatigue, light headedness, small "hives" appeared on his body, arms and legs felt hot to the touch, stomach pain, top left of the arm (and shoulder area) felt lightly numb, hot flash on chest and neck, slight pressure-like feeling on the neck, left eye dryness, both eyes sensitivity to light, nervousness, anxiety, light ringing on the right ear, slight pressure-like feeling on the chest, and left eye irritation, and the outcome of shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath), hands were clammy, pain in the rear of the right rib cage; sharp pain, trouble sleeping, slight left sided chest pain, drowsiness and slight neck stiffness was not reported. This report was non-serious.

Diagnosed with a case of Pityriasis rosea by general practitioner, symptoms started roughly 10 days after receiving Jansen vaccine. No possible cause could be identified.

Patient was given a Janssen Covid 19 shot on 7/5/21 around noon. After the shot we talked about different side affects and he had a few questions about adverse reactions. I had him sit down for 15 minutes while I finished his paperwork. As i was walking back from the immunization room toward the pharmacy I saw him drop his phone and he fell to the ground. I tried to reach for him but was not close enough to break his fall. I saw his eye roll back and his face turn very red. He was breathing very fast and loud. He regained consciousness and I told him 911 way on the way and to please try to relax his breathing. His brother was with me the whole time talking to him and reassuring that everything was ok. The paramedics came and hooked up a monitor. They were asking all sorts of questions to everyone in the area. I went back into the pharmacy and he walked out to the ambulance with his family and was taken to the hospital.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After administration of Jansen vaccine in less than one minute, patiet had a syncopal episode. He recovered within few minutes. Vital sigs within normal range. He stated he had not eaten or drink anything since night before. 911 was called.

Patient fell out of his chair to the left side and lost consciousness for about 5 seconds at 12:22pm. As soon as he started falling out of his chair on his side, three RNs went to his aid and helped him turn on his back and he regained consciousness. Patient was offered to be taken to the Emergency Department but he refused. He was also encouraged to call for someone to come pick him up since he drove on his own, but said he was 'okay.' Patient reported vaguely remembering falling over and slight pain in his left arm where he was given his vaccine. No rash or swelling around the vaccine site. A small abrasion and bruise above his right eyebrow was noted and patient was given an ice pack. Patient was assisted to a seated position and vital signs were taken at 12:25pm BP:118/55 HR: 62 pulse ox: 98% on room air. Patient was assisted to a standing position after he reported feeling 'fine' and was accompanied by a RN to the stretcher where he was monitored until 1:15pm. Patient was given an orange juice and a granola bar and an ice pack. Patient's vital signs were taken at 12:40pm BP:113/83 HR:61 pulse ox:100% on room air and he reported feeling 'good' and 'much better.' Last vital signs were taken at 12:56pm in a standing position in which patient reported no symptoms; no dizziness, lightheadedness or any other symptoms. BP: 112/64 HR: 58 pulse ox: 100%. Again patient was offered to be escorted to the Emergency Dept. and to also to call someone to pick him up. Patient refused both. Patient was accompanied by a RN to his car outside which he reported no symptoms at this time. We advised patient to wait longer and to come back into the hospital and to call someone if he felt any dizziness or lightheadedness. He verbalized his understanding. Patient discharged.

Hives breakout all over face and arms - I've been taking Benadryl but still present, swelling on eyelids so I could barely open eyes - Been taking benadryl, Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever, Sore arm and body aches, Overall weakness feeling

Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation.

Starting the night of vaccination and ending in the afternoon the day after: Headache, body/muscle ache, pain at injection site, fatigue, chills, low fever

Hypersensitive skin covering my torso and scalp; from my belly, armpits, chest, etc. I can feel my clothes rubbing against me at the slightest movement. I also get occasional chills from my torso thanks to the sensitivity.

Pain at site immediately - arm very sore after, very tired upon awakening in AM at 8:00 AM and throughout the day, chills muscle aches and slight headache - no fever. 2 regular strength tylenol at 10:00 AM and then 2 regular strength tylenol at 4 PM. Giving 2 regular strength tylenol at 10:00 PM because the other doses worked.

He mentioned feeling lightheaded in the car & severe arm pain at the injection site. 5 minutes later experienced cramping sensation in his facial cheeks on both sides. Within 10 more min encountered numbness in his face & his arms began to have sensation of, "dead weight" along w/nausea & unable to move rt. hand. VERY lightheaded all along. We had to travel due to limited supply. His symptoms mimiced a stroke; however, it was determined that it was a severe nuerological reaction & not a stroke. After arrival at the hospital his face felt fully numb & he was unable to smile, like normal. Lower extremities were fine. 102.5 fever next a.m. w/headaches, fatigure and aches that week.

after administering the johnson and johnson covid vaccine patient fainted a few minutes later. He fell to the floor . he also cut his jaw in the process once we saw what was happening we rushed to help patient but he got back up almost immediately and refused calling 911 or going to convenient care of emergency room from for further care. he reported that he had fainted in the past with a different vaccine and believes he will be fine. we had patient sit in the pharmacy for an additional 30 minutes and confirmed that he wasn't experiencing any more symptoms before letting him go.

RED RASH UNDER BOTH EYES; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 22 year old male.The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced red rash under both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on 02-APR-2021, and had not recovered from red rash under both eyes. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Onset lower lip swelling 14 hours after vaccine. Urticarial rash 18 hours after vaccine. No respiratory associated S&S. Treated with Allegra and Zytrec with improved S&S. Also had fever 100.5 with HA, myalgia and fatigue.

Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Confusion-Mild, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium

rash on hands and some spots above knees no rash at injection site given benadryl 25mg by mouth once monitored and discharged in stable condition

The patient (self) felt a soreness around the site of the injection begin immediately and grow throughout the day. The soreness continued to at least April 12 (at the time of this report). The soreness was immediate unlike a tetanus shot but the pain the following days was 2-3 times less that of a tetanus shot. By 4pm the same day, the patient felt fatigue and tired and had difficulty staying awake. Around 6pm the patient took 200 mg of ibuprofen by mouth because of a strong headache. At 7pm the patient was experiencing the following: headache, warm head to the touch, shivering/shaking, fatigue, mild aching. The patients pulse was consistent 100-104 bpm. The patients temperature at 8:30pm was 100.4 F. The patient then went to bed at 9pm. Patient had trouble falling asleep due to fever, shaking, aching. The patient slept intermittently until midnight. At midnight, the patient noticed the fever and shaking had ceased but the headache and aching were still strong. The aching was all over the body. The patients eyes hurt to move. The aching was constant and at times was throbbing. At 3am the patient could still not sleep well so he took 650 mg of Acetaminophen by mouth. The patient began to notice some relief approximately 30-60 min after. The patient fell asleep after the relief began and slept soundly til 9:15 am, April 11th. The patient awoke feeling much better. All side effects had stopped with the exception of a feeling of weakness and slight dizziness. The patient was able to carry on normally and took no more medications.

Approx 5 minutes post vaccine, patient lost consciousness but remained in chair. Patient was immediately given a cold compress to apply to back of neck and wrists. Patient regained consciousness but was very pale and was sweating profusely. Patient was able to hold a conversation but reported feeling very warm and sweating. After approx 5 minutes, patient began to feel normal. Patient's color returned to normal, stopped sweating and reported feeling normal. Patient was monitored for an additional 15 minutes before leaving.

Pt reports headache, fatigue and rash beginning 3 days after the injection. He notes the rash to his upper chest and back (maculo-papular), described as itchy and not radiating to other areas of the body. The rash has not gotten better or worse and remains today. He also notes "discoloration" (which was not seen on exam by this NP) to the right lower shin.

NAUSEA; FEVER; SORE ARM; CHILLS; FATIGUE; BRUISE; This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and had not recovered from sore arm, fatigue, chills, nausea, and bruise. This report was non-serious.

COULD NOT SLEEP; ITCHY RASH ON HIS ARMS AND LEGS WHICH WAS SPREADING UP; BODY ACHES; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included eosinophilic esophagitis. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced could not sleep. On 11-APR-2021, the subject experienced itchy rash on his arms and legs which was spreading up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash on his arms and legs which was spreading up, and the outcome of body aches and could not sleep was not reported. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt had tunnel vison and lost his vision for a split second, he could not remmember me asking if he was okay. I gave his benadryl and checked bp that was 95/65, Encoraged pt to drink water and got a sucker for him. He was clammy and seemed worried. His bp started coming up within 5 minutes and was 105/80. His bp was 120/80 in 5min later, asked pt to get a ride and his wife came and got him. It had happened to him one time giving blood. pt had chills and ackes last night and is fatigued

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

22 year old received Janssen vaccine at 10:50 am, and while in recovery area, reported that he became light headed, dizzy, and passed out. He slumped out of the chair hitting the right side of his head on the floor. Sustained a cut near his right eye. At 10:56 am blood pressure @140/65, pulse @ 53, 97% O2 sats while sitting on the floor. EMS was called 10:57am. When interacting with staff and friend accompanying him, eye was cleaned and ice applied. EMS arrived 11:05am. EMS reported vitals to be 86/49, 59, 100% O2. EMS recommended transport to client. Client accepted. EMS transported to Medical Center at 11:12 am.

chills, hot flashes that have persisted for more than 2 days, extremely hot/sweaty, constant headache/soreness at injection site.

FREQUENTLY HOT FACE AND HOT MOVES TO FEET; FEELS LOUSY; MOVING SUBJECTIVE FEVER; HOT AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced frequently hot face and hot moves to feet, feels lousy, moving subjective fever, and hot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moving subjective fever, hot at injection site, frequently hot face and hot moves to feet and feels lousy was not reported. This report was non-serious.

Pt received Johnson & Johnson vaccine on 6/12 @11:03 at the Vaccination Site. Patient started walking to observation area, reported feeling dizzy, lost consciousness, was assisted to the ground by staff at 11:05. When awakened, patient reported right elbow pain, headache, and was found to have a small amount of bleeding from his right ear. No preceding chest pain/palpitations/dyspnea, seizure activity, nor focal weakness. He was transported to the ED via EMS for further evaluation. In the ED patient reported previous history of syncopal episode with preceding dizziness several years ago but did not seek further evaluation. No nausea/vomiting. Evaluation revealed decreased hearing, drainage from ear, and right elbow tenderness. CT of head demonstrated right temporo-parietal bone fracture extending to skull base with blood within right mastoid air cells. Elbow x-ray showed no obvious fracture with right elbow contusion diagnosed. Trauma and neurosurgery further evaluated patient and recommended non-operative management of right temporal skull fracture extending into the auditory canal with no evidence of intracranial bleed nor depression. Hospital consulted and prescribed Ciprodex drops for 1 week with follow-up audiogram in 6 weeks. Patient to follow-up in trauma clinic or with PCP in 2-3 weeks. If hearing still muffled at follow-up, ENT will be consulted. Patient was discharge later in the evening on 6/12/2021.

patient received J & J vaccine at 1050 am patient was talking with nurse and suddenly stiffened his body with clenching fists curled upward to chest. He had bright red skin color, and could not speak. this lasted 10 seconds at most. Afterward the patient was sitting in chair had turned very pale and did not realize what had happened. one of the other nurses asked him if he knew where he was, he stated "In the Hospital", the nurse repeated that he was not in hospital, that he was at the health department getting a Covid shot. He stated "oh yeah.. I forgot," patient stated he was going to be sick, patient grabbed garbage can that was sitting next to him Patient was hooked up to oximetry, reading was 99% on RA, attempted Blood pressure 3 times but was unable to attain a reading, patient was holding garbage can tightly. patient had emesis 3x's that was clear in color, cold packs were placed on the nape of the neck and under armpit, patient was sweating and white in color. patient stated he had blurred vision, and noted that he was unconscious for approx. 25-30 seconds. 911 was called at 10:57. Nursing supervisor was notified at 10:58. Patient stated that he had nothing to eat today, and his mother stated that he had been anxious about getting the vaccine and that she made her son get it. Epinephrine was available but not given. no issues with breathing. EMS came in did a quick evaluation and transported patient to the hospital. Mother was with patient during the entire incident.

Id say approximately 60 seconds after administration of the vaccine, I started to become the most lightheaded I've ever felt, like I was really about to pass out. I felt a very extreme pins and needles feeling in both my hands and my feet, and my vision began to fade. After about 30 seconds of that and beginning to panic, I stood up and knocked on the doctors door and asked for water and told him how I was feeling. After about a few minutes of sitting and drinking Gatorade my vision returned fully and I began feeling stronger again. Since then I only feel a slight pain around the injection site.

On 3/12/21 day of injection The patient got the Johnson & Johnson Covid vaccine this afternoon around 1400, after which he noted a red, itchy rash on his chest, back, and bilateral upper extremities. He also notes a dry mouth and mild throat swelling, but denies shortness of breath, vomiting, lightheadedness, chest pain. He took benadryl about an hour after getting the vaccine without any improvement.. He states that amoxicillin is the only medication to which has had an allergic reaction. On 3/12/21 He was s treated with Vistaril 50 mg, Deltasone 50 mg, and epinephrine 0.3 mL. The medications relieve most of his symptoms for 2 hours before it returned along with having developed a sore throat and sensation of swelling to his throat. On 3/13/21 at 0139am patient returned to ED for further evaluation. Patient remedicated with benadryl, epinephrine and was given pepcid. On 3/14/21 at 1430 patient again seen in ED for further evaluation with worsening rash. patient that last night he had a severe allergic reaction and self administered epinephrine at 0440. This morning he woke up with a worsening rash that he describes as burning. He reports a sensation of throat swelling. He has had 3 episodes of diarrhea, but no nausea or vomiting. Yesterday, patient states that his heart was "racing" but denies any chest pain. He states that every time his rash is treated, it returns and is worse in severity

Took vaccine at 3:05pm on 3/27/2021. At 11:30pm started symptoms of site pain injection in left arm. Also started to feel flu-like symptoms. On the 28th he had really bad flu-like symptoms and could not walk or move without muscle pain and weakness, overall malaise, arm hurt too much to move or touch, migraine, swelling in left arm at injection sight, slept 24 hours almost completely other than to urinate, fever of 102.3. The following day, 3/28/2021, still had same symptoms but not as severe and was able to drink some fluids. On 3/29/2021, he was able to eat and drink but slept a good portion of the 24hrs. On 3/30/2021, fever gone, can move around some, eating and drinking improved, flu-like symptoms mild. Still slept a lot.

patient lost consciousness and did not regain it. ems services took the patient to a local hospital. complained of burning at injection site

major pulsating headache, malaise, fatigue, fever like symptoms (increase in temperature) - 1 day injection site soreness - ongoing (2 days)

Fatigue around 10 hours after initial vaccination. Radiating ache and joint pain from the injection site. After 12 hours, temperature reached 99.7 F. At 14 hours after vaccination, major aches and soreness, chills and fever rose to 101.2. By 1:00am fever had reached 103.0F (all temperatures taken with ear thermometer). I took 1000mg of Tylenol at that time, which greatly reduced the aches and pains. Woke up with a temp of 99.2, minor aches, almost all effects had subsided.

Experienced severe chills approximately 10 hours following vaccine, was shaking uncontrollably and could not properly function/move for about 10-15 minutes. Also experienced regular side effects such as stiff muscles, sore arm, and fever.

Systemic: small red dots on inside of right elbow-Mild, Additional Details: Patient has not sought medical attention at this time, but has a small red petichial rash on the inside of his right elbow. He thinks this may be signs of capillary leakage that have been reported with the vaccine. I advised he seek medical attention if required. No injection site issues or reactions in left arm.

Patient lost consciousness during the 15 minute waiting period after receiving the vaccine. He was pale and sweating, and lacerated his nose as he fell to the to floor. It appears that he fainted.

Apart from the expected side effects (headache and chills, some soreness at injection site), I believe I'm experiencing tinnitus or a similar ringing in my ears. It appears to be concentrated in my left ear, although it's hard to tell. There's a consistent high-pitched tone that won't go away. I'm not entirely sure when it started (maybe 24-36 hours after receiving the vaccine), but it's gotten slightly worse since then and is more noticeable. I have not been able to go to the doctor yet.

LITTLE WARM TO TOUCH; PAIN GOING DOWN AFTER RESTING; SORENESS ON INJECTION SITE; SEVERE STOMACH ACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol sometimes, and non-smoker, and other pre-existing medical conditions included the patient have no known drug allergies and there was no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced severe stomach ache. On an unspecified date, the subject experienced little warm to touch, pain going down after resting, and soreness on injection site. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, and the outcome of little warm to touch, soreness on injection site and pain going down after resting was not reported. This report was non-serious.

'Pt rec'd vaccine lying down on cot. pt stayed 3 min lying down talking to vaccinator. Pt Sat up on cot for 2 more min, gave water for hydration Pt Alert and orientated. Pt stated "I did better than I thought I would." moved to recovery chair. Pt AAO after sitting another minute stated" I think I need to lie down. " 5:35pm pt started to have syncoble episode. + LOC - SOB. Several people came to pt side. Caught pt to help to floor. pt regained consciousness after 10 sec, with verbal and sternal rub. Mother at side stated" this happens every time he gets a shot. " Pt immediately became pale, diaphoretic, warm and alert. Ice packs to back and front of neck. Elevated feet on chair. Medical MD responded. stated Vasovagal episode occurred. VS taken 5:37 pm 102/60, HR 48 weak, thready, resp 12 reg non labored SpO2 97%. After 15 min sat pt up on floor. Check head for any bumps. denied hitting head and denied any pain. No further episide of syncoble.2nd set VS taken 114/72, HR 78 reg, strong, resps 12 reg non labored. SpO2 97%. Paleness and diaphoresis subsided. pt stated I feel back to normal . Suggested to go to hospital to be checked out. Pt refused hospital. stated this happens all the time. Ok'd to exit after 30 min.

NECK PAIN VERY TENDER TO TOUCH; SHOULDER PAIN VERY TENDER TO TOUCH; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced low grade fever. On 07-MAY-2021, the subject experienced injection site pain. On 08-MAY-2021, the subject experienced neck pain very tender to touch. On 08-MAY-2021, the subject experienced shoulder pain very tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and injection site pain on 08-MAY-2021, and had not recovered from shoulder pain very tender to touch, and neck pain very tender to touch. This report was non-serious.

I got th eJassen COVID-19 Vaccine EUA at 10:50am. When the needle was removed, blood ran down my arm. That has never happened, but it might have been the nurse. I had nausea for a few minutes afterwards, but I think that was due to the blood. I didn't feel like eating after the shot. Hours later, around 5pm or so, I started to feel hypersensitive and weak. I also started to have a fever that went up to 102.2 farenheit before decided to take ibuprofen. I had shakes, a heartbeat of 146, and a headache. It lasted all through the night and into the next day. Around 11:20am, whenever I moved my head, I would feel pain in my head. By the end of this day, I started to feel more like myself. By the start of the third day, all I had was pain in my left arm from the shot. It was strange that the pain got worse from Day 1 to Day 3, but that might be from how the vaccine was given and the blood that ran down my arm at that time. Another thing is my appetite has gone down a lot. I don't want to eat and when I do, I just want to stop. It's been a couple days, so I'm hoping my appetite will come back.

after receiving the vaccine pt felt sweaty and lightheaded and wanted to lay down, so the nurse directed and walked with pt to move him by the privacy area so he can lay there. while walking to the privacy area pt fell on the floor. when i examined the pt his body felt hot at touch and he stated that he was feeling dizzy. after few minutes the pt felt better and after waiting for 20 minutes pt stated he is feeling better again.

Severe headache, severe muscle pain, loss of taste, severe skin sensitivity on whole body, sleepiness, lethargic, sharp eye pains

Patient became extremely faint immediately after the injection. Patient began to shake, got really hot, then really cold and felt as if he were going to pass out. Also said that his arm hurt & felt stiff at the injection site. This feeling he described lasted about 15 minutes, then he began to start feeling a little bit better. We gave him some water and had him sit for as long as he needed. Patient sat for total of 30 minutes, then left of his on accord.

About 8 hours after receiving the Jansen COVID-19 dose, the site around the injection point began to few sore and my entire body began to feel sore, especially at the joints. Furthermore, my heart rate became elevated and beat erratically. These symptoms continued for about 12 hours. I could not sleep overnight as I ached all over and my heart rate was rapid. The next morning, I began to feel much better. My heart rate began returning to normal, though my heart area still felt somewhat sore. By about 36 hours after receiving the dose, all of my side effects were minimal. By about 48 hours after receiving the dose, I had virtually no more side effects.

About 5 minutes after vaccination the patients body became stiff for about a minute, also went pale and lips turned white. Had patient lie down and rest for about 10-15 minutes. He also ate a protein bar. Color in face/lips returned to normal. Had patient remain in pharmacy for another 15 minutes for further observation, no other adverse effects. Although the patient stated never having an adverse effect to any other vaccines on the pre-vaccination questionaire; after recovering he asked "did I go stiff?", when told yes he said "that happened once before when I had a vaccine".

vasovagal reaction, patient passed out for less than 60 seconds. grayish skin, tired. Pt was feeling ok in about 20 minutes. no treatment

BUMP ON UPPER LIP; ITCHINESS AROUND VACCINATION SITE (LEFT ARM); This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced bump on upper lip. On 21-JUN-2021, the subject experienced itchiness around vaccination site (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on upper lip, and itchiness around vaccination site (left arm). This report was non-serious.

ACHY; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced achy. On 02-JUL-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and injection site pain on 03-JUL-2021. This report was non-serious. This case, from the same reporter is linked to 20210738857.

Immediate muscular pain and soreness at injection site Delayed muscle soreness in back, legs, and arms. Chills Headache/Sinus Pressure Nausea/dizziness

I experienced slight nausea the night I received the vaccine. The following morning was miserable. I had a fever of 101 all day long, a headache, my body was aching from head to toe, extreme lethargy, and occasional bouts of extreme nausea as well as throwing up twice. As of the following day (March 18), almost two days since receiving the shot, I feel pretty much completely normal again aside from a slight headache and some pain at the injection site still. I experienced some pretty bad side effects that only really lasted a day.

Janssen COVID-19 Vaccine EUA Roughly 1 hour after vaccination I started to experience nausea and fatigue. The fatigue continued for several hours until about 6-8 hours after vaccination. At that point I started to experience chills, muscle aches, and rash on my left arm (at injection site region) and over other parts of my body. Temperature at that time was still within normal range but close to 10 hours after I began to run a fever. Highest temperature at its peak was 100.3F. These symptoms continued into the night but began to considerably subside in the morning, close to 24 hours after vaccination. At this point, 26 hours after, I still feel mild muscle aches and a mild headache.

Patient passed out 5 minutes after receiving vaccine. 12 hours later the patient had severe chest pain and went to the ED. He received a ketorolac shot there and returned home. 36 hours later, red dots were noticed on the patients feet and ankles (appeared to be petechiae). No other s/sx of bleeding but extreme fatigue, nausea, head fogginess, etc. has been experienced over the past 4-5 days. Patient w/ no PMH of any significance.

Patient received Janssen COVID-19 vaccine at 123pm on 3/25/2021. Patient directed to observation area and fell backwards out of chair at 127pm on 3/25/2021. After falling backwards out of chair patient had a full body stiffening episode and was noted to be bleeding from his head. Bleeding controlled with gauze held by an RN. Patient initially GCS 13 and unable to answer questions appropriately, manual blood pressure 118/60 HR 50 SpO2 89% on room air, patient pale and dry. Patients legs raised by RN and pressure to laceration on top of forehead continued to be held by RN. After 5-7 minutes patient GCS increased to 15 and he was alert and oriented x 4, manual blood pressure 114/60 HR 62 SpO2 97% on room air, patient pink warm and dry. Fire arrived on scene at 147pm and Ambulance shortly after. Fire and Ambulance given report by RN on site while other RN on site continued holding pressure to laceration on forehead with gauze.

24yr AD male that presents on 28Mar2021 with left arm pain and concern that it may be related to the Johnson&Johnson COVID-19 vaccine that he received on 17MAR2021. He describes 2 days of post vaccine fatigue/chills/myalgias that resolved with rest. On day 3 post-vaccination, he states he had a circumferential rash from bilateral feet to upper thigh that lasted approximately 24hrs. The rash resolved without intervention. He states that he has had new onset left arm pain (side of injection) that started in his left hand 7 days after his shot and begin radiating up the arm into the neck over the next 4 days. He has been lifting weights but denies any changes in workout habits or a perceived injury. Pain is 6-7/10 per patient but has difficulty articulating the quality of the pain. He has no associated weakness/numbness/paresthesias. He denies any rash to the left arm. He has not utilized any medications for the pain. He does not have any functional limitations of the LUE. He was discharged to follow up with his PCM.

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.

Pt walked over and sat down in waiting area. Within 2 minutes he lost consciousness, fell out of his chair, hit his head on the floor. this lead to bleeding/ bump on left eyebrow. Pt was hot, sweaty, clammy, and pale. he laid on floor with feet raised for a few minutes. He felt better in about 15 minutes, parents arrived to drive him home.

4/10, 9:30 pm: chills, sensitivity, fatigue, arm pain at site of injection 4/11, 12:00am: dry heave followed by vomiting, extremely shakey, and fever. 12:52am: larger watery vomit, more shaking.

The evening after my vaccination shot, I started to feel groggy and unwell. I then started to develop a fever. This morning on 4/12/21, I woke up to my right hand itching and burning. Within a half hour I started to experience the same burning and itching sensation on my hands.

Vaccine administered at clinic. Pt is a 24yo male who received the J&J vaccine on 4/8/21. On Day 1 reported having mylagias, chills and pain at the site of injection. Symptoms resolved the next day and for two days had no other symptoms other than pain at the site of infection. He presents today, 4/13/21, with acute onset of shortness of breath this morning with cough as well as one episode of NBNB emesis at home. Rapid COVID test negative. no hypoxia, including ambulatory. exam and vitals reassuring.

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

Hyper feeling on the first day, headaches migraines (5 total days unsure if any more) ,chills the next day,dizziness currently ongoing, soreness currently ongoing

On Monday 4/12/21, 5 days after taking the J&J vaccine, I had an extremely itchy and painful full body rash. It was big red bumps like mosquito bites all over my body including legs, back, arms, chest, stomach, etc..I could not sleep all night due to the pain and itch and had to constantly apply cortisone cream as well as ice to make the pain bearable. The rash went away almost completely the following morning but then returned again the following night. I have never had any prior allergies or skin conditions and worry that this may become a recurring event since it has now happened for 2 nights. I did hear that a rash at the injection site was a possible side effect from the covid vaccines but this was way worse as it was all over my entire body.

4/13 coworker received text message from mother of pt who reports that began experiencing "hives" after taking the Janssen vaccine; started on abd then spread to extremeties, back and neck Phone call to (nurse at the jail) who states she is aware of the hives and has pictures, no c/o respiratory difficulties. They have administered topical antifungal and tx for scabies thinking maybe it was related to a new blanket. Advised that due to the new reports regarding Janssen, it would be advised to have him evaluated by a physician. agreed, she will reach out to her provider for guidance. Report from mom that was taken to the ER and given a topical steroid cream only.

after approximately 10 minutes of receiving Covid-19 vaccine, the patient fell out of chair in which he was seate. patient was unconscious for approximately 1 minute while I rolled him over and checked for pulse. his eyes were wide open and he seemed to have had an absensence seizure lasting upto a minute before regaining consciousness. he was quickly cognizant and I asked if he had any history of seizures or if he might be hypoglycemic. He did say that he had not eaten and it was 3:00pm. paramedics soon arrived and removed the patient from the scene. I did text patient the next day and he said only that he had a sore arm and symptoms consistent with having a vaccine administered.

non contiguous papular rash on back and back of arms; excoriated and healing well without any s/sx of infection; no weeping; some early papules developing; pruritic; will treat with prednisone taper;

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

Started with a headache, nausea, body aches, chills which was expected. Ever since I have noticed a difference in my skin, I randomly have rashes, itching, if I get a scratch my skin swells

About 9 hours after getting my vaccine, I started noticing my temperature rising to ~99.0. About 1 hour later (12 AM), it had risen to ~103. I also noticed my heart rate was extremely high (on average 140 bpm, the highest was 225 bpm); this was also accompanied by chest pains which seemed like they were on the right side of my heart; I also had difficulty controlling my bladder and would randomly start to urinate. I had taken two Advil then slept. The next day (~9 am) my fever went down but 3 hours later it had gone back up to ~101, I eventually kept cooling myself (removing shirt, fan on high, etc.) and took one Advil and my temperature started to get normal. For about two days after that, I had pain in my left shoulder - but this was where the injection took place so I wasn't too worried. Currently I am feeling fine, but the initial day getting the vaccine was quite harrowing - I was quite worried I was going to have a heart attack.

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.

The first night I experienced pain on the injection site of the arm. Tongue was very swollen the next day. I went to the emergency room and was given medication.

Right eyelid started itching, turning red and swelling along with rash on neck within 30 mins of receiving vaccine. Fever, Body Aches

patient was hot and sweaty, passed out, came around and felt better over next 15-20 minutes, patient's parent contacted ems but when they arrived patient was much improved

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient was sitting in chair after vaccination and <5 minutes later, he started shaking, then faceplanted on the ground. He regained consciousness within 30 seconds. I elevated his feet and laid him on his back/gave water bottle. Observed for total of 30 minutes before allowing him to leave. he denied emergency services.

Swelling at injection site, fatigue, nausea, chills, hot flashes, mental fog, upset stomach and trouble with appetite for 2-3 days.

HYPERSENSITIVITY; PRURITIC RASH; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included plaque psoriasis. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, batch number: UNKNOWN, route of admin was not reported) dose and frequency were not reported from 17-MAR-2021 for plaque psoriasis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced hypersensitivity. On 2021, the subject experienced pruritic rash. Laboratory data (dates unspecified) included: Skin biopsy (NR: not provided) Not reported. The action taken with covid-19 vaccine was not applicable; and action taken with adalimumab was not reported. The outcome of the pruritic rash and hypersensitivity was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

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

while in post vaccination observation, client thrust head back into the wall, while in a seated position. Became unconscious. Left arm tremor- observed. diaphoretic, skin warm to the touch, sweating. When client became alert and oriented, he was fearful of the situation and began to cry. stating he didn't know what happened, he was scared, and he was dizzy and didn't feel well. Patient given emesis bag, given water and Ice pack. He also reports no ability to alert anyone prior he had no physiological indicators of what was about to happen. He urinated himself. He then had the second emesis and EMS alerted and on site to assess patient .

Red blotchy skin, hives, blood pressure very high, trouble breathing, panic feeling, itchy everywhere to point of pain

Myocarditis. Chest pain, shortness of breath, pain when leaning over or increasing heart rate, referred pain in left shoulder

After 1-2 minutes of administering vaccine pt started sweating profusely and was light headed. Advised pt to sit, breathing seemed fine. Had manager call 9-1-1. Pt lost color of skin. Tried checking BP with arm cuff machine, but didn't work. Had EpiPen on standby while friend call pt parents. Gave bottle of water to pt while talking and observing. EMS arrived and checked BP-normal. Pt left on own accord after resting for 30 minutes.

Patient received the vaccine at approximately 10am on 6/21/21. Shortly after receiving the vaccine, he complained of a headache and arm pain. Patient was told to remain seated and was monitored by pharmacist and staff. After 20 minutes, he was still not feeling well. He was moved into a different observation area. Based on symptoms it appeared he was having a a vasovagal reaction. He did not want to lie down and elevate his feet. At approximately 1/2 hour, he became nauseous and threw up. We continued to monitor him. He still had a headache and said he felt off. He had no swelling in the face and was speaking without issue. No hives were noticed. Patient said he was having a hard time breathing- I suggested he remove his mask to get more fresh air. After removing the mask, he said it felt better to breathe. In total, patient was monitored for 3 hours. He did not lose conscience, exhibit facial swelling or hives. Patient went back to work for 1 hour then left to go home. Prior to receiving the shot, patient showed a lot of anxiety and was hesitant to get vaccine. In the end, he decided he wanted to get it. Per medical staff at his work, he does tend to be high stressed and anxious. I followed up with patient on 6/22/21. He stated that he was feeling a lot better. He did have redness at the injection site- I explained he could ice the area. He still had a headache= I instructed him he could take a pain reliever. He mentioned he had a purple spot on his back. I asked if he had any other spots and said he would have to check. I suggested he contact his PCP and make an appointment to be seen.

103 Fever and 115 resting heart rate in evening of the day of the vaccination. 2 days later I developed reactions upon consuming food and drink (besides water). Feeling of throat closing and itchiness in the cheek and jaw area of the face indicating an allergic reaction. Symptoms are still prevalent as of today 6/24/21. I have a feeling that something is stuck in my throat/throat closing after eating most foods and consuming hard alcohol and beer. Coffee doesn?t seem to be a factor, as I originally thought the reaction was acid reflux/digestion related. Sometimes the reactions are severe enough to make breathing difficult. I have no history with food allergies and no preexisting medical conditions. My father also had the same reaction following his Janssen vaccination. He reports that he no longer has this symptom.

2:50pm PT c/o itchy ankles and itchy throat. 3:00pm EMT and NP assessed PT. VS 143/81 HR 100 Sp02 98% NP assessed PT for rashes, swollen tongue, difficulty breathing, and mucous membranes. 3:10pm PT states he routinely takes Allegra for ankle itchiness. 3:12pm PT states his throat and ankles are no longer itchy. 3:20pm NP reassessed PT and cleared him to be released.

Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Rash with bumps appeared on both arms-Mild

The patient was waiting the regular 15 min after vaccination and with 10-12 minutes I heard a big sound . I ran and out site the Pharmacy Department and the patient was just getting up from the floor after a fainting episode. The patient was sweating perfusely and he was very pale and very warm to the touch.

Patient received the vaccine and 5 minutes later stated he became warm to touch, and walked to the cooler to get a bottle of water and fainted. He was found on the ground with no pain or injuries per patient. He stated he still felt warm. Patient refused 911 transport. Patient stated he had a history of fainting with a previous H1N1 vaccine. Patient did not have any difficulty breathing or itching.

Patient received Janssen (LOT#: 207A21A) on 6/29/21. Patient alerted EMT and stated that he noticed red dots on his arms thinking it was a rash. Patient stated that he had completed his observation time at 1210 and was walking home when he noticed small red dots on his arms. Patient decided to walk back to vaccination site and let EMT know what was wrong. EMT alerted PHN. PHN assessed patients arms. PHN was not concerned of the red dots on his arms. Patient stated that the red dots were not itchy or painful. PHN observed that the red dots did not resemble a rash. PHN educated patient on worsening signs and symptoms of an allergic reaction to the COVID vaccine and when to seek EMS. Patient verbalized understanding of education. Patient left vaccination site at 1250 unassisted and with a steady gait.

patient received vaccine 1330at Bakers 300 , 30 minutes later arm numbness 1400 1800 severe itching, 1900 altered mental status given Bendaryl 50 mg and Solumedrol 125 mg IV PTA by EMS squad 1925 arrived ED stroke alert activated - per neurology no stroke 2010 Compazine 5mg , ativan 0.5 mg and LR 1000mL IV r/o migraine

Thrombocytopenia resulting in undetectable platelets that improved with 4 days of dexamethasone and IVIG with improvement in gum bleeding and petechial rash of bilateral lower extremities

Patient received shot around 2:45pm. Around 2:48, patient started feeling nauseous, sweating, flushing in face. Gave patient bag incase of vomiting, applied two ice packs, one to back of neck, one to forehead. Around 2:52 patient said was feeling less nauseous, a little less flushing. Around 2:56 patient asked for a cool rag rather than ice packs, very little sweating, little redness in face, asked for water and felt better. Patient stated prior to immunization has problems like this with blood draws, however did not recall having this reaction before with vaccinations.

About a week after vaccine started exp chest pain and difficulty breathing, After the two week mark of those side effects I started exp joint pain, little fatigue, redness and swelling of both knees.This was causing difficulty for me to stand.As of today I'm still exp symptoms taking Ibuprofen causing stomach pains stopped and physician recommended Tylenol.

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.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt presented with a temperature of 99.1F after running from another pharmacy to our pharmacy. Shot was given at 1:10PM and within 5 minutes after pt's arrival time. Pt reported light headed, hard breathing and tingling in hands after 5 minutes of shot. Offered Epipen but pt refused. Continued to monitor pt, All adverse reactions were gone after 15 minutes. Pt was contacted after 24 hours and have no chief complaints except soreness at injection site.

Patient complained of pain at injection site, weakness & joint stiffness. Temperature obtained 101.6.

Symptoms included chills, headache, fatigue, lightheadedness, and soreness at the injection site. Symptoms began about 8 hours after the injection and lasted about 24 hours. Symptoms were most severe the morning after the injection (12-14 hours after the injection). Treatment included rest and hydration. Symptoms went away on their own within 36 hours.

On 04/02/2021 I had all Vaccine side effects listed on FDA&CDC websites. On 04/03/2021 At about 2000 hours I started breaking out in a rash across my abdomen and face which causes me to be itchy and red. Later at about 0400 hours am while driving my cruiser I noticed my throat was starting to swell. I drove my car to the emergency room and was treated for a allergic reaction given steroids and Benadryl through IV.

I had a fever that ranged from 99.3 to 100.8. I also had muscle aches, including pain at the injection site. I also was very fatigued. The side effects started approximately 12 hours after receiving the vaccine and were done approximately 24 hours after starting. The exception is the pain at the injection side which continued for an additional 12 hours.

When patient stood up to leave vaccination area he experienced light headedness and dizziness. He was instructed to take slow breaths and lower his head to his knees. Patient also was warm and sweating. He was observed in the immunization area for approximately 5 minutes when he began to feel better and moved to observation area for 1/2 hour. Patient left stating he was feeling ok.

Patient passed out and hit his head on the floor cause a laceration above left eyebrow which needed medical attention at local hospital. Also may have needed a concussion test done.

Woke up at 4:00am the next morning with fever, muscle aches over whole body, soreness at injection site, headache, sore throat. Starved the fever for a few hours and took Tylenol. I had broken the fever by 7:30am that morning and only minor body aches persist.

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.

One week after receiving the Johnson & Johnson vaccine, several small bruises (6-8) appeared on the back of my left leg. Throughout the day, my leg developed a soreness that, after reading a 10 Feb 2021 story in the newspaper about COVID vaccine recipients developing immune thrombocytopenia caused me to seek medical treatment in the afternoon of 4/6/2020. I first visited an urgent care facility where my high blood pressure (130/98) combined with my slight lightheadedness, soreness in the leg and observes bruising were enough for the tending physician to recommend rushing to the ER for bloodwork to be performed immediately. I was admitted to the ER in the early evening with an elevated blood pressure (~150/111) and the bruising still prevalent. The tending nurse practitioner authorized a complete blood count (CBC) and discharged me an hour later when the results came back ?extremely close to normal,? noting that my platelet count of 194 was no immediate cause for concern. Since then, the bruising and soreness has subsided.

After a few hours I know it is more common symptoms such as pain at the injection site, headache, fever, all over body soreness. I also noticed short-term memory loss and mood changes from feeling of Happy and sad and angry from around 5:00 p.m. to 8:00 p.m. and the feeling of complete uselessness and regretting getting the vaccine to the point I wanted to cry saying oh I made a mistake. Almost as if my body was trying to tell me this was a mistake. Throughout the evening the all over muscle soreness and headache and fever seem to be getting worse I even woke up in the middle of night between 2:00 and 3:00 a.m. and took Tylenol PM to help go back to bed. Started feeling better later in the afternoon on April 2nd. Almost if everything went away and back to normal. I have noticed that I have been having more head pain (I normally have none) than normal since receiving the vaccine.

Small eczema like rash near elbow. Mildly itchy but relieved with ointment (Aquaphor). Lasted 3-4 days

In the span of about 40 minutes following the shot, I had severe reactions. I initially felt really warm in my arm and my heart started to race for a bit. That subsided pretty quickly. Then I got really dizzy, lightheaded and warm and sweaty while waiting the 15 minutes. Then my vision started to blur and I felt tingly in both of my hands and both of my legs. According to others with me, I also went grey. I was given a cool cloth and fanned which helped with a lot of the issues. I also had my legs elevated and was given some slightly sugary food and drink to help the vaccine disperse better. Paramadics and amabulance arrived to assess me. I was improving by the time they arrived and was deemed stable, so I did not go to the hospital for this incident

Rash developed 4/15/21 or 4/16/21. Left side of neck. Very itchy. Worse at night. Rash is red, rlat and splotchy in appearance per patient. Reviewed other possible causes but only thing new was vaccine. Applied hydrocortison cream and use of antihistamines 4/17/21 and 4/18/21.

Unsure if related to vaccine but timing is very suspect. I am 25 years old and in good health but developed Shingles on 4/17/2021 (diagnosed at the emergency room on 4/20). Due to the very low likelihood of shingles at the age of 25 and my good health history I figured it could be worth a submission / a data point in the event others are experiencing the same.

Administered about 3:30pm and sent to observation area. At roughly 4:40pm client started getting dizzy and closing eyes, color gone from skin with lips getting grayish-purple. At 4:45pm client was going in getting "clamy" skin, sweating some. I had him recline in a chair and administered 1 dose (0.3mg) epinephrine using an auto-injector pen and called for emergency services. At 4:50pm blood pressure was 125/80. Client still coherent. Had mentioned that he had not eaten that day so gave him some saltine crackers and juice. Color started to return and emergency services arrived to take over.

Hair loss in a small circular area around the size of a nickel on the back of my head a few inches behind my left ear. Appears the same as alopecia areata. Began sometime within the month following vaccination. I have not had this symptom before.

Last week Monday - June 14 I worked 1pm-9pm. My opening pharmacist left around I'd say 2pm, or 2:15pm~ish and hadn't witnessed the incident. So somewhere around that approximate time I was inside the pharmacy working on a back computer by drive thru and I heard someone yell for help in the waiting area. It was the kind of help you just know means something really drastic has just occurred. I quickly entered the waiting area via the pharmacy consultation door and saw patient face down between two chairs and his nose had a consistent drip of blood that was apparent on the floor. My technician who was in the consultation room told me he had received a Johnson and Johnson Covid vaccine probably within 5 minutes of the incident. With the combination of that information and the visualization of an active bleed, I made eye contact with another staff member inside the pharmacy at will call and told him to call 911 which he turned around immediately and did. The man was alone, but the woman who yelled for help was also calling 911 I believe. At this point I'd say approximately every 3 seconds, a new drop of blood would emerge. There were a couple people nearby including the customer and I asked everyone to stay back a little, I surveyed the scene and it appeared to be safe and I approached patient as I tried to verbally get a response of some sort. I asked if he could hear me, if he knew where he was and what happened, both with no response. The bystander recommended turning him on his side but with the unknown cause of the bleed and the recent vaccination I didn't know if it could be CNS or spinal related and since we were on the phone with EMS, we could get their recommendation of whether to move him or not. Within 15-30 seconds probably, he started regaining consciousness and he was scared at first and rightfully so. He jolted up and back and looked at me like, "why am I face down in my own blood (and probably in a lot of pain i'm sure)", and it scared me a little to be honest. I told him what we had observed, and I saw the bridge of his nose stuck out beyond what was normal but I'm not sure what normal is to him..?? I saw two small lacerations on the side of his nose and a pair of glasses on the floor. I couldn't determine if they were broken or not but surmised, he must have fainted and fallen off the chair and landed on his glasses which cut and may have even broken his nose. Or maybe the ground broke his nose. Either way it looked bad. There were several store team members around at this point (those listed in this report), and the patient was given paper towels for the bleeding and bottled water. There was a store use wheelchair we put him in when he was ready and wheeled him into the consultation room where he could be monitored until EMS arrived. While speaking with the patient before EMS arrived, he rendered all the following information: Never had a reaction to a vaccine before Never had any knowledge of high or low BP issues Doesn't recall ever feeling lightheaded or dizzy upon quickly erecting Might have low blood sugar issues Reasonings for the above response: Hadn't eaten that day yet before his shot and was feeling a little anxious about it Last time he gave blood he hadn't eaten breakfast and passed out after that This was the only other fainting history mentioned He did say it was within the last 6 months EMS arrived within another 2-3 minutes I'd say at which time we had already began the cleaning process. We blocked off the area to other customers, we halted the vaccination process until the issue was resolved, I printed the Biohazard Spill procedures, we obtained the bio-hazard spill kit, and proceeded to clean with all the PPE and sanitization materials included within the kit. After the entire process was completed the store team even ran the cleaner over the area to go above and beyond. The patient refused the ride to the hospital via ambulance due to costs and signed a medical waiver I believe..??