Johnson & Johnson

Nervous system symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2021-03-07 weakness Fever 101F, extreme fatigue, weakness, aches, dizziness
40 2021-03-10 unresponsive to stimuli Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke u... Read more
Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke up after about 10 seconds, blood pressure 110/58. Pt was awake for about 5 minutes then pass out again, this time was longer with no response to stimulus, patient was moved to the floor from a chair where he woke back up. EMS arrived and monitored patient.
40 2021-03-12 feeling hot, flushing Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Pat... Read more
Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.
40 2021-03-16 tremor On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next da... Read more
On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend. Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling like I needed to burp and that I had GI problems. The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th. I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery.
40 2021-03-19 feeling hot, cold sweat, tingling 3 minutes after vaccination, I started to feel warm, sweaty, and tingling sensation. On-site nurses ... Read more
3 minutes after vaccination, I started to feel warm, sweaty, and tingling sensation. On-site nurses noticed I started to look pale and clammy and took me into evaluation room and checked my vitals. My vitals came back with low blood pressure and low oxygen levels. After resting and a cup of water, my vitals became all normal.
40 2021-03-19 pain in extremity Shot at 8:30am. Fine all day noticed soreness in both arms and the checked temp with 100.0 fever
40 2021-03-22 numbness, tingling I have numbness or tingling (pins and needles) in fingers, arms, feet, legs, back, knees
40 2021-03-23 pain in extremity During the day that I was administered the vaccine I had pain in my arm (area in where I was vaccina... Read more
During the day that I was administered the vaccine I had pain in my arm (area in where I was vaccinated). The next day, I woke up with general pain in the body, pain in the arm where the vaccine was injected and it swelled up a little the skin under the eyes (hives). As the day goes by, the pain in the arm has diminished, as well as the hives in the eyes.
40 2021-03-25 tingling Tingling sensation in left hand and on left side of head. Sore neck muscles and very sore joints all... Read more
Tingling sensation in left hand and on left side of head. Sore neck muscles and very sore joints all within 2 hours of the shot. Late that night (day of shot) I had a low grade fever. The first day after the shot I felt very sick and had very sore joints and stiff/painful muscles. By the second day I felt better but again had sickness and soreness in the evening.
40 2021-03-27 tremor, feeling of body temperature change Approximately 9 hours after injection, and in mid sleep, intense body heat and severe chills woke up... Read more
Approximately 9 hours after injection, and in mid sleep, intense body heat and severe chills woke up me up every hour for 5 hours(midnight to 5am). My body felt incredibly hot but I did sweat at all. If I would move the bed covers and any part of my skin below my neck felt the air I would get chills the would shake my entire body for a few seconds. Later that morning; body aches all over, a fever reaching 101.3, fatigue. Over the counter medicines, napping, and a shower helped reduce symptoms. All was gone by the next morning.
40 2021-03-28 flushing Patient reported at 1210 with hx of allergy to PCN (reaction hives), cephalosporins. Patient reporte... Read more
Patient reported at 1210 with hx of allergy to PCN (reaction hives), cephalosporins. Patient reported flushed, L side of face warm, 0 dizziness, 0 lightheadedness, 0 CP, 0 SOB, PMH-0. Hx of feeling warm with injections. Water was provided to patient, snack was as well but declined. VS initially were 173/104, 102, 98% Sp02, R 16 unlabored. Repeated after water and assessment at 135/90. Patient left at 1226.
40 2021-04-01 weakness I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't ... Read more
I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't sleep well because I got the chills and a fever. I went to use the bathroom around 3am. All of a sudden I got really nauseous, the room spun, everything went black and I fainted in the middle of my bathroom. My wife woke up and helped me back to bed. The next day I was very weak and tired. The chills and fever faded the next afternoon.
40 2021-04-02 feeling hot, tremor, pain in extremity Time-line: - Started with achiness in both legs - Chills onset about 30 minutes after achiness - Chi... Read more
Time-line: - Started with achiness in both legs - Chills onset about 30 minutes after achiness - Chills briefly (1-2 minutes) were so severe I was shaking (convulsion like), only time this happened - Chills persisted for over 2 hours, covered up and took a nap - Upon waking, entire body had a hot/searing sensation (under skin), but no elevation in temperature - Eyes were extremely dry - Body aches continued into the next morning, hot/searing sensation had stopped - Was fairly fatigued the entire next day, dry eye issue persisted - After more rest than normal, I seem to be back to normal, no body aches, fatigue, or dry eye issues.
40 2021-04-02 pain in extremity, feeling hot Patient came in to the clinic to receive his dose of the Janssen COVID vaccine. Within the 15 minute... Read more
Patient came in to the clinic to receive his dose of the Janssen COVID vaccine. Within the 15 minute post-vaccine period, the patient reported feeling warm, sweaty, having clammy hands, and the feeling of almost "passing out". Patient was taken to a patient room to rest, vitals were taken at 13:16 PM with readings of BP: 91/57, HR 72, SpO2 98%, temp 98.5. Patient denies any past medical history, reports he only takes vitamin supplements, and denies any past history of anxiety. He denied any chest pain or SOB. Patient was provided water and was told to rest for a few minutes. Vitals at 1:42 PM were noted to be: BP 108/71, HR 72, SpO2 99%, and temp of 98.1. He says he feels much better and denies any symptoms at this time. ER precautions were given to the patient Called patient again 4/2/21 at 09:59 AM - pt denies any ER visits, hospitalizations, or any visit to any other healthcare provider since his vaccine. The day after his vaccine, he says he developed a headache with left arm soreness (injection site was left upper arm) which was all improved by Monday, 3/22/2020. He says he took Advil, drank plenty of fluids, and rested for his symptoms of headache and arm soreness. He denies any other symptoms of near syncope after his near syncopal episode at the clinic. He denies any symptoms of fevers, CP, SOB, swelling, drainage, or pain at injection site, abdominal pain, dizziness, lightheadedness, or any other side effects/averse effects of the vaccine. He says he is doing well overall
40 2021-04-03 pain in extremity Aches fever diarrhea arm soreness fatigue brain fog
40 2021-04-04 weakness, pain in extremity dizziness and weakness 10 minutes post vaccination. observed patient for 20 more minutes while seat... Read more
dizziness and weakness 10 minutes post vaccination. observed patient for 20 more minutes while seated. called 911 for patient but patient refused service. patient was alert the entire time and able to converse coherently. Patient felt fine afterwards to drive home. Followed up with patient on 4/5/21. Patient stated that he's perfectly fine after reaching home with just a slight arm soreness which was resolved the next day.
40 2021-04-04 hot flush Fever (100 F at 11 pm, 4/3/21, 7 hours after vaccine; 101.9 F, at 11 am, 4/4/21, 19 hours after vacc... Read more
Fever (100 F at 11 pm, 4/3/21, 7 hours after vaccine; 101.9 F, at 11 am, 4/4/21, 19 hours after vaccine: fever fell to normal 98.6 F by 7:30 am 4/5/21. Severe chills, uncontrollable shivering for about 10 minutes at about 11 pm 4/3/21; chills and hot flashes, sweating, on and off all day 4/4/21. Moderate body aches 4/3/21 and 4/4/2 Slight nausea 4/3/21
40 2021-04-06 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT H... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.
40 2021-04-06 hot flush CHILLS; FEVER; BURNING SKIN; HOT FLASHES/FEELING HOT; FATIGUE; This spontaneous report received from... Read more
CHILLS; FEVER; BURNING SKIN; HOT FLASHES/FEELING HOT; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 77.1 kilograms, and height was 175.26 centimeters. The patient's concurrent conditions included seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/ toxoid for prophylactic vaccination; and experienced reactions to vaccines when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid, and tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hot flashes/feeling hot. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced burning skin. On 19-MAR-2021 22:00, the subject experienced chills. On 19-MAR-2021 22:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning skin, hot flashes/feeling hot, chills, fever, and fatigue on 20-MAR-2021. This report was non-serious. Additional information was received from the patient on 30-MAR-2021. Following information was updated into the case: other identification numbers added, patient's contact details added (address, city, zip code, email address and phone number), patient demographics added (age ,age group, gender, height, and weight), concurrent condition added ( seasonal allergy, non-smoker, alcoholic), event added (fatigue and hot flashes/feeling hot), past reaction added( reactions to vaccines), suspect drug route of administration added ((intramuscular), vaccination time added, past drug added (Tetanus and TDAP) and due diligence updated.
40 2021-04-07 flushing, weakness Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed... Read more
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number
40 2021-04-07 unresponsive to stimuli Fell off chair, striking head on floor. Briefly unresponsive No breakfast eaten.
40 2021-04-08 burning sensation Patient reported burning sensation shortly, ~10 minutes, after receiving vaccine that carried acros... Read more
Patient reported burning sensation shortly, ~10 minutes, after receiving vaccine that carried across back of shoulder. Patient reported feeling "loopy/drunk". Patient refused all treatment and EMS. Around 40 minutes or so, patient vomited. Patient left with friends an hour after vaccine given.
40 2021-04-08 feeling hot States he started feeling hot lowered to ground. Did hit his head. States this has happened in the p... Read more
States he started feeling hot lowered to ground. Did hit his head. States this has happened in the past with draws. Has allergies to PCN as hives Awake, alert and oriented x 3 99% O2 Sat, RR 18, BP 156/86, HR 88 Feels better while sitting in observation Only medical history of hypertension, is not taking meds
40 2021-04-08 feeling hot States he started feeling hot, lowered to the ground. Did hit his head. states this has happened in ... Read more
States he started feeling hot, lowered to the ground. Did hit his head. states this has happened in the past with blood draws. Has allergies to PCN= Hives. Awake and alert x 3 99% O2, RR 18, BP 156/84, HR 88 Feels better while sitting in observation Only medical history hypertension and patient doesn't take any meds
40 2021-04-09 weakness Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fi... Read more
Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fire (very painful 7 on the pain scale), my phantom pain is going nuts in my missing left forearm and hand (very painful too 7 on the pain scale)
40 2021-04-09 numbness ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA OF THE VACCINATION); NUMBNESS IN LEFT FINGER; ... Read more
ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA OF THE VACCINATION); NUMBNESS IN LEFT FINGER; CHILLS; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A2A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021; 13:16 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced aching body (including the chest and around the area of the vaccination). On 06-APR-2021, the patient experienced numbness in left finger. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, chills, and aching body (including the chest and around the area of the vaccination), and had not recovered from headache, and numbness in left finger. This report was non-serious.
40 2021-04-09 seizure Lost consciousness and had convulsions for 30-45 seconds
40 2021-04-10 pain in extremity, hot flush Arm pain, hot flash, then syncope
40 2021-04-10 pain in extremity Chills, fever, stomach cramps, vomiting, body aches, sore arm
40 2021-04-11 weakness Patient received Janssen vaccine around 10:30. He left the observation room feeling fine. once he go... Read more
Patient received Janssen vaccine around 10:30. He left the observation room feeling fine. once he got at his car and started to drive, he felt shortness of breath and some weakness. Then, he came back to the SR Vaccine site to get help around 10:50. We met him in front of the parking lot, he was having some trouble of breath and weakness. We put him in a wheelchair, brought him back to the Observation area. I asked him to lay down with elevated legs on a chair. He instantly felt better, no more shortness of breath. He did not need to use any Oxygen supply. Also, he drank some water, sit back in the chair and felt better ready to leave with his brother who came to help him just in case. At 11:10 he left the building with orientations about worsening of symptoms and when to call EMS.
40 2021-04-11 feeling hot warm, dizzy, hot, vision blurred, sweating
40 2021-04-11 feeling jittery Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rat... Read more
Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rate jumped up to 165bpm on my fitbit for a period of time even though i just began walking. I wasnt running or anything. I was foggy and very jittery. I also experienced the same symptoms today, 4.12.21 while also heading for a short walk. Im an athlete and in great shape and ive never had my heart jump to 165bpm just walking. That would happen normally after a sprint or long run, but not just walking.
40 2021-04-11 tingling Ten minutes after the vaccination, pt passed out and came right back. He said he was fine except his... Read more
Ten minutes after the vaccination, pt passed out and came right back. He said he was fine except his hands were tingling. We called 911 and they took him for the vital.
40 2021-04-12 muscle spasms SEVERE MUSCLE CRAMPING AND PAIN THROUGHOUT BODY. PROLONGED FEVER OF 102.9 DEGREES. SEVERE CHILLS AND... Read more
SEVERE MUSCLE CRAMPING AND PAIN THROUGHOUT BODY. PROLONGED FEVER OF 102.9 DEGREES. SEVERE CHILLS AND BODY SHIVERS. EXTREME HEADACHE. ENLARGED AND PAINFUL LYMPH NODE ABOVE LEFT COLLARBONE
40 2021-04-12 pain in extremity Painful swelling in right leg from knee to ankle. Skin is warm to the touch and red.
40 2021-04-12 pain in extremity I waited the advised 15min to assess any allergic reaction. I felt fine aside from a sore arm. I c... Read more
I waited the advised 15min to assess any allergic reaction. I felt fine aside from a sore arm. I called my wife and drove home. Once on the freeway I felt dizzy. This came on me very fast. I thought I better get off at the next exit.. but instantly blacked out. While unconscious I struck another vehicle going approximatley 65mph, rolled my vehicle on its side, skidded, then rolled back upright. I awoke to my car spun sideways on the freeway, paramedics, and fire dept working the wreck from my window, and no recollection of what happend. It felt instantaneous to me. I ate a breakfast of granola, yoguirt. I hydrated before the shot. I even took extra Vitamin C.
40 2021-04-12 tremor, weakness Woke up in middle of night extremely dizzy, lightheaded, weak, and shaking. Went to ER. They gave me... Read more
Woke up in middle of night extremely dizzy, lightheaded, weak, and shaking. Went to ER. They gave me an aspirin, drew multiple blood samples, performed two EKGs, and a chest x-ray. They could find nothing wrong with me. After about an hour at the hospital the symptoms begin getting better, and I was discharged approximately four hours later.
40 2021-04-13 discomfort First evening of the J&J vaccine (4/1/2021) I had a fever, chills, headache, and was lethargic. Thi... Read more
First evening of the J&J vaccine (4/1/2021) I had a fever, chills, headache, and was lethargic. This lasted for 2 nights. These symptoms I anticipated. What I didn?t anticipate was my abdominal pain. I still feel as of today (4/14), pain in my abdomen. The areas of the discomfort are all over my mid-section. I was so worried that I went to ?Urgency Care? doctor on 4/5/2021 and the nurse had me go for a ?CT Scan?. I also went to my Primary care physician on 4/13/2021 and described my concern and abdominal pain but didn?t get a diagnosis.
40 2021-04-13 numbness, pain in extremity 104 fever. Chills. Extreme body pain. Pain and numbness in lower legs for weeks after.
40 2021-04-13 muscle spasms Developed a fever 6 hours after vaccine administered, had chills, muscle aches, and severe headache,... Read more
Developed a fever 6 hours after vaccine administered, had chills, muscle aches, and severe headache, around 10 hours after vaccine, fever peaked at 101.4 then subsided, about 12 hours after shot woke up in night with cramping in my feet, severe headache continued 18 hrs after vaccine and took two Tylenol, headache subsided and went away, fever was reduced to below 99 degrees about 16 hrs after vaccine. After 24hrs from vaccine all symptoms were gone and has not return to date.
40 2021-04-13 pain in extremity Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This las... Read more
Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This lasted for 2 days at the same pain level. On the third day the stiffness, pain, hard to move went down to about 5% of what it was.
40 2021-04-13 tingling, pain in extremity, numbness headahce, lightheaded, sob, calf pain, numbness, tingling
40 2021-04-13 seizure After vaccine was given at clinic, patient had a seizure episode as per nurse staff
40 2021-04-15 hot flush Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmaci... Read more
Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medication and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:03 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 14:15, the subject experienced dizzy. On 10-APR-2021 14:15, the subject experienced hot flushes facial. On 10-APR-2021 14:15, the subject experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizzy, and the outcome of hot flushes facial was not reported. This report was non-serious.
40 2021-04-15 pain in extremity Injection administered on a Wednesday, by Saturday severe pain and inflammation on forearm below inj... Read more
Injection administered on a Wednesday, by Saturday severe pain and inflammation on forearm below injection location. Not at injection- but on same arm. Forearm stayed swollen and stay in severe pain with no ability to grip. Feels like internal grinding at joints, muscle and wrist. Resting has minimized pain, but has not improved much since Saturday.
40 2021-04-17 feeling hot I was working at and, around 5:30 am when I felt some strong pain both side of my chest. Sonner I f... Read more
I was working at and, around 5:30 am when I felt some strong pain both side of my chest. Sonner I felt a slight headache and from time to time it intensified to become unsupportable. At that time though about a lack of oxygenation, because I wore mask for the whole time I was working. About 9:am when I drove to home, I saw everything foggy in front of me. When I get home I took some paracetamol and another painkiller, because at that time my entire body was so warm, and the headache was very bad. I slept for 5 hours, when I woke up I went to the mechanic to fix my car. While I got back during the time I saw the same foggy vision.
40 2021-04-17 pain in extremity Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten u... Read more
Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.
40 2021-04-19 weakness Unusual exhaustion within an hour of the vaccine. Had to go to bed and slept into the evening devel... Read more
Unusual exhaustion within an hour of the vaccine. Had to go to bed and slept into the evening developing a fever of 103, severe thirst and chills. The fever lasted until 10:00 a.m. the following day, but weakness, thirst, chills and body aches continued for 3 more days intermittently. I would feel like I could finally exercise and then be too weak and tired to go back to routine. My appetite declined for 4 to 5 days as food didn't taste appealing. On Thursday, April 8, I announced to my mom in the morning that I finally felt like I was back at almost 100% and later in the afternoon felt nauseous, incredible pain in my chest and had dry heaves. I finally vomited some and was once again overcome by a fever of 101 and all I could do was sleep from severe exhaustion. I am against medication, but finally agreed to taking ibuprofen and tums. After sleeping into the next day around noon, I finally was able to eat some breakfast but the pain in my chest continued and I could rid it for another day. I intermittently had to sleep and gave up my exercise routine until my body has had time to recuperate. I have not fully recovered, but my appetite is picking up. I still require more sleep than normal.
40 2021-04-19 feeling hot, flushing Client returned to the clinic with c/o flushing and feeling very hot, numb, tingly lips, itching on... Read more
Client returned to the clinic with c/o flushing and feeling very hot, numb, tingly lips, itching on the face. Benadryl 50 mg PO given. Patient added some of the previous c/o after the initial communication. Improvement after 15 minutes. Client remained with the Facility HCP.
40 2021-04-20 bell's palsy, numbness, facial paralysis Bell's Palsy diagnosis. Paralysis on left side of face. Severe headache behind left ear. Numbness... Read more
Bell's Palsy diagnosis. Paralysis on left side of face. Severe headache behind left ear. Numbness in feet/toes.
40 2021-04-21 weakness, feeling hot LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE;... Read more
LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE; WOOZY/DIZZINESS; This spontaneous report received from a patient concerned a 40 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced woozy/dizziness. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced feeling warmer than usual. On 13-APR-2021, the subject experienced feeling achy. On 13-APR-2021, the subject experienced feeling sick. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, headache, chills, loss of appetite, weakness, woozy/dizziness, feeling achy, and feeling warmer than usual. This report was non-serious.
40 2021-04-22 night sweats, weakness Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist followi... Read more
Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist following tests Positive ANA, Elevated RO-SSA >200, Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4 days, at four weeks out continued pain, weakness, and swelling. Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules. Referral made to rheumatologist for further work up.
40 2021-04-24 pain in extremity FEVER, BODY PAIN, FINGER PAIN, WHOLE BODY IN PAIN.
40 2021-04-26 tingling The evening of the vaccination I began experiencing tingling at the site of the shot, then this exte... Read more
The evening of the vaccination I began experiencing tingling at the site of the shot, then this extended through the night to chest pains and tightness in the chest. That continued through the night and into the following day. The following day and lasting until present (4/27/2021) I have continued to experience tingling at night, extending to my arm and fingers, random very sharp pains in my chest, and some feeling of strong heart throbbing. This subsides during the day-time (when I'm upright versus lying down) but all of these symptoms return during the evening. These are all things I never experienced prior to the vaccine. Also, I have tested regularly for COVID-19 since my companyconducts covid-19 testing and I have not been infected with COVID-19 at any point during the past year. The continuation of these symptoms is concerning. There have been at least two instances where the sharp pains in my chest were much more intense than the other chest pains I have felt since the vaccine.
40 2021-04-28 cold sweat, tingling Patient reported acute onset of diffuse tingling sensation , light-headed, with cold sweats, blurred... Read more
Patient reported acute onset of diffuse tingling sensation , light-headed, with cold sweats, blurred vision, and acute complaints of shortness of breath within 9 mins of injection. Shortness of breath was immediate after administration. VS at 11:30 AM T97.4, HR 60, RR 16 BP 88/58 O2 87- rechecked at 95--lungs CTAB Reports a controlled 1600 cal/day diet, OJ and gummy snack given. Patient encouraged to push PO fluids and focused respirations. O2 stabilized at 94-95% on RA VS rechecked at 12:15 PM 96.9 Tympanic, HR 58, RR 16 even and unlabored, BP 98/72 O2 97% Reported feeling better and with appetite, was able to walk around parking lot for several mins to make sure he felt ok to independently leave and opted to depart. A&O x 3. Insight and judgement intact.
40 2021-05-02 hot flush, weakness, inability to speak Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away an... Read more
Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes. Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing. Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move. At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm. I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it. Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine. Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this. I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better. It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.
40 2021-05-03 cold sweat Patient passed out. dizziness, clammy skin, blood pressure low
40 2021-05-04 numbness My face went numb for several hours a day and a half after injection. I also had extreme fatigue, h... Read more
My face went numb for several hours a day and a half after injection. I also had extreme fatigue, headaches, and pain and swelling at the injection site for 7+ days.
40 2021-05-06 pain in extremity Arm soreness, fever, chills, body aches, and headache. All occurred throughout the night and improve... Read more
Arm soreness, fever, chills, body aches, and headache. All occurred throughout the night and improved by the following morning.
40 2021-05-08 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
40 2021-05-10 tremor Mild aches and joint pain all day. Didn't think anything of it. Then at 830 pm I very suddenly got ... Read more
Mild aches and joint pain all day. Didn't think anything of it. Then at 830 pm I very suddenly got the chills. Chills turned into shakes. My temp read 99.1. Normal is 97.4-97.7. Took Tylenol and went to bed. Woke up a few hours later sweating profusely. Took temp again, was 101.6. Was very unpleasant. Fever broke a few hours later, though it went up and down throughout the next day, but not nearly as high. This was easily the sickest I've been in 10-15 years.
40 2021-05-12 tremor Severe syncope, shaking, low blood pressure
40 2021-05-13 numbness, tingling patient became diaphoretic and dizzy, mild nausea hands went tingling and numb. pt was moved to wel... Read more
patient became diaphoretic and dizzy, mild nausea hands went tingling and numb. pt was moved to well ventilated area and recovered quickly. regained color and dizziness diminished.
40 2021-05-16 numbness, tingling Left sided numbness/paresthesia with difficulty with dexerity on the left side. Severe pain on enti... Read more
Left sided numbness/paresthesia with difficulty with dexerity on the left side. Severe pain on entire left side. Fatigue.
40 2021-05-19 seizure Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his e... Read more
Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.
40 2021-05-24 unresponsive to stimuli Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccinatio... Read more
Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccination, patient passed out (fainted) while sitting down in a chair. Moved patient on to floor lying down flat and observed him for a few seconds. Patient was un responsive and appeared to struggle to breath. Asked my staff to call 911 for emergency services, and to bring an Epipen just in case, and started to perform CPR on the patient. The patient gained consciousness in about 15 chest compassions and became responsive. He answered the questions like his name, where he lives etc. As the patient became conscious, responsive and appeared to breath normally, I did NOT administer Epipen. Kept patient in observation and kept him engaged in talking until EMS personnel have arrived. They checked his vitals and blood glucose. In the conversation with EMS personnel, they said he is hypertensive and hyperglycemic. Ems took him to the ambulance by walking him (stretcher wasn't necessary)
40 2021-05-25 weakness, feeling cold STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILL... Read more
STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.
40 2021-05-26 unresponsive to stimuli Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt... Read more
Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt started not feeling well. He experienced dizziness, sweating, swelling of the lips and tongue, and shortness of breath. Pt was non-responsive. Rph administered an Epipen and staff called the ambulance. At this time, pt was becoming more responsive in response to the Epipen. EMS came and checked the pt's vitals. Vitals were within normal range. Pt was not sent to the hospital. EMS advised the family to monitor the pt and call EMS if symptoms worsen. Pt is doing okay.
40 2021-05-27 pain in extremity Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All ... Read more
Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.
40 2021-05-31 pain in extremity Complained of Right lower leg pain, sent to radiology at local hospital for Ultrasound. Ultraspund w... Read more
Complained of Right lower leg pain, sent to radiology at local hospital for Ultrasound. Ultraspund was positive for DVT. Went from Radiology to Emergency room. Started on blood thinner medication and returned
40 2021-05-31 seizure Patient received his Janssen Covid-19 immunization. The patient arrived at 11:00am on 6/1/21 and c... Read more
Patient received his Janssen Covid-19 immunization. The patient arrived at 11:00am on 6/1/21 and completed his pre-screening questions and temperature check. The patient then completed his "Patient Questionnaire and Consent Form." The patient was administered his Janssen Covid-19 vaccine around 11:05am. About 2 minutes after administration, the patient appeared pale and sliding out of his chair. The pharmacy technician responded and held the patient under his arms. The patient convulsed and then became unconscious. We called 911, checked the patient for breathing and responsiveness. The patient didn't stop breathing and became conscious about 1 minute after losing consciousness. We placed the patient on the floor and placed cold compresses under his neck and on his wrists. EMTs arrived and evaluated the patient and made sure the patient was stable. EMTs offered to take the patient to the hospital but the patient declined.
40 2021-06-01 feeling hot Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he... Read more
Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he felt extremely nauseous and looked very pale. His blood pressure was checked and measured 120/66, he said he was starting to feel warm but did not have any chest tightness, difficulty breathing, or swelling. After about 2 more minutes he said he was starting to feel better and then after 5 more minutes his blood pressure was 120/81, and he was starting to show more color to his face. He said he felt fine to leave. In hind-sight he stated that he has fainted in the past after seeing his wife receive a previous immunization as well.
40 2021-06-03 cold sweat Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, p... Read more
Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, patient began feeling ill. As he was walking up to the drop-off window to tell staff how he was feeling, he fainted and hit the back of his head on the ground. Patient was unresponsive so 911 was called. Patient was extremely pale, hot, and clammy, but slowly started to regain responsiveness. Patient reported blacking out. While waiting for paramedics, two cold ice packs were applied to the patient's head and neck. Paramedics arrived and assessed the patient. They released him from their care as free to go. Patient sat down outside the pharmacy for approximately ten more minutes. Once he decided he was feeling better, he walked around outside the pharmacy until he felt okay to leave. Prior to leaving, patient reported he was feeling better and appeared to be in good spirits. He also reported having fasting labs drawn 45 minutes prior to receiving the vaccine, as well as low blood pressure at his doctor's office. He confirmed ability to drive. Patient left the pharmacy approximately 45 minutes after receiving the vaccine.
40 2021-06-03 unresponsive to stimuli Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical respon... Read more
Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated. Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.
40 2021-06-10 migraine DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE... Read more
DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.
40 2021-06-14 tremor 06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems... Read more
06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems on scene, pt GCS 10, spo2 92% RA, hypotensive. at home pt having bad reaction, vomiting, defecated. Pt on gurney moaning, shaking answering questioning. Per MD, CT results show multiple Pulmonary emboli
40 2021-06-20 sensory loss Main lingering adverse event is loss of sensation in the median nerve in both hands. Waited over two... Read more
Main lingering adverse event is loss of sensation in the median nerve in both hands. Waited over two months hoping it would go away but hasn?t. Brought it up at annual check up with doctor who ran labs and has recommended EMG.
40 2021-06-22 tremor, weakness The following day I was shaking uncontrollable head to toe. I could feel nothing but pain. If 10 w... Read more
The following day I was shaking uncontrollable head to toe. I could feel nothing but pain. If 10 was the standard before, this was 20-25. a month later a storm came and I had the exact same pain issues and the same pain levels. I went to see my rheumatologist and told him my issues. He sent me to a neurologist and scheduled an appointment with a pain clinic. The rheumatologist gave me a prescription for gabapentin after than, 300 mg two times a day, and it has seemed to help, but my pain problems are getting worse. It is now 3 months later and I am quickly loosing the ability to hand the pain. I have been in none stop pain for the last 18 hours. I am taking a 7.5mg/325 mg pill of Tylenol three that I got from the pain clinic, but it is barely holding the pain back. I have never felt pain like this in all my days.
40 2021-06-30 discomfort, nerve pain, pain in extremity I have had severe pain in my right leg, it feels like nerve pain. Its very uncomfortable to sit and ... Read more
I have had severe pain in my right leg, it feels like nerve pain. Its very uncomfortable to sit and drive. I saw my PCP ( Kip ) who ordered two rounds of oral steroids. I was then referred to an Ortho who ordered PT, I completed 4 weeks with little to no improvement. I had an X-Ray and MRI of lower back and just received an cortisone injection last Friday.
40 2021-07-08 discomfort Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barel... Read more
Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barely able to turn my neck to the right. A lot of pain and discomfort. Limited mobility of neck.
40 2021-07-09 night sweats After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night ... Read more
After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night sweats, headache, dizziness, and chills around 10pm. Along with these side effects I also developed an extreme ringing in my ears. The ringing is so constant that it's difficult to sleep and even think. The ringing has shown no signs of improvement and can best be described as a high pitch sibilant sound.
40 2021-07-18 weakness Since 7/3/21 patient complains of fever 104.5F, malaise, weakness, rigors, also developed cough and... Read more
Since 7/3/21 patient complains of fever 104.5F, malaise, weakness, rigors, also developed cough and shortness of breath on 7/6/21
40 2021-07-23 pain in extremity, tingling SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART O... Read more
SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 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 no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.
41 2021-03-07 unresponsive to stimuli Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the ... Read more
Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the floor. My wife found me unresponsive but breathing on the floor. My wife called 911 and was at the hospital around 6:15AM.
41 2021-03-11 numbness, tingling, feeling hot Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen... Read more
Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.
41 2021-03-15 weakness Sever body aches, fever, chills, low energy and now 4 days later a right earache with slight throat ... Read more
Sever body aches, fever, chills, low energy and now 4 days later a right earache with slight throat discomfort on the same side and mild fever.
41 2021-03-17 cold sweat Headache lasting nearly 18 hours, cold sweat and flu-like symptoms overnight, visual light sensitivi... Read more
Headache lasting nearly 18 hours, cold sweat and flu-like symptoms overnight, visual light sensitivity from the morning to the mid-afternoon following the vaccination. All symptoms resolved within 24 hours.
41 2021-03-17 tingling Patient reports that as soon as he received he experienced tingling through out the his body - to th... Read more
Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing.
41 2021-03-17 tremor pt stated after getting the vax he woke about 1 AM feverish, sweating, severe headache, his body was... Read more
pt stated after getting the vax he woke about 1 AM feverish, sweating, severe headache, his body was shaking and his teeth chattering. He put a blanket over him to break fever. His teeth were chattering. He took Tylenol and his temp it was 100.4. These symptoms latest a couple of days.
41 2021-03-17 unresponsive to stimuli Pt passed put after vaccination with the Janssen COVID-19 vaccine. Roughly 5 minutes after administ... Read more
Pt passed put after vaccination with the Janssen COVID-19 vaccine. Roughly 5 minutes after administration of the vaccine, the lady who accompanied the patient got the attention of the pharmacist. Pharmacist ran out to assess patient and saw that he seemed unresponsive. Pharmacist then called for an EPIPEN, but pt woke up before the EPIPEN was ready. No EPIPEN was given. We then monitored the patient's BP every 10 minutes or so. Pt stablized after roughly 45 minutes to an hour and then left the store.
41 2021-03-19 weakness, numbness Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I s... Read more
Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine. I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.
41 2021-03-21 weakness The effects started off as a general weakness, then progressed into nausea and, by the end of the da... Read more
The effects started off as a general weakness, then progressed into nausea and, by the end of the day, chills. I did not have a fever. I took my temperature and it was normal at 98.1. I describe it as having a cold without the congestion and runny nose. I was fine by the next morning.
41 2021-03-22 seizure Vasovagal event with syncope and seizure activity fir 15 to 20 seconds Client stated he always resp... Read more
Vasovagal event with syncope and seizure activity fir 15 to 20 seconds Client stated he always responds this way to shots. Hx of TBI at age 4 years. Blood pressure 106/68 pulse 84 and 02 saturation 100%. EMS and Dr on site and client released when symptoms resolved. Advised to seek medical attention later if needed. Client verbalized understanding.
41 2021-03-25 limb paralysis, tremor Severe chills, shaking Fever of 101F Knee partially paralyzed for 3 days in a row (difficulty walki... Read more
Severe chills, shaking Fever of 101F Knee partially paralyzed for 3 days in a row (difficulty walking) Severe headache
41 2021-04-01 weakness Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out... Read more
Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out of sorts - all lasted from 3-4 hours after shot for approximately 48-72 hours
41 2021-04-02 tenderness Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight ... Read more
Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.
41 2021-04-05 pain in extremity Arm pain, mild fever, muscle aches, and fatigue
41 2021-04-06 cold sweat At 12:05 am client came to the staff office treatment facility stating he feels sick and has been th... Read more
At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick. The staff took his temperature and it was 100.9 degrees. The client was dry heaving and red in the face and having cold sweats. Staff monitored him while 911 was called and paramedics showed up within 10 minutes. The Program Manager was notified and the client was given instructions for when going to the hospital.
41 2021-04-06 migraine Severe body aching Severe Migraine Headache Cold Chills Body weakness
41 2021-04-06 migraine 102 fever and a migraine
41 2021-04-06 muscle spasms 12 hours after vaccine, woke to high fever and muscle cramps, violent shivering, splitting headache,... Read more
12 hours after vaccine, woke to high fever and muscle cramps, violent shivering, splitting headache, spotty vision
41 2021-04-06 tingling The next day I noticed tinnitus (high pitch mild ringing in both ears) . Therefore it has been a to... Read more
The next day I noticed tinnitus (high pitch mild ringing in both ears) . Therefore it has been a total of 7 days with ringing in both ears and it has not gone away. It has been constant, no pulses, no frequency changes, etc. Just constant high pitch ringing in both ears. Sometimes by inner ear feels funny, slightly tingle feeling that is related to the tinnitus. The tinnitus is most noticeable in quiet settings, sleeping, reading, watching TV, I do not noticed it as much in office environments, listening to music, walking outside. I have experienced tinnitus in the past after loud music band or rock concert but do not attend live loud music often and try to avoid it because it hurts my ears. I do not have any known hearing problem, I try to protect my ears and use hearing protection often to avoid damage. When I cut my lawn I wear hearing protection, when I am working on shop floor I wear hearing protection. I am thinking the vaccine is related somehow. I never had COVID-19 in past. I use to be able to be in quiet settings and not have any tinnitus before vaccine.
41 2021-04-06 tingling Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started... Read more
Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started receiving warm tingly feeling, lost consciousness, drifted off the road crashed my vehicle into a tree head on collision 2:45pm. Cannot hear out of my left ear.
41 2021-04-07 weakness, migraine Chills, migraines, vomitting, excessive sweating, dizziness, fogginess, fever, weakness, very tired
41 2021-04-07 feeling hot, feeling cold Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling... Read more
Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches
41 2021-04-07 migraine constant migraine lasting more than 3 days
41 2021-04-08 burning sensation Hives start forming 12 hours after receiving vaccine. When I woke up in the morning my body was cove... Read more
Hives start forming 12 hours after receiving vaccine. When I woke up in the morning my body was covered in hives. I went to e.r. in the night as advised by my doctor. They gave me a oral steroid, a pepcid and some benadryl, also gave me prescriptions. When I woke up the next morning hives had mostly gone away, but returned later that evening due to not picking up prescription from pharmacy. I have it now and am taking them. I still get itchy and have some burning but it's very minor and a little more tolerable with the medications.
41 2021-04-08 cold sweat I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a ... Read more
I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a chair, I began to get tunnel vision and felt extremely tired. I broke out in a cold sweat all over my body. I began to lose my vision like I was fainting and I momentarily blacked out or dozed off, then came back awake. I started to get tunnel vision again for a minute, then it faded away. Then I continued sweating for a minute and then it faded away. After a couple minutes I felt fine again. I sat for another several minutes then left at 1:15 feeling ok with just a sore shoulder.
41 2021-04-08 feeling hot, tingling Patient stated he felt a tingling sensation and really hot about 5 minutes after receiving the vacci... Read more
Patient stated he felt a tingling sensation and really hot about 5 minutes after receiving the vaccine. Patient received Benadryl Liquid at 10mL (25mg) about 2 minutes later (4:07). At that time he stated that the tingling had stopped but he still felt hot. 5 minutes later (4:12) patient stated that he no longer felt hot and thought that it may have just been nerves about the vaccine. Patient left the pharmacy at 4:25 with no symptoms.
41 2021-04-10 feeling hot About 10 minutes after shot I asked patient how he was feeling, he said he was hot. I walked out to ... Read more
About 10 minutes after shot I asked patient how he was feeling, he said he was hot. I walked out to talk to him and he said he felt dizzy. He turned pale and fell sideways off chair onto floor lowering himself with his knee. He did not bump his head, he was sweating profusely, but did not lose consciousness. I yelled to the tech to call 911. Patient was sitting on floor. He said he did not eat much all day. He was alert and talking. He said he fainted when his wife had their baby. We gave his some orange juice. The paramedics arrived 8 minutes later and checked his vitals. In the meantime we called his wife. Paramedics checked his BP, glucose and questioned patient. Patient refuse to go with paramedics. Wife came and paramedics released him to her.
41 2021-04-10 tremor, pain in extremity Shot on Friday at 7pm, Immediate arm soreness (fairly severe), then I woke up at 4am sweating and sh... Read more
Shot on Friday at 7pm, Immediate arm soreness (fairly severe), then I woke up at 4am sweating and shaking and vomiting. I threw Up 8 times between 4am and 3pm the following day (Saturday), and it is now Sunday morning at 9:30 and the sweating and shaking seems to be subsiding. I would Describe Saturday as ?violently ill?. These were not minor side effects.
41 2021-04-11 feeling hot Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and ... Read more
Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.
41 2021-04-11 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
41 2021-04-11 muscle spasms Severe Chills, Temp of 102, muscle spasms in back, and minor headache Lasted for several hours in t... Read more
Severe Chills, Temp of 102, muscle spasms in back, and minor headache Lasted for several hours in the evening following vaccination. Needed to sleep in a heated blanket for a few hours. Took NyQuil for symptoms relief and sleep aid. The headache persisted for additional 24 hours (36 hours from vaccination)
41 2021-04-11 tingling Vaccine given in right deltoid, same day pt reports tingling in left fifth digit.
41 2021-04-11 tingling Tingling in Pinky on Left Hand
41 2021-04-11 tremor, feeling cold FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEI... Read more
FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.
41 2021-04-12 feeling cold Chills and shivering before bed, (could not get warm). Lasted until morning 10APR. Headache in the ... Read more
Chills and shivering before bed, (could not get warm). Lasted until morning 10APR. Headache in the AM 10APR. Lasted a few hours. Achy feeling all over. Very tired. Lasted until morning 11APR.
41 2021-04-12 numbness, pain in extremity About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, nu... Read more
About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn. I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released. The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm). Again presented to emergency room on 03.28.2021, treated and released.
41 2021-04-12 pain in extremity I had chills the first night after the vaccine. In addition to that I have continuous pain in the le... Read more
I had chills the first night after the vaccine. In addition to that I have continuous pain in the legs, feeling of dizziness and fatigue even after sound sleep in the night. I am having feeling of nausea and vomiting on a continuous basis which have not gone away even after four days have been complete since vaccination.
41 2021-04-12 tingling Awoke with right lower leg paresthesias. Intermittent, anterior aspect of leg, no other explanation... Read more
Awoke with right lower leg paresthesias. Intermittent, anterior aspect of leg, no other explanation for symptoms. Normal exam, no swelling, normal neuro exam.
41 2021-04-12 seizure Seizure and lost of consciousness 3 minutes after vaccine was administered. No treatment was given a... Read more
Seizure and lost of consciousness 3 minutes after vaccine was administered. No treatment was given at pharmacy, but patient was taken by paramedics.
41 2021-04-13 bell's palsy Bells Palsey - right side. Has had 3 episodes of left bells palsey in the past.
41 2021-04-13 feeling of insects crawling on skin red dots all over arms, body that itch, feels crawling, on set 4/6/2021
41 2021-04-13 muscle spasms Headaches. Dizzy. Chills. Leg cramps. Heavy chest. Breath shortness
41 2021-04-14 weakness never ending headache on the right side of my head, temple to jaw, ear, since about four days after ... Read more
never ending headache on the right side of my head, temple to jaw, ear, since about four days after receiving the vaccine on 3/27/21. The first three days were weakness and flu like symptoms
41 2021-04-14 impaired body coordination, face paralysis 11 days after vaccination patient had the onset of generalized myalgias, headaches. This was followe... Read more
11 days after vaccination patient had the onset of generalized myalgias, headaches. This was followed by the onset of unilateral facial weakness 17 days after vaccination. On examination, he had ataxia and facial weakness. He had MRI's, LP and EMG/NCS which confirmed demyelinating polyradiculoneuropathy, presumably Miller Fisher variant of Guillain Barre Syndrome.
41 2021-04-14 cold sweat I woke up Monday morning after receiving vaccine on Sunday with a severe headache and cold sweats. ... Read more
I woke up Monday morning after receiving vaccine on Sunday with a severe headache and cold sweats. The cold sweats have subsided however I am still having a headache. Its not as severe as it was on Monday but i have kept a headache since Monday even taking Tylenol and ibuprofen doesn't make it completely go away.
41 2021-04-17 cold sweat Clamminess, headache, swollen joints, fever, muscle pain, sweating, nausea.
41 2021-04-18 pain in extremity Night of vaccination approx. 10pm, very painful body aches with fever and chills; especially in lowe... Read more
Night of vaccination approx. 10pm, very painful body aches with fever and chills; especially in lower legs, felt like a deep muscular ache that could not be stretched out; I would relate this feeling to "growing pains" experienced as an adolescent. Fatigue lasted for 3 days after this event
41 2021-04-19 facial paralysis, mild one side paralysis Patient had initial onset of headache which worsened to left facial droop and left sided weakness pr... Read more
Patient had initial onset of headache which worsened to left facial droop and left sided weakness prompting his presentation and subsequent admission to the hospital. The patient's left sided weakness has resolved, however, his left sided facial droop persists. It includes significant left obicularis muscle weakness and tearing suggestive of LMN etiology (Bell's)
41 2021-04-20 numbness, pain in extremity, feeling hot Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection sit... Read more
Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.
41 2021-04-20 pain in extremity pt say soreness in leg, fatigue since 0411
41 2021-04-20 seizure Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple ... Read more
Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple partial seizure lasting 10 seconds, became incontinent, IV started, A and O x4 , transported to hospital via ambulance
41 2021-04-21 tingling, muscle twitching pins & needles sensation and "twitching" in muscles of bilateral lower extremeties, chest discomfort... Read more
pins & needles sensation and "twitching" in muscles of bilateral lower extremeties, chest discomfort, abdominal pain, headache
41 2021-04-22 muscle spasms, pain in extremity CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous repo... Read more
CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg muscle pulled. On 10-APR-2021, the subject experienced headache daily. On 21-APR-2021, the subject experienced cramping sensation. On 21-APR-2021, the subject experienced bad left leg pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad left leg pain, headache daily, and cramping sensation, and the outcome of left leg muscle pulled was not reported. This report was non-serious.
41 2021-04-23 tingling TINGLING AND NUMBNESS ON LEFT SIDE OF FACE; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous repor... Read more
TINGLING AND NUMBNESS ON LEFT SIDE OF FACE; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced tingling and numbness on left side of face. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on MAR-2021, and had not recovered from tingling and numbness on left side of face, and fatigue. This report was non-serious.
41 2021-04-24 pain in extremity Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath... Read more
Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can't sleep
41 2021-04-25 mild one side paralysis patient reported acute onset of left sided weakness with associated left visual field deficit with l... Read more
patient reported acute onset of left sided weakness with associated left visual field deficit with left sided lateral hemianopsia.
41 2021-04-26 pain in extremity, cold sweat, tremor Day 1-3-headache, body pain, cold sweat, so took tylenol. Day 4-6- hard to walk and leg pain, take t... Read more
Day 1-3-headache, body pain, cold sweat, so took tylenol. Day 4-6- hard to walk and leg pain, take tylenol. Day 7-13- can walk but my leg and hand pains and shaking and headache feel like electric thru my head, take tylenol. Day 13-present- still have leg pain and headache like electric thru my head and my b ody shake itself when i move or stand little while
41 2021-04-27 pain in extremity continuous muscle pain on the left shoulder/neck area. identical feeling to having a crick in the ne... Read more
continuous muscle pain on the left shoulder/neck area. identical feeling to having a crick in the neck
41 2021-04-30 feeling of body temperature change INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned... Read more
INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue. On 23-APR-2021, the subject experienced internal itchiness. On 23-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 11-APR-2021, and was recovering from internal itchiness, and mild chills. This report was non-serious.
41 2021-05-03 night sweats Night sweats, fever, cough, chills, swollen lymph nodes, mass located on lymph node
41 2021-05-04 weakness 5/5/21: "Good morning sorry to bother you had a question about this shot (Janssen Covid19 vaccine). ... Read more
5/5/21: "Good morning sorry to bother you had a question about this shot (Janssen Covid19 vaccine). I have been checking in with that website (V-safe App) you gave me no one has contacted me. Monday (5/3/21) I missed work due to me not feeling good and still today (5/5/21) I'm at work but feel like I could fall asleep, no energy, nausea still, and like I haven't slept in weeks even though I get good sleep. My breathing has gotten to the point that it hurts to take a deep breath. I believe this is all due to the shot but didn't know what you thought."
41 2021-05-04 facial paralysis Approximately 2 weeks after vaccination, patient diagnosed with UTI. Was prescribed a course of Ceph... Read more
Approximately 2 weeks after vaccination, patient diagnosed with UTI. Was prescribed a course of Cephalexin. Patient did not take full course but symptoms resolved one day after initiation. Approximately one week later, he began to experience a metallic taste for about 1.5 days, followed by right sided facial palsy. As of date of this report, facial palsy has not resolved.
41 2021-05-07 tingling, numbness Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 15 minutes post admi... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 15 minutes post administration patient reported numbness /tingling @ left wrist and left hand (outside edge of hand along little pinky finger side).
41 2021-05-08 facial paralysis Cant move a Lot of the left side of face, almost seems like bell palsy., left eye waters a bit as i ... Read more
Cant move a Lot of the left side of face, almost seems like bell palsy., left eye waters a bit as i cant independently blink my left eye, unless 8 close them both...cant move left cheek (can only smile on one side) difficulty drinking since i cant curve my lip on the left..talking challenges (lisp) since it seems im speaking out of one side of my mouth. When eating, a little hard to feel it on the left aide in jaw area.. I have zero pain, just unable to completely move all parts of the the left side of my face in general.. I had my shot on thursday, first felt this on saturday when i woke up.... hasnt gotten any worse, just the same (its 420pm on sunday now) - havent had any treatments, not usre if its temporary
41 2021-05-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted. Responded after about 10 second... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted. Responded after about 10 seconds. Has history of fainting / abscent seizures. Pulse and blood pressure normal immediately after incident occured.
41 2021-05-12 pain in extremity, muscle spasms April 30th began to notice dull ache in calf. At first assumed it was a muscle cramp. The pain beg... Read more
April 30th began to notice dull ache in calf. At first assumed it was a muscle cramp. The pain began to increase through the weekend and into the following week. I went to urgent care on May 6th. They sent me to the ER to get an ultra sound as their preliminary evaluation was that it could be a blood clot. The ER ultrasound confirmed the presence of a superficial thrombosis in my left calf. No blood work was performed. I was told to take ibuprofen and use a heated compress and to wear compression stockings. If the pain grew worse, I was to return to the ER. I scheduled a follow-up with my Primary the next day. Blood tests show all values to be in normal range. I have no history of blood clots and perform cardiovascular exercise on a daily basis.
41 2021-05-13 facial paralysis, mild one side paralysis Patient is 41 year old who presented with right sided upper and lower extremities weakness with fac... Read more
Patient is 41 year old who presented with right sided upper and lower extremities weakness with facial drip , call as code stroke level 1 -CTbrain, CTA showed right basilar ganglia hemorrhage with small volume subarachnoid hemorrhage, left middle cerebral artery thrombosis with left basilar ganglia infarct and right basilar ganglia infarcts. TEE was negative for LV thrombus /vegetation .
41 2021-05-15 paralysis, feeling hot Patient claims 3 minutes after vaccination, his body felt like "it was on fire", he started sweating... Read more
Patient claims 3 minutes after vaccination, his body felt like "it was on fire", he started sweating and he felt like passing out. He also claims he could not move or speak for 30 minutes. The patient then claims he was completely fine after 1 hour and has no reaction today.
41 2021-05-16 bell's palsy BELLS PALSY SX
41 2021-05-16 tingling Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head ... Read more
Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head hurts constantly. Tingling still comes and goes. It?s been 5 weeks after vaccination.
41 2021-05-19 feeling cold, weakness COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRE... Read more
COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.
41 2021-05-19 numbness Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were ... Read more
Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.
41 2021-05-20 weakness REPORTED FAINTING BY WITNESSES, NURSE VISUALIZED DIAPHORESIS, DRY HEAVING, PT REPORTED WEAKNESS.
41 2021-05-24 tingling Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side.... Read more
Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side. Elevated heart rate and fatigue. Dizziness and lack of focus. Overall feeling that something is wrong.
41 2021-05-26 bell's palsy, numbness Numbness and information if left side of face. Diagnosis Bell's Palsey
41 2021-06-05 face paralysis, slurring Patient presented 6/3/2021 with thrombus in the top of the basilar artery. Received IV alteplase. We... Read more
Patient presented 6/3/2021 with thrombus in the top of the basilar artery. Received IV alteplase. Went for mechanical thrombectomy, but catheter angiogram showed resolution of basilar thrombus. He is improving neurologically, currently has some L visuospatial neglect, left lower motor neuron facial weakness and mild dysarthria. He remains hospitalized. This week he will have MRI of brain, cardiac MRI and transesophageal echocardiogram performed. He may have right heart catheterization and closure of the patent foramen ovale.
41 2021-06-06 pain in extremity My arm started getting soar that nigh and persisted the next day followed by two days after that (he... Read more
My arm started getting soar that nigh and persisted the next day followed by two days after that (headache, fatigue, fever). It gradually decreased in pain and on Wednesday it was gone (felt as though I had a rigorous workout). I slept all day Sunday after taking the shot on Saturday! The tele-doctor asked what were my symptoms (allergies and sinus trouble with a cough all the time). He had me to switch allergy medications and my eyes were no longer watering (switched from Zyrtec to Claritin. My eyes were watering so much until I could barely do anything.
41 2021-06-08 pain in extremity 5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini... Read more
5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots
41 2021-06-10 muscle spasms shortness of breathe, fever, chills, muscle spams, headache and diarrhea.
41 2021-06-12 pain in extremity Background:41-year-old male reported that he awakened with right lower leg pain intermittently since... Read more
Background:41-year-old male reported that he awakened with right lower leg pain intermittently since approx. May 10 2021. Woke on June 10 with increased pain and swelling to RLE. He tried to "run it out" but the pain worsened. In the ER he was noted to have elevated D-Dimer- 1980, ESR of 27, labs otherwise normal. Ultrasound showed DVT. He was started on hydrocodone-APAP and Xarelto. Returned on 11 June with SOB. PE was confirmed. Admitted to ICU Note today states continued swelling and pain to RLE. Considering transfer to hospital for vascular consultation and further management.
41 2021-06-16 feeling hot SOB; dizziness; warmness, tingling on left arm (started before vaccination per patient)
41 2021-06-17 cold sweat FEELING FAINT, PALE, SKIN COLD AND CLAMMY, ICE PACK APPLIED TO FOREHEAD STATES FEELING FINE WENT HO... Read more
FEELING FAINT, PALE, SKIN COLD AND CLAMMY, ICE PACK APPLIED TO FOREHEAD STATES FEELING FINE WENT HOME WITH FATHER
41 2021-06-29 face paralysis I63.9 - Cerebral infarction, unspecified R29.810 - Facial weakness
41 2021-06-30 weakness fainting multiple times, significant drop in blood pressure, sent in ambulance to ER, returned home... Read more
fainting multiple times, significant drop in blood pressure, sent in ambulance to ER, returned home that evening but remained very physically weak and had spurts of fever for several days following
41 2021-07-11 grand mal seizure, unresponsive to stimuli, feeling hot Within minutes of receiving vaccination, pt stated he was hot and thirsty, became unrepsonsive to ... Read more
Within minutes of receiving vaccination, pt stated he was hot and thirsty, became unrepsonsive to verbal stimuli. Pt proceeded to have tonic-clonic seizure lasting 25 seconds. Pt lowered to the ground by staff, monitored VS. No incontinence, no biting of tongue. pt regained consciousness, and oriented x3. VSS. pt reported he felt light-headed. When attempted to place in chair, symptoms returned, and pt was placed back in supine position. EMS arrived, and after VS established, EKG indicated sinus rhythm, placed in chair. Pt stated he did not feel good, and similar symptoms began with eyes rolling back and contractures. Pt taken to hospital.
41 2021-07-11 pain in extremity, nerve pain Pain started at elbow and shot down to the wrist and hand. Worsened with time. Could not lift anyth... Read more
Pain started at elbow and shot down to the wrist and hand. Worsened with time. Could not lift anything, had to wear a sling to avoid movement and pain has not fully gone away until now. It's lessened, but I have to avoid doing many things with my left arm now. Diagnosed with Compression of right radial nerve, left lateral epicondylitis, left ulnar nerve irritation on Friday April 23, 2021.
41 2021-07-12 tremor, feeling cold Woke up on morning after shot with uncontrollable shaking. I ended up needing to lay under several b... Read more
Woke up on morning after shot with uncontrollable shaking. I ended up needing to lay under several blankets in order to feel warm and stop shaking. My temperature was normal and shaking was not due to a fever. The shaking stopped about 15 hours after I received the shot but then I continued to have a headache and extreme fatigue. The following day (about 48 hours after injection) I had an extremely high pulse. I took both my blood pressure and was able to take an EKG using a EKG recorder. Both devices came back that I was having an irregular heartbeat. I repeated both tests about a half dozen times and they kept coming up the same indicating an irregular heartbeat. I have never had an irregular heartbeat before in the past. Finally after a couple of hours my heart rate slowed and the irregular heartbeat went away. As of right now (6 days post injection) it has not come back.
41 2021-07-19 nerve pain, muscle spasms, numbness NUMB IN HANDS; SHOCKING PAIN/EXTREME PAIN; NEUROPATHY PAIN; CRAMP IN HANDS AT NIGHT; This spontaneou... Read more
NUMB IN HANDS; SHOCKING PAIN/EXTREME PAIN; NEUROPATHY PAIN; CRAMP IN HANDS AT NIGHT; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 240 pounds, and height was 76 inches. The patient's concurrent conditions included diabetes, high dose penicillin allergy, adhesive tape allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had otc drug allergy. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 21-MAR-2021, the subject experienced shocking pain/extreme pain. On 21-MAR-2021, the subject experienced neuropathy pain. On 21-MAR-2021, the subject experienced cramp in hands at night. On 02-JUL-2021, the subject experienced numb in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy pain, shocking pain/extreme pain, cramp in hands at night, and numb in hands. This report was non-serious.
41 2021-07-22 tremor, burning sensation, feeling cold, feeling hot, numbness, muscle spasms SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WE... Read more
SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has 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: 205A21A and 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 headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.
42 2021-03-04 pain in extremity, numbness, flushing When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache be... Read more
When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity
42 2021-03-06 weakness have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy,... Read more
have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest
42 2021-03-07 muscle spasms Reports slight muscle spasm on injection site
42 2021-03-07 night sweats, pain in extremity About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle... Read more
About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.
42 2021-03-07 tingling 20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs t... Read more
20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs to bilateral arms and hands. Patient reports fatigue and headache. Patient able to hydrate with water. After 1 hour of observation, patient reports symptoms improved significantly. Patient informed to take Acetaminophen/Ibuprofen, to consume food/fluids and rest. Advised to follow up with primary care physician. Advised to call 911 if symptoms persist or respiratory distress. Patient declined transportation to hospital for evaluation. Patient reports able to drive home safely which is about 10 minutes away. Patient was ambulatory upon discharge. BP 118/80. HR 82.
42 2021-03-11 unresponsive to stimuli Fainting, sweating, blood sugar dropped, unresponsive.
42 2021-03-13 cold sweat, tremor I had the vaccine at 4:00 PM. I woke up at 12:05 AM with severe chills that turned into uncontrollab... Read more
I had the vaccine at 4:00 PM. I woke up at 12:05 AM with severe chills that turned into uncontrollable shaking for the next hour and twenty minutes. The shaking stopped at that time and my temperature went from 101.1 to 102.5. My skin was warm and I began to be very clammy. Around 3:45 AM, the fever broke and I was down to 99.5. I?ve subsequently had muscle aches and the feeling of being fatigued.
42 2021-03-14 muscle spasms severe headache feeling very tired muscle cramping and muscle aches
42 2021-03-23 feeling cold, cold sweat Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to slee... Read more
Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to sleep. By 9 pm I was alternating between hot and cold sweats. By 10 pm I was vomiting and defeating uncontrollably while still alternating between hot and cold sweats. I dry heaved until around 3 am and then finally passed out. My fever never exceeded right about 100 degrees. For the next 2 days I was incredibly exhausted with muscle aches and a minor headache. I didn?t return to baseline for approximately 6 days after the shot.
42 2021-03-24 feeling cold Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain l... Read more
Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain level to 10. Fever, chills, naseau, dizziness, tiredness.
42 2021-03-25 tremor Muscles started to shake mildly, 8-10 hrs later. Next day Severe HEADACHE. Not pounding, but stiff... Read more
Muscles started to shake mildly, 8-10 hrs later. Next day Severe HEADACHE. Not pounding, but stiff pressure on both sides of temples. Treatment was 2 IB motrin, Slept for an hour and felt GREAT afterward. By 3 pm I was in great shape, no other issues to report even after 10 hours have past.
42 2021-04-03 tremor, weakness Headache, chills, fever, weakness, shakiness
42 2021-04-04 burning sensation Burning behind knees and elbows, skin irritation feels like was on fire
42 2021-04-06 feeling hot After the initial 12 hour period, I experienced night-time chills followed then by being too warm an... Read more
After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats. This happened both the first and second night. During the day I was taking Tylenol every 6 hours for aches and pain. Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy. The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times). The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack. I mention the last symptom as I have never had an episode like this previously in my life. Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.
42 2021-04-06 pain in extremity, tingling KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART R... Read more
KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
42 2021-04-07 weakness Patient received covid vaccine at 12:56pm on March 31, 2021. At 1:00pm he sat down on the floor. H... Read more
Patient received covid vaccine at 12:56pm on March 31, 2021. At 1:00pm he sat down on the floor. He remained conscious but complained of feeling dizzy. HR was 40. Staff was able to assist pt into a wheelchair and escort him into a private side room. Pt was assisted onto a cot and his legs were elevated. At 1:05 his BP was 130/75 and HR 60's. Patient's skin at 1:06pm appeared pink and WNL. 1:13pm = BP 115/75 and HR 67. 1:23pm = 130/75 HR 68. Patient denied shortness of breath/chest pain throughout the entire episode and did not lose consciousness. At 1:23 patient stated he no longer feels faint, just a bit weak. At 1:24pm patient dangled on cot. 1:27pm = 130/80, HR 70. 1:33pm = left facility in the care of his mother who is driving. He stated he feels a little weak, but not faint or dizzy. He left ambulatory. He refused transport or the need for additional medical care. Follow up call was placed to pt on Friday, 4/2/21. Pt denied any residual effects and stated he is at baseline.
42 2021-04-07 cold sweat Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair.... Read more
Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.
42 2021-04-07 feeling hot, burning sensation, cold sweat, tingling, pain in extremity, numbness and pain in extremities, hypersensitivity of all senses 3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still c... Read more
3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms. 3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain 4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
42 2021-04-07 feeling hot DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 ... Read more
DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included unspecified medical history from military service. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 31-MAR-2021, the subject experienced did not sleep. On 31-MAR-2021, the subject experienced feeling hot. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep on 01-APR-2021 and the outcome of feeling hot was not reported. This report was non-serious.
42 2021-04-08 cold sweat, feeling cold He got cold and clamy and passed out in the chair with head slumped. His wife rubbed his chest and ... Read more
He got cold and clamy and passed out in the chair with head slumped. His wife rubbed his chest and spoke to him and I, waved ammonia inhalants under his nose. He immediately came to. We got him a bottle of water and a snack (he had not eaten yet today). I also checked his blood pressure and it was normal. We had him sit a little longer until he felt better. We initially called an ambulance, but called it off at his request.
42 2021-04-09 weakness dizziness, lightheadness, pt felt weak and like he was going to pass out
42 2021-04-09 weakness Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the... Read more
Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the vaccine, headache and weakness for several days after injection. Resolved after about a week.
42 2021-04-10 tremor Started with a mild rash on my neck, shoulders, head and inner thighs. After about 30 minutes of not... Read more
Started with a mild rash on my neck, shoulders, head and inner thighs. After about 30 minutes of noticing that I started getting tremors for about 30-45 minutes in my legs. All symptoms started at 7:15pm cst amd lasted until 9pm cst. No symptoms after that.
42 2021-04-11 cold sweat Vasovagal / syncope episode with subsequent fall to the ground, striking head; taken to the Emergen... Read more
Vasovagal / syncope episode with subsequent fall to the ground, striking head; taken to the Emergency Department, stated prior to syncopal episode felt lightheaded, sweaty, clammy. Patient discharged to home within 3 hours of ED admission.
42 2021-04-11 cold sweat Vasovagal / syncope with subsequent fall to the ground, striking head; transferred to Emergency Depa... Read more
Vasovagal / syncope with subsequent fall to the ground, striking head; transferred to Emergency Department - stated lightheaded, dizziness, clammy prior to syncope and fall. Patient discharged to home in stable condition from facility within 3 hours.
42 2021-04-11 feeling cold My initial symptoms were light swelling a region around the shoulder of my injection arm and excessi... Read more
My initial symptoms were light swelling a region around the shoulder of my injection arm and excessive sweating in the armpit on my injection arm side. Following this, symptoms similar to being on a hallucinogenic gradually manifested over the next several hours, including euphoria, a persistent urge to grind teeth, and some mild-to-moderate visual and physical effects. Following the date of the injection, the primary symptom has been a bruise/cramp hybrid pain in the upper arm of the injection site that is gradually receding (but still ongoing), along with random light bouts of nausea and headaches, random light pains throughout my injection arm, and occurrences of coldness in my injection arm (lasts about an hour)
42 2021-04-12 weakness Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly afte... Read more
Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.
42 2021-04-12 pain in extremity, night sweats NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spon... Read more
NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
42 2021-04-12 pain in extremity Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it... Read more
Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.
42 2021-04-12 tingling About 45 minutes after, my left arm started to feel like there was pins and needles all the way down... Read more
About 45 minutes after, my left arm started to feel like there was pins and needles all the way down to my finger tips, and I started to feel very lethargic on and off for 2 days and I also had a few rounds of tachycardia. As of Monday I have developed severe lower back pain
42 2021-04-12 seizure Two different Seizures one on March 15th and the other on April 5th
42 2021-04-13 muscle spasms Dehydration and body cramps mainly in legs
42 2021-04-13 pain in extremity Headache fever leg pain left chest pain
42 2021-04-14 grand mal seizure 2 grand mal seizures the day after shot, mild (99 degree) fever the night of shot
42 2021-04-14 pain in extremity, weakness, tingling At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I wa... Read more
At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I was at the doctors clinic for an appointment and suddenly felt tingling on the left side, temporal area, after some minutes start having rapid heart rate and blood pressure was high, felt lightheaded, weak. The symptoms last for few minutes.
42 2021-04-14 pain in extremity Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medi... Read more
Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medical history. 4.10.21: Went to ED on 4.10.21 - for hematuria. CHIEF COMPLAINT: BLOOD IN URINE (patient reports hematuria an hour prior to arrival along with spitting up a large clot (hemoptysis). denies rectal bleeding at this time. denies being on a blood thinner. c/o back pain starting a few hours ago. HX aortic aneurysm and scheduled to get surgery in a few weeks. )Urinalysis returned showing moderate amount of blood was 73 RBCs. Patient did not have frank hematuria on specimen. Patient's laboratory work otherwise remains unremarkable. Electrolytes within normal limits. Patient has a stable hemoglobin of 13.8. CT scan showed evidence of acute aortic dissection. There were scattered faint ground-glass opacities along the right upper lobe as well as left upper lobe. COVID-19 testing was added on after results. At this time I do not have a great explanation for the patient's hematuria. I did instructed to follow up with Urology for further evaluation of this. He is hemodynamically stable I do not believe further testing is warranted at this time. Return precautions were discussed including urinary retention, large volume bleeding or any other concerning symptoms. He voiced understanding of this and was discharged stable condition. He was provided a work note as he is on probation and it is for her of his hospitalization at this time. 4.13.21: Went to ED on 4.13.21: CHIEF COMPLAINT: LEG PAIN (pt c.o. right leg swelling/pain that started 3 days ago; had johnson&johnson vaccine on 3/24 and is concerned for blood clots; supposed to have surgery at the end of the month; recently seen for blood in urine; c.o. generalized body aches)42-year-old male presents with right calf pain and reported swelling. On presentation patient is well-appearing and nontoxic, afebrile, hypertensive 134/113 with otherwise normal vital signs. On exam, the patient has no swelling in the bilateral lower extremities, he does have very mild tenderness to palpation in the right posterior proximal calf just below the knee. Remainder of physical examination is otherwise unremarkable. Given history of blood clot and reported right calf pain, right lower extremity duplex venous ultrasound ordered to evaluate for DVT. EKG was obtained on arrival, and showed normal sinus rhythm with no evidence of ST segment elevated for depression, no dysrhythmia, no comparison when compared with prior EKG from July 2019. Right lower extremity ultrasound showed no evidence of DVT. I shared results of the workup with the patient and told him that there is no indication for further workup or treatment at this time. I recommended Tylenol or Motrin as needed for right leg pain. I recommended compression stockings as needed for right leg swelling. I encouraged him to follow up with all specialists physicians as previously scheduled and with his primary care physician as needed. Office visit 4.14.21: Subjective: a 42 yr.. male evaluated with a video visit on 4/14/2021 Currently he complains of headache, hot/cold flashes (no fever), nasal congestion, and Bilat ear pain. R leg is swollen. The symptoms have been present for 2 day(s). Was incarcerated - has been out for about week. He denies a history of chills and fevers He has tried acetaminophen, Flonase for his symptoms. Sick Contacts: none known History is provided by patient There is history of asthma or recurrent respiratory infections. Went to the ER yesterday and 4/10 Had his J&J vaccine: 3/24 COVID19: negative 4/10
42 2021-04-15 pain in extremity SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; This spontaneous report received ... Read more
SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; This spontaneous report received from a patient concerned a 42 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) UNKNOWN. 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 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced total body muscle aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, fever, and total body muscle aches on 10-APR-2021, and had not recovered from fatigue, and sore arm. This report was non-serious.
42 2021-04-16 pain in extremity Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Mon... Read more
Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Monday and continues today, 5 days later
42 2021-04-17 pain in extremity 1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd A... Read more
1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd Adverse Event 4/16/2021 Left posterior knee pain, pain is still present but pain level has decreased, no treatment 3rd Adverse Event 4/16/2021 Left supraclavicular tender and enlarged lymph node for 2 days, no longer tender but lymph node is currently slightly enlarged, no treatment.
42 2021-04-19 tremor HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous rep... Read more
HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 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: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
42 2021-04-20 pain in extremity First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle ache... Read more
First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle aches. Nothing major that kept me from working or sleeping. Some time after, maybe 3rd or 4th day, I noticed a shortness of breath. This I did not expect since it's not a listed side effect for the vaccine but it is one for Covid. I notice it everyday while sitting/working. It does not keep me from being active (running/yard work) but I notice I'm not 100% healthy feeling. It feels like the shortness of breath is closer to the top of the chest/throat area if that makes any sense. If I breathe deeply it feels like I may want to cough although I don't usually cough from doing so. It's mostly just a constant feeling of a very slight shortness of breath.
42 2021-04-21 pain in extremity Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12t... Read more
Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12th.)
42 2021-04-22 tremor PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKIN... Read more
PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
42 2021-04-26 face paralysis, sciatica, facial paralysis On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Cloth... Read more
On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.
42 2021-04-26 numbness, muscle spasms, pain in extremity NECK LOCKED UP; ARM DEAD; PAIN ABOVE ELBOW; HIGH FEVER; SHEETS COMPLETELY SOAKED; This spontaneous r... Read more
NECK LOCKED UP; ARM DEAD; PAIN ABOVE ELBOW; HIGH FEVER; SHEETS COMPLETELY SOAKED; This spontaneous report received from a consumer concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 sheets completely soaked. On APR-2021, the subject experienced high fever. Treatment medications included: diazepam, and lidocaine. On 15-APR-2021, the subject experienced neck locked up. On 15-APR-2021, the subject experienced arm dead. On 15-APR-2021, the subject experienced pain above elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever on APR-2021, was recovering from neck locked up, had not recovered from arm dead, and pain above elbow, and the outcome of sheets completely soaked was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
42 2021-04-26 seizure, grand mal seizure Headache from 4/14/21 to 4/24/21, tonic-clonic seizure on 4/24/24 admitted to hospital on 4/24/24
42 2021-04-27 tingling Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermitte... Read more
Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermittent pins and needles. Received Janssen COVID vaccine on 4/12/21 at an outside facility. Diagnostic workup revealed Cerebral Vascular Accident (CVA).
42 2021-04-29 weakness Patient vaccinated with J&J vaccine 3 weeks ago with 4.5 weakness and decreased mobility in the arm ... Read more
Patient vaccinated with J&J vaccine 3 weeks ago with 4.5 weakness and decreased mobility in the arm that he received vaccine in- cannot lift arm above shoulder . No inflammation noted
42 2021-04-29 muscle twitching, tremor fever of 102, body aches, muscle twitching and shaking, extreme sweating, started approx. 10pm, feve... Read more
fever of 102, body aches, muscle twitching and shaking, extreme sweating, started approx. 10pm, fever broke approx 7am, still having muscle twitching and body aches
42 2021-05-01 feeling cold, cold sweat, weakness Patient started filling dizzy about 10 minutes after vaccine. He felt weak and tired and also start... Read more
Patient started filling dizzy about 10 minutes after vaccine. He felt weak and tired and also started sweating profusely. Skin was cold and clammy to the touch. I checked his BP and it was 89/53. I called 911 as precautionary and ems arrived within 5 minutes. Patient had stopped sweating by then and was able to stand and walk with EMS to another area of the store to be evaluated further and monitored.
42 2021-05-02 feeling hot warm feeling, light headed
42 2021-05-05 tenderness Complain of headache to right back side of head and reports its moving to front of head. Reports it... Read more
Complain of headache to right back side of head and reports its moving to front of head. Reports its started on Monday. Was using ice packs and heating pads. Reports 10/10 on pain scale. Reports his head is tender to touch in the back. Denies any head injuries recently.
42 2021-05-06 migraine Hours later I experience a crushing migraine, chills, fever, body aches, and soreness through the ni... Read more
Hours later I experience a crushing migraine, chills, fever, body aches, and soreness through the night for the next 14+ hours
42 2021-05-08 pain in extremity Fever spiked at 101.9 14 hours after the shot but has was completely gone 28 hours after the shot. ... Read more
Fever spiked at 101.9 14 hours after the shot but has was completely gone 28 hours after the shot. Mild headache the day following the shot. Arm is mildly sore two days after the shot.
42 2021-05-11 flushing, unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-S... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.
42 2021-05-13 cold sweat, feeling hot started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, ... Read more
started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, was hot and thirsty, I gave him cool wet papertowels, and ice pack a few sips of water and had him sit in imz booth while I talked to him and watched him. He felt better and had his ride pick him.
42 2021-05-19 pain in extremity Right toe began hurting on May 8. 3 out of 10 pain. No redness or warmth. Fever (103 F), body aches... Read more
Right toe began hurting on May 8. 3 out of 10 pain. No redness or warmth. Fever (103 F), body aches, and fatigue on May 8. Took Tylenol 500 mg TID that day. No fever, body aches on May 9 but fatigue remained. Fatigue remains mild to moderate. Right toe continues with discomfort.
42 2021-05-19 pain in extremity I experienced three days later bilateral leg pain, left greater than right., I also had headaches th... Read more
I experienced three days later bilateral leg pain, left greater than right., I also had headaches that were constant. I went to urgent care where they did exams. I can say that to this day I still have leg pain, L>R and some headaches that come and go.
42 2021-05-20 pain in extremity Patient is a 42 y/o male residing. At approximately 4: 40PM received a Johnson and Johnson Janssen... Read more
Patient is a 42 y/o male residing. At approximately 4: 40PM received a Johnson and Johnson Janssen vaccine in the left from . Client approached this nurse at 5:37PM complaining of pain in his left arm. Client described pain as ?pressure? in his left upper and lower arm and the pain radiated to the left side of his neck and left jaw. Client was alert and oriented; client was had no diaphoresis and client color was within normal limited; reparations deep even and unlabored; heart rate 70 bmp and pulse were strong and regular. Explained to client the need to call 911 and client refused.5:40PM Client remained alert and oriented without change in physical appearance; heart rate 80 bmp and pulse remained strong and regular. Resident denies any routine medications. Reports he had ibuprofen twice during the day from the staff. Client reports he had been clean from cocaine use for the last 6 weeks. 5:40PM Had Program Assistant/Counselor summoned to the room and explained to Patient client's refusal for 911 assistance. Patient was able to get client to agree to a 911 call. At 5:45PM 911 was called. 5:55PM Paramedics arrived and assessed client. According to paramedics? EKG and vital signs ?looked good?. Paramedics suggested client go to the emergency room for further evaluation; client declined. Paramedics explained to client the risk involved in refusing additional assessment by the emergency room. Client verbalized he understood the risks he was taking by refusing transportation to the emergency room. 5/21/2021 approximately 11AM Called to follow up with client; was not in but spoke with Manager. According to has no residual effects and was ?up and about? as usual.
42 2021-05-21 cold extremities Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessi... Read more
Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.
42 2021-05-22 numbness, nerve pain Nerv and pain loss of feeling headaches
42 2021-05-22 pain in extremity I, am reporting this VAER on behalf of my brother who is currently incarcerated in a state correctio... Read more
I, am reporting this VAER on behalf of my brother who is currently incarcerated in a state correctional facility in PA. During a phone call a few days following his vaccine, he told me that his continues to experience shoulder pain and issues with range of motion following administration of the J&J COVID vaccine. When he first informed me, I asked him if the discomfort he was feeling was expected pain and discomfort at the injection site, to which he responded no. He reports that a couple days following administration upon stretching when waking he experienced shooting left upper arm/shoulder pain and reduced ROM the arm in which he received the vaccine. I am reporting this adverse event as he is still having this issue.
42 2021-05-22 seizure Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passin... Read more
Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passing out , ambulance had to come get me from vehicle and take me to emergency room in the hospital, kept me there for about 6 hours then released me to go home, went to my Doctor next day and he immediately sent me to hospital. I was checked for Blood Cloth due to the signs being there along with other tests I am home however I still do not feel well.
42 2021-05-24 pain in extremity, burning sensation This is to report my side effects since the vaccine shot, because I haven?t heard any of these regar... Read more
This is to report my side effects since the vaccine shot, because I haven?t heard any of these regarding this vaccine. Lower leg below the knee on the left and right leg varicose veins have constantly burned and ached. Only my right leg had previous varicose veins that would burn ache in the evenings following a day of manual labor. From Friday morning to Monday late night my left temple would randomly throb. Same days either my lower left or right lung would ache or be sore. For about 2 hours everyday same days above I would have a metallic taste in my mouth no matter what I ate or drank. No pain ever severe enough for immediate medical attention
42 2021-05-24 tremor I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. ... Read more
I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.
42 2021-05-26 numbness, tingling, electric shock sensation, pain in extremity Soreness in feet, ankles and calves starting on March 24th, then soreness started progressing up the... Read more
Soreness in feet, ankles and calves starting on March 24th, then soreness started progressing up the body with numbness and tingling within my trunk, skull, arms, hands, legs and feet. Lightning Strikes throughout my whole body
42 2021-05-26 pain in extremity, muscle spasms 11 days following the single shot I developed severe pain in my right calf muscle that felt like a c... Read more
11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.
42 2021-06-03 unresponsive to stimuli, tingling Reported he walked to health department from home. After administration of vaccine, complained of ti... Read more
Reported he walked to health department from home. After administration of vaccine, complained of tingling in right hand and wrist at 1544. Drank some bottled water. Complained of feeling sleepy and a headache. Began nodding off and then became unresponsive. BP at 1600: 98/78. Pulse: 80. BP at 1607: 100/70. Pulse: 72. Was beginning to rouse around this time but drowsy. Respirations 16. BP at 1615: 86/60. 911 called. Taken to hospital via ambulance at 1628.
42 2021-06-08 pain in extremity Pain in left arm, fever, tiredness
42 2021-06-09 migraine Migraine, fever, chills, muscle pain, joint pain
42 2021-06-10 nerve pain, numbness HYPOAESTHESIA; NEURALGIA; HEADACHE; This spontaneous report received from a health care professional... Read more
HYPOAESTHESIA; NEURALGIA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [VAERS FDA Inbound Unit] concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and illness at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 265AZ1A 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 hypoaesthesia. On 30-APR-2021, the subject experienced neuralgia. On 30-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, hypoaesthesia, and neuralgia. This report was non-serious.
42 2021-06-14 cold sweat PATIENT FELT DIZZY, LIGHTHEADED, GOT VERY COLD AND CLAMMY, WAS "OUT OF IT" FOR A FEW MINUTES. TREATE... Read more
PATIENT FELT DIZZY, LIGHTHEADED, GOT VERY COLD AND CLAMMY, WAS "OUT OF IT" FOR A FEW MINUTES. TREATED BY LAYING PATIENT DOWN, GIVING COLD WATER, AND MAKING SURE SAFE AND NO AMBULANCE NEEDED. RECOVERED SOON AFTER.
42 2021-06-14 unresponsive to stimuli Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feelin... Read more
Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feeling dizzy, appeared pale and slightly diaphoretic. Pt had witnessed syncopal episode at approximately 08:50. Pt seated with nurse and site employees at side to assist in ensuring safety. No injury occurred. Syncopal episode duration approximately 30 seconds. Pt became unresponsive, bradycardic and slightly hypotensive. Vitals: 110/55, 50, 13, 98%. EMS activated, PD called, and Capt called to be made aware of situation. Pt given Gatorade 150 ml and endorsed prior syncopal episodes with vaccines and blood draws. 8:53- Pt able to sit upright independently, drink fluids w/ no complication, AAO x4. Pt vital signs stabilized within 5 minutes with no other interventions other than PO fluids. PD arrived onsite 8:56, asked pt if he required medical assistance, pt declined. PD officer given report by lead RN. RA 51 arrived 8:58, report given by lead RN, pt evaluated, performed EKG finding NSR, and fingerstick glucose result of 163. 09:00- pt reports dizziness resolved, and declined transport to hospital by PD and signed AMA. 09:45 pt remained continuously monitored by site RNs, along with PD assessment. Pt exited site ambulatory with no further incidents accompanied by wife.
42 2021-06-20 grand mal seizure Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus... Read more
Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus buildup (nose and back of throat throughout the day), regular headaches, depression, loose stool, eye redness, and tonsil stones (couched up daily). Events/symptoms after vaccine: tonic-clonic seizure (twice admitted to Hospital last event on 5/31/2021), petite-mal seizure (not admitted to hospital but noted by others in household), severe pounding headache (on and off in middle and back of cranium)
42 2021-07-10 hypersensitivity of all senses Symptoms of extreme skin pain on extremities (Hands, Feet, Knees, Face) upon being exposed to cooler... Read more
Symptoms of extreme skin pain on extremities (Hands, Feet, Knees, Face) upon being exposed to cooler temperatures. Symptoms of extreme pain upon being brushed against or scratched causing feelings of being cut on skin. Symptoms started approximately 2 weeks after receiving COVID19 Vaccination- Johnson and Johnson.
42 2021-07-12 migraine I have been getting migraines since the vaccine. I get 3-5 every week and I NEVER had them before. ... Read more
I have been getting migraines since the vaccine. I get 3-5 every week and I NEVER had them before. They especially occur when pushing like going to the bathroom.
42 2021-07-12 tingling BEGINNING ABOUT 1 WEEK AFTER VACCINATION PATIENT BEGAN EXPERIENCING MUSCLE WEAKNESS AND TINGLING IN ... Read more
BEGINNING ABOUT 1 WEEK AFTER VACCINATION PATIENT BEGAN EXPERIENCING MUSCLE WEAKNESS AND TINGLING IN THE LEFT ARM, HAS PROGRESSIVELY GOTTEN WORSE AND HAS IMPACTED DAY TO DAY ACTIVITY
42 2021-07-12 cold extremities, cold sweat, pain in extremity In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (... Read more
In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.
42 2021-07-13 nerve pain The first day after the vax was fine, but towards the end of the day I felt strange. Half way throu... Read more
The first day after the vax was fine, but towards the end of the day I felt strange. Half way through the second day, my pancreatitis came back with a vengeance for about a month, along with whole body inflammation for about a week, resufacing of neuralgias and other pain also. The first week was the worst. The whole body inflammation went away after a week. But the pancreatitis flare up was worse than experienced before, and the amount of pain increased since the injection of the pancreas has increased by about 10 to 15 %, and has not returned to pre-vaccination levels. I am taking more tramadol than ever now. I WILL NEVER GET A COVID VACCINE AGAIN.
42 2021-07-14 weakness, muscle spasms, bell's palsy, pain in extremity, facial paralysis, tingling April 24 rush to ER because of urine retention then april 28 he started with facial paralisis wich ... Read more
April 24 rush to ER because of urine retention then april 28 he started with facial paralisis wich the doctor said it was bellpalsy but 1 week after all that he lost all the strenght on his legs he was using Foley cateter sin april 24 thrue may 21 and now he could barely move he has limited balance i have to take him out of bed hold him he could not be seat because he feel sever pain on his legs an feets and sever cramps and tingling
42 2021-07-14 pain in extremity, numbness 5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, di... Read more
5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, didn't leave bed 6/9/21 - Severe side pains and bloating below rib cage 6/16/21 - Woke up to 10/10 pain in my abdominal region, felt like knives were being stuck directly under my rib cage, around this same time, I noticed that both of my inner legs, from roughly my ankles up was going numb to the touch, severe stomach bloating as well 7/6/21 - Everything described for 6/16/21 progressively getting worse to the point where my legs were so sore that I can barely climb up stairs, can't eat much so went to the ER. During the visit they didn't address my leg issues, released me with diuretics to deal with bloating (which have not helped). My stomach is generally bloated anywhere from 50-75% and I have pain in my stomach , legs, and shoulders and seem to be losing muscle and a rapid rate. I'm a healthy eater so all of this is very unusual and extremely concerning. I cannot work as well.
42 2021-07-15 feeling hot Patient reports feeling hot and warm all over body. Reported itching on palms of hands, nurse notice... Read more
Patient reports feeling hot and warm all over body. Reported itching on palms of hands, nurse noticed sizable welts. Patient contacted his PCP and PCP recommended giving patient 2 doses of Benadryl. Patient was given 2 doses of Benadryl per PCP request and reported feeling better.
42 2021-07-18 tingling Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresth... Read more
Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresthesia worsened to both sides of my face and has not gone away; have experienced this for 10 weeks now. Also experiencing sporadic parethesia in right forearm down to fingers, and right calf down to toes. I have also experienced intermittent bouts of muscle fatigue/weakness in arms and legs, as well as lightheadedness.
42 2021-07-19 pain in extremity Developed muscle pain in left leg. No swelling, tenderness, or visible signs of issue. Other symptom... Read more
Developed muscle pain in left leg. No swelling, tenderness, or visible signs of issue. Other symptoms from vaccine have resolved, but this area is still sore. States it feels like a pulled muscle. Patient was advised to seek medical care if symptoms have not resolved soon.
42 2021-07-21 tingling, weakness, numbness Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21)... Read more
Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21). This then progressed to numbness in lower body (4/12/21), the numbness then became weakness and inability to walk (4/26/21). I was then hospitalized 5/5/21 and had many, many tests. Ultimately I have been diagnosed with neurosarcoidosis and am currently undergoing treatment.
42 2021-07-27 pain in extremity Patient has history of MS well controlled with Cosentix injections. Patient reports approximately on... Read more
Patient has history of MS well controlled with Cosentix injections. Patient reports approximately one week after taking vaccine he began experiencing pain in his feet and ankles. Reports the pain has ascended to lower back and reports he can no longer lift heavy objects and cannot perform required duties for his occupation. Denies numbness, tingling, burning. Difficulty with walking, especially distances or stairs. Reports pervasive fatigue and sleeping until late in the day but waking up exhausted.
42 2021-07-28 numbness, tingling MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE THIGHS; NUMBING SENSATION T... Read more
MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. 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 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.
43 2021-03-06 tremor Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hosp... Read more
Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night
43 2021-03-09 numbness AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, d... Read more
AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home
43 2021-03-11 hot flush, tremor Moderate Headache Shaking Chills Fever Sweating Hot Flashes Injection Site Soreness Fatigue
43 2021-03-12 feeling cold About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday M... Read more
About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday Mar 13th.
43 2021-03-12 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Jan... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \"mental\" and does not attribute it to the vaccine itself.
43 2021-03-17 weakness Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense h... Read more
Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense headache that dulled after about 24 hours, but has persisted for 4 + days at this point. It is now day 5, and I still feel quite weak and my headache, though getting better, persists. I experienced dizziness on days 1 and 2 that has also dulled, but has not quite fully resolved. Frequent urination on days 1, 2, and 3.
43 2021-03-26 pain in extremity Fever, headache, sore arm
43 2021-03-27 tremor, weakness 103 degree fever, uncontrollable chills/shaking, headache, nausea, body aches, dizziness, weakness. ... Read more
103 degree fever, uncontrollable chills/shaking, headache, nausea, body aches, dizziness, weakness. Fever lasted 36 hours, aches and headache lasted 48. Felt like the worst flu of my life. Sickest I've felt in 10+ years.
43 2021-04-03 weakness Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpi... Read more
Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.
43 2021-04-05 seizure While waiting 15 minutes after receiving the shot patient suffered a seizure roughly 5 minutes after... Read more
While waiting 15 minutes after receiving the shot patient suffered a seizure roughly 5 minutes after receiving the vaccine. Seizure lasted approximately 10 seconds. Paramedic was on site and assisted in monitoring the patient until ambulance arrived. While waiting patient was sweating, nauseas and 'didn't feel well'. Patient suffered a second smaller seizure before the ambulance arrived. Patient was monitored and taken to ER.
43 2021-04-05 tremor Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands... Read more
Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands began shaking and eyes were moving erratically. Patient would not respond to verbal commands so called 911. The patient came responsive about 1 minute later and had no recollection of the event. Pharmacist checked bllod pressure and it was low (97/46 ) and upopn recheck in 3 minutes it was high (199/90). Paramedics arrived and patient said he felt fine at that point but he would still go to hospital to get checked out.
43 2021-04-06 weakness Fever (101.5), Chills, Aches, Headache, Racing heartbeat for about 4 hours and then started to get a... Read more
Fever (101.5), Chills, Aches, Headache, Racing heartbeat for about 4 hours and then started to get a bit better. Took Tylenol and slept. Next morning felt weak and achey, but better. Was find within 24 hours
43 2021-04-06 tremor Body temperature increase to 102.5 degrees Fahrenheit. Shaking, fever, and severe fatigue and sweat ... Read more
Body temperature increase to 102.5 degrees Fahrenheit. Shaking, fever, and severe fatigue and sweat all over body.
43 2021-04-07 feeling hot Lightheaded, slight nauseau, feeling of heat
43 2021-04-07 hot flush Body aches, chills, hot flashes, fever
43 2021-04-08 feeling hot Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all hi... Read more
Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all his vital signs are fine, he called to let us know that he is at home and is feeling well.
43 2021-04-08 pain in extremity Metal taste in mouth with soda, water, coffee. 26 hours after vaccine and still have the metal tas... Read more
Metal taste in mouth with soda, water, coffee. 26 hours after vaccine and still have the metal taste. It started right away. I also had a sore shoulder that has turned into a sore arm.
43 2021-04-08 tingling I have a strange pin prick feeling in the top of my head that only exhibits pain when my facial expr... Read more
I have a strange pin prick feeling in the top of my head that only exhibits pain when my facial expressions or other movements cause my scalp to be moved or stretched. When I try to feel for something poking the top of my head, there is nothing there and touching the area does not cause pain. But then I may look to the right and frown, and suddenly there is a sharp needle feeling in the top of my head.
43 2021-04-09 weakness, tremor Fever, Shakiness, Hight Blood Pressure, up to 166/85, Weakness overall.
43 2021-04-09 cold sweat Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a... Read more
Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on right deltoid, given by RN. Immediately following the vaccination at 2:40 pm, Patient reportedly slumped his head forward in his seat and was caught by RN, sustaining zero physical bodily injuries. The patient was unconscious for approximately 2 seconds. EMT'S responded immediately at 2:40 pm and took the patient's vitals. At 2:40 pm, the patients vitals were: 117 systolic BP and HR 89 (EMT unable to hear the diastolic BP due to environmental noise). The patient appeared diaphoretic, pale, with warm, clammy hands and a weak radial pulse. The patient was given a water and tolerated intake of water. The patient was assisted by EMT to a anti-gravity chair at 2:43pm. The patient was observed to have a steady gait and reporting no dizziness. At 2:44 pm, the patient's vitals were: HR 54 and 110 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:50, the patient had a strong, bounding radial pulse with a HR of 70 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:55 pm, the patient's vitals were: HR 75 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At this time the patient reports feeling "better". At 3:00 pm the patient's vitals were: HR 81 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:05 pm the patient's vitals were: HR 77 BPM and 120 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:10 pm the patient's vitals were: HR 74 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:15 pm, the patient was assisted up from anti-gravity chair. The patient had a steady and balanced gait. The patient denied any additional dizziness, lightheadedness, or nausea. EMT provided patient with education related to when to call his HCP (i.e. dizziness, itching of throat). The patient reported he was "ok to drive home" and left to the parking lot at 3:15 pm.
43 2021-04-09 tenderness, pain in extremity PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN I... Read more
PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.
43 2021-04-10 unresponsive to stimuli, depressed level of consciousness Approximately five minutes after the shot, I experienced vasovagal syncope. I was, reportedly, non-... Read more
Approximately five minutes after the shot, I experienced vasovagal syncope. I was, reportedly, non-responsive for about three minutes. When aroused, my heart was reportedly beating about 40 beats per minute, my blood pressure was low, and it took me quite a while to regain my senses.
43 2021-04-12 weakness Headache will not go away , shortness of and trouble with breathing , weak after a short time of phy... Read more
Headache will not go away , shortness of and trouble with breathing , weak after a short time of physical anything , chest pains , veins in legs are showing. These all came on a few days ago and the headache last night was almost unbrarible and i never have headaches
43 2021-04-12 feeling cold Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also sti... Read more
Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/
43 2021-04-12 severe one side paralysis Large left-sided infarction. Patient is paralyzed from the right side
43 2021-04-12 migraine Sweating, chills, migraine,
43 2021-04-12 pain in extremity on 4/9/2021 I felt very fatigue and had a headache all day long my eyes where burning of my headache... Read more
on 4/9/2021 I felt very fatigue and had a headache all day long my eyes where burning of my headache. When I cough it hurts all the way down my right arm.
43 2021-04-12 pain in extremity COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous ... Read more
COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous report received from a patient concerned a 43 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: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at 14.30 to left deltoid at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced couldn't sleep last night. On 07-APR-2021, the patient experienced tiny headache. On 07-APR-2021, the patient experienced left arm hurting. On 07-APR-2021, the patient experienced left shoulder hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny headache, left arm hurting, and left shoulder hurting, and the outcome of couldn't sleep last night was not reported. This report was non-serious.
43 2021-04-12 tenderness large lump in right axilla >7cm round soft mildly tender lump, no warmth, redness noted.
43 2021-04-14 weakness, pain in extremity sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes. dull a... Read more
sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes. dull ache in arm at injection site for four days after injection. flu-like symptoms including body ache, tiredness, weakness, fatigue, loss of appetite & general malaise starting approximately 24 hours after injection, lasting about 12 hours.
43 2021-04-14 difficulty speaking Had COVID on 2/7/21- Feverish feeling x 1 day, fine after. Tested negative 2/17/21. One half hou... Read more
Had COVID on 2/7/21- Feverish feeling x 1 day, fine after. Tested negative 2/17/21. One half hour after receiving the vaccine, onset of hoarseness. Severe hoarseness persists until today. Eyelids pink, swollen slightly, persisted 2 weeks. Did not feel well. 4/15/21 -Hospital Emergency Room. Chest pain. Elevated blood pressure. COVID test positive. Disharged with azithromycin, zinc sulfate 220mg, ProAir. High blood pressure, new onset. On 4/6/21 BP 160/120 both arms. 4/7/21 Hospital ER. MRI, CT brain showed Dural Venous Thrombosis. To ICU for anti coagulation, until 4/14/21. MRV done. Now on floors, started coumadin. 9 days hospitalization so far. CT done again 4/15/
43 2021-04-15 tremor SHAKING; STIFF BODY; SHIVERING; This spontaneous report received from a patient concerned a 43 year ... Read more
SHAKING; STIFF BODY; SHIVERING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic breathing problems .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced stiff body. On 09-APR-2021, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, shivering and stiff body was not reported. This report was non-serious.
43 2021-04-15 tremor SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report receive... Read more
SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.
43 2021-04-16 weakness Severe flu-like symptoms consisting of myalgias, nausea, vomiting, fatigue, generalized weakness.
43 2021-04-17 tremor By midnight after my vaccine: Shortness of breath. Three days later around 6:25 am on April 15, 202... Read more
By midnight after my vaccine: Shortness of breath. Three days later around 6:25 am on April 15, 2020: I got out of bed, next moment I recall is of me on the floor. No memory of falling. I was shaking uncontrollably as if my body was getting many commands at the same time but I had no control over it. I could not call out for help. At one point I was biting my right hand but could not make myself stop until my shaking stopped. Bite did not penetrate skin but I had visible bite mark on my hand. I regained control suddenly and just got up slowly and shaken by the experience. Wife then drove me to the ER. Been feeling pressure on my head.
43 2021-04-18 numbness Patient presented to ED with right sided numbness including arm, leg and body. Face not involved. O... Read more
Patient presented to ED with right sided numbness including arm, leg and body. Face not involved. Over 14 days since J&J COVID vaccine. Patient admitted with left thalamic stroke, neurologist involved, not believed to be related to vaccine. Started on aspirin 325 mg daily and Plavix. Still hospitalized.
43 2021-04-19 involuntary muscle movements The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of ... Read more
The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm
43 2021-04-20 involuntary muscle movements, numbness, tingling I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetanin... Read more
I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.
43 2021-04-22 seizure INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report receive... Read more
INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
43 2021-04-23 weakness COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATI... Read more
COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.
43 2021-04-25 pain in extremity extreme sweating, joint pain and swelling, leg pain, muscle pain
43 2021-04-26 pain in extremity EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS ... Read more
EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self 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.
43 2021-04-27 numbness Nausea, chest pain, numbness in arm, vomiting and diarrhea.
43 2021-04-29 pain in extremity Experienced severe leg pain for several days. Ultrasound in ER revealed right calf DVT. Prescribed 2... Read more
Experienced severe leg pain for several days. Ultrasound in ER revealed right calf DVT. Prescribed 21 day regimen of Xarelto starting yesterday.
43 2021-04-30 flushing Systemic: Flushed / Sweating-Mild, Additional Details: Pt experienced a brief episode of sweating, a... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: Pt experienced a brief episode of sweating, after drinking water and eating something he felt fine.
43 2021-05-01 feeling cold I thought I was going to get the first shot of the Moderna vaccine, it wasn't until the needle was i... Read more
I thought I was going to get the first shot of the Moderna vaccine, it wasn't until the needle was in my arm that I was told I had received the Janssen vaccine. At approximately 4:46pm I developed a strong pain at the injection site. At approximately 8pm I began to run a fever and feel extremely fatigued. My back and all my joints started to ache, I was sweating but also freezing cold. I had a dull, throbbing pain in my testes. I had pain in my scalp, my eyebrows, my ear lobes, my fingernails, my toes and toenails, the soles of my feet hurt. Least of all I also had a headache. I took 500mg Ibuprofen for the pain. Now, almost 48 hours later I still have a low grade fever, still have considerable pain at the injection site, still have a headache. The remaining symptoms dissipated on 5/2/21 at about 12pm. Took another 500mg Ibuprofen for breakfast, but otherwise have had no appetite since receiving the vaccine.
43 2021-05-05 weakness Severe pain in bones and joints for 3 days extruciating pain the worse pain imaginable unable to eve... Read more
Severe pain in bones and joints for 3 days extruciating pain the worse pain imaginable unable to even get up from bed. Extreme fatigue and weakess
43 2021-05-06 breast pain I received the vaccine on April 12. I was to have my next period on April 19. Instead it came early ... Read more
I received the vaccine on April 12. I was to have my next period on April 19. Instead it came early on April 13. I had a lot of cramping and breast pain the first 48 hours after the vaccine injection which is not normal for me. My period also lasted 15 days. It normally lasts 2 - 3 days.
43 2021-05-06 paralysis, numbness on 4/10/21 headache, feet felt numb, continued to get worse until almost total paralysis of body. H... Read more
on 4/10/21 headache, feet felt numb, continued to get worse until almost total paralysis of body. He is still currently in hospital getting treatments. ,
43 2021-05-07 tremor PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, A... Read more
PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, AS I WAS PREVENTING HIM FROM STANDING HE BEGAN TO SHAKE AND THEN WENT LIMP, I USED SMELLING SALTS AND HE CAME TO, HE WAITED IN PHARMACY HIS BP WAS LOW, WE GAVE WATER AND AFTER ABOUT AN HOUR HE WAS ABLE TO WALK OUT ON HIS OWN
43 2021-05-10 muscle spasms ringing in ears, dizzy, scattered headaches, muscle cramps in arms. Classic flu like symptoms 24 ... Read more
ringing in ears, dizzy, scattered headaches, muscle cramps in arms. Classic flu like symptoms 24 hours after injection. 99.9 fever for 10 hours, headache, fatigue. They resolved 24 hours later.
43 2021-05-15 night sweats Initial extreme fatigue 1 day following the vaccine, which resolved after overnight rest Five (5) da... Read more
Initial extreme fatigue 1 day following the vaccine, which resolved after overnight rest Five (5) days after vaccine, extreme fatigue and chills, and several hours later a temperature of 103.5, as well as some muscle soreness Night sweats first night; next morning temperature returned to normal. Fatigue continued with some daytime sweating for 2-3 days. Saw primary care doctor 5 days after symptom onset; mostly cleared up, normal temperature Patient suspected a flare-up of mononucleosis / Epstein Barr as cause.
43 2021-05-22 pain in extremity Painful Arm, 4 days Fever 2 days Swollen lymph nodes in groin with tenderness, from day 7, currently... Read more
Painful Arm, 4 days Fever 2 days Swollen lymph nodes in groin with tenderness, from day 7, currently ongoing.
43 2021-05-23 pain in extremity Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/d... Read more
Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).
43 2021-05-24 muscle spasms, numbness, migraine PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY ... Read more
PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
43 2021-05-29 tremor, feeling cold, burning sensation Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 1... Read more
Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 103.6, slight nausea - all lasting 12 hours and then subsiding.
43 2021-06-02 muscle spasms Intense shoulder soreness that day. The next morning woke up with extreme muscle cramps all over my... Read more
Intense shoulder soreness that day. The next morning woke up with extreme muscle cramps all over my entire body. Developed sore throat later in the day. Symptoms worsened over the course of the week, sore throat, headache, malaise, extreme sinus congestion, coughing, sneezing, excess saliva production. It was as if I contracted a sever cold. Today is June 3'rd and it is the first day I am feeling close back to 100%. I should note that I have a strong immune system and have not been sick in years.
43 2021-06-07 feeling hot Patient was administered 0.5 ml Jannsen COVID-19 vaccine into the left deltoid with no complaints. ... Read more
Patient was administered 0.5 ml Jannsen COVID-19 vaccine into the left deltoid with no complaints. After completion of vaccine patient continue to sit in waiting area, while sitting in waiting area patient described feeling extremely dizzy and hot. Patient was given water/Benadryl and was able to alleviate issue without any further action necessary.
43 2021-06-08 pain in extremity Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pa... Read more
Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones. He says he has trouble sleeping. He did go to the Emergency Room and was evaluated. He says he still currently has the pain.
43 2021-06-15 tremor High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hour... Read more
High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.
43 2021-06-16 tremor Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walke... Read more
Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walked away from people around me. Fortunately my wife was there, I called out to her because I was getting dizzy, she came over as I was passing out, I grabbed onto her and we both fell to the floor (I used her to cushion my fall). I passed out on her as she screamed for help. Two male customers assisted me into a chair as I was disoriented, my wife asked me what her name was and I didn't her name as I was pale, trembling, and sweating. The pharmacy tech thought I was going into convulsions and called 911. The paramedics arrived and fortunately I was breathing and slowly coming back. Paramedics remained there and took all my vital signs and stayed with me. Since my vitals were okay and my color came back, I felt much better and was coherent again. This event was at least 30-minutes or more. I declined going to the hospital with ambulance and the paramedics told me to call 911 if it happens again.
43 2021-06-16 unresponsive to stimuli patient was asked to stay in the waiting are for 15 minutes.he went and sat down then he got up to t... Read more
patient was asked to stay in the waiting are for 15 minutes.he went and sat down then he got up to talk to his wife at that time he felt sick and passed out. his breathing was shallow and he was unresponsive for 2 minutes. he was pale. paramedics were called and they came right away and assessed him. he did not need any medical help. he felt fine. they did not take him to hospital.
43 2021-06-30 pain in extremity after the vaccine I had a fever and was able to treat with Tylenol, and within two days my legs and ... Read more
after the vaccine I had a fever and was able to treat with Tylenol, and within two days my legs and knees were in pain and I had a cough. The pain is behind my knee on both legs and does up to my thigh and down to my ankle. When i sit it hurts realy bad behind the knee, especially when sitting on the toilet.
43 2021-07-05 pain in extremity COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND... Read more
COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.
43 2021-07-13 pain in extremity Fatigue, soreness of arm, lost of appetite, 12 hours later 8am
43 2021-07-15 feeling of body temperature change ive never been sicker throwing up,diarehaa,cold/hot flashes,super tired,and basically havent felt a... Read more
ive never been sicker throwing up,diarehaa,cold/hot flashes,super tired,and basically havent felt all trhe way well since taking shot i totally regret getting shot
43 2021-07-16 migraine, slurring, involuntary muscle movements INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPEL... Read more
INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPELLS OF STUTTERING; SLURRED SPEECH 2-3 TIMES A DAY; DIFFICULTY SEEING; MIGRAINE "WORST PAIN IN LIFE"; RINGING IN EARS; NON-CONTAGIOUS MENINGITIS / BRAIN SWELLING / UNABLE TO MOVE NECK TO THE LEFT / STIFF NECK RADIATED TO SHOULDERS AND LEFT ARM AT INJECTION SITE / STIFF NECK TO THE LEFT SIDE; LIME DISEASE / CHILLS / MUSCLE ACHE / MILD FLU LIKE SYMPTOMS; HEADACHE; TIRED/ FATIGUE; COULD NOT SLEEP ALL NIGHT; KNEE SWELLED UP; LEFT KNEE PAIN; SPINAL CORD SHIFTING FROM BASE OF SKULL TO TAILBONE- POPPING AND CRACKING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and penicillin allergy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported with frequency 1 total administered on 25-MAR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient did not have any side effects initially and he was fine after vaccination and suddenly he felt tired an hour after arriving home, also could not be to sleep all night, mild flu-like symptoms including chills, muscle aches, fatigue and a headache. He took ibuprofen 200 mg via oral route (frequency unknown) for headache or pain. On 26-MAR-2021, the patient experienced headache again. On 02-APR-2021, the patient experienced headache which continued to get worse, brain swelling, non-contagious meningitis, lime disease (Lyme disease), migraine "worst pain in his life", difficulty seeing, ringing in ears. Then, he took more ibuprofen (frequency unknown) as the migraine was unbearable for him and had mild relief. The patient went to the hospital and was admitted on 02-APR-2021. At hospital he received morphine (indication unknown). On the same day, the laboratory testing or data of patient included CT scan reported as brain swelling reduced in size and spinal tap reported as unknown chemical found, positive for lime disease and meningitis. Laboratory testing revealed the meningitis of patient was non-contagious. The patient started on blood thinners and antibiotics (drugs name unknown). The patient got followed-up with (Centers for Disease Control and Prevention) CDC disease specialist who said that it could not be clearly revealed whether it was related to the vaccine or not. On 05-APR-2021, the patient experienced difficulty thinking straight, intermittent, involuntary movement of left fingers, spells of stuttering, slurred speech. The patient hospitalized for 4 days and got discharged from hospital on 05-APR-2021 at 20:00. On the night of 06-APR-2021, it was reported that in the middle of the night the patient woke-up at 01:00 as his spinal cord was shifting from base of skull to the tailbone, it was popping and cracking, no pain, just moving. It was gone when he work-up that morning. On 08-APR-2021 at morning, the patient experienced stiff neck to the left side / stiff neck radiated to shoulders and left arm at injection site as unable to move neck to the left side and the stiff neck got progressively worse each day and by 09-APR-2021, the stiff neck was more severe and radiated to the shoulders and to the left arm where he received his vaccine, not the right side, unable to move neck to the left side. However, this lasted until 13-APR-2021. On 26-MAY-2021, the patient woke up with pain and swelling in the left knee. On an unspecified date, the patient experienced intense pain. Treatment medications (dates unspecified) included: ibuprofen several times, morphine, antibiotics and blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lime disease / chills / muscle ache / mild flu like symptoms, migraine "worst pain in life", difficulty seeing, and ringing in ears on 05-APR-2021, non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side, spinal cord shifting from base of skull to tailbone- popping and cracking on 07-APR-2021 and knee swelled up, and left knee pain on 30-JUN-2021, had not recovered from tired/ fatigue, headache, spells of stuttering, intermittent, involuntary movement of left fingers, difficulty thinking straight, and slurred speech 2-3 times a day, and the outcome of could not sleep all night and intense pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210718928-covid-19 vaccine ad26.cov2.s-spinal cord shifting from base of skull to tailbone- popping and cracking ; non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side; lime disease / chills / muscle ache / mild flu like symptoms; difficulty thinking straight; migraine "worst pain in life"; ringing in ears; intermittent, involuntary movement of left fingers; spells of stuttering; slurred speech 2-3 times a day; difficulty seeing; intense pain; could not sleep all night. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210718928-covid-19 vaccine ad26.cov2.s-headache; tired/ fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
43 2021-07-17 weakness "Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light... Read more
"Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light headed so I sat on the floor and notified medical personnel. I then passed out for an unknown amount of time but long enough to urinate on myself. Medical staff put me on a bed and started taking vitals. My Blood pressure was low but had a high heart rate. Medical Personnel called the ER to see if I needed to be transfered but it was reccommended to continue observation. After an hour or two I was released to go home. I felt weak for over a week after the vaccination.
44 2021-03-09 unresponsive to stimuli patient received covid vaccine and went to sit out in waiting area. about 5 min later patients eyes... Read more
patient received covid vaccine and went to sit out in waiting area. about 5 min later patients eyes rolled back, became unresponsive, was grunting, stiff muscles, and had uncontrolled urination. this continued for a few minutes. was able to get patient on the floor and in doing that he became responsive and alert. patient almost immediately felt fine. paramedics were called and they did check him out but he left without going to the hospital
44 2021-03-10 tremor Fever, chills, shakes approximately 13 hours after shot. Lasted for an hour until asleep. No issues ... Read more
Fever, chills, shakes approximately 13 hours after shot. Lasted for an hour until asleep. No issues in the morning.
44 2021-03-11 tingling Patient reported a "tingling sensation" to his face 10 minutes post vaccine. Swelling under eyes w... Read more
Patient reported a "tingling sensation" to his face 10 minutes post vaccine. Swelling under eyes were also noted. At 1410 patient reported symptoms subsided. By 1440 patient requested that he leave and another individual to drive was confirmed. Importance of following with PCP was enforced.
44 2021-03-13 pain in extremity pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid... Read more
pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid vaccine on 03/13/2021 in the left shoulder and he woke up this morning with pain in the left shoulder radiating down his arm and it originates at the site of the vaccine. pt denies substernal chest pain , dyspnea , doe. he has h/o elevated blood pressures at the level seen today (180/100) when he has poor sleep and he had poor sleep last night due to pain at injection site. no CAD hx. pain is not changed with walking but will be worsened by moving his left arm. PE: a+ox3, in moderate pain left arm: injection site clean and intact. left arm is neurovascularly intact. no bony deformity of the shoulder lung: normal respiratory status, cv rrr no mgr Signed on 3/14/2021 at 11:54am
44 2021-03-17 flushing 3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm brok... Read more
3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body hives, very red and became flushed and hot
44 2021-03-17 tingling At 15:00 Patient received Janssen vaccines, Lot 1805018 Exp 05/25/2021 At 5:15 Patient started exper... Read more
At 15:00 Patient received Janssen vaccines, Lot 1805018 Exp 05/25/2021 At 5:15 Patient started experiencing tingling around the nose. VS: 74 HR , BP 137/101, O2 97 % Room air. Observed patient an additional 15 minutes. Offered patient a bottle of water. 15:35 VS: 62 HR, BP 135/93 Left arm. 98 O2, sat room air. Patient states he feels better and the tingling is gone.
44 2021-03-18 pain in extremity, bell's palsy Sore arm for two days. Diarrhea. Developed Bell's Palsy after six days.
44 2021-04-05 cold sweat 03/08/2021 11:31 am Patient C/O feeling light headed and dizzy. Patient also noted pale and clammy a... Read more
03/08/2021 11:31 am Patient C/O feeling light headed and dizzy. Patient also noted pale and clammy and laid himself on the floor. Patient stated that he ate a granola and coffee for breakfast. V/S 97.4 temp. BP 101/60, R 18, Pulse 48. Snacks and water offered, water taken only. Patient then stated that he feels sick and cannot sit up on his own, close monitory in progress. 11:34 am Wife called and notified. 911 rescue called. 11:50 am Rescue arrived and assessed patient declined going to the hospital. 12:00 pm. Patient VS 97.7 temp, BP 110/64, Pulse 56, R 16.. Patient left facility with wife.
44 2021-04-06 feeling cold Cold hands/feet, shivering, chills, fever, massive sinus-like headache, nausea and felt like vomitin... Read more
Cold hands/feet, shivering, chills, fever, massive sinus-like headache, nausea and felt like vomiting.
44 2021-04-07 weakness Three hours after the vaccine I had nausea and tiredness, slept for five hours. After waking up, I'... Read more
Three hours after the vaccine I had nausea and tiredness, slept for five hours. After waking up, I've had muscle ache, high fatigue and weakness, soreness all over the body, headache, head pressure, and pain in my muscles when an area of my body is pressed or grasped. Yesterday at 4pm, had chills and temperature for a total of 4 to five hours.
44 2021-04-07 weakness Dizziness and weakness
44 2021-04-07 hot flush, feeling hot Felt a little warm for first 30 minutes after receiving the shot at 1015am but then felt fine until ... Read more
Felt a little warm for first 30 minutes after receiving the shot at 1015am but then felt fine until about 6pm that same day. At that point, started getting chills, which progressed into mix of chills and hot spells, fever, headache, and frequent urination throughout the night (though was also hydrating a lot). Had fever the next morning still and Diarrhea. Still feel modest headache and chills the next evening (before bed where I had felt the worst overnight the first night of the vaccine) but feeling better than the first night. Per the form I received, I was told to include Janssen COVID-19 Vaccine EUA in this section of the form. I am reporting this on the day after the vaccination, so don't yet know final outcome, but again, improving and don't feel like I need medical attention.
44 2021-04-07 pain in extremity TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received... Read more
TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen. 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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.
44 2021-04-08 involuntary muscle movements, hot flush, seizure Five minutes after shot started losing consciousness, sweating, hot flashes, trouble breathing, num... Read more
Five minutes after shot started losing consciousness, sweating, hot flashes, trouble breathing, numbness on tongue, seizure ( several minutes) came in and out of consciousness during it, eyes rolled back in head. Arms flailing.
44 2021-04-09 tremor, pain in extremity - Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor ... Read more
- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21
44 2021-04-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild
44 2021-04-10 weakness -fever -body aches -head ache -abdominal pain -extreme dizziness/lightheadedness -dry cough -increse... Read more
-fever -body aches -head ache -abdominal pain -extreme dizziness/lightheadedness -dry cough -incresed tinnitus -nervous system disorientation -tiredness -weakness All lasting ~36+ hours.
44 2021-04-10 pain in extremity Pain in arm Mild fever Chills Headache
44 2021-04-10 tremor I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was... Read more
I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.
44 2021-04-11 numbness Neck numbness - 90 minutes after shot, lasted 30 minutes Dizziness - 120 minutes after shot, lasted ... Read more
Neck numbness - 90 minutes after shot, lasted 30 minutes Dizziness - 120 minutes after shot, lasted 40 minutes Chills - 120 minutes after shot, lasted 10 minutes Body aches - 4 hours after shot, lasted 16 hours Fever - 12 hours after shot, lasted 1 hour Headache - 19 ours after shot, lasted 20 minutes Stuffy head - 20 hours after shot, lasted 1 hour
44 2021-04-11 migraine Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, e... Read more
Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, extreme fatigue, shortness of breath and sensitive to light.
44 2021-04-11 pain in extremity, tingling Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to... Read more
Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm
44 2021-04-12 bell's palsy Had normal pain, fatigue and low grade fever after vaccination. About 3 weeks later I experienced on... Read more
Had normal pain, fatigue and low grade fever after vaccination. About 3 weeks later I experienced onset of Bell?s Palsey defined as mild to moderate by the ER doctor.
44 2021-04-12 feeling cold, tremor Symptoms: Extreme cold and shaking from cold. No fever. Was taken by ambulance to ER. They used heat... Read more
Symptoms: Extreme cold and shaking from cold. No fever. Was taken by ambulance to ER. They used heated blankets to warm me up and gave me a shot of Motrin. Symptoms began approximately 11 hours after shot was given. After returning home and sleeping, currently have a headache and muscle aches.
44 2021-04-12 feeling cold Chills, headache, nausea, body aches, dizzyness
44 2021-04-12 pain in extremity itchiness, extreme thirst, pain in leg reminscent of blood clots I have had in the past
44 2021-04-13 hot flush, feeling hot Felt tightening of chest cavity along with warm ?flush? feeling. After a few minutes left side felt ... Read more
Felt tightening of chest cavity along with warm ?flush? feeling. After a few minutes left side felt less pressure but pressure persisted in right chest area with pain radiating from right arm to back (behind shoulder blade). The right back pain persisted for multiple days. Sought Urgent Care help after a few days. Was prescribed muscle relaxant and pain relief gel, and advised to continue using inhalers.
44 2021-04-13 muscle spasms Got the J&J on March 9th. Had severe cramp/knot in my left leg starting the 19th. Lasted through t... Read more
Got the J&J on March 9th. Had severe cramp/knot in my left leg starting the 19th. Lasted through the 29th and right leg got it the 24th through 30th. I attributed it to pushing too hard at the gym. When they didn't go away after heat/cold/rolling/hot tub I did worry about clots, but not due to vaccine. Was going to call Dr but they went away.
44 2021-04-13 pain in extremity Sore arm for 2 days and 100.5 degree fever for 6 hours
44 2021-04-13 pain in extremity In sleep, on the night of vaccination, i thought I twisted my left leg ankle. It was not hurting if ... Read more
In sleep, on the night of vaccination, i thought I twisted my left leg ankle. It was not hurting if not moving but hurt when walking on uneven surface or when tried to move the ankle. I used bandage few days. its not completely gone, but much better and hurts when try to push the foot/toe downwards.
44 2021-04-14 pain in extremity Patient developed mild case of Guillain Barre Syndrome 34 hours after injection of the Johnson and J... Read more
Patient developed mild case of Guillain Barre Syndrome 34 hours after injection of the Johnson and Johnson vaccine. Patient has severe extremity pains. The patient has a personal history of being diagnosed with Guillain-Barre after a yellow fever vaccination.
44 2021-04-14 pain in extremity Blood Clot and bruising on lower backside of leg, I noticed leg Pain (just uncomfortable) in the rig... Read more
Blood Clot and bruising on lower backside of leg, I noticed leg Pain (just uncomfortable) in the right leg at the location of clot. A time frame in relationship to the time of shot is unkown. Estimated within 24 hours. Bruising appeared morning of 04/14/21, PCP recommended in person visit. I went to urgent care, they had me drive to emergency Room at local hospital. Evaluation, blood testing and imaging concluded a blood clot in the lower right leg. Blod thinners was prescribed Eliquia 5 mg, discharged same day. It may be possible the hospital had submitted this form on my behalf.
44 2021-04-14 tingling Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal.... Read more
Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.
44 2021-04-15 migraine pt called vaccine hotline saying since last week patient has had migraines every evening after work ... Read more
pt called vaccine hotline saying since last week patient has had migraines every evening after work , lasting 2-3 hrs. Pt does not have a family hx or personal hx of migraines. He is not taking medications and is drinking a lot of water. Pt is currently working in a remote area. Pt was concerned re ER costs and was reluctant to go but did say he would try. He was advised to go to the nearest ER. He then had to get off phone
44 2021-04-16 pain in extremity, muscle spasms At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose a... Read more
At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine. 4-5 hours after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through. Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home. 30-60 minutes later congestion completely cleared up. 9-12 hours after vaccination had extreme chills. Day after vaccination had pain below the injection site... injection was 2? above pain. Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.
44 2021-04-17 migraine 6/11-6/14 : Extreme migraine, fever, extreme chills, fever, extreme body aches, extreme fatigue, di... Read more
6/11-6/14 : Extreme migraine, fever, extreme chills, fever, extreme body aches, extreme fatigue, diarrhea 6/14-present: moderate migraines, moderate fatigue, moderate body aches, moderate fatigue, diarrhea
44 2021-04-21 migraine I'm on day 3 of a blistering migraine headache. Usually over-the-counter remedies are not working.
44 2021-04-21 seizure LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES RO... Read more
LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
44 2021-04-22 feeling hot 5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZ... Read more
5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.
44 2021-04-23 speech disorder, bell's palsy, involuntary muscle movements Bell's Palsy on right side of face developed 4/22/21. Pt thought he was having a stroke and went to... Read more
Bell's Palsy on right side of face developed 4/22/21. Pt thought he was having a stroke and went to the ER. Doctor gave him B12 to inject 2 doses. Worsening 4/24/21 and having a lot of trouble speaking and eating/drinking.
44 2021-04-26 seizure Patient reports seizures on 4/25/2021 requiring 911 call, ambulance, and hospitalization stay. Pati... Read more
Patient reports seizures on 4/25/2021 requiring 911 call, ambulance, and hospitalization stay. Patient mental status changed to violent and resulted in a dislocated shoulder when hospitalized. Patient has no history of seizures or violent behavior.
44 2021-04-28 muscle spasms CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COUL... Read more
CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COULD NOT BREATH; SEVERE CRAMPING IN LEFT SHOULDER AND UPPER BODY; DIFFICULTY IN STANDING; SINUS; THOUGHT THAT HE WAS ABOUT TO PASS OUT; BUNCH OF CLOTS IN THE BOTTOM SIDES OF BOTH LUNGS AND ON THE TOP OF ONE OF THE SIDES; BEGINNING STAGES OF PNEUMONIA ON BOTH LOBES OF THE LUNGS (COLLAPSED); CRAMPING IN CHEST; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered to left arm on 06-APR-2021 at 12 noon for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 6-APR-2021 at 12 noon, patient got vaccinated and was fine that day . Next morning on 07-APR-2021, patient woke up with sever cramping in same shoulder which he got the shot in, most pain was in the upper left quarter of his torso to down half way to chest up to the shoulder till the neck . By the end of the day it spread to his whole chest and upper body. Also he had shortness of breath ,could not breath .The cramping and shortness of breath came at same time. He took Advil and went along with his day . He took 3 tablet of Advil 200mg every 4-5 hours all day ( total of 3 dose that day) . By night time the case was progressively worse as the whole chest had a lot of pain . He thought that he had heart attack . He thought that he was about to pass out . He could not stand on his own . So his wife took him to emergency room at mid night at 12:30 am on 08-APR-2021. He stayed there for 5 hours and they did bunch of tests , EKG which rolled out the heart attack .They did Chest X-ray which found things then did D-dimer which its level was very high . They found bunch of clots in the bottom sides of both lungs and on the top of one of the sides. They did ultra sound on the legs which had no evidence of blood clots . They discharged him from the emergency room as they felt that he was ok to be out . After couple of hours after discharge , patient's health care professional wrote for him Eliquis, antibiotic and pain reliver. He was given antibiotic because he had beginning stages of pneumonia on both lobes of the lungs (collapsed) . It was found air sacs in lung with signs of pneumonia in both lobes . He came home and started to monitor his blood oxygen . He stayed in the same position till recovery . He was better each day since last week but still had sinus and cramping in the chest ( very minor but was still there). The lung capacity was very limited to take some steps. Patient stated that he needed a specialist to understand his condition. He had no medical history before that incidence . He was wondering regarding which type of blood thinner was good for this type of blood clots because he read that the regular blood thinners are not good for that type of blood clot which his HCP gave (regular blood thinner). Laboratory data included: Total lung capacity decreased (NR: not provided) lung capacity is very limited. On 08-APR-2021, Laboratory data included: Chest X-ray (NR: not provided) found things, EKG (NR: not provided) rolled out heart attack, Fibrin D dimer (NR: not provided) level was very high, and Ultrasound scan (NR: not provided) no evidence of blood clots. Treatment medications (dates unspecified) included: apixaban, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe cramping in left shoulder and upper body, chest pain (whole chest had lot of pain)/thought that he had heart attack, shortness of breath/could not breath, thought that he was about to pass out, difficulty in standing, bunch of clots in the bottom sides of both lungs and on the top of one of the sides, beginning stages of pneumonia on both lobes of the lungs (collapsed), cramping in chest and sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 44-year-old male patient reported blood clots of both lungs 2 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient denies any medical history/condition prior to vaccination. The symptoms reported were severe cramping of arm that spread to his whole chest and upper body and shortness of breath; the patient thought he had a heart attack, about to pass out and could not stand because of the progression of pain. EKG done at the emergency room ruled out heat attack, D-Dimer was reported to be very high, clots were found in the bottom sides of both lungs and on the top of one of the sides, x-ray showed beginning stages of pneumonia on both lobes of the lungs (collapsed). The patient was prescribed with Eliquis, an unspecified antibiotic and pain reliever. Outcome of the events were not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.
44 2021-04-29 weakness 1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vac... Read more
1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vaccine (4/29) - shortness of breath after physical activity, irregular pulse 3 days after vaccine (4/30) - back to normal - no symptoms
44 2021-04-29 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
44 2021-04-30 hot flush, weakness, pain in extremity SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING... Read more
SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body. On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
44 2021-05-02 numbness Allergic reaction, swollen lips, numb skin on face, itching all over body, scratching hives, blister... Read more
Allergic reaction, swollen lips, numb skin on face, itching all over body, scratching hives, blisters
44 2021-05-04 pain in extremity RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; This spontaneous report received from a pati... Read more
RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included hematomas, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and drug abuse and drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 30-APR-2021, the subject experienced pain in arm. On 01-MAY-2021, the subject experienced body aches. On 01-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced red spot under skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 02-MAY-2021, and pain in arm on 01-MAY-2021, and was recovering from red spot under skin. This report was non-serious.
44 2021-05-05 weakness Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 1... Read more
Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
44 2021-05-05 unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up
44 2021-05-06 facial paralysis, bell's palsy, tenderness At first on April 23rd, my tongue felt like it was burned and tingling. By 4/26 I woke up with righ... Read more
At first on April 23rd, my tongue felt like it was burned and tingling. By 4/26 I woke up with right side of face dropping, swollen, and paralyzed. Went to the ER and was diagnosed with Bells Palsy. ER doctor also performed CT scan which was normal. Was given prednisone and valacyclovir, instructed to protect and dress my eye. The right side of my neck under my ear is very swollen and tender. I have pain in the back of my neck on the right side. I had a follow up with PCP 5/05/21. She told me to use an eye ointment. It has been two weeks and my face is still paralyzed. Some of the swelling has gone down in my check.
44 2021-05-06 feeling hot, flushing Patient approached pharmacy staff during 15 minute observation to report feeling of overheating and ... Read more
Patient approached pharmacy staff during 15 minute observation to report feeling of overheating and anxiousness. He was brought into the consultation room where blood pressure was taken which was normal. Patient was given water and a dose of Benadryl as well as provided direct cooling with table fan. He mentioned getting a taste in his mouth prior to the flushing and anxiety as well as blurred vision. He was observed for an additional 45 minutes with symptoms subsiding and was advised to seek medical attention if symptoms reappear as he refused any further medical intervention. Patient was called several hours after vaccine at home where he said he was feeling improvement but was resting.
44 2021-05-06 migraine 12 hrs after shot felt exhaustion, mental brain fog, mild nausea and migraines. In the weeks follo... Read more
12 hrs after shot felt exhaustion, mental brain fog, mild nausea and migraines. In the weeks following vaccine, exhaustion and migraines have persisted at an interval of several times a week. This is abnormal for me - i do not have headaches regularly or migraines. It has almost been 2 months and I am still having exhaustion and migraines.
44 2021-05-06 tingling, flushing, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy
44 2021-05-10 inability to speak, facial paralysis, mild one side paralysis The patient woke up at around 0230 on 5/11/21 with aphasia, right sided weakness and facial droop. H... Read more
The patient woke up at around 0230 on 5/11/21 with aphasia, right sided weakness and facial droop. He was immediately brought to the ER and after CT was given tenecteplase.
44 2021-05-11 feeling cold, hot flush For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, an... Read more
For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, and general malaise. Then, after the first week of having the vaccine, I began to have these symptoms about once a week. Last week, it was on 5/6 when I gradually become colder regardless of layers and my stomach was repelling the idea of food (no vomiting or actual nausea). I went to bed and I was better by morning. Yesterday (5/12), I had the same thing. Chills and the inability to stay warm, loss of appetite, and a sort of sleepy vertigo.
44 2021-05-12 pain in extremity, flushing METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This... Read more
METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient could not take statins because they cause muscle pain but not an allergic reaction. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced metallic taste in mouth. On 10-MAY-2021, the subject experienced face was red. On 10-MAY-2021, the subject experienced flushing on face. On 10-MAY-2021, the subject experienced right leg pain described as dull ache. The action taken with covid-19 vaccine was not applicable. The patient recovered from face was red, and flushing on face on 10-MAY-2021, and was recovering from metallic taste in mouth, and right leg pain described as dull ache. This report was non-serious.
44 2021-05-17 cold sweat COLD SWEATS; COUGHING; DIARRHEA; TIRED AND SLEEP; NAUSEA; This spontaneous report received from a co... Read more
COLD SWEATS; COUGHING; DIARRHEA; TIRED AND SLEEP; NAUSEA; This spontaneous report received from a consumer concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced cold sweats. On 14-MAY-2021, the subject experienced coughing. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced tired and sleep. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the cold sweats, tired and sleep, diarrhea, coughing and nausea was not reported. This report was non-serious.
44 2021-05-17 migraine MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a pa... Read more
MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced migraine headache. On MAR-2021, the subject experienced pronounced fatigue. On MAR-2021, the subject experienced nausea (no vomit). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The outcome of the pronounced fatigue, nausea (no vomit) and migraine headache was not reported. This report was non-serious.
44 2021-05-17 pain in extremity Presented to ED for left leg pain. Noted to have a DVT
44 2021-05-19 night sweats, hot flush Dull head pain located at the front of the head to the temples, almost like when you have a fever bu... Read more
Dull head pain located at the front of the head to the temples, almost like when you have a fever but without a temperature. Severe night sweats, and have had hot flashes around the ears a few times. This has been going on since the evening of my vaccine. The head pain is constant and the night sweats have occurred almost every night. On night one the head pain was moderate.
44 2021-05-22 tremor 102 temperature. Strong involuntary shaking. Chills. Back pain. Elevated pulse. Muscle Weakness. F... Read more
102 temperature. Strong involuntary shaking. Chills. Back pain. Elevated pulse. Muscle Weakness. Fever broke around 0600. Adverse reaction appeared to be resolved by 36 hours from time of administering vaccine.
44 2021-05-26 night sweats Still having aches, chills, and sweating at night over a week later. I had the same shot the day be... Read more
Still having aches, chills, and sweating at night over a week later. I had the same shot the day before and my issues were gone 48 hours later.
44 2021-05-27 tension headache HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE N... Read more
HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.
44 2021-05-29 pain in extremity It started with a pain around my spine and it proceeded through my hand. I thought it was a muscle s... Read more
It started with a pain around my spine and it proceeded through my hand. I thought it was a muscle strain. I had blotches in the crevice area of my arm.
44 2021-06-07 weakness, numbness, cold sweat FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUS... Read more
FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg was not reported. This report was non-serious.
44 2021-06-10 tremor At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroo... Read more
At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats
44 2021-06-25 feeling hot 9:48am during his 15 minute wait time, reported having a tingling in tingling in his throat, feeling... Read more
9:48am during his 15 minute wait time, reported having a tingling in tingling in his throat, feeling flushed, and light headed. Declined us calling 911. He reported that he has a lot of allergies to foods and has experienced this reaction after having exposures to poultry products. Patient was brought in the nurses office and vital signs checked and stable. Lung sounds clear on auscultation. Given benadryl 50mg and monitored in office. Once patient reported feeling back to normal he asked to leave and went home. We called patient to verify that he got home and continued to feel fine.
44 2021-07-05 feeling cold Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatig... Read more
Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatigue
44 2021-07-06 pain in extremity The day of the vaccine, I have the normal regular arm pain. The following day, I had minor body ac... Read more
The day of the vaccine, I have the normal regular arm pain. The following day, I had minor body aches and a lot of joint pain in my knees and legs. Those symptoms lasted a few days and resolved. My doctor prescribed a new medication called Cymbalta for my depression on 5/3/2021. I took the medication and developed tinnitus on 5/8/2021 and thought the tinnitus from the medication and stopped the medication. I called my doctor who advised that Cymbalta does not cause that reaction. The tinnitus went away and I was not taking Cymbalta. Around mid June, I developed tinnitus again. I consulted my doctor and was prescribed Dramamine. I did not take the medication since the tinnitus have resolve. I had only those 2 episodes of tinnitus and haven't had any other episode. I am going to follow up with a specialist ENT doctor.
44 2021-07-11 numbness Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the wh... Read more
Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the whole right arm from shoulder to fingertips.
44 2021-07-11 tingling Pins & needles in fingers and toes. Started in the days following my Covid Shot (J&J) and has lasted... Read more
Pins & needles in fingers and toes. Started in the days following my Covid Shot (J&J) and has lasted about 4 months, although it seems like it's been going away gradually. I can barely feel it anymore, but still a bit. It was at its worst about a month after the vaccine shot. My left fingers were the worst. I went to Urgent Care and saw my doctor, but they couldn't explain it. In the news this morning I read about Guillain-Barré syndrome from the J&J vaccine, so thought I should write in case it's of any help.
44 2021-07-12 tingling, numbness and pain in extremities After getting vaccinated I was fine for almost a month, then I started getting tingling in toes and ... Read more
After getting vaccinated I was fine for almost a month, then I started getting tingling in toes and feet, I went to the ER and was x-rayed and CT, I had lose of feeling in left cheek. I saw a Neurologist that referred me to a nerve spesi9list that said I am having aggressive neuropathy in my feet, and now the tingling has traveled to my left hand also. I went to the ER 3 times.
44 2021-07-13 burning sensation, throat numbness, tingling, pain in extremity, nerve pain, numbness On 4/23/2021 patient began having pain in his lower legs and feet. The pain then moved up to his up... Read more
On 4/23/2021 patient began having pain in his lower legs and feet. The pain then moved up to his upper legs. Patient states " I felt like I had a really bad sun burn on my arms and chest". These symptoms lasted about one week. Patient states then his lower legs/feet and hands feel "numb and tingly with nerve like pain". He states the rest of his body has a numb like feeling. He says his tongue, lips, and back of his throat are really numb. He continues to have these symptoms. He says he has decreased taste and due to this has lost 28 pounds.
44 2021-07-16 numbness, tingling About 6 to 8 weeks after my vaccine shot, i started to experience numbness in my last 3 fingers on m... Read more
About 6 to 8 weeks after my vaccine shot, i started to experience numbness in my last 3 fingers on my left arm. The fingers tingle / numb through out the day and is most noticeable when i shower or when i sleep in a certain way and my fingers really tingle. It has been about 6 weeks now and it hasn't gotten worse nor really better. I feel like I got a mild case of guillain-barre.
44 2021-07-16 tingling, weakness Weakness or tingling sensations, especially in the legs or arms
44 2021-07-19 burning sensation, tingling, pain in extremity, weakness Sharp stabbing pains weakness in my right hip, and tingling sensation in my right upper leg. Lower ... Read more
Sharp stabbing pains weakness in my right hip, and tingling sensation in my right upper leg. Lower back tightness and pain. Recently my leg pain has turned to burning, ripping pain.
44 2021-07-23 feeling cold, pain in extremity, numbness Fatigue, Muscle weakness, and soreness primarily in arms. Constant Numbness in arms, numbness in re... Read more
Fatigue, Muscle weakness, and soreness primarily in arms. Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
44 2021-07-25 flushing 5 mins post administration of J and J vaccine, patient complained of flushing nausea and light heade... Read more
5 mins post administration of J and J vaccine, patient complained of flushing nausea and light headedness. Vital signs obtained 98% room air, post rate of 72, blood pressure 138/72 temp 97.1. Patient provided water and 1 cooling pack and observed for 10 mins. 2nd vital signs were obtained which was 98% room air 72 heart rate 130/70 and 98.1. Patient was observed until symptoms resolved. final vital signs showed 98 room air, 74 heart rate 126/78 BP 98.1 temp. Patient was safely discharge without further incident.
44 2021-07-26 weakness, pain in extremity Aching, Soarness leading to loss of mobility in right arm. Loss of strength. Constant aching
45 2021-03-10 feeling hot, tremor Nine hours after receiving vaccine I started "trembling, shaking." Not convulsing, more like really... Read more
Nine hours after receiving vaccine I started "trembling, shaking." Not convulsing, more like really cold. My temperature read 97.2 degrees. My normal temperature is 98.6 degrees. Shaking stopped around 11:30 p.m. I woke up at 3:15 a.m. very hot with my heartbeat racing. I did not measure heartbeat rate. I woke up this morning at 5:30 a.m. with no side effects.
45 2021-03-12 flushing Mild fever (99.5), slight chills, flush face. Still ongoing after 2 hours with 1000 mg Tylenol take... Read more
Mild fever (99.5), slight chills, flush face. Still ongoing after 2 hours with 1000 mg Tylenol taken promptly after symptoms started.
45 2021-03-13 pain in extremity Extreme chills starting at 11:30pm. Needed to wear layers of clothing and turn up heat to get warm. ... Read more
Extreme chills starting at 11:30pm. Needed to wear layers of clothing and turn up heat to get warm. Wife was hot while I was freezing and shivering uncontrollably, so I know something was wrong with me. The shivering and chills lasted for a couple of hours until about 2:30-3:00am. Then I got really hot. Took my temperature, was at 99.1 degrees. But room was really warm so I turned down the temperature and took off my layers of clothing. Woke up this morning, around 7am, to a headache and aching legs. I took 2 Excederin, but the headache is still there. Legs are feeling better after a couple of hours.
45 2021-03-15 muscle spasms, night sweats About five hours after I received the vaccine I began to run a fever that averaged 102 degrees fahre... Read more
About five hours after I received the vaccine I began to run a fever that averaged 102 degrees fahrenheit. At that time I also developed chills and extreme fatigue. These symptoms persisted until I fell asleep at 10:00 PM 3/13/21. I was awakened at 1:00 AM with severe muscle spasms in my left bicep and a fever of 102.5 I started taking tylenol to begin reducing the fever. I also lost my appetite around that time. Things were pretty much the same all day 3/14/21. I went to sleep at 10:00 PM I got up every four hours to take tylenol. I woke up at 7:00 AM 3/15/21 to prepare for work my bed sheets and shirt were soaked with sweat but my fever was gone. I ate breakfast and drank a cup of coffee. When I got to work I begin having stomach problems. When I started working I noticed that I was having a lot of trouble concentrating. I decided to leave early to go home and rest. Things have improved since then but I do have a headache that won't go away.
45 2021-03-17 tremor Lightheaded, shaky; B/P-135/78, P- 78, pulse ox- 95%; cleared by onsite nursing supervisor Client re... Read more
Lightheaded, shaky; B/P-135/78, P- 78, pulse ox- 95%; cleared by onsite nursing supervisor Client reports past history of fainting with blood draws
45 2021-03-20 tremor, feeling cold After the shot, I was feeling fine for 12 hours, I worked out at the gym, helped my roommate carry a... Read more
After the shot, I was feeling fine for 12 hours, I worked out at the gym, helped my roommate carry a desk up a flight of stairs. Then 12 hours into the shot I started getting chilly and immediately statrted shaking for 20 minutes, no warning, head to toe, more than just the average chills. So I took two tylenol and hoped in bed with a few blankets. The next day I felt like crap, but ok
45 2021-03-21 pain in extremity Flu like symptoms, chills, fever, tired and sore arm
45 2021-03-26 weakness Light headed. Weak body and mind.
45 2021-03-28 pain in extremity Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most inju... Read more
Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.
45 2021-03-31 feeling hot Around 09:00 pm I started to feel muscle pain, hot breath, hot ears, headache and a slight fever 99 ... Read more
Around 09:00 pm I started to feel muscle pain, hot breath, hot ears, headache and a slight fever 99 ° F. Approximately at 10:30 p.m., the fever increased to 104 ° F, muscle pain intensified all over the body, my teeth hurt, headache and chills. I took one (1) tablet of ACETAMINOPHEN 650MG, I took a cold bath and I put an ice pack on my head to lower my fever. I kept monitoring the temperature that at some point reached 104.9 ° F. Around 1:30 am I began to see that the temperature started to go down little by little. Around 2:30 am my temperature returned to 98 ° F and I no longer felt chills, no hot breath, neither hot ears, nor muscle pain was mild, I felt tired, headache was minimal. My last temperature was 97.5 ° F at 3:00 am. I got up around 10:30 am and I just felt tired and mild muscle pain.
45 2021-04-02 seizure Patient began having a seizure approximately 5-10 minutes after receiving the vaccination. Patient c... Read more
Patient began having a seizure approximately 5-10 minutes after receiving the vaccination. Patient came to before epipen was given. EMS were called to the scene and continued care for patient.
45 2021-04-05 tingling, numbness Pt experienced dizziness, feeling light-headed, and numbness, and tingling in L arm, face, and BIL L... Read more
Pt experienced dizziness, feeling light-headed, and numbness, and tingling in L arm, face, and BIL LE within 15 minutes of vaccine administration. Pt BP and HR were elevated for approximately 30 minutes after administration as well.
45 2021-04-05 tremor, weakness At 5:45 I suddenly felt weak all over and had to lay down. Within 15 minutes I started shaking uncon... Read more
At 5:45 I suddenly felt weak all over and had to lay down. Within 15 minutes I started shaking uncontrollably from body chills. Within a half an hour I had a 102.5 fever. After 2 hours the chills had dissipated but my fever was at 103.5. I took acetaminophen and slept fitfully all night. The next morning at 6:00 my fever was still 102 and I felt weak. By mid morning the fever was finally gone and I was exhausted and mildly nauseous for the rest of the day.
45 2021-04-06 tingling Pt reports body feeling "tingly and off" By received water and stated "the tingly was less" at ... Read more
Pt reports body feeling "tingly and off" By received water and stated "the tingly was less" at 1210. Pt stayed for 30 minutes
45 2021-04-07 involuntary muscle movements Patient post Johnson and Johnson vaccination and in observation period when EMS and Nursing staff no... Read more
Patient post Johnson and Johnson vaccination and in observation period when EMS and Nursing staff noticed patient to be unresponsive with 10-20 seconds of mild jerking movements. Patient able to regain consciousness and state that he has a history of seizures Blood pressure124/80, blood glucose 63. Patient transported by EMS to hospital.
45 2021-04-08 weakness Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device a... Read more
Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.
45 2021-04-08 cold sweat At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomi... Read more
At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomited about 50 cc of yellowish emesis. Vaccinated on the L arm at 0923. Vitals: BP - 128/58, HR ? 62, RR ? 18. Head-to-toe assessment completed. After vomiting, client states he felt so much better. He stated, ?I probably did not eat enough.? He has no PMH, NKA, and did not take any medications today. He has not experienced a reaction with any other vaccine, medication, or food product. Throughout monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition and did not experience dizziness or nauseousness anymore. He was no longer clammy. Client left vaccination clinic at 0948, accompanied by his family, ambulatory, in stable condition.
45 2021-04-08 feeling cold my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chil... Read more
my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chills, is perspiring profusely. an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104. his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.
45 2021-04-08 migraine, weakness nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fati... Read more
nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.
45 2021-04-08 muscle spasms EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event parame... Read more
EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.
45 2021-04-08 tremor, pain in extremity Sudden fever of 101.7 with severe headache, severe chills, and shaking. Some nausea. Arm only slight... Read more
Sudden fever of 101.7 with severe headache, severe chills, and shaking. Some nausea. Arm only slightly sore from injection. Took 2 Advil which did not seem to help much. Could not sleep all night and held cold pack on head to try to help headache. At 4:00 am was due to take 2 more Advil, and that finally seemed to help so he finally stopped having chills and could sleep. Woke up in the morning tired, but feeling better, symptoms pretty much gone.
45 2021-04-08 tremor Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began... Read more
Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.
45 2021-04-09 hot flush Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved... Read more
Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved higher on day 2, hot and cold flashes, sweating, extreme fatigue, upper back muscle aches (severe). Diarrhea, total loss of appetite.
45 2021-04-09 migraine, feeling hot Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizz... Read more
Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.
45 2021-04-09 pain in extremity, numbness, weakness 3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went ... Read more
3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went to urgent care. Was given antibiotic/steroid to combat sinus/ear infection type symptoms. Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs. Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms. Took blood for tests. COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands. Head still hurts too. More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP. Was given Gabapentin to help with the pain. Was referred to neurologist. 4/8 - Initial exam at neurologist. Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.
45 2021-04-09 pain in extremity Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began wat... Read more
Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began watering. It was hard to tell but my throat felt slightly swollen also. I drank some water and a few minutes later things seemed to clear up. Randomly throughout the afternoon I had similar dry/itchy/tingling in my throat but not as strong as the time right after the vaccination. I didn't suspect this was directly related to the virus since I have allergies to grasses, trees, pollen, etc. and take over the counter allergy medicine as needed. At 3:30am today (4/10/21) I woke up having to use the restroom and when standing up out of bed I was extremely dizzy. After laying down in bed the dizziness disappeared. When waking up later in the morning the dizziness/light headed feeling was still present when standing. I also have noticed random strange pinching pain in my legs that only last for 1-2 seconds and sends a quick short pain sensation throughout my body. I have no clue if any of this is related to the vaccination received, but after noticing news articles with issues in a few folks receiving the Janssen vaccine, I decided I would pass this info along just in case.
45 2021-04-09 seizure Questionable seizure activity x 30 seconds.
45 2021-04-11 involuntary muscle movements Approximately 2.5 minutes post vaccination- patient became diaphoretic, pale, and exhibited a flat a... Read more
Approximately 2.5 minutes post vaccination- patient became diaphoretic, pale, and exhibited a flat affect. Upon opening his car door to further assess, client began to jerk and froth at the mouth. Event lasted <30 seconds. Epi pen administered at 5:20 pm and ambulance called. B/P 88/42, P-120, R-20, SaO2- 96%. Patient evaluated by ambulance personnel, but refused transfer. His girlfriend stated that she would take him via private car to hospital. Patient strongly encouraged to go via ambulance- repeatedly refused.
45 2021-04-11 pain in extremity Became light headed, Fainted, Turned Pale, Sweated. EMTs were called who took BP, Blood Sugar, and... Read more
Became light headed, Fainted, Turned Pale, Sweated. EMTs were called who took BP, Blood Sugar, and ran EKG (I think). and was told all were normal.
45 2021-04-12 weakness, migraine Took the vaccination on Sunday woke up Monday morning with flu like symptoms and a fever of 101, wok... Read more
Took the vaccination on Sunday woke up Monday morning with flu like symptoms and a fever of 101, woke up today Tuesday feeling fine until this afternoon with a sudden severe migraine with both eyes going blurry and feeling really weak.
45 2021-04-12 bell's palsy 5 days after shot came down with Belle Palsy
45 2021-04-13 burning sensation Woke up with eyes swollen almost shut, red rash all around eyes. Blurry vision, eyes feel like they ... Read more
Woke up with eyes swollen almost shut, red rash all around eyes. Blurry vision, eyes feel like they are on fire. Skin on eye lids are peeling. Fever and chills
45 2021-04-13 feeling cold, weakness I started shivering uncontrollably in the evening. I could not warm up, and my body was shivering. ... Read more
I started shivering uncontrollably in the evening. I could not warm up, and my body was shivering. I wasn't sure if I had a fever, but I did not feel well. My wife was trying to warm me up and she thought I was having a seizure because she had never felt someone shiver so violently. My eyes were watering abnormally as well. The shivering subsided after about 30 minutes. I was soar and weak over the couple of days, but I believe those are normal symptoms.
45 2021-04-13 muscle spasms, pain in extremity Had leg pain in the form of a knot in my left calf muscle. The muscle would tighten and feel like a ... Read more
Had leg pain in the form of a knot in my left calf muscle. The muscle would tighten and feel like a Charlie horse. The issue lasted for about 3 weeks. I tried cooling and then warming it since it felt like a pulled muscle at first. Then as the days went on there was more of a knot in the muscle and then tried warming, stretching, compression sleeve, hot tub, and then tried a massage gun. The issue finally went away but not sure if it was rest or a combination of the treatments.
45 2021-04-13 muscle spasms Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abd... Read more
Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt. I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.
45 2021-04-13 pain in extremity Left lower thigh muscle/gout-like pain/can?t add weight without buckling/Started 11 April, gradually... Read more
Left lower thigh muscle/gout-like pain/can?t add weight without buckling/Started 11 April, gradually got worse until receiving care from the hospital.
45 2021-04-15 weakness Constant headache, and I never get headaches. Flu-like symptoms, general weakness, fatigue and feel... Read more
Constant headache, and I never get headaches. Flu-like symptoms, general weakness, fatigue and feeling sleepy all day.
45 2021-04-15 pain in extremity SHARP HAND PAIN; SWOLLEN INJECTION SITE; FATIGUE; INJECTION SITE PAIN; BODY ACHES; This spontaneous ... Read more
SHARP HAND PAIN; SWOLLEN INJECTION SITE; FATIGUE; INJECTION SITE PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206a21a, 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 body aches. On 08-APR-2021, the subject experienced swollen injection site. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced sharp hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen injection site on APR-2021, and injection site pain on 08-APR-2021, was recovering from body aches, had not recovered from fatigue, and the outcome of sharp hand pain was not reported. This report was non-serious.
45 2021-04-18 pain in extremity Typical arm soreness right after the shot. The next morning however, a severe headache that lasted m... Read more
Typical arm soreness right after the shot. The next morning however, a severe headache that lasted most of the day and the soreness was more pronounced - treated with Advil II.
45 2021-04-19 numbness, tingling after receiving vaccine, about 12 hours later i had the standard side effect of moderate fever (appr... Read more
after receiving vaccine, about 12 hours later i had the standard side effect of moderate fever (approx 102), chills, and was very fatigued. The fever was gone the next day, but i took the next day off and stayed in bed. The concerning problem was i developed tingling and numbness throughout most of my body, especially on the side where i had the shot, in my arm, neck mouth and tongue. After about 36 hours after the shot i started to feel about 80% better, but the tingling/numbness continued and i continued to have major fatigue. From day 3-5, i was having some trouble moving around - almost like my legs weren't wanting to respond to my brain. Since these symptoms lasted until about day 5, i got concerned and called the doctor. However, right before talking with the doctor in day 5 i was able to do some yoga and was feeling much better, and it all seemed to resolve. I feel better now.
45 2021-04-19 pain in extremity I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed un... Read more
I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.
45 2021-04-21 feeling cold, numbness, pain in extremity, feeling hot FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WA... Read more
FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.
45 2021-04-21 numbness, pain in extremity NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; B... Read more
NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.
45 2021-04-21 muscle twitching This spontaneous report received from a patient concerned a 45 year old male. The patient's height, ... Read more
This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and eye twitches. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.
45 2021-04-21 seizure, sensory loss, migraine, tingling Patient does not remember most of the adverse event. Patient's partner reports that patient started ... Read more
Patient does not remember most of the adverse event. Patient's partner reports that patient started feeling a tingling sensation on his left arm about 10 minutes after vaccination. Partner also reports that patient was hallucinating and sending her confusing text messages during his 15 minute observation period. The patient did not report feeling any adverse symptoms at the checkout station after his 15 minute observation period and before leaving the vaccination clinic. After patient returned home, his partner reports considerable swelling on his left arm, continued hallucinations and trying to dismiss her concerns. Subsequently, that same day, partner reports the patient had a severe migrane and began to lose feeling on his left arm and leg, at which point the patient also lost consciousness. Also at this point, the partner calls 911. After arrival of emergency personnel, the patient regains consciousness, but does not remember name and complains of continued pain on his arm. He is transported to hospital where he spends 3 nights and receives treatment and care for stroke symptoms. Patient reports that he does not remember much of anything 1.5 days after vaccination. After returning home from hospital, patient complains of memory lapses and begins seeing neurologist for minor seizures during his sleep. Wife reports that patient now lashes out and easily loses temper due to the fact that his memory is foggy.
45 2021-04-22 pain in extremity CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK O... Read more
CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK OF LEGS BELOW KNEE (RIGHT LEG IS MORE SENSITIVE TO THE TOUCH THAN LEFT); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left). On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced chest pain radiating to stomach on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left), and chest pain, and the outcome of chest pain radiating to stomach on and off was not reported. This report was non-serious.
45 2021-04-22 tingling 5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling... Read more
5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling and tense all over his body." Client felt very anxious today and he reports having history of anxiety. His BP is 155/97 p 101, after 5 minutes manual BP is 142/90 p 110. 911 was called and medics performed an EKG on site. Client indicates that his symptoms are improving and was not transported to the hospital.
45 2021-04-22 tremor SHAKING; BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concer... Read more
SHAKING; BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspergers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021 17:00, the subject experienced shaking. On 25-MAR-2021 17:00, the subject experienced body ache. On 25-MAR-2021 17:00, the subject experienced chills. On 25-MAR-2021 17:00, the subject experienced fever. On 25-MAR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, fever, and headache on 27-MAR-2021. This report was non-serious.
45 2021-04-25 bell's palsy, facial paralysis Bell Palsy, left side of face severe paralysis. Treatment Prednisone 20MG Tablets (7 days) / follow ... Read more
Bell Palsy, left side of face severe paralysis. Treatment Prednisone 20MG Tablets (7 days) / follow up with primary care doctor.
45 2021-04-26 pain in extremity Patient started to have left leg pain. Presented to facility on 4/26/21. Ultrasound examination sh... Read more
Patient started to have left leg pain. Presented to facility on 4/26/21. Ultrasound examination showed DVT
45 2021-04-27 weakness, pain in extremity HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HU... Read more
HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
45 2021-04-27 numbness Guillain Barre syndrome- symptoms of BLE numbness with ascending bulbar weakness developed 4/18 and ... Read more
Guillain Barre syndrome- symptoms of BLE numbness with ascending bulbar weakness developed 4/18 and diagnosed on 4/27
45 2021-04-27 pain in extremity VIRAL PERICARDITIS; LEFT ARM PAIN; SEVERE HEADACHE; ABDOMINAL PAIN; This spontaneous report received... Read more
VIRAL PERICARDITIS; LEFT ARM PAIN; SEVERE HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient via a company representative concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies and no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, 01 total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced abdominal pain. and severe headache. On 03-APR-2021, the patient experienced severe chest pain and left arm pain. On 04-APR-2021, the patient was admitted to the hospital and diagnosed with viral pericarditis and was discharged on 06-Apr-2021. Laboratory data included: On 04-APR-2021, Angiogram (NR: not provided) Not reported, CT (computed tomography) scan (NR: not provided) Not reported, EKG (electrocardiogram) (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Troponin increased (NR: not provided) Troponin levels increased, and X-ray (NR: not provided) Not reported. On 05-APR-2021, Laboratory data included: Angiogram (NR: not provided) No blockages. On 06-APR-2021, Laboratory data included: Echocardiogram (NR: not provided) No blockages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, and left arm pain on APR-2021, and had not recovered from severe headache, and the outcome of viral pericarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210436265-covid-19 vaccine ad26.cov2.s-Viral pericarditis, Abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210436265-covid-19 vaccine ad26.cov2.s-severe headache, Left arm pain. This event(s) is labeled per Agency and is therefore considered potentially related.
45 2021-05-01 flushing Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refu... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refused epi-pen. Most likely anxiety-related event per patient and wife/observation. EMS showed up to store within 20 minutes; patient was discharged to home and did not follow up with ER. Spoke with wife at 5PM --patient has been fine all afternoon and went shopping after AE.
45 2021-05-02 pain in extremity Patient felt unwell after administration. He complained of headache and muscle soreness in both arm... Read more
Patient felt unwell after administration. He complained of headache and muscle soreness in both arms
45 2021-05-03 inability to speak, migraine Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I ... Read more
Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.
45 2021-05-05 feeling hot Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minu... Read more
Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minutes after the vaccine, he reported feeling very faint and was about to pass out. He wasn't feeling well so 911 was called. He also reported feeling hot and was visibly sweating. He drank some water and sat in front of a small fan until medics arrived. They assessed him and he walked out with them for further evaluation. I called patient at 7:30 to see how he was feeling. There was no answer and his voicemail didn't allow me to leave a message.
45 2021-05-06 tremor, seizure Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked ... Read more
Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked if he ever fainted after getting a vaccination or injection and patient reported no. The vaccine was administered to the patient and patient appeared to be fine for the next few minutes after getting vaccinated. Patient was told he could take a seat in the waiting area and wait until his 15-minutes were up and he could go. Patient was seated in the waiting area for about a minute but then got up to walk down one of the isles. When walking down the isle patient fainted and collapsed. This occurred approximately 10 minutes or so after he received the vaccine. Patient was helped to a chair and once seated appeared to shake/convulse (almost like a seizure) for approximately 5-10 seconds before snapping out of it and regaining consciousness. Afterwards he was alert and talking but didn't remember fainting. 911 was called and he was checked out by paramedics. After observing him for 15 minutes or so and determining his heartrate and blood pressure were normal and he appeared to be ok, the paramedics told him they can take him to the hospital to be evaluated further, or he was free to leave on his own without going to the hospital. The patient said he felt fine and declined being taken to the hospital. After another 10-15 minutes the patient left under his own power. Patient mentioned he would possibly be calling his physician and alerting them to the episode.
45 2021-05-10 muscle spasms, feeling hot, facial paralysis, face paralysis Patient felt warm and was sweating profusely later the evening on the day of vaccination. 1 week lat... Read more
Patient felt warm and was sweating profusely later the evening on the day of vaccination. 1 week later patient started experiencing muscle spasm initially starting at the lower legs, progressively walking upwards to the upper thigh. And this time patient also developed a new left-sided facial droop, with facial muscle weakness. He was evaluated at the ED 2 weeks after his Covid vaccine. CT head, CT angio was unremarkable. However MRI showed some mild diffuse cerebral atrophy. On neuro exam There Is Mild Left-Sided Facial Droop, unable to raise left side eye, unable to puff out his cheeks. There is also stocking glove distribution of decreased sensitivity to vibration, temperature, light touch. At this time th
45 2021-05-14 seizure On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021... Read more
On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.
45 2021-05-26 facial paralysis, bell's palsy Bilateral facial paralysis - symptoms started on the right on April 21, 2021. Patient was seen by P... Read more
Bilateral facial paralysis - symptoms started on the right on April 21, 2021. Patient was seen by PCP on April 22, 2021 and started on Valtrex and steroids for the treatment of Bell's Palsy. On April 24, 2021 the left side developed paralysis as well. Patient was seen in the ED. Labs, MRI and CT of the head were performed. Lumbar puncture was attempted but unsuccessful. Patient was discharged home and had lumbar puncture as outpatient on April 29, 2021 as well as additional blood work. Tests showed no malignancy or infectious etiology. He was started on another round of steroids on May 7, 2021. Started physical therapy the following week. Still has minimal facial mobility at the time of this submission.
45 2021-05-28 numbness, tingling Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, ... Read more
Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, blurry vision. Still have tinnitus, hearing sensitivity, vison problems and chest pai.
45 2021-05-30 tremor Uncontrollable shaking. Fever, malaise, neurodeficit.
45 2021-05-31 slurring, mild one side paralysis, seizure MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COU... Read more
MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL. MOSTLY AFFECTED RIGHT SIDE.
45 2021-05-31 pain in extremity Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasou... Read more
Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism
45 2021-06-03 pain in extremity, muscle spasms FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON LEFT ARM; ... Read more
FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker. 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 28-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
45 2021-06-05 seizure Patient came to the pharmacy for the Janssen COVID vaccine. He was feeling fine, and was injected wi... Read more
Patient came to the pharmacy for the Janssen COVID vaccine. He was feeling fine, and was injected with vaccine in the left deltoid at 1:05pm. He remained alert throughout the time information and instructions were provided. Later, he mentioned fear of needles and looked pale. I gave him a Gatorade drink and glucose tablets. At about 1:10pm he fainted while seated in our pharmacy waiting area. He was accompanied by his significant other. He had mild convulsions that lasted less than 5 seconds. Our request to call 911 was denied. Store management responded to our call immediately. Observation and care was provided. Moist cloths were given to patient. He recovered in about 15-20 minutes. He walked out with his significant other. He was very thankful and said he felt normal.
45 2021-06-07 migraine Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine star... Read more
Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine started around 11 am that lasted until the next morning after which a dull headache lasting till Friday, 102.3 fever, EXTREMELY painful body aches, metallic taste in mouth, thirst that could not be quenched, dizziness, blurred vision, confusing, nausea.
45 2021-06-11 burning sensation TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE HEADACHE; Thi... Read more
TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever (genetic variant). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced ring-worm like rash around injection site. On 06-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced severe headache. On 07-JUN-2021, the subject experienced teeth pain. On 07-JUN-2021, the subject experienced jaw-line on fire. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, severe headache, ring-worm like rash around injection site, jaw-line on fire and teeth pain was not reported. This report was non-serious.
45 2021-06-20 tremor pt received Janssen vaccine around 10:28a. Patient was sitting in the post vaccination area. Around ... Read more
pt received Janssen vaccine around 10:28a. Patient was sitting in the post vaccination area. Around 3-5mins, he fainted, hit the floor. I ran out once this was brought to my attention. I found him on floor, blood on the floor and he was shaking and then stop. I don't know how long he was shaking but it stop. I checked the pt and he regained conciousness. I asked if he is ok. He ask what happened because he does not remember. He speaks another language and an associate was there to translate. We asked if he wants us to call 911, he refused. The firefighter/paramedics suggested they will come over anyway to make sure he is ok, he does not have to go with them to go to the hospital. Pt did not want to go to hospital because he does not have insurance. He was checked by a medic who also speaks his language. He checked pt's vital signs, asked questions like allergies, medical conditions, asked what day is today and what is his name (which were the same questions I asked before medic arrived). Medic informed patient the importance of seeing to a dr, the sooner the better. Pt still does not want to be taken to the hospital. Patient signed a refusal form. Nephew picked up the pt
45 2021-06-21 tremor About 3 minutes after vaccination while seating patient said that he fills that he is going to faint... Read more
About 3 minutes after vaccination while seating patient said that he fills that he is going to faint. 911 was called by the stuff. Second later his eyes rolled his and started shaking. In a few minutes he came back and said he fills better. EMS arrived checked his vitals. Hi seemed fine, refused to go to the hospital. Eventually he left after sitting for 30 more min saying he is fine.
45 2021-06-24 pain in extremity Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same l... Read more
Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.
45 2021-07-01 grand mal seizure On vacation in, just got to hotel and fell asleep. Wife said I lifted my head with a strange look on... Read more
On vacation in, just got to hotel and fell asleep. Wife said I lifted my head with a strange look on my face, laid back down. Then one minute later had a grand mal seizure. Called 911 and was sent to ER via Ambulance. ER conducted EKG, CAT Scan and other tests to determine the root cause. Found, no tumors or other explanations for the seizure. No prior history of neurological problems. Interestingly both of my parents are also now suffering neurolgical side effects after taking the Pfizer Covid vaccine.
45 2021-07-01 pain in extremity, numbness, weakness CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN A... Read more
CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
45 2021-07-01 cold extremities, tingling Attendee with history of fainting with needles. was given his single shot while sitting. Had declin... Read more
Attendee with history of fainting with needles. was given his single shot while sitting. Had declined offer to go to cot, Staff observed Attendee's color changed after Initially attempted to stand up, observed and told to remain sitting. Given ICEPacks, Monitored, reports tingly cold hands Transitioned to lying down. declines EMS and medications, Symptoms resolve after WIfe arrives, transitioned to standing, D/c to wife /daughter/ car to home.
45 2021-07-11 bell's palsy Bells Palsy symptoms
45 2021-07-11 numbness, tingling On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then ne... Read more
On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then nearly had a syncopal episode, had trouble speaking and was leaning to the right. My wife had to hold me up. My brother in law had to carry me to the car as my left leg was not working at all. I was taken by ambulance to the nearest hospital and was worked up for possible CVA (which was ruled out). I was also checked for DVT of lower extremities which was negative. I am still having residual numbness and tingling to my left leg. I am still having symptomatic bradycardia with near syncope.
45 2021-07-12 numbness, cold extremities NUMB FACE INITIALLY, NUMBNESS DOWN BOTH LEGS. NO FEELING OF HOT OR COLD ON THIGHS, ARMS. LIPS CURREN... Read more
NUMB FACE INITIALLY, NUMBNESS DOWN BOTH LEGS. NO FEELING OF HOT OR COLD ON THIGHS, ARMS. LIPS CURRENTLY NUMB. ICY-HOT SENSATION WHEN WIND HITS BODY WHEN SWEATING. HANDS IN COLD WATER FEELS "ICE, ICE, ICE FREEZING COLD". HEAT FROM SUN IS SIGNIFICANTLY ENHANCED AS IF THE SKIN WERE BURNING
45 2021-07-13 facial paralysis After receiving the vaccination I experienced headaches, face drooping on the left side possible Bel... Read more
After receiving the vaccination I experienced headaches, face drooping on the left side possible Bells Palsy. I also experienced panic attack symptoms as well.
45 2021-07-14 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt HR at 49-55, loss consciousness for less than 10 seconds, became diaphoretic. BP at 96/62. Pt felt better after 5 minutes.
45 2021-07-18 hypersensitivity of all senses Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body. It felt lik... Read more
Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body. It felt like every pore on my body was open and hyper sensitive to touch. My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm. Symptoms persisted for about 36 hours.
45 2021-07-21 hypersensitivity of all senses Almost 24 hours after receiving my shot on 7/20/2021 I felt extreme fatigue, malaise, moderate to se... Read more
Almost 24 hours after receiving my shot on 7/20/2021 I felt extreme fatigue, malaise, moderate to severe headache and eye pain, chills all over body with sensitivity to skin all over body, diarrhea, loss of appetite, loss of smell. All of these symptoms have continued 48 hours later with no relief.
45 2021-07-21 tingling Tingling in hands and feet, started estimated 2-3 weeks after receiving the vaccine. Still there, as... Read more
Tingling in hands and feet, started estimated 2-3 weeks after receiving the vaccine. Still there, as of today 7/22. But has not gotten worse nor have I experience muscle weakness or other symptoms.
45 2021-07-27 night sweats MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; P... Read more
MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.
46 2021-03-07 pain in extremity Achy knees. sore arm, tired
46 2021-03-09 tingling, pain in extremity Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm h... Read more
Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm headache slightly stronger and discomfort in knees. 4:00pm joint aches specially in the knees, ankles and finger joints. 6:00pm tingling sensation on cheeks and headache persist. Walking uncomfortably because of joint aches.
46 2021-03-10 feeling hot The 46yo patient came in to get his covid vaccine. His parents reported he has a medical condition/... Read more
The 46yo patient came in to get his covid vaccine. His parents reported he has a medical condition/disability that requires him to receive services in their home. After receiving the vaccine the patient reported feeling lightheaded, dizzy, hot, and that his blood pressure felt abnormal. He requested an ambulance and some water. I called 911 and provided him water, but did not administer any epinephrine or any other medications. The paramedics arrived and talked to him for about 15 minutes. He then left on his own accord with his parents and declined further medical attention.
46 2021-03-16 tremor Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headac... Read more
Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal
46 2021-03-17 tremor, seizure Violent uncontrollable shaking (convulsions) for about 30 minutes in the middle of the night. Start... Read more
Violent uncontrollable shaking (convulsions) for about 30 minutes in the middle of the night. Started around 2 am I believe. My wife had the same vaccine the day prior and a similar experience. Can't overemphasize how serious the shaking was and it was scary.
46 2021-03-20 flushing, hot flush, feeling cold, feeling hot Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very... Read more
Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very hot and body below neck felt very chilled. After five minutes these symptoms intensified, feeling hot flushed in face and vision darkened, feeling like a black out may occur. Pharmacist provided water. Symptoms began dissipating after 20 minutes after injection. After 30 minutes, symptoms ended.
46 2021-03-24 pain in extremity Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination.... Read more
Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.
46 2021-03-28 discomfort Redness around left eye developed into severe rash spread all over body. Intense itching and discomf... Read more
Redness around left eye developed into severe rash spread all over body. Intense itching and discomfort. All started to occur 3/16 and progressively got worse and continued to spread. 1st dx was shingles (2nd time having it?2018) treated with prednisone and then dx contact dermatitis steroid shot and antihistamines then diflucan and went to Derm gave another steroid shot and antibiotic?all since 3/16 still progressing
46 2021-03-28 feeling hot, numbness, difficulty speaking 24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, b... Read more
24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass. Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.
46 2021-04-01 tingling, limb paralysis immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and ... Read more
immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.
46 2021-04-03 feeling hot, weakness, cold extremities I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I wok... Read more
I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.
46 2021-04-07 weakness Severe fatigue lethargy weakness, lightheadedness
46 2021-04-08 feeling hot At 1412, RRT was activated for a 46 y/o M with c/o feeling warm. 5 minutes after this complaint, he ... Read more
At 1412, RRT was activated for a 46 y/o M with c/o feeling warm. 5 minutes after this complaint, he threw up about 100 cc of yellowish emesis. Client stated he felt better after vomiting. Vaccinated at 1350 on the L arm. Vitals: BP ? 118/72, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client was in stable condition and did not feel warm anymore. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by his family (Wife and daughter).
46 2021-04-08 pain in extremity, tremor, hypersensitivity of all senses day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a we... Read more
day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.
46 2021-04-09 weakness PATIENT REPORTED VISUAL DISTURBANCES (DARKENING OF VISUAL FIELD), SWEATING, AND WEAKNESS ABOUT 5 MIN... Read more
PATIENT REPORTED VISUAL DISTURBANCES (DARKENING OF VISUAL FIELD), SWEATING, AND WEAKNESS ABOUT 5 MINUTES AFTER VACCINE WAS GIVEN.
46 2021-04-10 feeling hot, tremor, seizure like phenomena Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and s... Read more
Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and started to slide sideways. His body was shaking slightly and his eyes were open but there was no cognitive awareness. This lasted no more than 90 seconds and then patient came to abruptly and reoriented himself on the chair before I had the opportunity to get him to the floor. Patient then stated that he was lightheaded, warm and sweaty. EMT had been called and upon assessment of the patient transported him to the ER.
46 2021-04-11 weakness Headache, chills, fever, vomiting, diarrhea, weakness. From just after midnight day of injection for... Read more
Headache, chills, fever, vomiting, diarrhea, weakness. From just after midnight day of injection for around 12 hours following on and off.
46 2021-04-12 weakness DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer conce... Read more
DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of medical conditions and no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, dizziness, weakness, and feeling unwell. This report was non-serious.
46 2021-04-12 feeling cold Fever, sever chills for 2 hours, sustained heart rate around 90~100 for more than 4 hours, intermitt... Read more
Fever, sever chills for 2 hours, sustained heart rate around 90~100 for more than 4 hours, intermittent headaches 24 hours, mild confusion for 4 hours, loss of appetite for 48 hours
46 2021-04-13 tingling, numbness Felt numbness on bottom of left foot primarily at back of heel to fourth and fifth toes. Slight num... Read more
Felt numbness on bottom of left foot primarily at back of heel to fourth and fifth toes. Slight numbness/tingling just above and below left elbow. Symptoms lasted for approximately 2 days from onset.
46 2021-04-13 seizure EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the C... Read more
EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS. Patient became pale, 5 second seizure, dizziness and vomiting. EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers. Patient waited another 30 minutes and stated he felt much better. Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day. He stated he felt better and had no more problems. He did not seek additional medical care.
46 2021-04-14 burning sensation, cold sweat Burning Arm initially, later that day, high fever, chills, vomiting, body aches, and overall clammin... Read more
Burning Arm initially, later that day, high fever, chills, vomiting, body aches, and overall clamminess that lasted for 2 days.
46 2021-04-14 night sweats That evening , started getting feverish and had temperature fluctuations, night sweats, body was sor... Read more
That evening , started getting feverish and had temperature fluctuations, night sweats, body was sore all over. Then the next day notied that my eyesite in my left eye seemed off- noted I had floaters and could not see as well as previously. I assume this is a flare up of Toxoplasmosis as the eye symptoms are the same.
46 2021-04-14 unresponsive to stimuli After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he pas... Read more
After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he passed out in the bathroom and was unresponsive. The EMTs arrived and were able to revive him in the ambulance. When they reached the hospital he was put on life support. After he coded again in the Emergency room they told me he was without oxygen for too long and was taken off the respirator. He passed away at 4:10 PM.
46 2021-04-19 pain in extremity Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and p... Read more
Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache
46 2021-04-21 numbness FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient... Read more
FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 69 inches. The patient's concurrent conditions included penicillin allergy, smoking, and abstain from alcohol, and other pre-existing medical conditions included no illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced shortness of breath. On 04-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced foot numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from headache, and had not recovered from foot numbness, and shortness of breath. This report was non-serious.
46 2021-04-21 pain in extremity Arm muscle pain, leg muscle pain, back pain, headaches, metallic taste in mouth : all lasting up to ... Read more
Arm muscle pain, leg muscle pain, back pain, headaches, metallic taste in mouth : all lasting up to 2 weeks
46 2021-04-29 weakness At 10PM day of vaccination, started feeling weakness. Weakness became fever and mild headache around... Read more
At 10PM day of vaccination, started feeling weakness. Weakness became fever and mild headache around 11PM. Low grade fever and weakness and intense fatigue persisted into the next day, April 30th. Low grade fever still ongoing at time of this writing. Headache has mostly resolved, along with regaining some strength.
46 2021-04-30 feeling cold Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue. Th... Read more
Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue. The next day, started experiencing BPPV. This last 2 days. This was helped slightly by Hallpike maneuver. Sense of haziness, inability to concentrate/focus, irritable, difficulty sleeping, tired, which are all still here to the time of this reporting.
46 2021-04-30 limb paralysis HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; Th... Read more
HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
46 2021-05-02 weakness, cold sweat, tingling Immediately after getting the shot I broke out in cold sweats, body went limp, arms and hands were t... Read more
Immediately after getting the shot I broke out in cold sweats, body went limp, arms and hands were tingling very badly and I lost my hearing to fast ?whooshes? couldn?t really speak or move for at least 15-20 minutes. Then got up and couldn?t stand up felt almost drunk. I had another spell exactly the same about 4 hours later
46 2021-05-04 discomfort I am experiencing slight ringing in what appears to be my right ear. I don't know if it is both ears... Read more
I am experiencing slight ringing in what appears to be my right ear. I don't know if it is both ears. I have not seen my primary doctor yet. The feeling is similar to having head congestion or sinus pressure, I guess. It is not an emergency for me. I will be checking with my primary doctor soon. The only discomfort I have is when I try to fall asleep. I hear the slight ringing in my right ear. Still optimistic that it will go away on its own. I am tolerating it at the moment and can work throughout the day. But, sleeping appears to be the most interruptive. With that being said, I do end up falling asleep. I am pretty sure this is a vaccine reaction. I have not had any history of it before. As soon as I see my doctor, I will update the notes for more clarity on what these symptoms are. Thank you.
46 2021-05-04 pain in extremity For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches... Read more
For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches and my legs were hurting too. My blood pressure was elevated as well. And that was not going away either. I went to doctor. My headaches have decreased. But for the last two to three days I have been getting chest pains. I have called the doctor this morning and I'm waiting to call me back. It's not ongoing pain - just every now and then - I'm not sure what it is.
46 2021-05-05 feeling hot pt was hot and lightheaded while sitting then fainted in his chair pt reawoke after maybe 2 minute... Read more
pt was hot and lightheaded while sitting then fainted in his chair pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy
46 2021-05-09 seizure like phenomena, seizure Systemic: Hypertension-Medium, Systemic: Seizure-Medium, Additional Details: Pt had seizure like act... Read more
Systemic: Hypertension-Medium, Systemic: Seizure-Medium, Additional Details: Pt had seizure like activity / HTN crisis 3 min after injection. Hx of heart problems and phobia of needles. Pt lost airway and then consiousness, Pt was assisted to floor. EMS was called. After airway postioning and sternal simulation pt regained consiousness. Pt was handed off to NP care and then later to EMS after being evaluated. Wife stated they did not go to hospital and later went to dinner, when she picked up vaccine cards.
46 2021-05-10 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip. Pt unconscious for less than 1 minute. Blood pressure taken about 5 minutes later and was 65/40. 911 was called and paramedics arrive on scene. Care was transferred to them
46 2021-05-11 flushing Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweatin... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was unresponsive for few seconds less than a min and came back 911 paramedics evaluated him and took to emergency for further evaluation
46 2021-05-13 cold sweat, weakness Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale. W... Read more
Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale. When we went to assist him he asked to lay on the floor, before we could help him to this position he fainted, we got him on the floor and on his side, within about twenty seconds he woke up and was very aware of his situation. We applied ice packs under his neck and on his forehead. After about twenty minutes he sat up and started to gain his color back. At this point he told us he had fainted before after a flu shot and and donating blood. Several minutes later he was able to stand up and sit in a chair. Cold packs were continued and he drank a bottle of orange juice. Twenty minutes later he said he was back to normal just felt weak like after a work out. He wanted to use the restroom and was escorted, showed no additional signs or symptoms at this point, and wanted to go home.
46 2021-05-18 cold sweat 3 minutes after injection patient started to stand up to get pharmacist's attention and pharmacist l... Read more
3 minutes after injection patient started to stand up to get pharmacist's attention and pharmacist looked over at patient and noticed patient was clammy and looking like he was going to fall over. Pharmacist told patient to sit back down and immediately grabbed e-kit and headed to patient's side. Patient was clammy (like just got out of shower). At 3:45 PM BP was 128/63 and PR was 44. At 3:50 PM BP was 92/56 and PR 51, at this point RPh decided it was more than a vaso-vagal reaction and administered the epinephrine injection at 3:51 PM - EMS was called. At 3:52 PM BP was 130/76 and PR 59, 3:55 PM 134/86 PR 66, 3:58 PM BP was 148/83 and PR 68 at 3:59 PM EMS arrived and patient declined them taking him to hospital via ambulance due to no insurance. He had pharmacist escort him to his car so he could get his cell phone and back to pharmacy so he could call his son to pick him up and take him to the hospital. Unknown if patient ended up going to hospital.
46 2021-05-18 tremor, feeling cold Freezing (no chills) literally woke up freezing and shaking bad trying to get warm, fever, bad muscl... Read more
Freezing (no chills) literally woke up freezing and shaking bad trying to get warm, fever, bad muscle and joint pain and bad fatigue
46 2021-05-21 weakness Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and ... Read more
Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and had a 104.7 fever with vomiting, nausea, join pains, weakness, fatigue, and headache, along sinus tachycardia. Went to the ER to be evaluated, it was determined that this was an adverse reaction. I was released from care around 2:30 am.
46 2021-05-25 feeling cold Since I got the vaccine I felt cold and I had flu till now and my buddy so tired but the main proble... Read more
Since I got the vaccine I felt cold and I had flu till now and my buddy so tired but the main problem is MY BLOOD PRESSURE IS TOO HIGH SINCE I TOOK IT UNTIL NOW it's over one month. My blood pressure never get down 160.
46 2021-05-25 muscle spasms, discomfort Within 2 minutes of receiving shot, overwhelming deadening of sound, blackness in eyes, full body sw... Read more
Within 2 minutes of receiving shot, overwhelming deadening of sound, blackness in eyes, full body sweats, full body discomfort, very close to fainting for first 6-8 minutes. As those symptoms started to diffuse severe muscle cramping started in opposite arm of shot, moved thru body. Within 15 minutes the only symptoms left were the muscle cramps. Those continued for several days. Still lingering today, a week later.
46 2021-05-25 unresponsive to stimuli Patient became non responsive within 2 min of receiving shot. Was lowered to the floor, diaphoretic... Read more
Patient became non responsive within 2 min of receiving shot. Was lowered to the floor, diaphoretic and pale, revived within 1 min, confused. States he has had this effect during previous shots/ blood draws/ being around ?sick people?. Patient given water and crackers (has only some green beans at noon today). Feels fine 10 min later.
46 2021-05-31 weakness Soreness, weakness, fatigue, abdominal pain. No treatment or prescription.
46 2021-06-07 pain in extremity I experienced a bit of soreness to my left arm, my arm felt a little bit warm to touch. I also felt ... Read more
I experienced a bit of soreness to my left arm, my arm felt a little bit warm to touch. I also felt tired and some fever on the second day. The pain went away in 3-4 days.
46 2021-06-14 feeling hot Patient was known to have fainting spells due to vaccinations in the past. Shortly after immunizatio... Read more
Patient was known to have fainting spells due to vaccinations in the past. Shortly after immunization took place he became hot and fainted while sitting in his chair. After a few moments he came to and we provided him a cooling pack for the back of his neck. He confirmed he was able to leave after another 15 minutes of monitoring.
46 2021-06-22 hot flush, muscle spasms 24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for t... Read more
24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle
46 2021-07-11 numbness Severe fatigue and numbness in fingers and toes
46 2021-07-12 tingling, coordination abnormal All my Lyme Disease symptoms returned after 19 months of absence. Tingling sensation in my left hand... Read more
All my Lyme Disease symptoms returned after 19 months of absence. Tingling sensation in my left hand. Dropping and coordination issues has become a constant occurrence.
46 2021-07-12 tingling, numbness, migraine Fatigue, migraine headaches, dry cough, numbness and tingling in both arms, more severe in left arm
46 2021-07-13 discomfort End of May i had some vision issues seeing double but did not think much about it . Went to my PCP ... Read more
End of May i had some vision issues seeing double but did not think much about it . Went to my PCP for annual physical exam where he did the bloodwork and everything came back normal except Cholesterol which was marginally higher. The issue was not causing much discomfort for me and it sort of went away the best i recall or dont recall. Around June 14th 2021 I started having trouble focusing with my eyes again. It was causing me more discomfort than before so i visited my PCP Dr June 15th. Dr mentioned there was slight difference in ear pressures and maybe it was that. Not totally satisfied with that i visited my Optometrist Dr the next day and he suspected 4th nerve Palsy and asked me to
46 2021-07-15 numbness Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pre... Read more
Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.
46 2021-07-15 tingling, numbness random body rashes from my feet to my neck for 15 days now. None on the genitals. Itchy and skin we... Read more
random body rashes from my feet to my neck for 15 days now. None on the genitals. Itchy and skin welts without even touching it. I've changed my diet, changed detergents, stopped taking all vitamins, nothing helps. they come and go all day and night. On 7/13/21 between 3pm-10pm my whole head went tingly, itchy, and semi-numb, including when I flossed my teeth.
46 2021-07-15 tingling Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat... Read more
Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat, unable to focus. All began a few weeks after shot and have not gone away.
46 2021-07-20 slurring, speech disorder Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications... Read more
Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications. He received the J&J vaccine on 04/06/2021. On 04/28/2021 he had a fall from probable syncope. He sustained a laceration to his forehead. He was sent to Hospital for evaluation. He had CTs of head and neck, which were unremarkable. A drug screen was negative. Both before and after his return he was having issues with his speech. He seemed to understand words but when he tried to respond, his speech was garbled . He was observed in the infirmary. There was slight improvement in speech. He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021. This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct. While an outpatient workup was being scheduled, he had another episode of witnessed syncope. This was on 06/14/2021. An MRI at hospital showed a larger infarct than seen on 06/03/2021. He was hospitalized for 3 days. No cause for the CVA was found during this hospitalization. He has continued with speech symptoms and is starting speech therapy in the near future. In summary, this I/M was in a normal state of health with no risk factors for vascular disease. Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021. After multiple tests, no reason was found for the CVA to occur. It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
46 2021-07-24 pain in extremity The vaccine gave me quite severe side effects (COVID symptoms). I think this is because I had COVID ... Read more
The vaccine gave me quite severe side effects (COVID symptoms). I think this is because I had COVID twice previously (last time in Dec 2020). About 8 hours after injection, I had sudden onset of high fever, chills, aches, headache - the symptoms were worse than full blown COVID itself (without the breathing problems) and lasted about 4 full days. I was so sick I took 2 days off work, which is very uncommon for me. My arm was quite sore for about 5 days. I've never had any reaction to a vaccine before and thought I should mention this. I didn't have any anaphylaxis or allergic reaction that I know of, just very, very severe COVID symptoms.
46 2021-07-26 seizure like phenomena, muscle twitching Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c... Read more
Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c/o "feeling funny" and felt like he was going to pass out. Client started to have a seizure-like activity, and loss consciousness two times. Ice packs and cooling clothes were applied to clients forehead and neck after client seizure-like activity stopped, feet elevated. Client was diaphoretic, gray, started twitching (which he said is normal when he gets nervous.) BP was low at 86/64. EMT called and client evaluated. Client refused transport to hospital. Client recovered from episode after an hour and left with his wife from the health department able to walk and communicate on his own.
47 2021-03-05 feeling hot About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his visio... Read more
About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred. Resolved after about 2 minutes after removing glasses and drinking water
47 2021-03-08 burning sensation Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30... Read more
Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.
47 2021-03-14 numbness, tenderness Shingles on left side of face. It's a mild case, but pain and extreme sensitivity to touch, numbness... Read more
Shingles on left side of face. It's a mild case, but pain and extreme sensitivity to touch, numbness in some areas, fluid-filled blisters that break open and crust over, itching.
47 2021-03-14 pain in extremity Fever, chills, loss of appetite, diarrhea for 30 hours. Soreness in left arm still there
47 2021-03-15 migraine Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour s... Read more
Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often. --- Thank you ---
47 2021-03-16 feeling of body temperature change dizzyness, fever, hot and cold chills, fatige, diahria, muscle aches
47 2021-03-23 muscle spasms muscle spasms/cramping of L side entire body Narrative:
47 2021-03-23 pain in extremity Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 min... Read more
Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 minutes, had to go to the restroom twice. The next morning at 4:45 am I woke with chills and moderate muscle , joint aches and random sharp muscle pains all over my hips, arms, and legs. Chills, aches, and fever continued until 8:30pm the same night. My fever would go to 102.8 as a high to 100.2 depending on how close I was to my next timeframe to take Tylenol. I took 4 extra strength Tylenol (2000 mg) every 4 hours, give or take 30 minutes. Around 8:30 pm my fever broke and I sweated mildly Until around 10:30pm
47 2021-03-26 flushing After 2 minutes felt wave of flush, heart rate accelerated from 55 to 90, blood pressure rose to 150... Read more
After 2 minutes felt wave of flush, heart rate accelerated from 55 to 90, blood pressure rose to 150/100. Experienced light headedness. BP and HR returned to normal after 30 minutes. Light headedness remained for 2 hours. After 20 minutes heart started squeezing feeling and remained for two days. After 2 hours, began feeling sharp pains in heart and palpitations, continued for 5 days. After 12 hours began feeling mild aches and chills and fatigue. Continued for 3 days.
47 2021-03-29 burning sensation Woke up with intense arm pain at injection site on 15th day after vaccine. Radiated down arm , subsi... Read more
Woke up with intense arm pain at injection site on 15th day after vaccine. Radiated down arm , subsided after approximately 30 minutes. Deep tissue, burning pain. Remained only slightly sore remainder of day. Had not experienced arm pain at injection site since day 3 previously.
47 2021-03-31 migraine Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour s... Read more
Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often.
47 2021-03-31 night sweats, feeling cold I am filling this this out to report similar symptoms and reactions for three of us in the same hous... Read more
I am filling this this out to report similar symptoms and reactions for three of us in the same household (ages 47, 45, and 18). Flu-like symptoms: fever reaching as high as 101.2, night sweats, joint pain, chills, unable to get warm, exceedingly tired, loss of appetite, upset stomach. Missed work (two of us) and school (one of us) within a couple days of the shot.
47 2021-04-05 tremor pt states he started feeling nauseas, developed a headache, and had diarrhea. The next day he had f... Read more
pt states he started feeling nauseas, developed a headache, and had diarrhea. The next day he had fever, chills, body aches, he was shaking. His headache was getting worse. All symptoms were getting better except the headache. He thought he was feeling better but when he woke up today 4/6/2021 he was SOB and diarrhea was back. Pt has taken Pepto Bismol for his symptoms and will probably need to go to the ER since he is having trouble breathing. He feels like he has had such a bad reaction to this since he possibly has had the covid vax in the past 90 days.
47 2021-04-06 involuntary muscle movements, unresponsive to stimuli Patient received the vaccine. Immunizing tech stated: the patient seemed fine at the time of the sho... Read more
Patient received the vaccine. Immunizing tech stated: the patient seemed fine at the time of the shot. After administration of the shot the patient began to bleed out of injection site (like normal). The immunizing tech swabbed the area with cotton and placed a Band-Aid on the patient then stepped back into the pharmacy to grab another band aid while the patient remained at the immunization chair. The tech applied another band aid and told the patient to wait 15 minutes after the immunization and directed him to a waiting chair. The tech came back into the pharmacy and was cleaning the immunization basket when the patient's wife yelled for help. At this point I went out to the patient. Another tech called 911, another grabbed a nearby EpiPen. The immunizing tech grabbed the e-kit while I was out with the patient while he was unresponsive. Patient was unresponsive and slouched in chair. His wife and I supported the neck of the patient and laid him on the floor. I checked pulse and breathing to which both were present. Patient was still unresponsive and making strange movements. Pulse and breathing remained present and then the patient became responsive relatively quickly. At this point patient responsive and answering questions and moving fine. He asked if he had passed out then stated, he had a phobia of needles and said he felt nauseated. (wife previously stated he had a fear of injections). Soon after the ambulance showed up and I told the paramedics the above story. After a few more minutes I checked in with the paramedics and they said the patient was doing fine. Lastly, he was taken out of store with paramedics.
47 2021-04-06 flushing after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsu... Read more
after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsusual taste in mouth, tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.
47 2021-04-06 tremor Extreme chills causing full body shaking Extreme fatigue to the point that holding head up and stayi... Read more
Extreme chills causing full body shaking Extreme fatigue to the point that holding head up and staying conscious was difficult Mild Fever All started about 12hrs after the vaccine and lasted about 32hrs
47 2021-04-07 muscle spasms, muscle twitching 1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pa... Read more
1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder. Most importantly pain in the spine from middle to lower back.. (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees.. 1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows. I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.
47 2021-04-09 feeling hot about 3 hours post shot, mild headache,. about 7 hours after severe chills, lasted 4 hours, switched... Read more
about 3 hours post shot, mild headache,. about 7 hours after severe chills, lasted 4 hours, switched to overheated, low grade fever 101. resolved with acetametaphine. All symptoms resolved with 24 hours.
47 2021-04-09 muscle spasms Symptoms started around 4pm with muscle ache all over and the body chills. Severe muscle spasms foll... Read more
Symptoms started around 4pm with muscle ache all over and the body chills. Severe muscle spasms followed in back and chest area, hard to relax. By 6pm, very high fevers - T-105.5, 105.6. interventions didn't drop temp unless stripped completely naked and temp would drop to 103.3 at lowest, Tylenol administered and temp and no clothes - just a sheet on temp is 101.9. and bad body aches currently.
47 2021-04-10 seizure Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Med... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Seizure-Severe
47 2021-04-11 burning sensation When injected after about 60 seconds semi severe achy-burning feeling in my arm that subsided in a ... Read more
When injected after about 60 seconds semi severe achy-burning feeling in my arm that subsided in a few minutes. After 15 minutes slight tingling/numbness on the tip of my tongue and slight tingling in the upper lips of my mouth. I was not worried. I took 1 Benadryl and 2 Ibuprofen (400 ml) at that time for symptoms. I took additional 1 Benadryl and 4 Ibuprofen about 6 hours later as a precaution. Day 2 after about 36 hours I had slight soreness, and some sweating as I slept the 2nd night. Treated with 4 ibuprofen. Also I woke up with a feeling of uneasiness in the middle of the night on the 2nd night. Day three, just a general feeling of tiredness. Day 4 and 5 still slight ache in the injection sight if pressure is applied. Other than that I feel normal as of day 5.
47 2021-04-11 numbness Did the adverse event start after the first or second vaccination? only one dose (after the shot 5m... Read more
Did the adverse event start after the first or second vaccination? only one dose (after the shot 5min after his arm completely went numb) when waiting at the site for 15min he experienced nausea and dizziness Recommendation: Please make sure he drinks lots of fluids he could take Pedialyte and if symptoms worsen please contact doctor and go the nearest ER. Mother would like a follow up call tomorrow at 10:00am I told her we would try to call her back at that time if its not busy, if not expect a call later in the afternoon.
47 2021-04-12 feeling jittery, tingling, numbness Thursday April 8th 1:00PM Shot was injected into my left arm 1:15PM left hand was numb and tingling ... Read more
Thursday April 8th 1:00PM Shot was injected into my left arm 1:15PM left hand was numb and tingling 2:00 PM left side of my face went numb and tingled. cheek, ear, neck and into my hair line Friday (4/19) midnight my heart was racing for about 2 hours. It was like I drank WAY too much caffeine Sunday (4/11) my hand was back to "normal" Tuesday (4/13) my left side of my face is getting much better, but it still feels a little different
47 2021-04-12 numbness and pain in extremities, pain in extremity, muscle spasms, hypersensitivity of all senses 04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild... Read more
04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue
47 2021-04-12 pain in extremity EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report receiv... Read more
EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.
47 2021-04-12 pain in extremity I hurt for three days,headache, body hurt, tired, sick to my stomach, sore arm, tired and felt like ... Read more
I hurt for three days,headache, body hurt, tired, sick to my stomach, sore arm, tired and felt like I had the flu. I then got better. About a week later, I started coughing a lot. My head hurt,but i didn't run any fever. I thought I was having bad allergies from changing weather, but it lasted longer than usual, over a week. I was sore, tired, not really hungry. I feel better now, but I still have this lingering dry cough and it won't completely go away. I still feel sore and very tired. I get a headache every now and then. I thought it was allergies, but it falls into the time period that people are having reactions to this JJ Janssen shot. The cough is annoying. I get short breathed and winded rather easily or more easily now. I thought I'd at least report it.
47 2021-04-13 burning sensation, tingling Hives itching burning and with intermittent pain extremely painful like large needles stabbing. Rig... Read more
Hives itching burning and with intermittent pain extremely painful like large needles stabbing. Right Chest and right back close to injection site. About 10-15 hives
47 2021-04-13 tremor About 10 hours after shot I had uncontrollable shakes, restlessness, and insomnia. Fever between 10... Read more
About 10 hours after shot I had uncontrollable shakes, restlessness, and insomnia. Fever between 101-102 all the following day. Fever between 100-101 all the day after that. Along with the fever I had body and head aches.
47 2021-04-15 pain in extremity Both Lower Legs are swollen, pain below the knee area. Unable to walk, feet. Boady pain.
47 2021-04-15 pain in extremity Longer-term headaches, tired feelings, abdominal cramping in the mornings, tiring pain in legs. Spec... Read more
Longer-term headaches, tired feelings, abdominal cramping in the mornings, tiring pain in legs. Specially left leg feeling Sharp shooting pains.
47 2021-04-16 numbness, burning sensation, tingling, slurring 47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine... Read more
47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.
47 2021-04-16 muscle spasms The day after injection: severe flu-like symptoms (high fever, body aches all over (former injury si... Read more
The day after injection: severe flu-like symptoms (high fever, body aches all over (former injury sites), headache. Symptoms subsided after 24 hrs. The following days featured muscle cramps all over my body, brought on by exercise. Calves cramped the most with the left calf being injured from cramps. Upper shoulders and neck muscles seized. 'Hot spots' on my torso. Skin very sensitive to touch on side and back. Sleeping a lot more than usual. Fatigue has lasted a week. A week later and muscles are feeling somewhat better. Skin still very sensitive. Still more tired than usual. Still avoiding exercise until muscles feel 100%.
47 2021-04-16 muscle spasms about 1 hour after injection got a nose bleed, then started experiencing on 2nd week after shot st... Read more
about 1 hour after injection got a nose bleed, then started experiencing on 2nd week after shot started feeling nauseous and fatigue, 3 rd and 4th week started feeling extreme fatigue, gut issues, no appetite, chills ,sweating profusely, muscle cramping all over body. Went to my Dr. April 6 & 13, all vitals good, had flu and Covid test both negative, Had labs drawn both times, liver enzymes was high with both results. Still currently having all symptoms
47 2021-04-17 weakness 1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grad... Read more
1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness, right fore arm and lower right leg bottom half felt little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness, little stiff right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)
47 2021-04-17 hot flush, pain in extremity Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache... Read more
Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.
47 2021-04-18 muscle spasms Leg cramps pain especially at night. Worst with left leg. Headache and feeling heavy headedness. Lo... Read more
Leg cramps pain especially at night. Worst with left leg. Headache and feeling heavy headedness. Lost of taste and small cramps on light side of tongue.
47 2021-04-18 pain in extremity, tingling Severe neck and arm pain started about 30 minutes after vaccination was given. Often times it is a t... Read more
Severe neck and arm pain started about 30 minutes after vaccination was given. Often times it is a tingle from the neck to my elbow and the pain lasts 24 hours a day.
47 2021-04-18 pain in extremity On 4/14/2021, right elbow started to hurt. This was a site of a removed gout-caused mass over a yea... Read more
On 4/14/2021, right elbow started to hurt. This was a site of a removed gout-caused mass over a year ago. That subsided within a day. On 4/15/2021, left foot started to hurt. By 4/17/2021, the next to smallest toe and the large toe was swollen and very tender to any sort of touch. It was not warm. The pain was almost unbearable on 4/18/2021 and the suspicion that it might be gout was considered. On 4/19/2021, after a visit with his doctor, gout was confirmed as the likely cause of the pain/swelling. However, no blood tests were run to confirm. Treatment for gout was initiated.
47 2021-04-19 seizure, grand mal seizure Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20... Read more
Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM
47 2021-04-19 tenderness Two days after receiving vaccine, patient developed acute swelling and tenderness in right lower ext... Read more
Two days after receiving vaccine, patient developed acute swelling and tenderness in right lower extremity and diffuse whole body urticaria.
47 2021-04-20 feeling hot, tingling 7 DAYS AFTER THE SHOT (APRIL 12TH 2021, THERE ARE HOT TINGLY AND PRICKLY SENSATION ALL OVER (AND STI... Read more
7 DAYS AFTER THE SHOT (APRIL 12TH 2021, THERE ARE HOT TINGLY AND PRICKLY SENSATION ALL OVER (AND STILL HAS THIS SIDE EFFECT ON APRIL 21ST 2021) 2ND AND 3RD DAY, HAD FEVER AND FATIGUE BUT WENT AWAY ON THE 4TH DAY
47 2021-04-20 pain in extremity, muscle spasms Pt experienced pain/cramping in his right leg on or about 4-15-21. Thought this was due to new work ... Read more
Pt experienced pain/cramping in his right leg on or about 4-15-21. Thought this was due to new work shoes. Pain continued through the weekend and on Monday 19th visited his PCP where a scan was preformed confirming a clot in his right leg between his thigh and ankle. Pt started on therapy and has a follow up with his physician on Friday 23rd. Pt doing well and in good spirits.
47 2021-04-20 pain in extremity Chief complaint of worsening lower leg pain. Initially the patient though that he had pulled a musc... Read more
Chief complaint of worsening lower leg pain. Initially the patient though that he had pulled a muscle however he had complaints of claudication upon ambulation. Patient reports having J&J COVID vaccination approx 2.5 weeks prior. Patient reported his friend informed him that he might potentially have a blood clot and that he should come to the emergency department. Imaging consistent with acute DVT and patient taken to IR for tPA direct catheter infusion.
47 2021-04-21 pain in extremity RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG... Read more
RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
47 2021-04-21 pain in extremity SEVERE PAIN IN ARM; This spontaneous report received from a patient concerned a 47 year old male. Th... Read more
SEVERE PAIN IN ARM; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 205 pounds, and height was not reported. The patient's concurrent conditions included pencilin allergy, non smoker, and alcohol user, and other pre-existing medical conditions included patient had no drug abuse or drug illicit usage patient had no available diagnostic lab data. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042192119 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced severe pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in arm. This report was non-serious.
47 2021-04-22 tingling My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin... Read more
My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms. It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso. I had full muscle control but I did have problems with my bladder and bowels. I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully. No treatment was administered except to wait and see. Three days later and I am improving but not fully recovered yet.
47 2021-04-23 migraine BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN... Read more
BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
47 2021-04-25 mild one side paralysis, slurring Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 202... Read more
Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 2021 Hospital course 47M pmh DMII, HTN, HLD, L basal ganglia stroke, pw right-sided weakness, gait imbalance, double vision and slurred speech beginning at 2:00 p.m. 4/22. on admission, double vision resolved; slurred speech, headache and right-sided weakness imbalance gait remain. 4/23am pt developed L pupil dilation and lethargy, MRI brain demonstrating acute stroke, allow permissive htn treat for sbp>220mmhg or DBP >120mmhg, cont asa/statin; US carotid nonacute/benign; TTE pending; ST/PT/OT. Tele benign. 4/24 BPs remain elevated, allow permissive htn to standards <220/120; cont st/pt/ot, a little improved participation today po intake etc. 4/25 cont to improve slowly, will be good candidate. cont allow permissive htn, no events on tele, cont asa/statin for significant stroke, add plavix. 4/26 pt cont improve clinically, BP stabilizing still permissive htn, recommend start home BP meds within 2-3 days once out of acute phase, pt accepted today, TTE benign doppler benign, but doesn't seem like bubble study done, recommend repeat as outpatient to ensure no positive bubble defer to pt's pcp f/u. double vision persists, pt currently w eye patch relief, recommend outpatient ophtho follow up closely after or during time. cont asa/plavix/statin, then transition to asa/statin as rx per guidelines. no afib on tele, consider zio patch on d/c to ensure no afib in young patient w x2 stroke. recommend hypercoag workup outpatient. Acute stroke, L lacunar -asa/plavix/statin -permissive htn -tele -PT/OT/ST -TTE benign, nml ef, no bobble done? -repeat tte outpatient w bubble to ensure no R>L shunt -US carotid nonacute -MRI Brain 4/23 1. Focal patchy restricted diffusion and FLAIR signal hyperintensity in the left medial thalamus/rostral midbrain compatible with acute lacunar type ischemic infarct. 2. No significant intracranial mass effect, midline shift or extra-axial collection. 3. Chronic left basal ganglia infarct approximating the anterior limb of the left internal capsule involving the head of the left caudate nucleus.
47 2021-04-25 numbness Cold chills for three days post vaccination. Diarhea for 12 days post vaccination. Lump near ear NOT... Read more
Cold chills for three days post vaccination. Diarhea for 12 days post vaccination. Lump near ear NOT a gland from day 4 - 13 post vaccination. Numbness in top of left foot from day 4-13 post vaccination. Hazy thinking trouble concentrating from day 9-10 post vaccination. Altered "poop cycle" from day 2-13 post vaccination. Headaches, not migraine intense only 4-5 on a 1-10 scale from day 2-day 15 (currently still have them but only a 2 on a scale to 10).
47 2021-04-25 pain in extremity Lower back and left leg pain
47 2021-04-26 pain in extremity on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach a... Read more
on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach ache, nausea, headache, ..the nest day, my legs were so sore that I could barely stand & I had to wait for. while until I could walk. the headache lasted for a few days, the muscle pain is lessening but not gone until today, it makes my legs & feet grow sore & tired very quickly. last Sunday, April 18 2021, started around 5 pm, I started having nausea , then stomach pain so bad & vomitted many times until I was admitted to ER around midnight . the med staff at the ER did X-ray & citi scan, told me there was some bowel obstruction , gave me ivy, painkiller injection & some others then I was transferred to a medical center. they did another citi scan & found everything was ok, I asked what may cause it, they didn't really know beside probably not enough water etc .
47 2021-04-27 coordination abnormal, numbness NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; L... Read more
NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; LOSS OF COORDINATION; HARD TO WALK; LITTLE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of diabetes except family history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced little fever. On 15-APR-2021, the subject experienced numbness in left arm from shoulder down to finders and in both legs. On 15-APR-2021, the subject experienced swollen right foot 2x bigger. On 15-APR-2021, the subject experienced loss of coordination. On 15-APR-2021, the subject experienced hard to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 03-APR-2021, and had not recovered from numbness in left arm from shoulder down to finders and in both legs, swollen right foot 2x bigger, loss of coordination, and hard to walk. This report was non-serious.
47 2021-04-29 flushing, unresponsive to stimuli Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fain... Read more
Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.
47 2021-04-29 pain in extremity 4.3.21: soreness throughout body, fever 4.4.21: fingers turned blue 4.5.21: tongue swelled and turn... Read more
4.3.21: soreness throughout body, fever 4.4.21: fingers turned blue 4.5.21: tongue swelled and turned bright red fingers mottled for 5 days intense body aches for 6 days 4.26.21: antecubital fossa hot, swollen and red, significant pain 4.27.21: pain extends down into forearm and red and streaked 4.30.21: pain continues
47 2021-05-05 tremor, seizure Patient experienced a seizure episode immediately after I administered his COVID-19 vaccine. I admin... Read more
Patient experienced a seizure episode immediately after I administered his COVID-19 vaccine. I administered the vaccine at 10:22 AM and a few seconds later Patient started to shake and toss his head back. I immediately called 911/paramedics after his wife and I helped him to lay to his side. His seizure episode lasted about 2 or 3 minutes. He quickly regained consciousness and became fully responsive before the paramedics arrived.
47 2021-05-11 inability to speak, tremor Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control brea... Read more
Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control breathing, intense very shallow hyperventilation, Inability to speak or answer questions, severe muscle aches, soreness.
47 2021-05-12 pain in extremity, flushing FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WI... Read more
FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
47 2021-05-19 migraine, pain in extremity Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever ov... Read more
Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)
47 2021-05-23 facial pain 4/11 around 8am my nose just out of the blue started bleeding profusely. I tried about 40 minutes t... Read more
4/11 around 8am my nose just out of the blue started bleeding profusely. I tried about 40 minutes to stop it but wasnt successful so I was transported to hospital ER where they had to cauterize it just to get it to stop. I was advised I could not take anything but Tylenol to try to ensure the bleeding did not start again. It never really got any better and I began developing a weird head pain in my head, which caused severe headaches which the pain being felt in my face and behind my eye area. After the pain continued to get worse on 4/22 I had a virtual visit with Dr. who prescribed a steroid and antibiotic and advised I see an ENT. I havent had any more nose bleeds but I do still get intermitten headaches from time to time
47 2021-05-25 feeling cold RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report ... Read more
RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.
47 2021-05-25 feeling hot Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 ... Read more
Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.
47 2021-05-31 nerve pain The first day I noticed a burning rash on the back of my leg, that lasted for about a few days until... Read more
The first day I noticed a burning rash on the back of my leg, that lasted for about a few days until the pain was unbearable. Blisters started to appear and spreading. Nerve pains started to occur throughout the body that resulted into going to the clinic and was diagnosed with Shingles. The doctor prescribed a 7 day anti-viral prescription that helped with the pain, after taking it the pain went away a few days later. After taking the medication as prescribed I did recover from my symptoms.
47 2021-06-02 seizure Flu symptoms immediately. 1 week +1 day post injection, severe body aches, fever, 1 week + 2 days s... Read more
Flu symptoms immediately. 1 week +1 day post injection, severe body aches, fever, 1 week + 2 days seizure requiring hospitalization, ICU and vent for 4 days.
47 2021-06-05 unresponsive to stimuli, tremor, seizure Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient fainted 1 min after receiving vaccine, then started seizing in chair was moved to ground with legs up. Was checked to make sure breathing was occuring, after 3 min patient was back to normal. when woke up felt dizzy asked what year and where they were and answered correctly. Ambulancewas called pt denied being taken to hospital. bp low
47 2021-06-08 unresponsive to stimuli, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt had syncopal episode but recovered quickly
47 2021-06-09 bell's palsy Bell's palsy 6 days after vaccine, mild to moderate, unresolved at this time
47 2021-06-09 pain in extremity, tingling Right upper arm pain and paresthesias
47 2021-06-10 bell's palsy On 5/31/21 I got a headache and noticed blurry vision. At approximately 11pm I noticed I was dribbl... Read more
On 5/31/21 I got a headache and noticed blurry vision. At approximately 11pm I noticed I was dribbling when I drank from a cup. At 2am on 6/1 I went to the Medical Office at my work and spoke to the Nurse. After seeing my face the Nurse determined I needed to go to the ER immediately. I went to the ER . After CT scan and physical test they determined I had Bell's Palsy.
47 2021-06-17 tremor, seizure like phenomena Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symp... Read more
Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.
47 2021-06-20 difficulty speaking Had a raspy throat and nasal itch almost like allergies but more. 2nd day it increased its severity.... Read more
Had a raspy throat and nasal itch almost like allergies but more. 2nd day it increased its severity. The third day I was really congested. I felt like my lungs were only filling up half way; I was a little shortness of breath. Mucous buildup and had to cough to clear my throat to breathe. I felt like there was swelling in my throat. By Thursday, I went to get seen by doctor. Dr. noticed little pustules on my lymph nodes and she tested me for strep, negative. QR, inhaler steroid, prednisone for 5 days. Nasal spray to clear the nasal passages, Flonase. I have taken albuterol when needed to help clear up my breathing. I'm still feeling a little congested with sinus drainage, voice a little horse. Note: I did have a Tetanus shot about a month or a little bit more than a month before this vaccine.
47 2021-06-22 pain in extremity Have had severe nonstop pain in both arms
47 2021-06-22 unresponsive to stimuli ~01:15PM PATIENT RECEIVED IM VACCINE IN LEFT DELTOID WHILE SEATED. ADMINISTERED BY PHARMACY INTERN, ... Read more
~01:15PM PATIENT RECEIVED IM VACCINE IN LEFT DELTOID WHILE SEATED. ADMINISTERED BY PHARMACY INTERN, PATIENT REPORTED NO ISSUES. "FEELING FINE, I'M OK" ~01:17PM AFTER RECEIVING VACCINE CARD AND BEING REQUESTED TO WAIT THE 15 MINUTES FOR OBSERVATION, PATIENT STATED THAT HE HAD NEVER FAINTED AFTER A SHOT, ONLY AFTER BLOODRAWS, BUT WAS ADVISED TO REMAIN SEATED JUST IN CASE. IMMEDIATELY AFTER HE STATED HE FELT LIGHT HEADED AND THEN PROCEEDED TO SLUMP IN AN ADJACENT CHAIR. PATIENT WAS UNRESPONSIVE TO INQUIRIES, BUT SNORING WAS AUDIBLE. ~01:17PM PATIENT WAS LOWERED TO THE FLOOR INTO A SUPINE POSITION WHILE NECK WAS SUPPORTED DURING THE MOVEMENT PROCESS, AND EMTS WERE NOTIFIED BY PHARMACY STAFF VIA 911. ~01:18PM PATIENT REGAINED CONSCIOUSNESS AFTER ABOUT ~10-20 SECONDS TOTAL, OPENED HIS EYES, AND WAS SPEAKING TO HIS WIFE AND STAFF. PATIENT WAS ADVISED TO REMAIN IN POSITION UNTIL EMTS ARRIVED TO ASSESS THE PATIENT ~01:21PM EMTS ARRIVED ON SITE TO ASSESS SITUATION, VITALS WERE CONSIDERED NORMAL AND PATIENT REFUSED AMBULANCE TO HOSPITAL. ~01:30 EMTS LEFT SCENE, PATIENT REPORTED FEELING NORMAL AND WOULD BE ASSISTED BY WIFE, LEFT THE SCENE WALKING NORMALLY BELIEVED TO BE A VAGAL RESPONSE FOLLOWING THE IMMUNIZATION
47 2021-07-01 night sweats Several weeks after vaccination, had mild cough, fatigue, and fever whenever tired, usually at night... Read more
Several weeks after vaccination, had mild cough, fatigue, and fever whenever tired, usually at night. Cough and night sweats still recurring when fatigued 5 weeks after vaccination.
47 2021-07-03 pain in extremity I have been having soreness in my left lower leg.. I am concerned it has to do with the vaccine
47 2021-07-12 weakness, discomfort, tingling, muscle spasms Monday, March 29 I was warming up for a chest workout - bench press with 135# (2- 45# plates) on the... Read more
Monday, March 29 I was warming up for a chest workout - bench press with 135# (2- 45# plates) on the bar. On my first rep I noticed the muscles in my right arm were not firing properly and I pressed the wt up very unevenly - I repeated two more reps (total of 3) and repacked the bar. I then proceeded to attempt push ups- on my first rep my wt shift over my left arm and my right arm only served to balance me- again no pushing strength. I then proceeded to do a pull up- as I attempted my first pull-up my weight again shift to my left side- no pulling strength in right arm. The week prior I was showing signs of tennis elbow in my right arm. The week of March 29, the intensity of discomfort was high as I experienced muscle spasms alternating between my right tricep, right lateral muscle and my right pectoral muscle- my tennis elbow pain was intense and I experienced tingling in my right ring finger and pinky. On April 9 I went to family Dr they gave me a muscle relaxer and pain pills and scheduled an x-ray of right elbow and shoulder. April 16 the pain continued and I went back into the doctor and had an MRI scheduled for Sunday May 2 along with a referral to an ortho doctor. May 17 I went to the ortho doctor who did another X-ray. The ortho doctor first Mentioned that this could be GBS. I started Physical therapy on June 21.
47 2021-07-14 migraine About a month after receiving the vaccine I began getting migraine headaches during sex, specificall... Read more
About a month after receiving the vaccine I began getting migraine headaches during sex, specifically at the time of ejaculation.
47 2021-07-22 cold sweat I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating.... Read more
I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating. I slept 13 hours and woke up with a fever . I took IB-profrin and the fever continued for about 3 days. I still have chest pains
47 2021-07-22 feeling cold The night of the vaccine I felt like I was coming down with a cold, had chills, felt cold and my bod... Read more
The night of the vaccine I felt like I was coming down with a cold, had chills, felt cold and my body temperature was 100.4. A week later I still have adverse symptoms such as laryngitis, sore throat, runny nose, watery eyes and cough.
47 2021-07-25 pain in extremity severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several time... Read more
severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.
48 2021-03-04 feeling hot Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour... Read more
Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.
48 2021-03-06 numbness Jansen COVID-19 Vaccine EUA I got strange sensations in the back of my neck, then later on in the d... Read more
Jansen COVID-19 Vaccine EUA I got strange sensations in the back of my neck, then later on in the day I have numbness in the back of my neck and some fin the upper back and shoulders. Don't know how much more will go numb and how bad it will get. But I can feel the back of my neck and shoulders and upper back, but it is like there is a layer in between that is numb.
48 2021-03-08 weakness Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and wea... Read more
Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache
48 2021-03-09 seizure like phenomena, inability to speak Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered... Read more
Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.
48 2021-03-13 seizure 7hrs post- Fever, 100 & chills begin 9hrs post- Fever, 100 11hrs post- Fever 101 13hrs post- Fever 1... Read more
7hrs post- Fever, 100 & chills begin 9hrs post- Fever, 100 11hrs post- Fever 101 13hrs post- Fever 103, mild sore throat 15hrs post- Fever 103-104 16hrs post- Fever 102, headache begins (Ibuprofin Taken) 22hrs post- Fever 100, (Ibuprofin Taken) 28hrs post- Fever 100, (Acetometaphin Taken) 30hrs post- Fever 102, severe convulsing 36hrs post- Fever 100, headache 42hrs post- Fever normal, headache ends (Acetometaphin taken)
48 2021-03-15 seizure presented to ER within 18 hours of vaccine with fever, and seizure.
48 2021-03-16 pain in extremity pain in the back of the left heel. No trama or activity related
48 2021-03-22 pain in extremity I started having the next day after vaccine a fever and a severe muscle and body aches, headache , t... Read more
I started having the next day after vaccine a fever and a severe muscle and body aches, headache , then a day later I had severe knee and foot pain that is continuing to this day it?s unbearable.
48 2021-03-22 tremor Fever started approximately 6 hours after injection. Symptoms included high fever, sweating, chills... Read more
Fever started approximately 6 hours after injection. Symptoms included high fever, sweating, chills, shaking, entire body aches and pains, headache and disorientation. Fever peaked about 11pm and began for the most part subsided by morning with a persistent headache.
48 2021-03-23 pain in extremity Pt felt pain in arm, dry mouth, dizzy, lightheaded
48 2021-03-25 pain in extremity Aches, restlessness, arm hurts, headache
48 2021-03-27 weakness Temperature over 102, nausea, joint and muscle pain, no energy, no appetite for more than 24 hours.
48 2021-03-31 seizure, cold sweat AT ABOUT 1PM, PATIENT BECAME APPEARED TO BE HAVING A SEIZURE WITH HEAD BACK SITTING IN A CHAIR, WAS ... Read more
AT ABOUT 1PM, PATIENT BECAME APPEARED TO BE HAVING A SEIZURE WITH HEAD BACK SITTING IN A CHAIR, WAS TONIC, CLONIC AND STIFFENED WITH A SHORT LOSS OF CONCIOUSNESS. CALLED 911 AND ADMINISTERED EPI-PEN X 1 DOSE AT 1:03PM PATIENT WAS ALREADY CONSCIOUS AND TALKING. FELT CLAMMY TO TOUCH AND WAS PALE. BP 144/82 PULSE 97, O2 SAT 98. MOVED PATIENT TO BENCH IN SHADE WHILE WAITING FOR EMS. BP 140/95 PULSE 88 WHEN EMS ARRIVED AROUND 1:20, PATIENT DID NOT WISH TO BE TRANSPORTED TO THE HOSPITAL AS HE WAS FEELING BETTER AND EVERYTHING SEEMED OK. HE REMAINED WITH US AND HAD A CLIFF BAR, COKE AND WATER UNTIL 2:20PM AT WHICH TIME HE LEFT. I FOLLOWED UP WITH HIM AT ABOUT 3PM AND HE WAS STILL DOING WELL. HE WAS ADVISED TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN AND IF HE HAD ANY OTHER SYMPTOMS TO GO TO THE ER/CALL 911.
48 2021-04-01 slurring, facial paralysis Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower faci... Read more
Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower facial droop, weakness of extremities, generalized fatigue. On 3/15 he sought medical attention and was sent to ER -- > diagnosed w/ TIA. Pt sent back to jail where simvastatin -- > atorvastatin, pt started lisinopril, ASA. Pt denies deficits today
48 2021-04-03 weakness rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness... Read more
rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.
48 2021-04-05 migraine, tremor Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/che... Read more
Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches
48 2021-04-05 night sweats Chills, low-grade fever, aches, ear pain, night sweats, headaches
48 2021-04-07 weakness, feeling cold Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past... Read more
Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past when fever went up extremely quick. I did not measure my body temperature because I immediately ran under the blanket. Icy-cold hands and feet, even after my body temperature seemed to stabilize. I fell asleep but not a restful sleep. I woke up after 2.5 to 3 hours with the feeling that it was morning, but in fact it was between 2am and 3 am. At that point I felt the worst part had gone, I felt weak and with muscle aches but I could drink water and go back to bed. I did not have a restful sleep all night and I woke up may times. By the morning I was tired but no fever.
48 2021-04-07 tremor pt says he developed a fever, was shaking with chills, and he had trouble sleeping. He still has fa... Read more
pt says he developed a fever, was shaking with chills, and he had trouble sleeping. He still has fatigue and headache but is feeling about 70% better today 4/8/2021.
48 2021-04-09 feeling hot Full body aches, fatigue, mild euphoria/delerium. Periods of chills and hot feeling though no fever.... Read more
Full body aches, fatigue, mild euphoria/delerium. Periods of chills and hot feeling though no fever. Symptoms started 24 hours after injection, 90% resolved at 42 hours post. Took low dose of Ibuprofen and drank liquids.
48 2021-04-09 hypersensitivity of all senses BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; ... Read more
BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 48 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: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.
48 2021-04-10 flushing Pt stated he was nervous about drs office/vaccines. Shortly after (1 or 2 mins) patient got shot he... Read more
Pt stated he was nervous about drs office/vaccines. Shortly after (1 or 2 mins) patient got shot he got warm around the face and said he felt slightly dizzy. So we laid him on his back and elevated his feet. We put cold compress around his neck. This only lasted about 5-10 mins. Called pt couple hours later with no concerns.
48 2021-04-10 hot flush At night time, felt my face getting hot and felt as if I had a fever. 4 days later, developed itchy... Read more
At night time, felt my face getting hot and felt as if I had a fever. 4 days later, developed itchy rash under the armpits, and sides, lower stomach inner thigh near groin.
48 2021-04-10 muscle spasms Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficult... Read more
Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing. Nausea, vomiting. Headache.
48 2021-04-12 hot flush Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting ho... Read more
Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!
48 2021-04-12 muscle spasms, discomfort Ongoing, beginning two days after injection. In addition to injection site/arm soreness, began to ex... Read more
Ongoing, beginning two days after injection. In addition to injection site/arm soreness, began to experience a constant tightness (cramp-like) within the left side of torso, like the muscles around heart or lung is cramping. Unable to take a full inhale of breath without discomfort/pain.
48 2021-04-12 pain in extremity Started with chills and fever, progressed into body aches and joint pain in knees and ankles, contin... Read more
Started with chills and fever, progressed into body aches and joint pain in knees and ankles, continued with 102.5 degree fever and exhaustion over the course of 2 days. Third day was severe dehydration and exhuastion. Pain continues in legs, knees, hips, feet and ankles.
48 2021-04-12 tremor Began with headache. Turned to nausea roughly 8 hours after shot. Nausea turned to sever vomiting ... Read more
Began with headache. Turned to nausea roughly 8 hours after shot. Nausea turned to sever vomiting and for several hours. Tremors. Sweating. Fatigue. More headache. Loss of appetite. Joint and muscle aches. Continued joint pain, appetite loss and fatigue.
48 2021-04-13 facial paralysis, numbness Sudden onset of facial droop and facial numbness
48 2021-04-13 feeling hot I had received the vaccine on April 12, 2021 at 11:30am. I felt a warm sensation go down my arm whe... Read more
I had received the vaccine on April 12, 2021 at 11:30am. I felt a warm sensation go down my arm when I received the vaccine. No ill effects however. Around 2:30am the following morning (April 13, 2021) I started feeling ill. I had flu-like symptoms including: body aches, chills, fatigue, etc. I did not take my temperature, however, I believe I was feverish. I took 400mg of Ibuprofen around 11:30am (24 hours after receiving the vaccine). After sleeping for 2 hours, I began feeling better.
48 2021-04-13 pain in extremity Headache, fairly bad, leg aches and shortness of breath
48 2021-04-13 pain in extremity Leg aches
48 2021-04-14 muscle spasms Fever, chills ,muscle cramps, headache approx 14 hours - all symptoms subsided approx 48 hours from... Read more
Fever, chills ,muscle cramps, headache approx 14 hours - all symptoms subsided approx 48 hours from time of vaccination
48 2021-04-15 weakness The following morning I felt mild flu like symptoms and very low energy. While at working my right ... Read more
The following morning I felt mild flu like symptoms and very low energy. While at working my right upper ankle/ lower knee became extremely sore for no reason. A mild headache and upper respiratory irritation also occurred. My right arm at injection point was extremely sore. I figured it was a immune response and didn?t get too worried. These symptoms have persisted. Hopefully will subside soon
48 2021-04-15 pain in extremity On April 7th in the morning, I woke with sharp pain in right calf. It was not swollen, discolored,... Read more
On April 7th in the morning, I woke with sharp pain in right calf. It was not swollen, discolored, or hot. I had not participated in any activity recently that I felt caused an injury. I took Advil and Tylenol and rested for a few days, but the pain got worse. On April 14th, after reading reports on some adverse affects from the J&J vaccine, I made an appointment to see my primary physician. After blood work and an ultrasound, I was diagnosed with a DVT in my right calf. I have a started a 90-day cycle of Xarelto to treatment the DVT.
48 2021-04-16 pain in extremity Flu-like symptoms which patient expected but also severe leg pain and loss of appetite. Pt was advi... Read more
Flu-like symptoms which patient expected but also severe leg pain and loss of appetite. Pt was advised to consult with physician who advised patient seek emergency help if issue persisted which it did not. Patient's spouse reported symptom onset the morning after the vaccination
48 2021-04-18 weakness headache, dizziness, no energy, insomnia since 04/13/2021
48 2021-04-19 feeling hot Patient experienced sweating, feeling hot and syncope post vaccination, recovered and released
48 2021-04-19 pain in extremity SWOLLEN ARMPIT; SORE ARM; This spontaneous report received from a patient concerned a 48 year old ma... Read more
SWOLLEN ARMPIT; SORE ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced swollen armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen armpit, and sore arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
48 2021-04-21 pain in extremity, muscle spasms STRONG HEADACHE; CRAMPS IN HAND; ARM PAIN; This spontaneous report received from a patient via a com... Read more
STRONG HEADACHE; CRAMPS IN HAND; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levothyroxine sodium. On APR-2021, the subject experienced cramps in hand. On APR-2021, the subject experienced arm pain. On 12-APR-2021, the subject experienced strong headache. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps in hand, and arm pain on APR-2021, and was recovering from strong headache. This report was non-serious.
48 2021-04-21 pain in extremity Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so p... Read more
Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so presented to clinic for evaluation. Has multiple varicose veins in this area.
48 2021-04-21 pain in extremity L leg pain starting 4/15/2021, symptoms similar to superficial thrombus he has in the same leg in 20... Read more
L leg pain starting 4/15/2021, symptoms similar to superficial thrombus he has in the same leg in 2017 . No recent injury. J and J COVID 19 vaccine on 4/6/2021. Started on Eliquis on 4/16/2021. Improved but still having significant L medial thigh pain during follow up appt on 4/20/2021. Scheduled to be seen by PCP next on 5/10/2021.
48 2021-04-23 weakness BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGR... Read more
BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.
48 2021-04-23 burning sensation, discomfort TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS ... Read more
TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 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, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious. Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.
48 2021-04-25 weakness Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and ... Read more
Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep Intermittent nausea Higher bp
48 2021-04-26 muscle spasms Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week pri... Read more
Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week prior. Reviewed records from that visit. Work up was significant for bilateral lower extremity DVTs and thrombocytopenia. Patient was started on Xarelto at that time. Patient does not have any significant risk factors for blood clots. He is not obese, denies tobacco use, recent procedures, recent travel, prolonged immobility, family history of bleeding or clotting disease, etc. He is up to date on cancer screenings based on age/family hx. He did receive the Johnson and Johnson vaccine on 04/07.
48 2021-04-27 face paralysis Facial muscle weakness, loss of taste, difficulties swallowing. Suspected vaccine induced multiple ... Read more
Facial muscle weakness, loss of taste, difficulties swallowing. Suspected vaccine induced multiple cranial neuropathy, most consistent with a Miller Fisher variant type of GBS. Received IVIG with improved symptoms.
48 2021-04-28 pain in extremity LEFT CALF TO ACHILLES SORENESS; FLU SYMPTOMS/ BODY ACHES/ LETHARGY/ DECREASE APPETITE/ CHILLS/ FEVER... Read more
LEFT CALF TO ACHILLES SORENESS; FLU SYMPTOMS/ BODY ACHES/ LETHARGY/ DECREASE APPETITE/ CHILLS/ FEVER; LEFT CALF TO ACHILLES SORENESS; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included difficult breathing, and concurrent conditions included asthma, non-smoker, non-alcohol use, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 12-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced left calf to achilles soreness. On 12-APR-2021, the subject experienced flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever. On 12-APR-2021, the subject experienced left calf to achilles soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever on 14-APR-2021, and had not recovered from left calf to achilles soreness, and left calf to achilles soreness. This report was non-serious.
48 2021-04-28 trigeminal neuralgia, facial paralysis, facial pain, bell's palsy Right sided facial paralysis, diagnosed as bells palsy, also right facial pain later diagnosed as tr... Read more
Right sided facial paralysis, diagnosed as bells palsy, also right facial pain later diagnosed as trigeminal neuralgia, patient was seen in hospital for symptoms
48 2021-04-29 pain in extremity Continued pain at injection site. And arm soreness
48 2021-05-11 pain in extremity I had some head pressure - dull headache each day for a couple of weeks starting about five days aft... Read more
I had some head pressure - dull headache each day for a couple of weeks starting about five days after vaccine; I didn't notice until the evenings when I was relaxing. From day 5 or so - for about two weeks I noticed this head pressure. My blood pressure did rise at that time-it was elevated - within about two weeks after the shot, I couldn't control my blood pressure. I went to the doctor - they had to raise my blood pressure medication to the max because I couldn't get my blood pressure down and I even donated blood. Today I am at 135 over 90 which is good for me but at that time when I noticed the rise after the vaccine - I was running 165 over 115 . I'm still taking the maximum blood pressure medication that I can take currently but it is at a good level currently. I was taking 20 mg pills and after the vaccine we tried to raise it to 25 mg and then raised it up to 30 mg and then they finally said up to 40 mg a day. It's the most I can take. I have chest pains on the right side of my chest -it will start (on a scale from 1 to 10 - it's about a four) - it's shooting pain - in my chest for about 10 minutes and then it will move to my left side - not my pecs - it feels like it's my heart. It's not enough that I feel like I'm having a heart attack - it happens about four days a week. It doesn't last real long - but it's intense. A "4" pain for me is intense. It goes on for about 5 minutes - switch sides and then another five minutes - I try to relax/watch tv during that. I did have leg pains in the middle of all of this time - hand, inner thigh, then on my right leg - single spots of pain that moved - like ant bites - that happened in the beginning - at day five and after - the same time I was getting the head pressure. I would rub over the spot with my hands and then it would go away and go to a different spot.
48 2021-05-12 weakness CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report... Read more
CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
48 2021-05-12 flushing Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flus... Read more
Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at12:12pm pt felt dizzy and faint and was sweating, bp1:12:22pm 117/38 pulse 79, bp2:12:30pm 97/53 pulse 51, bp3: 12:39pm 95/61, bp4: 106/69 pulse 49 at 12:46pm. pt left at 12:50pm advised not to drive had daughter driv ehim home
48 2021-05-12 seizure Patient said he had a seizure at home in his sleep. He said he wetted his pants and his wife told h... Read more
Patient said he had a seizure at home in his sleep. He said he wetted his pants and his wife told him he had a seizure. He sought medical attention after and his doctor changed his seizure medications. He is now asked by his doctor not to drive for 2 months
48 2021-05-19 tremor Approximately 8 hours after vaccine, high fever ranging 102-103 degrees began. Severe chills set in... Read more
Approximately 8 hours after vaccine, high fever ranging 102-103 degrees began. Severe chills set in. Shaking and teeth chattering to the point one tooth was chipped (small) Fever and chill continue through the rest of the day. Down to 100 by 5pm on 5-20-21. Also extreme fatigue, joint and muscle aches, as common with the flu.
48 2021-05-23 pain in extremity, tingling, numbness About three weeks ago began to experience swelling in lower right arm, above wrist (he had vaccine ... Read more
About three weeks ago began to experience swelling in lower right arm, above wrist (he had vaccine in left arm), fever, cough at nighttime and tingling to point of pain from right shoulder to elbow, and left little finger numb
48 2021-05-31 tremor LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING... Read more
LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
48 2021-06-01 migraine Since May 28th, 2021, been having migraine headaches that have continued for three days now.
48 2021-06-06 discomfort Within 72 hours of receiving the vaccine, I began experiencing itchiness in random locations on my b... Read more
Within 72 hours of receiving the vaccine, I began experiencing itchiness in random locations on my body. However, it was intermittent and not too severe - initially. The itchy rash would pop up and subside, until Weds May 26th. In the middle of that night (5/26) I awoke with the most severe itching and discomfort that I've ever experienced, and it was in spots across my arms, legs, abdomen, inner thighs, underarms, soles of feet, wrists, and elsewhere. The next morning (Thursday 5/27) I began calling dermatology offices and clinics hoping to secure a Doctor's appointment ASAP to get a diagnosis and hopefully some relief. I was able to secure an appointment at Immediate Care for later that morning. At that time I received a steroid shot in my arm, and began a cycle of Prednisone to address the rash. It persisted and was very uncomfortable for the following three days, but thankfully began to subside due to the steroids by Monday 5/31. I would like to stress that I've had no known allergies in my life, and that this was the most extreme rash and itching I've ever experienced. If I had it to do over again, I would not get the vaccine.
48 2021-06-13 pain in extremity, numbness PATIENT CALLED JUNE 10TH OF 2021 AND REPORTED HE HAD A SORENESS IN THE MIDDLE OF HIS BACK STARTING T... Read more
PATIENT CALLED JUNE 10TH OF 2021 AND REPORTED HE HAD A SORENESS IN THE MIDDLE OF HIS BACK STARTING THE DAY AFTER THE COVID-19 JANSSEN VACCINATION. PATIENT REPORTED THE SORENESS IN HIS ARM WENT AWAY AFTER THE THIRD DAY FROM RECEIVING VACCINE. PATIENT REPORTED THE SORENESS IN THE MIDDLE OF HIS BACK CONTINUED TO BE SORE TO PAINFUL. PHARMACY HAS THE PATIENT RECEIVING VACCINE IN THE LEFT ARM. PATIENT REPORTED ABOUT A WEEK PRIOR TO HIM CALLING THE PHARMACY HIS LEFT ARM HAVING NUMBNESS AND NOW HIS HAND IS GOING NUMB. PHARMACY TOLD HIM TO CONTACT HIS DOCTOR. PHARMACY CHECK WITH PATIENT ON JUNE THE 11TH OF 2021 AND PATIENT STATED HE HAD MADE AN APPOINTMENT WITH HIS DOCTOR'S CLINIC.
48 2021-06-13 pain in extremity My left are never stopped hurting and it has progressively gotten worse I can barely lift my arm up ... Read more
My left are never stopped hurting and it has progressively gotten worse I can barely lift my arm up and I?m in constant pain.
48 2021-06-18 weakness BODY ACHE; NOT EATEN ANYTHING OR DRINK ANYTHING; CHILLS; FEELING VERY WEAK; FEVER; This spontaneous ... Read more
BODY ACHE; NOT EATEN ANYTHING OR DRINK ANYTHING; CHILLS; FEELING VERY WEAK; FEVER; This spontaneous report received from a pharmacist concerned a 48 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, and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUN-2021, the subject experienced body ache. On 13-JUN-2021, the subject experienced not eaten anything or drink anything. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced feeling very weak. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, feeling very weak and not eaten anything or drink anything was not reported. This report was non-serious.
48 2021-06-22 tingling Generalized tingling sensation of especially the joints. Evaluated by EMS-Cleared
48 2021-06-23 pain in extremity RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The pa... Read more
RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201ALIA expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced right arm pain. On 21-JUN-2021, Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain. This report was non-serious.
48 2021-07-01 muscle spasms, pain in extremity BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED;... Read more
BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED; DEEP VEIN THROMBOSIS; VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; ULTRASOUND DOPPLER ABNORMAL; FULL BLOOD COUNT; METABOLIC FUNCTION TESTS; MUSCLE SPAMS; SWELLING; MILD HEADACHE; This spontaneous report was received from a health care professional via a Regulatory Authority and from literature: Vaccine-induced thrombotic thrombocytopenia following Ad26.COV2.S vaccine in a man presenting as acute venous thromboembolism. 2021 Jun 03;1-4., and concerned a 48 year old white male (not Hispanic or Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, and no tobacco use (both current and historically), and other pre-existing medical conditions included the patient had no known allergies. The patient was not obese, denied recent procedures, prolonged immobility, family history of bleeding or clotting disease, etc. The patient was up to date on cancer screenings based on age/family history. He was reported as being an unusually physically active and fit 48 year-old male who has enjoyed good health and exercised regularly. In 2019, his platelet count was 177 10*9/L. The patient reported flying out of town and back on 30-MAR-2021 and 04-APR-2021 respectively with the longest continuous flight lasting around 4 hours. The patient at age 48, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included finasteride, and salbutamol. On an unspecified date in APR-2021, the patient experienced mild headache. On 18-APR-2021, 11 days after receiving the vaccine, the patient experienced deep vein thrombosis, vaccine induced thrombotic thrombocytopenia; new pain in his big toe, bilateral leg cramping (muscle spasm), bilateral lower extremity pain, and swelling. The patient attributed soreness in the large muscle groups of his thighs to Peloton riding and exercise. The patient travelled again via airplane to an unspecified location 22-APR-2021 and 25-APR-2021 (both1 hr long flights). The patient administered Advil for the leg pain when he returned on an unspecified date. On an unspecified date he felt a leg vessel that "didn't seem right." On 26-APR-2021 the patient went to emergency department for evaluation presenting with leg pain and chest discomfort. He had normal vital signs and oxygen saturation. Additional laboratory results: Platelet count (NR 140-440 K/uL) 74; fibrinogen (NR 150-430 mg/dL) of 254; D-dimer (NR 0-499 ng/mL FEU) 15,109 ng/mL FEU; activated partial thromboplastin time (aPTT) (NR 25.1-36.5 s) 31.8. Venous duplex ultrasound of the lower extremities revealed non-occlusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, an occlusive DVT of the left posterior tibial vein, as well as occlusive superficial venous thrombosis in the bilateral saphenous veins. The patient was discharged from the emergency room on rivaroxaban 15 mg twice daily with two-day follow-up with his primary care physician. He had no known exposure to heparin before the onset of symptoms and no exposure during his emergency room visit. On 28-APR-2021 (also reported as the next day), the patient complained of a new onset of chest pain (pleuritic) and presented again to the emergency room. Chest CT showed presence of acute pulmonary embolism, with emboli present in segmental and more proximal arteries. He had already taken his rivaroxaban for the night (1800). The patient was hospitalized for further evaluation and work up. A peripheral smear showed thrombocytopenia without schistocytes. The hematology service was consulted, and a presumptive diagnosis of VITT (vaccine induced thrombotic thrombocytopenia) was made. His anti-PF4 enzyme-linked immunosorbent assay (ELISA) (LIFECODES PF4 IgG), performed on a sample collected prior to initiating IVIG therapy, demonstrated a strongly positive result of 3.323 optical density (OD) units (reference interval < 0.399), consistent with a diagnosis of VITT. The patient was immediately treated with 1 g/kg of intravenous immunoglobulins (IVIG) for 2 days, 1 mg/kg of prednisone, and switched from rivaroxaban to an intravenous argatroban infusion drip, during which he achieved therapeutic aPTT levels between 44 - 50 sec. The patient was also treated with apixaban. Other studies included: Magnetic resonance venography (MRV) and angiography (MRA) of the brain, performed due to symptoms of mild headaches, were unremarkable. Platelet factor 4 (NR: not provided) strong positive at 2.9 OD; Prothrombin mutation G20210A not detected, Red blood cell count (NR: 3.98 - 5.98) 5.07 M/ microliter, Red blood cell sedimentation rate (NR: not provided) Normal, SARS-CoV-2 test was negative, Serotonin release assay was positive, and WBC (NR: 3.2 - 10.6) 5.8 K/microliter. Anticardiolipin antibodies (NR: not provided) 5 GPL, Beta-2 glycoprotein 1 antibodies (NR: 0 - 20) 0 SGU, 5 SMU, Blood homocysteine (NR: not provided) 13.4 nml (normal), C-reactive protein (NR: not provided) 2.6, Cardiolipin immunoglobulin G (NR: 0 - 12) 6 MPL, Cell marker increased was positive, EKG (NR: not provided) Normal, Hematocrit (NR: 36.9 - 52.1) 42.2 %, Hemoglobin (NR: 2.5 - 18.0) 15.0 g/dL, Lupus anticoagulant (NR: not provided) not detected, MCHC (NR: 33.4 - 35.3) 35.5 g/dL, MCV (NR: 80.6 - 97.6) 83.2 fL. On an unspecified date the serotonin release assay was no longer positive. Within a week post-discharge, the patient developed recurrent thrombocytopenia, with a platelet count that down trended to 107 10*9/L His thrombocytopenia appeared to somewhat correlate with prednisone dose adjustments, suggesting an autoimmune-driven process, although it did not respond to repeat IVIG administration. Due to the normalized D-Dimer levels and negative SRA, it was assumed that there was no further ongoing platelet activation. The authors stated the patient had no prior risk factors for thrombosis other than the 2 recent 4-hour flights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral lower extremity pain, was recovering from deep vein thrombosis, vaccine induced thrombotic thrombocytopenia, platelet count decreased, swelling, full blood count, metabolic function tests, muscle spasms, ultrasound doppler abnormal, and multiple acute bilateral pulmonary emboli, and the outcome of mild headache was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210642952. Additional information was received from literature article on 19-JUN-2021. The following information was updated and incorporated into the case narrative: literature reference information, additional reporters, laboratory data, updated events. It has been determined that Manufacture Report Number 20210514958 is a duplicate of deleted case 20210642952. All relevant information from Manufacture Report Number 20210642952 will be reported in this case 20210514958.; Sender's Comments: V2: Follow up consisted of a literature citation, presenting this case as a case report. This does not change the previous assessment. This case obtained via VAERS (ID 1264060) concerns a 48-year-old White male who developed symptoms of bilateral lower extremity deep vein thromboses (DVT) and thrombocytopenia 11 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included exercise induced asthma. Patient was not obese, did not smoke, denied recent procedures, family history of bleeding/clotting disease & was physically active. He was up to date on cancer screenings based on age/family history. He had taken two 1-hour long flights 15 days and 18 days post-vaccination. Concomitant medications included finasteride & salbutamol. After 1 week of bilateral leg cramping & swelling which began 11 days post-vaccination, he presented to emergency department (ED) where complete blood count showed platelets 74 k/uL, peripheral smear with giant platelets, and d-Dimer 15K. Venous duplex ultrasound showed nonocclusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, occlusive superficial vein thrombosis in the bilateral saphenous veins, and occlusive DVT of the left posterior tibial vein. He was started on rivaroxaban & was not hospitalized. Two days later, he developed new chest pain & returned to ED, where CT chest showed numerous bilateral pulmonary emboli. He was hospitalized; empiric treatment for vaccine-induced immune thrombotic thrombocytopenia was started: IVIG, steroids, & argatroban. Anti-PF4 resulted as OD=2.9 and 3.323 (strong positive), confirming diagnosis. The patient was recovering from the events. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), low platelet count & temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.
48 2021-07-12 pain in extremity, bell's palsy, facial paralysis WAS FINE AFTER SHOT, SOAR ARM AND TIRED. IN EARLY MAY NOTICED MY LEFT SIDE OF FACE WAS NOT ABLE TO ... Read more
WAS FINE AFTER SHOT, SOAR ARM AND TIRED. IN EARLY MAY NOTICED MY LEFT SIDE OF FACE WAS NOT ABLE TO MOVE, SEEMED DROOPY. I WAITED TO SEE IF THE SYMPTOMS WOULD GO AWAY. ON MAY 28, WENT TO ER. MY BLOOD PRESSURE WAS HIGH AND ALSO MY SUGAR WAS ALSO HIGH. THEY BELIVED I HAD BELLS PALSY.
48 2021-07-12 tingling, burning sensation, cold extremities, numbness 14 days after the injection developed severe headache and fever. Went to ER. More symptoms develo... Read more
14 days after the injection developed severe headache and fever. Went to ER. More symptoms developed: Severe Numbness from the waste down Severe pins and needles sensation from the waste down Severe Burning sensation from the waste down Severe coldness on feet that has moved up past ankles Unable to urinate Unable to have a bowel moment Blurry vision
48 2021-07-14 numbness About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which ca... Read more
About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes. Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg. I have never had any blood clots before. Dr. referred me to Hematologist, Dr. She ran extensive blood tests and found no genetic predisposition for clots. She stated it was likely the vaccine that caused me to develop blood clots. I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months. Follow up ultrasound scheduled 9/7/21.
48 2021-07-17 night sweats, hot flush Night sweats and overall feeling tired. Hot flashes. Low grade fever. Missed 60 hours of work in ... Read more
Night sweats and overall feeling tired. Hot flashes. Low grade fever. Missed 60 hours of work in the 2 weeks following the vaccine due to not feeling right
48 2021-07-18 tingling, muscle twitching, numbness, involuntary muscle movements, coordination abnormal, tremor JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDI... Read more
JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone. On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
48 2021-07-20 pain in extremity SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous rep... Read more
SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 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, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.
48 2021-07-21 weakness, pain in extremity Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left side ... Read more
Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left side but also presented on the right too. Pain/Discomfort in back on both sides. Sometimes upper back, sometimes lower. Pain/Discomfort and sometimes a burning sensation in ribs. Many times this presented itself at the lower tips of the ribs. Arms: Pain/Discomfort under armpits. Tingling in arms. There was a point where my arms would fall asleep when I was laying down at night. General weakness/fatigue in the arm. Sometimes arms (particularly the forearms) feel tight Leg Pain/Discomfort in calves. Many times, the pain would be a sharp, pointed sensation in both calves. This discomfort always presents itself in the back of my calves. *Weakness/Fatigue in thighs. Many times my thighs will feel weak/fatigued. Neck: Pain/Discomfort in my neck. Primarily this occurs on the sides of my neck. There is also a tightness that occurs on the sides of my neck too. At times, the back of my neck is also tight and uncomfortable. Spine: General tightness and discomfort running down the middle of my back. This occurs primarily in the upper to middle part of my back. Overall: Along with the different sensations listed, I have battled constant fatigue and a feeling of weakness. This weakness could be overall throughout the body or sometimes just in certain regions in my body. For example, some days I might feel like my arms are weak/fatigued, other days it might be my legs, and then sometimes throughout my body. I have also been dealing with persistent headaches from time to time.
48 2021-07-21 numbness, weakness, muscle spasms, feeling hot OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FE... Read more
OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.
48 2021-07-23 feeling hot Patient experienced hives on face/neck after first Moderna dose in Feb, treated w/ benadryl at that ... Read more
Patient experienced hives on face/neck after first Moderna dose in Feb, treated w/ benadryl at that time, lasted several hours, no mouth/throat swelling. Patient was scheduled for his 2nd Moderna dose at clinic. Given his reaction to moderna previously he was sent to outpatient pharmacy to get Janssen (J&J) vaccine. After the Janssen Covid vaccine was administered patient immediately began feeling red, hot, and itchy. Was given benadryl 25mg/5ml oral dose x2 after being monitored for 30 min. Told patient if symptoms got worse or persisted to come back to hospital. After monitoring patient he felt safe to go home and had no visible signs of reaction after 30 min. Called patient to follow up 24 hours later and he stated he felt a "little itchy" that evening and had flu like symptoms when he woke up in the morning (achy, chills) but the itching went away last night.
48 2021-07-25 pain in extremity Pain in left arm, left shoulder and left shoulder blade. The pain comes and goes, but has not waned ... Read more
Pain in left arm, left shoulder and left shoulder blade. The pain comes and goes, but has not waned since getting the vaccine shot in April.
48 2021-07-29 weakness FEELING TIRED; LOW ENERGY; This spontaneous report received from a patient concerned a 48 year old m... Read more
FEELING TIRED; LOW ENERGY; This spontaneous report received from a patient concerned a 48 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: 1820096, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, treatment medications included: paracetamol. On 24-JUL-2021, the subject experienced feeling tired. On 24-JUL-2021, the subject experienced low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and low energy. This report was non-serious.
49 2021-03-07 night sweats "Janssen COVID-19 Vaccine EUA" Joint pain, including shoulders, hips knees and ankles. Chills. Swea... Read more
"Janssen COVID-19 Vaccine EUA" Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. Low grade fever. General body aches. Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time.
49 2021-03-11 pain in extremity dizziness day 2 minor arm soreness, body aches & chills
49 2021-03-14 pain in extremity Sore arm, chills, fever, headache and fatigue
49 2021-03-15 inability to speak Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty ... Read more
Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation
49 2021-03-16 weakness, night sweats Debilitating headache from 1030pm on night of vaccination til about 48 hours later. Lower right bac... Read more
Debilitating headache from 1030pm on night of vaccination til about 48 hours later. Lower right back of head. Random muscle aches overnight. Night sweats on 2nd night. Weak and tired 2nd day.
49 2021-03-16 pain in extremity, burning sensation 3/15 13:30 Tightness in right shoulder about 30 minutes after application. 21:00 Burning in lower ba... Read more
3/15 13:30 Tightness in right shoulder about 30 minutes after application. 21:00 Burning in lower back and hips. 23:00 Burning extending down the legs and further around the core. No swelling, but almost as though nerves are being stimulated. Chills. Pain at a 6. 3/16 Same burning in joints down legs, pain still at 6. Persistent with low dosage of Tramadol. 3/17 02:00 still burning, with pain generalized in the hips, back and legs. Still at a pain level of 6
49 2021-03-18 weakness Fever, tiredness, weak, dizziness , frequent urinating
49 2021-03-21 tingling, cold sweat Vasovagal event without syncope post vaccine. Clammy and nauseous with tingling to hands. EMS and ... Read more
Vasovagal event without syncope post vaccine. Clammy and nauseous with tingling to hands. EMS and Dr on site. Blood pressure 90/49 at 18.10. at 18.15 blood pressure was 114/81. Released home and advised to seek medical attention later if needed, client verbalized understanding.
49 2021-03-22 cold extremities hard chills, cold hands, fever of 101.4 Fahrenheit, muscle aches, joint pain began approximately 10 ... Read more
hard chills, cold hands, fever of 101.4 Fahrenheit, muscle aches, joint pain began approximately 10 hours after receiving vaccination. Acetaminophen was taken every 4 hours to reduce fever.......by 2a.m. the fever broke and fatigue sat in.......by the next morning around 10:30am, subject had normal temperature and returned to regular activity. The side effects of the vaccination lasted only about 14 hours total but were severe.
49 2021-03-23 seizure DIC, intracerebral hemorrhage, intubation, requiring plts transfusion, seizure
49 2021-03-23 tremor 9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. ... Read more
9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.
49 2021-03-25 weakness Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbe... Read more
Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbeat since injection. Insomnia. Rapid weight loss. Dry mouth. Loss of appetite. Ongoing chills (10 days after shot). Depression. Lack of energy.
49 2021-04-02 feeling hot headache on day 2 with low energy and felt lethargic Also felt hot all night like I couldn?t cool ... Read more
headache on day 2 with low energy and felt lethargic Also felt hot all night like I couldn?t cool off. Woke up with rash all over body. Mostly around neck and right chest/armpit area. Also speed to arms and legs but to a lesser degree.
49 2021-04-04 cold sweat Burning eyes, cold sweats, headache, extreme fatigued
49 2021-04-04 pain in extremity severe arm pain for 2 weeks post shot
49 2021-04-05 burning sensation, pain in extremity Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having ... Read more
Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient's lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.
49 2021-04-07 weakness, cold extremities After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, m... Read more
After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, my feet were weak with tiredness and cold. Then I drank water and fluids and my heart rate stabilized. Then within 2 hours I had 4 tachycardia events but milder and then normalized.
49 2021-04-07 weakness Fever, Nausea, Vomiting, Weakness, Muscle Aches, Increased Heart Rate, Shortness of Breath
49 2021-04-07 involuntary muscle movements Patient passed out fell to ground and started with jerking motions. Pateinet was taking by ambulanc... Read more
Patient passed out fell to ground and started with jerking motions. Pateinet was taking by ambulance to the emergency room. Pateints blood pressure and pulse where low when checked by paramedics.
49 2021-04-07 flushing Flushed at first. Extreme fatigue for two days. Rash on chest which is most visible after showering.... Read more
Flushed at first. Extreme fatigue for two days. Rash on chest which is most visible after showering. Rash seems to be lessening with each passing day.
49 2021-04-08 pain in extremity, feeling cold Sore Arm within a few hours Cold chills fever 7 hours after shot
49 2021-04-08 tremor One minute after he got the shot, he did not feel ok, he was shaking, sweating and dropped his phone... Read more
One minute after he got the shot, he did not feel ok, he was shaking, sweating and dropped his phone. The pharmacist was next to him, we called 911 immediately. They came like 10 minutes after, but by this time, he was ok, they checked his blood pressure , it was 115/75. He was completely alert, and did not want to go with them. we asked him to stay at the pharmacy till he feels completely fine. we called him at 7 pm to follow up, he said he is ok.
49 2021-04-10 feeling cold, tremor 6 hours after shot, body started shaking involuntarily for 3 hours. I was extremely cold, 3 layers ... Read more
6 hours after shot, body started shaking involuntarily for 3 hours. I was extremely cold, 3 layers of clothes and 3 layers of blankets. Unable to sleep all night. Got up 6 am, had major headache, swollen nodes in neck, all over body aches and still had chills. After 24 hours I may have been 50% to normal, after 48 hours approx 75%, 72 hours about 85%. Headache was gone unless cough or sneeze. On third day. I did not take any over the counter Medicine after the shot at all in fear of affecting the vaccine.
49 2021-04-10 migraine chills; started night of started 09Apr2021 fatigue started 09Apr2021 muscle aches started 09Apr2021 ... Read more
chills; started night of started 09Apr2021 fatigue started 09Apr2021 muscle aches started 09Apr2021 anal bleeding when going to restroom - quite a lot and did not stop right away - started 11Apr2021 migraine starting 09Apr2021
49 2021-04-12 cold sweat Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's go... Read more
Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's going to pass out. He also c/o being dizzy. His skin was cold and clammy. This happened about 5 minutes after the vaccine. We assisted him to a room where he laid down flat and I applied ice pack to his head and chest. Pt felt better after about 30 minutes. Pt stated he had never had this reaction before. Pt was discharged from the clinic with his father, in stable condition.
49 2021-04-12 feeling cold, cold sweat 5 minutes after vaccine received, patient reports feeling dizzy and lightheaded. Patient diaphoretic... Read more
5 minutes after vaccine received, patient reports feeling dizzy and lightheaded. Patient diaphoretic, skin cool and clammy to touch. Patient instructed to drink orange juice. No respiratory issues noted. Patient reports not eating anything today and he woke up at 9 am. Patient reports feeling nervous about vaccination before appointment. Patient observed for 30 minutes. Patient able to answer questions and follow commands appropriately. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to have food/fluid and rest. Patient ambulatory and reports symptoms resolved about 10 minutes after drinking juice. Patient returning to work; manager and supervisor aware of patient's condition and notified to allow patient food/drink/rest as needed. Patient declined transportation to hospital. BP 110/70. HR 74.
49 2021-04-12 migraine Injection at 9:30 am on 4/8. Dizziness and euphoria beginning at 1:30 pm, 4 hours post-injection. Di... Read more
Injection at 9:30 am on 4/8. Dizziness and euphoria beginning at 1:30 pm, 4 hours post-injection. Dizziness became severe at 5:30 pm, 8 hours post-injection with fever, chills, and nausea. Severe headache beginning at 7:30 pm, 10 hours post-injection, becoming severe migraine headache lasting for 24 hrs until ~7:30 pm on 4/9, 34 hours post-injection. Mild headache persisted until 2:00 am on 4/10, 40.5 hours post-injection.
49 2021-04-12 pain in extremity Headache, coughing, sneezing, leg pain
49 2021-04-12 pain in extremity Pain in the legs and sole of the foot purple, light purple color.
49 2021-04-12 pain in extremity Left arm swole redness 6 to 7 days bumps over my body
49 2021-04-13 facial paralysis, numbness, slow speech, bell's palsy, feeling of body temperature change Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to n... Read more
Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.
49 2021-04-13 hypersensitivity of all senses, tenderness 8:00 PM- felt tired, achy, headache, cough, nausea, tenderness left axilla. Resolved today. On Apr... Read more
8:00 PM- felt tired, achy, headache, cough, nausea, tenderness left axilla. Resolved today. On April 4th, felt like he had shingles rash starting, (client has history of shingles) but no rash erupted. Skin affected across chest across the nipple line, and back.
49 2021-04-14 tenderness, pain in extremity Patient began having back pain on Friday but by Saturday was having a hard time walking. Having pai... Read more
Patient began having back pain on Friday but by Saturday was having a hard time walking. Having pain at the left elbow, both shoulders, left knee and left foot. Dr. came in to examine patient as well. Think he is having tendinopathy as pain was not in the joint itself. Patient having pin point tenderness. Denies fever.
49 2021-04-14 unresponsive to stimuli 1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was u... Read more
1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.
49 2021-04-15 discomfort Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such tha... Read more
Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19
49 2021-04-15 pain in extremity Moderate headaches, leg soreness, shortness of breadth
49 2021-04-16 weakness received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home be... Read more
received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home because I became incredibly weak, tired and without energy. struggled at driving home had to repeatedly slap my face to stay awake. checked my temp. when arrived home, had a low fever (100.1) went to bed slept for 4 hours, checked temp (100.1) went back to sleep. woke 9 am on 4/9/2021 checked temp. (normal) fever broke on 4/9/2021 used restroom at 11:01 am 4/9/2021 large amount of bleeding from rectum LARGE AMOUNTS of blood clots in stool (shaped like Candy) Contacted medical provider. Spoke to a triage nurse, explained my concerns about bleeding from rectum and blood clots in stool... she dismissed that my restroom issues were related to the vaccine,
49 2021-04-17 facial pain Headache, chills, fever, body headache, rigors, fatigue, malaise, through the vaccination night. Sin... Read more
Headache, chills, fever, body headache, rigors, fatigue, malaise, through the vaccination night. Since vacation has continuous fatigue and headache. 4/12/21 right side neck/face pain and headache on right side.-worsening 4/16/21-went to walk in clinic. 4/17/21 headache/neck pain extreme went to ED. Continues to have neck/face and headache.
49 2021-04-18 grand mal seizure, seizure HAD A SEIZURE AND THEN RUSHED TO THE ER AND ALSO HAD A BRAIN BLEED ALSO.
49 2021-04-18 tenderness INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; This spontaneous report received from a con... Read more
INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, tiredness, and sore to touch. This report was non-serious.
49 2021-04-22 weakness Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, un... Read more
Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.
49 2021-04-23 muscle spasms Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic ... Read more
Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.
49 2021-04-26 muscle spasms about 8 days after receiving my shot, i noticed muscle cramping in my hands, legs and feet. As of to... Read more
about 8 days after receiving my shot, i noticed muscle cramping in my hands, legs and feet. As of today, I still have some cramping but not as bad.
49 2021-05-03 face paralysis, facial paralysis The patient is a 49 year old male who has a past medical history significant for bipolar disorder wi... Read more
The patient is a 49 year old male who has a past medical history significant for bipolar disorder with manic episodes, OSA on CPAP, morbid obesity, HLD, and relapsing remitting MS. Per chart review, patient's MS was initially diagnosed in 2012 on MRI and LP and was on Copaxone for several years but stopped taking in 2017. Symptoms and imaging remained stable through 2019 then patient was lost to follow up until he was seen by Dr. on 4/12/21 who ordered an outpt MRI. Patient had COVID vaccine with Jansen vaccine on 4/10/21. He developed bilateral upper and lower exremity weakness and urinary retention on 4/21/21 which prompted presentation. He came into ED 4/21/21 and had foley placed but removed foley and decided to leave AMA. Returned on 4/22/21 with worsening symptoms and was subsequently admitted. Patient was seen by neurology and started on high dose steroid x5d for MS exacerbation. Initial MRI of the brain obtained on 4/22/21 was notably stable without change in previously described white matter disease. No new lesions to suggest active demyelination. New plaques were noted on MRI C and T spine (4/22/21). It is noted that patient received COVID19 vaccination with J&J vaccine on 4/10/21 and temporal relationship between his acute presentation and recent vaccination was questioned. On 4/30/21, patient developed severe bilateral facial weakness and he additionally was reported to have had an episode of aspiration. Repeat MRI brain on 4/30/21 showed new bilateral facial nerve enhancement. Etiologies could include: GBS, Lyme disease, botulism, neurosarcoidosis, less likely myasthenia gravis. LP was pursued on 5/1/21 which was significant for tube 4 with 136 WBC, 88% lymphocytes, glucose 89, protein 632. Meningitis/encephalitis panel was negative. Lyme CSF was negative, Lyme antibody panel was positive. MuSK antibody negative. ACE blood level normal. Ganglioside antibody panel and myasthenia graivs adult panel pending. He is being treated for Lyme disease with Ceftriaxone 2g IV daily since 5/1/21 with plan for 2-4 week course to cover for Lyme disease. He is still admitted and is still having symptoms of facial palsy as of today (5/4/21)
49 2021-05-05 pain in extremity Right knee and right elbow pain
49 2021-05-05 tremor Severe cold/flu symptoms beginning late evening of the shot date, lasting from 11:00PM until 7:00AM ... Read more
Severe cold/flu symptoms beginning late evening of the shot date, lasting from 11:00PM until 7:00AM the following morning. Body shaking, extreme fatigue, feverish, significant aching in upper half of body including head. Tinnitus. After cold/flu symptoms subsided, heavy fatigue and some tinnitus persisted for 20 days. This was followed by approx. five days of tapering fatigue, after which approx 95% of symptoms had subsided. Unclear 5 weeks later if symptoms are 100% subsided, as diminished activity and exercise over three week period has left an unclear sense of physical norm (I suspect the symptoms are 100% subsided and my energy will return to normal with resumption of exercise habits).
49 2021-05-06 speech disorder While eating dinner, my lips and face around my mouth began to swell. They swelled to the point that... Read more
While eating dinner, my lips and face around my mouth began to swell. They swelled to the point that it was very visible and became hard to enunciate due to the excessive swelling of the lips. The swelling lasted over 24 hours and did not respond to antihistamines.
49 2021-05-11 feeling hot Pt. stated, "I have a history of passing out after shots or blood draws". After receiving the inject... Read more
Pt. stated, "I have a history of passing out after shots or blood draws". After receiving the injection, he was asked to remain seated for a few minutes. After 2 minutes he stated that he felt dizzy and warm. He put his head down on the table and continued to feel hot and sweaty. He was given water and the EMS team came in to evaluate him.
49 2021-05-13 numbness, pain in extremity The big toe on my left foot started to hurt. It lasted a few days and then went numb on the bottom a... Read more
The big toe on my left foot started to hurt. It lasted a few days and then went numb on the bottom and tip and has stayed numb. Feeling does return on occasion but infrequently and not noticeable usually.
49 2021-05-16 pain in extremity, numbness I started having a lot of pain in my right leg. I could actually feel and see that my veins were swo... Read more
I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.
49 2021-05-18 feeling cold, cold sweat about 10 at night I started feeling cold, followed by chills that were uncontrollable for like four ... Read more
about 10 at night I started feeling cold, followed by chills that were uncontrollable for like four hours, body aches, sweating cold sweat all through the night. about 6 weeks later started having symptoms like a sinus infection went to an Urgent care, they did a covid test it was positive.
49 2021-05-18 pain in extremity Sore arm, extreme exhaustion, fever, body aches, racing heartbeat while resting, headaches out of th... Read more
Sore arm, extreme exhaustion, fever, body aches, racing heartbeat while resting, headaches out of the blue that's don't fade away, fluid in ears, soreness in left knee/inflamed hamstring, fever, sweaty, post nasal drip, minor cough, rattling noise in lung when breathing
49 2021-05-22 bell's palsy Neurological problems , Bells Palsy, Loss of muscle, taste, smell. Nerve Issues throughout body
49 2021-05-31 burning sensation, hot flush BURNING ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE;... Read more
BURNING ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 279 pounds, and height was 67 inches. The patient's past medical history included asthma younger, and concurrent conditions included non smoker. The patient experienced drug allergy when treated with methylprednisolone sodium succinate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced weird taste in mouth. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced sleepiness. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced super fatigue. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced burning ( around eyeballs, neck and body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, weird taste in mouth, super fatigue, hot flashes, chills, sleepiness, and burning ( around eyeballs,neck and body). This report was non-serious.
49 2021-06-02 pain in extremity initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe musc... Read more
initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms. Within 24 hours unable to walk easily. No other symptoms and no physical signs of infection. Urine became dark brown at 24 hours and clinically has myositis with suspected rhabdomyolysis - was admitted for iv fluids and analgesia and is improving clinically but gait still disturbed. No demonstrable weakness and no neuro deficit or symptoms. no other obvious cause for acute myositis so consider ?vaccine related.
49 2021-06-03 hot flush, pain in extremity CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAI... Read more
CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.
49 2021-06-10 seizure, cold extremities, tremor I've experienced 8 what appear to be seizures/body tremors since being vaccinated. The first beginn... Read more
I've experienced 8 what appear to be seizures/body tremors since being vaccinated. The first beginning on the Saturday May 22, 2021 at around 1:00pm. That being the longest and most intense of the 8, which actually brought me to the ground. I generally have a few seconds to prepare as i can fill when they are about to come on. The most recent was on Sunday June 6, 2021 at 4:23am. It woke me up out of sleep and only lasted about 3 seconds, where as the first one i had lasted at least 15-20 seconds. The others in between have decreased in size and time since the one i experienced on Sunday morning. I've also experience cold spots or chills in strange areas, like behind forearms or one side of shoulder one day and the next side the other day. the top of my hands get the chills and there has been times that my waist and lower back will have it. I have experienced blurred vision occasionally but mostly it seems to be at night and seems to be not as bad like when it first started, which was Sunday May 23, 2021. I've experienced my teeth being very sensitive to hot and cold, and a tooth ache from time to time, and the most recent thing to experience has been an ear ache in my left ear, that started on the Monday June 7, 2021, that seem to happen when i first wake up in the morning and again when im about to go to sleep. They last for about 10 minutes and build up in intensity and then just stop. Those I've been have daily to this day or this morning i should say. Other then for the usual side effects of feeling fatigued and fever, those have went away, but other than for that... I guess i fill normal.
49 2021-06-13 bell's palsy Patient states he can't control his mouth or his left eye, started yesterday morning and seems to be... Read more
Patient states he can't control his mouth or his left eye, started yesterday morning and seems to be getting worse. He reports random tearing from the left eye. Also has left ear/jaw pain. Developed 4/29/2021. Dx with Bells Palsy.
49 2021-06-14 numbness, tingling Six weeks after the vaccine I started to get headaches. It is a dull headaches at the back of my hea... Read more
Six weeks after the vaccine I started to get headaches. It is a dull headaches at the back of my head where my neck connect. I have not been able to find any medication that helps. I have the headache all day every day. Occasionally my eyes get blurry and I get some numbness and pins and needles on the right side of my face. I have been experiencing these headaches for ten weeks to date. I have seen a Neurologist and other specialists.
49 2021-06-16 seizure SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous repo... Read more
SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
49 2021-06-21 throat numbness Numbness of throat. Evaluated by EMS-Cleared
49 2021-06-27 slurring Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision, weak muscles,... Read more
Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision, weak muscles, lack of thirst and appetite, fever
49 2021-07-01 pain in extremity EYESIGHT IS A LITTLE BLURRY; BLEEDING GUMS WHEN BRUSHING TEETH; LIKE A BLISTER; PAIN IN LEG; This sp... Read more
EYESIGHT IS A LITTLE BLURRY; BLEEDING GUMS WHEN BRUSHING TEETH; LIKE A BLISTER; PAIN IN LEG; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient was healthy and fit. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prevention of covid-19 vaccine. No concomitant medications were reported. On APR-2021, the subject experienced like a blister. On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced eyesight is a little blurry, and bleeding gums when brushing teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in leg, eyesight is a little blurry, bleeding gums when brushing teeth, and like a blister. This report was non-serious.
49 2021-07-02 pain in extremity arm soreness from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawe... Read more
arm soreness from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
49 2021-07-05 sciatica Tired and sleepy - for the next couple of days right after the vaccine. June 14, I started getting o... Read more
Tired and sleepy - for the next couple of days right after the vaccine. June 14, I started getting on my right side - from cheek to toes - and my whole leg and is still in pain today. For the last three weeks - the pain level was from 9 or 10 out of 10. I missed work for three weeks. I can barely sleep at night - maybe for three to four hours because the pain would wake me up. Today was my first day after three weeks that I was able to go to work. Today the pain is 5 out of 10. No treatment at the hospital. They prescribed me with 800 mg of Ibuprofen - two pills at night. The medicine was not strong enough. The prescribed me cream on my neck. The day I went to pick up my prescription to the pharmacist advised me to take another brand - so found a generic brand for $25 instead of $525. The cream doesn't numb my leg or make me fill better. I was applying hot water in the shower on my neck and that helped a bit. Told me to watch videos to stretch and exercise my neck every day.
49 2021-07-06 cold sweat Patient started experiencing periods of sweating and cold/hot sweats with visible beads of sweat on ... Read more
Patient started experiencing periods of sweating and cold/hot sweats with visible beads of sweat on his face.
49 2021-07-12 numbness He reports right after getting the vaccine he got a golf ball sized lump on his arm. His left arm is... Read more
He reports right after getting the vaccine he got a golf ball sized lump on his arm. His left arm is now numb and it is radiating more "out". Denies any shortness of breath, headaches, or chest pain.
49 2021-07-12 muscle twitching, muscle spasms, tingling, nerve pain Started having nerve issues which I thought needed chiropractor care. Several adjustments over the l... Read more
Started having nerve issues which I thought needed chiropractor care. Several adjustments over the last couple months with no relief. Symptoms are tingling left arm and left leg to fingers and toes. Muscle spasms and twitches and cramps in the forearm, wrist, and foot that cause my fingers and toes to pull in
49 2021-07-13 numbness, tingling Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in ... Read more
Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in my fingers. Pressure on the chest. High blood pressure.
49 2021-07-13 tingling, numbness Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble brea... Read more
Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.
49 2021-07-15 numbness, muscle spasms - Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and ti... Read more
- Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and tingling in feet and hands, headaches, chest tightness, - prolonged severe daily headaches, blurred vision, high blood pressure
49 2021-07-16 numbness, tingling arm numbness or tingling, similar to what was reported for Guillain-Barré syndrome. Always since va... Read more
arm numbness or tingling, similar to what was reported for Guillain-Barré syndrome. Always since vaccination
49 2021-07-17 flushing 49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance pre... Read more
49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,
49 2021-07-20 electric shock sensation PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING I... Read more
PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
49 2021-07-23 sensory loss, slurring, numbness, pain in extremity, tingling NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURR... Read more
NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 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: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.
49 2021-07-25 bell's palsy, facial pain months later i started with a ear ache which spread 2 days later across my face. i go to hospital to... Read more
months later i started with a ear ache which spread 2 days later across my face. i go to hospital to be told i had bell pasy which i never had in my life. This reaction had to come from the shot.Never had anything else that would have caused this. Im going my doctor's office in a couple of days
49 2021-07-29 weakness, pain in extremity LEFT ARM WEAKNESS; PAIN ON LEFT ARM AND FINGERS; CAN'T SLEEP BECAUSE OF PAIN; This spontaneous repor... Read more
LEFT ARM WEAKNESS; PAIN ON LEFT ARM AND FINGERS; CAN'T SLEEP BECAUSE OF PAIN; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included kidney stone surgery, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced can't sleep because of pain. On 20-MAY-2021, the subject experienced pain on left arm and fingers. On 15-JUN-2021, the subject experienced left arm weakness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: gabapentin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm weakness, can't sleep because of pain, and pain on left arm and fingers. This report was non-serious. This case, from the same reporter is linked to 20210760712.
50 2021-03-09 numbness Having numbness in right arm from fingertips to shoulder. Also numbness in right ear and cheek. Pati... Read more
Having numbness in right arm from fingertips to shoulder. Also numbness in right ear and cheek. Patient was advised to contact his PCP or go to the ER.
50 2021-03-11 seizure Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subj... Read more
Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subjective fever, tiredness) and wife found him having a seizure while lying in bed.
50 2021-03-12 cold sweat, night sweats 3/7: No adverse reactions observed 3/8: 12:30 a.m. Awoke vomiting and with fever of 99.8 F ... Read more
3/7: No adverse reactions observed 3/8: 12:30 a.m. Awoke vomiting and with fever of 99.8 F 2:30 a.m. Fever of 102 F Multiple measurements prior to 10 a.m. fever of 101.6-102 F 10:00 a.m. Full adult dose Vick NyQuil Severe Cold & Flu. Additional doses as directed. Scheduled rapid Covid-19 test at pharmacy 2:00 p.m. fever of 99.5 F 4:50 p.m. COVID-19 test, no fever 6:00 p.m. Negative test result Remaining evening of 3/8 and until early morning, 3/12, heavy night sweats, clamminess, extreme fatigue
50 2021-03-14 feeling cold Fever Chills Body ache Feeling cold Sleepiness
50 2021-03-14 feeling hot, discomfort I received the vaccination at 6:50 PM on 13 March 2021. After the vaccination I did not have any sy... Read more
I received the vaccination at 6:50 PM on 13 March 2021. After the vaccination I did not have any symptoms; I was feeling just fine. I went to bed around 10:30 PM and woke up at 4:30 AM with my whole body feeling achy and lethargic; my bones and muscles were achy all that day, my body felt hot but my temperature was normal; I had a headache; I was also very tired; my body felt heavy and my normal resting heart rate is around 50 bpm and my resting heart rate was fluctuating from 72 to 79 bpm all day; all I could do was lay in bed. 14 March 2021 I went to bed around 9:30 PM and woke up around 2:30 AM feeling nauseous and I threw up; I went back to bed and woke up at 7:30 AM and felt much better; still had a headache and feeling achy in my legs and lower back, still tired and I slept from 10:30 AM to 01:45 PM.
50 2021-03-16 cold sweat, unresponsive to stimuli Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 s... Read more
Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.
50 2021-03-20 weakness Fever, soreness and weakness
50 2021-03-26 migraine Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches... Read more
Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches Migrane
50 2021-03-30 migraine, weakness Severe chills, aches, weakness, migraine, ear ringing. I was back to normal after 3 days, but after ... Read more
Severe chills, aches, weakness, migraine, ear ringing. I was back to normal after 3 days, but after 11 days the ear ringing and headaches came back
50 2021-04-04 pain in extremity Immediately on injection felt severe pain in arm - the pain radiated downward but at time of typing ... Read more
Immediately on injection felt severe pain in arm - the pain radiated downward but at time of typing this report patient states pain is lightening up and remains only at injection site.
50 2021-04-04 seizure, tremor Patient received first Johnson and Johnson, 2 minutes into a 30 min observation, patient began to ha... Read more
Patient received first Johnson and Johnson, 2 minutes into a 30 min observation, patient began to have seizure like activity. Patient's eyes rolled back and he started to quickly shake for about 1 minute. Patient came to and was responsive. Provider arrived, vitals and physical exam were within normal limits. Patient was recommended to schedule an appointment with PCP and ask for a referral to Neurology, since patient had seizure like activity with a Tdap a few years ago.
50 2021-04-05 cold sweat About 10 minutes after injection, got dizzy/clammy. It took about 5-10 minutes after that with EMTs ... Read more
About 10 minutes after injection, got dizzy/clammy. It took about 5-10 minutes after that with EMTs to wait until my blood pressure normalized, and then I was fine. Walked off site. Slowly throughout the day had an increasingly bad headache, which peaked about 10 hours after the injection. Around that same time, bad fatigue started, and then slight chills. The headache at this point was extremely severe for about 10-12 hours. After that (so 20-22 hours after initial injection) the fatigue and chills subsided, but came back occasionally. The headache was less severe at that point, but in total did not go away until an additional 15 hours had passed. My estimate is that took about 36-40 hours to feel 100% normal again.
50 2021-04-05 tremor, throat numbness Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after sho... Read more
Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.
50 2021-04-05 unresponsive to stimuli, seizure Gave patient vaccination, patient rolled eyes back and then started having seizing activity. This ha... Read more
Gave patient vaccination, patient rolled eyes back and then started having seizing activity. This happened at around 10:30 AM, held patient head to make sure he did not hit his head, patient was not responsive for about 1-2 minutes, 911 was called, EMT came.
50 2021-04-07 unresponsive to stimuli The patient came in for J&J vaccine. He said he had no history of severe allergic reaction to anythi... Read more
The patient came in for J&J vaccine. He said he had no history of severe allergic reaction to anything, including meds, food, vaccines or any injections. He said that he did not receive any other vaccine in the past 14 days. According to the patient, he did not have test positive for Covid or was in contact with anyone with Covid for the past 2 weeks. He appeared perfectly fine prior to receiving the vaccine. Once the vaccine was given, within about 5 seconds, he said that he was seeing spots, he closed his eyes and made sounds that were similar to snoring. His neck was completely down on his right side and he almost fell off his chair. I held him so he would not fall off the chair and called for help. A few of the co-workers came to hold him. He was non responsive and my co-workers helped to put his legs on the chair. At point, I gave him an epipen. Once the epipen was given, he opened his eyes in about few seconds and became responsive. The nurses came and took over at this point. I stayed with him and the nurses for a few minutes. The patient was fully responsive and talking by the time I left the nurses and the patient. 911 was activated after the first epipen was given. The patient was then evaluated by EMS and the onsite nurses. The patient was AOx4 with stable vital signs. The patient had orthostatic vital signs taken and were within normal limits. The patient demonstrated that he was able to ambulate with no assistance. The patient signed a refusal for transport to the hospital and was driven home by a colleague. The patient remains in care of that colleague for monitoring. The patient was instructed that if he were to begin feeling the previous symptoms that he is to activate 911 and be seen in a hospital. Patient understood the instructions and went back to his residence.
50 2021-04-08 feeling cold, cold sweat Vaccination + 3 hrs - Headache, Fatigue Vaccination + 8 hrs - Headache, Severe Fatigue (took over th... Read more
Vaccination + 3 hrs - Headache, Fatigue Vaccination + 8 hrs - Headache, Severe Fatigue (took over the counter Ibuprofen) Vaccination + 14 hrs - Severe Chills, Headache, Muscle Ache (took over the counter Tylenol) Vaccination + 16 hrs - Cold sweats, Headache, Muscle Ache, Fever = 103 deg F Vaccination + 20 hrs - Headache, Muscle Ache, fever = 101 deg F Vaccination + 24 hrs - Headache, Muscle Ache (took over the counter Ibuprofen)
50 2021-04-08 feeling hot About 10 minutes post vaccine, patient felt faint, hot, like he needed air, and "panicky"
50 2021-04-09 feeling cold, cold sweat By midnight my husband had severe chills (he could not get warm no matter how many blankets he cover... Read more
By midnight my husband had severe chills (he could not get warm no matter how many blankets he covered himself in) - severe headache - lethargic flu like - body aches - he was nervous and checked on me and my mom- as we all got the in home vaccine together . We were both fine but he had side effects on the higher/ more severe end. Lasting about 24 hours where it then began to break into cold clammy sweats (he did use Tylenol starting about 3-4:00pm on the 25th and by the morning of the 26th he felt much better. The Vaccine did not write our lot number on our vaccine cards - I have to call and attempt to find out. I am reporting this in case it is helpful for others. He did not have to be admitted anywhere but he would say that for those first 24 hours he was having side effects more on the severe side.
50 2021-04-11 weakness Fever 103.0 Vomiting Diarrhea Chills Muscle Aches Weakness Prolonged low grade fever of 99.4
50 2021-04-11 flushing Nausea for 15 minutes shortly after the vaccine, mild flushing of hands and face shortly after the s... Read more
Nausea for 15 minutes shortly after the vaccine, mild flushing of hands and face shortly after the shot, and fatigue for 24 hours after shot.
50 2021-04-11 numbness swelling in throat, numbness (face). Evaluated by EMS-Refusal to transport.
50 2021-04-12 weakness Headache, nausea, weakness
50 2021-04-12 numbness Vomiting, nausea, numbness in the arm of the injection, severe headache, blurry vision.
50 2021-04-12 pain in extremity Leg pain in left calf for a number of days starting almost a week after getting vaccinated. I thoug... Read more
Leg pain in left calf for a number of days starting almost a week after getting vaccinated. I thought it might be a blood clot (this was e any news of blood clots was known). I had an ultrasound and it showed nothing. But I thought I?d report it anyway.
50 2021-04-12 pain in extremity Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hou... Read more
Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hours after shot and progressively got worse for two days. Symptoms have got better, but still lingering. A few red scabs appeared on upper arm of arm shot administered to, but not sure if related or not.
50 2021-04-12 pain in extremity Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm ... Read more
Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm pain and headache.
50 2021-04-12 pain in extremity Arm hurt badly immediately after shot, around 12:30pm today I started to feel aches, chills and head... Read more
Arm hurt badly immediately after shot, around 12:30pm today I started to feel aches, chills and headache, and fever of 101.7 around 7:30pm
50 2021-04-12 tingling Hives (all over body) Spent the day outside on a high-pollen-count day. At 6PM noticed itchy/tingly ... Read more
Hives (all over body) Spent the day outside on a high-pollen-count day. At 6PM noticed itchy/tingly and upon inspection noticed hives all over body. I have had Hives at least once before while on high-dose (400-600mg) ibuprofin, but never from allergies. Not certain this is related to J&J shot, but doctor said it wouldn't hurt to report. Next day stayed indoors. Hives are less common, but still present.
50 2021-04-12 seizure Pt reports that 23 hrs after receiving the vaccine he experienced " a massive seizure" and was tran... Read more
Pt reports that 23 hrs after receiving the vaccine he experienced " a massive seizure" and was transported by paramedic to the Hospital. A neurologist he saw mentioned that he had seen "other seizures like this ' and they presumed he meant after COVID vaccines
50 2021-04-13 pain in extremity History of Present Illness The patient presents with 50-year-old male with a history of hypertensi... Read more
History of Present Illness The patient presents with 50-year-old male with a history of hypertension and diabetes who presents via private vehicle with complaints of atraumatic left calf pain x4 hours. Symptoms started while typing on computer at work sitting in chair. Described as mild soreness to his left medial calf rating behind his knee. No frank tenderness with palpation. No fall, trauma, injury, or overuse syndrome including gym. No swelling, edema, or asymmetry. No associated motor/sensory disturbance able to wiggle and feel all digits with good pulses. No chest pain, shortness breath, palpitation, lightheadedness, or syncope. No spasms, cramps, or charley horses. Patient denies any history or DVT/ PE, hypercoaguable disorder, recent immobilization or surgery, recent long trips or travel, or active malignancy (w/ treatment in last 6 months) but does take prescribed clomiphene for androgen replacement/stimulation. Discomfort scribed as soreness, minimal intensity, 2 out of 10 without provocative or palliative factors.
50 2021-04-13 pain in extremity Diarrhea, mild temperature, sore body initially. 3 days after pain in right leg. It feels like a sha... Read more
Diarrhea, mild temperature, sore body initially. 3 days after pain in right leg. It feels like a sharp stabbing pain. Like a charley horse or dehydration. Drank water and Gatorade does not stop pain. Started to take 81 mg aspirin and did not stop pain. Just went to Dr. for blood test on 4/14/21.
50 2021-04-13 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
50 2021-04-14 pain in extremity Tonsillitis, fatigue, sore tongue, gas, foot pain, pain on left side of head.
50 2021-04-15 weakness Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the va... Read more
Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to "do him in." He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021
50 2021-04-15 bell's palsy Bells Palsey
50 2021-04-15 cold sweat Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that... Read more
Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that evening. ( did not mentione until 4/16.) HE said around 4/11- 4/12 he has cold sweats, dizziness and some coughing started. He said he started to feel better but noticed 4/16 that he was having a little shortness of breath/congestion -- he is taking mucinex to relieve congestion
50 2021-04-15 tingling BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; T... Read more
BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; This spontaneous report received from a patient concerned 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, administered on 06-APR-2021 at about 8:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, after about 5 minutes of vaccination, the patient experienced 'white noise' in ears, vision changes, had a visual aura (a pattern around side of vision and moved to front of vision) and blacked out only for few minutes. He blacked out in the pharmacy but was not sure for how long. On 06-APR-2021, the patient felt a little dizzy, experienced headache, and tingling in arms and legs (reported as ''arms and legs felt like they were gone''). On the same day, he also had a rapid/strong heartbeat for a while that made him cough and it went away after about 45 minutes. The strong heart beat had come and gone throughout the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out and cough, and the outcome of white noise in ears, tingling arms and legs, rapid/strong heartbeat, and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411724 - Covid-19 vaccine ad26.cov2.s- BLACKED OUT. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
50 2021-04-18 hot flush On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomit... Read more
On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomiting, dizziness, body ache, chills/hotflashes Two days later, mid afternoon: Nausea Five days later, lunchtime for several hours: severe headache Six days later, lunchtime for several hours: severe headache
50 2021-04-19 numbness, tingling, pain in extremity LEFT HAND NUMBNESS; TINGLING OF THE TIPS OF THE LEFT HAND FINGERS; SORE RIGHT ARM; This spontaneous ... Read more
LEFT HAND NUMBNESS; TINGLING OF THE TIPS OF THE LEFT HAND FINGERS; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux for more than 10 years, alcohol user 4 times a week, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 16:15 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux. On 09-APR-2021, the subject experienced sore right arm. On 13-APR-2021, the subject experienced left hand numbness. On 13-APR-2021, the subject experienced tingling of the tips of the left hand fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand numbness on 13-APR-2021, was recovering from sore right arm, and had not recovered from tingling of the tips of the left hand fingers. This report was non-serious.
50 2021-04-19 pain in extremity A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back... Read more
A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.
50 2021-04-20 weakness MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report ... Read more
MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid- 19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.
50 2021-04-20 pain in extremity Pt phoned our office on 04/19/21 with complaints of abdominal pain and bilateral leg pain. Pt was i... Read more
Pt phoned our office on 04/19/21 with complaints of abdominal pain and bilateral leg pain. Pt was instructed to seek immediate health care for evaluation. He refused. Pt was very agitated and concerned about covering costs of medical care despite having health care insurance. Pt again instructed to seek health care and he refused.
50 2021-04-20 pain in extremity Persisted for three days: Arm soreness Headaches Body Aches Tiredness/fatigue These faded and on 4/7... Read more
Persisted for three days: Arm soreness Headaches Body Aches Tiredness/fatigue These faded and on 4/7/2020, liver began to feel enlarged for two days. This was followed by UTI; pain in kidneys and groin; rigidity, discoloration, and extreme swelling in right testicle; inability to urinate; 100-degree fever. Remains on antibiotic (Keflex 500mg 4/pd) and Flomax. Testicle rigidity & some swelling remain.
50 2021-04-21 tingling, numbness On top of flu like symtoms that didn't concern me I started experiencing numbness and tingling on th... Read more
On top of flu like symtoms that didn't concern me I started experiencing numbness and tingling on the right side of my face. I also had irregular heart beat for 16-18 hours. I have had neurological issues with 2 other medications in the past which calmed my concerns. I had my arms lock up on me while on Humira and I had the exact facial numbness and tingling with Enbrel. Both of those drugs work through TNF cells. I do not know the mechanism with J&J vaccine but wanted you to know that.
50 2021-04-22 flushing Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT ... Read more
Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.
50 2021-04-22 numbness my right thumb and index finger from the point where i bend it to the top of the thumb and index fin... Read more
my right thumb and index finger from the point where i bend it to the top of the thumb and index finger it is completely numb like its dead since three weeks after having vaccine.
50 2021-04-22 pain in extremity Back pain, severe leg pain (muscle pain) , patient wobbles when he walks. Lethargy.
50 2021-04-22 pain in extremity PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; This spontaneous report received from... Read more
PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; This spontaneous report received from a patient concerned a 50 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: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain extending to the neck. On 17-APR-2021, the subject experienced feeling pain from shoulder to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling pain from shoulder to arm, and pain extending to the neck. This report was non-serious.
50 2021-04-23 bell's palsy Developed Bell?s Palsy on right side of my face. Gained most movement back in 1 1/2 weeks.
50 2021-04-25 pain in extremity Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultr... Read more
Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen
50 2021-04-26 weakness About a week after receiving vaccine, both my shoulders and both hips started experiencing pain and ... Read more
About a week after receiving vaccine, both my shoulders and both hips started experiencing pain and weakness that is still ongoing, though improving. Until recently, it was difficult to raise my hands over my head, and it would be difficult to stand up from a sitting position. I have regularly exercised and done resistance training for several years. I'm not sure if this is coincidental nor am I concerned, but a pharmacist encouraged me to report it here.
50 2021-04-27 hot flush Patient passed out walking down the hall to the bathroom about 5 minutes after receiving the vaccine... Read more
Patient passed out walking down the hall to the bathroom about 5 minutes after receiving the vaccine. When patient regained consciousness, he stated he was having a hot flash and was going to the bathroom to get something to wipe off his face.
50 2021-04-28 feeling hot BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RI... Read more
BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RIGHT FOOT SWOLLEN; CHILLS; RUNNY NOSE; FEELING HOT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1802070, expiry date unknown), dose not reported, 1 total administered on 19-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amlodipine besilate for drug used for unknown indication, empagliflozin for drug used for unknown indication, fenofibrate for drug used for unknown indication, insulin aspart for drug used for unknown indication, insulin glargine for drug used for unknown indication, losartan for drug used for unknown indication, and pioglitazone hydrochloride for drug used for unknown indication. On an unspecified date (reported as 22-MAR-2021; 28 days prior to vaccination), the patient experienced shortness of breath, heart rate increased, runny nose, chills and was hospitalized (date unspecified). He reported that on this past Saturday, 17-APR-2021 (2 days prior to vaccination), he went to the emergency room. He reported that his toenails were coming off, the skin on his toes was coming off, and he had swelling in his right foot and up his leg. He says there was no circulation going to his toe and he was diagnosed with having a blood clot in his right leg. He says he had surgery to open up the arteries in his leg, and also reported gangrene in his toe. The subject was discharged on 21-APR-2021. On 23-APR-2021, the patient experienced feeling hot. He also reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. He reported that he is going to go back to the hospital, to which he would seek medical attention if he was having issues. Treatment medications (dates unspecified) included paracetamol. When called back due to his vaccination dates being after event start dates, the patient said that his memory is not too good, so he 'had to take his time to remember the correct dates'. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from blood clot in leg, and had not recovered from runny nose, shortness of breath, heart rate increased, chills, feeling hot, gangrene in toe, right leg swollen, and right foot swollen. This report was serious (caused hospitalization).; Sender's Comments: V0: This 50-year-old hypertensive and diabetic male patient reported that he was feeling hot and may need to have his fifth toe amputated because it has gangrene 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection and 2 days after discharge form the hospital. The patient was hospitalized for shortness of breath, heart rate increased, runny nose, and chills 28 days prior to vaccination. The patient went to the emergency room 2 days prior to vaccination because his toenails/skin on his toes were coming off, swelling in his right foot and up his leg, gangrene in his toe; he reported that there was no circulation going to his toe and was diagnosed with having a blood clot in his right leg; the patient reported he had surgery to "open up" the arteries in his leg. Four days after vaccination, the patient felt hot and reported reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. The patient is taking paracetamol as treatment. No other details was reported. Based on the lack of temporal association, the causality is considered not related for the events blood clot in leg, shortness of breath, heart rate increased, right leg swelling, right foot swelling, chills, and runny nose. The information available regarding event gangrent of fifth toe and feeling hot precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.
50 2021-05-02 cold sweat Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light h... Read more
Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light headed. Patient fainted, with seconds patient was awake and knew where he was. he was clammy and in the face. Gave patient a water, he immediately felt better.
50 2021-05-03 tenderness I experienced pain in my left shoulder after my J&J vaccine, have trouble any pushups. My pain is co... Read more
I experienced pain in my left shoulder after my J&J vaccine, have trouble any pushups. My pain is constant in my left arm above my head. The day I went to the doctor, a guy crashed into me and the pain I experienced was more. I can put my fingers into my shoulder region and it is very painful. I saw a doctor 04-23-2021 ad he advised me if my symptoms persists I should come back for a re-evaluation. I can not put my left arm first, my left arm is unstable. Before the J&J vaccine, I did not have this pain to my left shoulder. I have also taken OTC Tylenol but it does not help with my pain.
50 2021-05-05 pain in extremity Pt developed calf pain ~ 1-2 week after COVID vaccine. Diagnosed with DVT/PE on 5/6 with platelet co... Read more
Pt developed calf pain ~ 1-2 week after COVID vaccine. Diagnosed with DVT/PE on 5/6 with platelet count decreased from baseline at 92,000.
50 2021-05-06 tingling Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told h... Read more
Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission. Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands. Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands. Pt states that he is still having minor headaches.
50 2021-05-10 tingling Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minut... Read more
Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies. Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.
50 2021-05-15 cold sweat DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED ... Read more
DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED SNACK AND WATER, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
50 2021-05-20 burning sensation Burning on the both feet
50 2021-05-21 inability to speak, coordination abnormal Pt was vaccinated with the Johnson and Johnson Vaccine on 5/3/21. he presented to the emergency room... Read more
Pt was vaccinated with the Johnson and Johnson Vaccine on 5/3/21. he presented to the emergency room with a stroke on 5/15/2021. 50-year-old male presents emergency department with difficulty finding words and difficulty getting his hands to do what he wants. Last known normal was 1030 the previous night when he went to bed. He has a past medical hx sign for controlled HTN, seasonal allergies and obesity with a bmi of 48. Family members noticed him having difficulty finding words the morning of admission and it got slightly worse throughout the day. According to his wife he was holding the phone and could not dial the right numbers. His hands were working but they could not follow instructions from what his brain wanted to do. On evaluation the patient felt as though he was stuttering and could not get the right words. No numbness or tingling. No weakness on one side or the other. wife and pt reported no prior problems with word finding or memory in the past and other than obesity and controlled HTN he was healthy. He does not smoke. he had no prior hx of atrial fibrillation. telemetry monitoring showed no atrial fibrillation. His LDL was 109, chol 167,trig 119, hdl 34. No prior hx of covid 19 infection. echo with normal EF, no thrombus. He received Physicial therapy and Occupational therapy and speech therapy. He was discharged home on 5/17 on an aspirin. He was called on 5/22 and is still experiencing expressive aphasia and word finding difficulty. He previously worked full time as a machinist and has not been able to go back to work. He is also complaining of fatigue still.
50 2021-05-21 bell's palsy TWO TO THREE DAYS AFTER SHOT 5/2-5/3 PT HAD STIFF/ CRICK IN NECK FELT LIKE IT NEEDED TO VBE CRACKE... Read more
TWO TO THREE DAYS AFTER SHOT 5/2-5/3 PT HAD STIFF/ CRICK IN NECK FELT LIKE IT NEEDED TO VBE CRACKED BUT COULDNT CRACK IT.. ONE WEEK AFTER INJECTION 5/8 PT DEVELOPED BELLS PALSEY ON LEFT SIDE OF FACE PT STILL HAS BELLS PALSELY PT WAS SEEN BY HIS PHYSICIAN AND WAS ADVISED TO REPORT ADVERSE EVENT(S) TO PHARMACY TO REPORT TO VAERS
50 2021-05-24 tremor Fever over 104.8, chills, shakes, headache, muscular aches and pain, fever continues at 20 hours aft... Read more
Fever over 104.8, chills, shakes, headache, muscular aches and pain, fever continues at 20 hours after shot hovering around 101.
50 2021-05-26 feeling hot Dizzy, Fell down several times in shower, can't walk, extremely dry mouth, fatigue, hot (no fever)
50 2021-05-27 night sweats Severe headache for 48 hours Mild headache for one week Severe fatigue for 48 hours Fatigue for one ... Read more
Severe headache for 48 hours Mild headache for one week Severe fatigue for 48 hours Fatigue for one week Loss of appetite for 24 hours Night sweats and low grade fever for 72 hours Loss of concentration for one week
50 2021-05-28 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
50 2021-06-01 unresponsive to stimuli He was admitted to Hospital unresponsive as Ventricular Fibrillation cardiac arrest. Found to be COV... Read more
He was admitted to Hospital unresponsive as Ventricular Fibrillation cardiac arrest. Found to be COVID-19 positive upon testing on 5/31/2021. No prior positive tests on record.
50 2021-06-02 weakness Patient developed progressive weakness, ultimately found to be an atypical idiopathic myositis
50 2021-06-10 migraine, seizure After receiving Janssen vaccine, I experienced feelings of fatigue, ringing in ears, blurry vision, ... Read more
After receiving Janssen vaccine, I experienced feelings of fatigue, ringing in ears, blurry vision, migraine type headaches. I had not suffered from any of these symptoms prior to the vaccine. On 6/2/21, I was feeling similar symptoms, and particularly a severe headache and some fatigue. I was driving to the gym, to see if perhaps, doing a little walking or exercising may make me feel better, when I experienced a seizure while driving, lost control of vehicle and ended up, off the road and hit a tree, I do not remember anything from the crash. I awoke in an ambulance, and was taken by helicopter to Hospital. I received emergency care and was admitted to the hospital.
50 2021-06-12 numbness, pain in extremity bicept pain and numbness since day after injection still ongoing as of today
50 2021-06-13 hot flush Male patient reported dryness in the lips, blurry vision, and hot flash in the neck. In that moment ... Read more
Male patient reported dryness in the lips, blurry vision, and hot flash in the neck. In that moment head of staff are notified and paramedic attended the situation. Vital was perform; HR 52, BP 100/60, SO2% 95. Patient was sweeting and was reclined in the floor we legs lifted. After works patient was observed by the paramedic and head nurse. Patient was alert, oriented and responding to questions. Final Vital sing; BP 120/70, SO2% 96, and was transfer to observation area with 30 minutes.
50 2021-06-17 pain in extremity FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER T... Read more
FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.
50 2021-06-19 pain in extremity Body aches throughout first night, severe leg pain second night
50 2021-06-19 tingling, numbness 2 days after shot, numbness/weakness in left leg and pins and needles in left hand. Upper arm pain ... Read more
2 days after shot, numbness/weakness in left leg and pins and needles in left hand. Upper arm pain where injection given. Neck pain. Seems to be autoimmune reaction. Hospitalized for 2 nights, seeing neurologist, having physical therapy for leg and neck
50 2021-06-29 hot flush Patient immediately got a bad hot flash. Drank some water and a few minutes later was fine.
50 2021-06-30 feeling hot PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEAT... Read more
PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
50 2021-07-02 nerve injury, cold extremities, tingling, bell's palsy Severe tingling and coldness in hands and feet. Temporary bells palsy. Neurologist has diagnosed ne... Read more
Severe tingling and coldness in hands and feet. Temporary bells palsy. Neurologist has diagnosed nerve damage with unknown cause.
50 2021-07-04 tingling, weakness, feeling cold Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (in... Read more
Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.
50 2021-07-06 feeling of body temperature change, pain in extremity I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). TH... Read more
I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.
50 2021-07-08 tingling, pain in extremity After approx 10 mins of monitoring after injection in exam room, patient reported tingling and pain ... Read more
After approx 10 mins of monitoring after injection in exam room, patient reported tingling and pain in his fingers and joints of both hands. Provider was alerted and patient was examined. recommended to stay an extra 15 minutes for monitoring. Patient was monitored for an extra 15 mins before being assessed again by MA and let go after determining he was fit to leave.
50 2021-07-12 inability to speak, pain in extremity, migraine, numbness migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldn... Read more
migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min). I went to hospital and had CT, ekg, blood work, all were ok. Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure. Surgeon also said to get the procedure but as of now my insurance has not approved payment. I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue. I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay. I have gone from a healthy person who is very active to someone who is always tired and is constantly worried about having another TIA.
50 2021-07-12 tingling Pt came back today 7/13/2021 and mentioned that he was having some kind of steady tingling sensation... Read more
Pt came back today 7/13/2021 and mentioned that he was having some kind of steady tingling sensation on the vaccinated arm (left) that started around July 2nd. He heard about the recently reported side effect Guillain Barre Syndrome on the news so he tried to seek out how he can report this and came back to our pharmacy. Told him we need to report thru VAERS and will reach out to him if more info is needed. He was also advised to sign up thru Vsafe for monitoring.
50 2021-07-18 numbness, facial paralysis Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, b... Read more
Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.
50 2021-07-20 speech disorder, severe one side paralysis, numbness, weakness RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND SEVERAL TIMES A DAY; INSECURE FEELIN... Read more
RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
50 2021-07-21 tingling developed a myelitis, presenting and paresthesias and leg weakness, responsive to high dose steroids... Read more
developed a myelitis, presenting and paresthesias and leg weakness, responsive to high dose steroids.
50 2021-07-23 hot flush, cold sweat, tingling CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP... Read more
CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.
50 2021-07-23 tingling 15-20 minutes after vaccine pain in chest on left side near heart, sharp for 10-15 sec and than ting... Read more
15-20 minutes after vaccine pain in chest on left side near heart, sharp for 10-15 sec and than tingling constant dull pain, sharp pain happened multiple times since the injection. Went to ER on advice from physician, had multiple tests including blood work, EKG, CT angiogram d-dimer high, did not show heart issues but it did show minimal basilar atelectasis. Currently still having pain and started incentive spirometer.
50 2021-07-28 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt previously had episodes of fainting after getting blood drawn in the past
51 2021-03-06 weakness, sensory loss Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Sy... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
51 2021-03-08 burning sensation, pain in extremity Fever, chills, aching palms, hands/fingers, shoulders, burning sensation in feet
51 2021-03-08 tremor Fever, fatigue, congestion, sore arm, sore muscles. The fever started the morning after the shot, a... Read more
Fever, fatigue, congestion, sore arm, sore muscles. The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were gone. But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night. On day three I continue to be fatigued, but no fever.
51 2021-03-09 feeling cold, pain in extremity Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lo... Read more
Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lower back. This was then followed with severe fatigue, cold chills and diarrhea. Symptoms subsided after approximately 24 hrs of onset.
51 2021-03-09 pain in extremity, feeling cold Sore arm. About 3 hours after getting the shot, I started getting aches, feeling cold, and tired. ... Read more
Sore arm. About 3 hours after getting the shot, I started getting aches, feeling cold, and tired. The next morning my joints ached and I had a sore throat. I took a couple of Ibuprofen (200 mg each) and about an hour later, my aches started going away. By 8 pm the next day, I didn't have many side effects.
51 2021-03-09 pain in extremity 2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke... Read more
2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?. I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate. My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again
51 2021-03-10 feeling cold, tremor Janssen Covid-19 Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extr... Read more
Janssen Covid-19 Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extreme fatigue, dizziness, and sleepiness. About 1 hour later I started getting the cold chills, a headache and shaking. About 1 more hour later I had a fever, achy joints and muscle aches. The symptoms lasted through the night until about 8:30 the next morning when I started sweating. I decided then to take aceteminiphen and Naproxen. This helped me to feel a little better. Side effects were resolved after 24 hours
51 2021-03-10 night sweats The first day at night woke up with night sweats and fatigue. Second-day headache and have a rash on... Read more
The first day at night woke up with night sweats and fatigue. Second-day headache and have a rash on the upper front part of my body and the upper part of my body on my back.
51 2021-03-11 mild one side paralysis Approximately 30 minutes post vaccination, patient complained of not feeling well. BP checked 130/9... Read more
Approximately 30 minutes post vaccination, patient complained of not feeling well. BP checked 130/92, P =82. Diabetic. Had not taken meds this morning. Admits to having eaten irregularly throughout the day. Hydrated with water, gave Gatorade and a snack. Continued to monitor. BP rechecked which was recorded at 145/97 and P= 80. Resident on site. Neuro checks done by resident. Left sided weakness with sensory changes on left side were noted. Ambulance called. Patient transported to Hospital for observation.
51 2021-03-12 tingling Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm inj... Read more
Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm injection, no redness or swelling noticed. Pt was quite anxious & nervous (but already has severe anxiety). Pharmacist called patient following afternoon, the 11th and patient noted he was doing marginally better but still sounded anxious. Pharmacist called patient on Fri the 12th 5:16p and this was when the patient explained the following: Muscle stiffness on left side & pain down left leg; cranial pain; shoulder stiffness; nasal congestion; some shortness of breath; soreness & fatigue. Patient called back and said he had partial shortness of breath at 7:34p on the 12th. On Sat the 13th at 11am, pharmacist called to check on pt; found him quite agitated & saying, "He feels the shot was botched", noted he had called Janssen to report his issues. At 4:30pm, pt came to pharmacy, looked fine, arm showed no redness, was more subdued in person than on the phone earlier. He said he was feeling better but was not happy with Janssen and wanted the Moderna 2 series shot because he feels Janssen's vaccine wasn't doing what it was supposed to.
51 2021-03-19 nerve pain Pt had a feeling like his bp had gone up as well as flushed feeling. He was sent to lie down and adm... Read more
Pt had a feeling like his bp had gone up as well as flushed feeling. He was sent to lie down and administered zyrtec 10 mg PO. Pt then began to have tingling in his fingers. Pt was evaluated by ems. Denied wanting to go to hospital. Pt observered for 1 hr when symptoms resolved. Pt was turned over to wifes care with instructions to f/u with md as well as if symptoms occurr again or worsen to follow up with EMS/ER.
51 2021-03-23 weakness, pain in extremity, hot flush March 17 at 6pm - Experienced chills and fatigue. March 17, during the evening - experienced pain in... Read more
March 17 at 6pm - Experienced chills and fatigue. March 17, during the evening - experienced pain in left arm, right arm, nausea, chills, hot flashes, restless feeling, unable to get comfortable to get to sleep. Woke up several times during the night. Woke up, took up to 4 Tylenol, still could not sleep. March 18 - Woke up - Fatigued, dry mouth, and in a fog. All I wanted to do was sleep. This is what I ended up doing most of the day. By the end of the day, felt a little better. March 19th - Feeling a little better, but still weak, but still somewhat dizzy. March 20th - Same as the 19th. March 21st - Finally feel 80 - 100% better.
51 2021-03-24 pain in extremity, night sweats HEADACHE, STIFF AND ACHING NECK, LOWER BACK PAIN, NIGHT SWEATS, DIARRHEA, PAIN DOWN ARM
51 2021-03-25 pain in extremity Severe fatigue, severe headache, fever, arm pain
51 2021-03-26 pain in extremity Paramedic assessed patient. Pt stated neck tension on the side (R) arm, 3/10 pain, light head, natu... Read more
Paramedic assessed patient. Pt stated neck tension on the side (R) arm, 3/10 pain, light head, natural low pulse rate. Vitals BP 159/78, HR 51 bpm, respiratory 16. Pt was monitored and stale to leave upon expired observation time frame.
51 2021-04-06 burning sensation BURNING SENSATION TO THE LEFT OF THE GROIN AREA AND LEGS; INFLAMED GROIN AREA AND LEGS; This spontan... Read more
BURNING SENSATION TO THE LEFT OF THE GROIN AREA AND LEGS; INFLAMED GROIN AREA AND LEGS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 13:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the patient experienced burning sensation to the left of the groin area and legs. On 27-MAR-2021, the patient experienced inflamed groin area and legs. The action taken with COVID-19 vaccine was not applicable. The patient had not recovered from burning sensation to the left of the groin area and legs and inflamed groin area and legs. This report was non-serious.
51 2021-04-06 discomfort SLUGGISHNESS; HEAVINESS; PAIN; CHILLS; FEVER; HEADACHES; TIREDNESS; SWEATING; DROWSY; WALKING AROUND... Read more
SLUGGISHNESS; HEAVINESS; PAIN; CHILLS; FEVER; HEADACHES; TIREDNESS; SWEATING; DROWSY; WALKING AROUND LIKE FOG; DID NOT REMEMBER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included normal headache. The patient was previously treated with paracetamol for headache. 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-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced walking around like fog. On MAR-2021, the subject experienced did not remember. On 21-MAR-2021, the subject experienced sweating. On 21-MAR-2021, the subject experienced drowsy. On 21-MAR-2021, the subject experienced sluggishness. On 21-MAR-2021, the subject experienced heaviness. On 21-MAR-2021, the subject experienced pain. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headaches. On 21-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, drowsy, pain, chills, and fever on 22-MAR-2021, and walking around like fog, sluggishness, heaviness, did not remember, headaches, and tiredness on MAR-2021. This report was non-serious.
51 2021-04-06 pain in extremity ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; ... Read more
ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 235 pounds, and height was 65 inches. The patient's past medical history included skin boils, and pimples, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 at right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced acne on face, back and thigh. On 21-MAR-2021, the subject experienced arm sore. On 21-MAR-2021, the subject experienced run down. On 21-MAR-2021, the subject experienced injection site pain. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore, run down, injection site pain, fatigue, and low grade headache on 23-MAR-2021, and had not recovered from acne on face, back and thigh. This report was non-serious.
51 2021-04-09 unresponsive to stimuli, flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
51 2021-04-10 seizure patient had a seizure and lost consciousness; pt regained consciousness after a couple minutes; pale... Read more
patient had a seizure and lost consciousness; pt regained consciousness after a couple minutes; pale and perspiring, paramedics came and provided care from there
51 2021-04-12 weakness, sciatica On Monday The next day I woke up with chills and crooked. My sciatic nerve was pinched and i was so... Read more
On Monday The next day I woke up with chills and crooked. My sciatic nerve was pinched and i was so weak I spent all day in bed with no strength. I was as weak as when I got Covid last year. It hurts to stand straight as my sciatic nerve got pinched.
51 2021-04-12 feeling cold Slight fatigue in the afternoon. Was a little chilled at 10PM. At midnight, I had severe chills and... Read more
Slight fatigue in the afternoon. Was a little chilled at 10PM. At midnight, I had severe chills and could not get warm. Around 1:00 AM, I had fever followed by sweats. Then more chills and fever and sweats. Then more chills and fever and sweats. Symptoms were gone by morning except for fatigue that could have been from lack of sleep. Was tired most of that day (day after shot). Had slight chills and sweats the next night. By morning two (3/27. shot was received on 3/25) symptoms were gone.
51 2021-04-12 pain in extremity Pain to right leg (hip to foot) started at 7:30pm on 4/7/2020 and continued to worsen until medicati... Read more
Pain to right leg (hip to foot) started at 7:30pm on 4/7/2020 and continued to worsen until medication ordered on 4/12/2020. Also developed rash to right shin on 4/10. Several "knots" to arms, neck, and back.
51 2021-04-12 pain in extremity Developed DVT. Complains of calf pain and swelling starting evening of 4/8/2021, worsening over wee... Read more
Developed DVT. Complains of calf pain and swelling starting evening of 4/8/2021, worsening over weekend. To walk in care on 4/13/2021. Dx DVT in left lower extremity. Ultrasound shows DVT in the proximal femoral vein through the portal vein. Physician notes indicate patient seen for "left leg soreness, tender to touch, protruding veins, redness, cramping in calf, radiating up to posterior thigh"
51 2021-04-12 tremor, weakness On or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work a... Read more
On or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work about 7:00 am due to an extreme headache and muscle weakness. By the afternoon my fever was up to 101. On 4/7 my fever went up to 102.7 and I was shaking uncontrollably, sweating , dizzy, headache, and had heaviness in my chest. I felt as if I were going to have a stroke. The headache was excruciating. I took acetaminophen 500 x 2 and 400 mg of ibuprofen, and Theraflu to try and alleviate the symptoms. On 4/9/21 my fever broke, but the weakness, dizziness and headaches have continued. I currently have ongoing headaches and dizziness. I have not gone to the doctor because I do not have a PCP. I am looking for one now.
51 2021-04-13 tremor Approximately 4-5 after receiving the Covid Vaccination, my heart rate dropped, the top of my body ... Read more
Approximately 4-5 after receiving the Covid Vaccination, my heart rate dropped, the top of my body was shaking and I passed out. The ambulance arrived and took me to the ER. My heart rate was at 40 . I was in the hospital for observation for 3+ hours.
51 2021-04-14 feeling hot, tingling AFTER 10 MINUTES OF THE VACCINE, HE FELT HOT, TIGLING IN HANDS AND FEET. HE DRANK SOME WATER, THEN H... Read more
AFTER 10 MINUTES OF THE VACCINE, HE FELT HOT, TIGLING IN HANDS AND FEET. HE DRANK SOME WATER, THEN HE LAY OUT ON THE SOFA BED FOR 10 MINUTES. AFTER THAT,HE SIT UP, THEN HE THREW UP. HE SAID THAT HE FELT BETTER TO LAY DOWN THAN SIT UP. WE STARTED TO CALL PARAMETIC. AS SOON AS PARAMETIC TEAM CAME, THEY CHECKED HIS VITAL SIGN , BLOOD PRESSURE. HE WAS OK, BUT THEY TOOK PT TO NEAR BY HOSPITAL TO MONITOR. PT WAS DISCHARGE FEW HOURS AFTER WITH ANTINAUSA MEDICATION. WE FOLLOWED UP WIHT PT , AND HE SAID HE WAS OK NOW.
51 2021-04-14 tingling, feeling hot, numbness NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOL... Read more
NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.
51 2021-04-15 discomfort HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UN... Read more
HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UNDER WEIGHT; MUSCLE WEAKNESS; JOINT PAIN IN LOWER BACK / KNEE AND RIGHT HAND KNUCKLES; CHILLS; MUSCLE ACHES; MILD HEADACHES; This spontaneous report received from a patient concerned a 51 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced joint pain in lower back, knee and right hand knuckles. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild headaches on APR-2021, and the outcome of muscle aches, muscle weakness, joint pain in lower back, knee and right hand knuckles and heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight was not reported. This report was non-serious.
51 2021-04-15 numbness LEFT HAND NUMBNESS; FELT TIRED; ACHY; This spontaneous report received from a patient concerned a 51... Read more
LEFT HAND NUMBNESS; FELT TIRED; ACHY; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: not reported) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced felt tired. On 12-APR-2021, the subject experienced left hand numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired, and achy, and had not recovered from left hand numbness. This report was non-serious.
51 2021-04-15 muscle spasms NOSE BLEED; MUSCLE CRAMPING; MUSCLE ACHES; FEVER; This spontaneous report received from a patient co... Read more
NOSE BLEED; MUSCLE CRAMPING; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 51 year old. 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: 041A21A, expiry: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle cramping. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 13-APR-2021, and fever on 10-APR-2021, and had not recovered from muscle aches, and muscle cramping. This report was non-serious. This case, from the same reporter is linked to 20210427147.
51 2021-04-16 muscle spasms Muscle spasms in arm & forehead, LUQ pain. Ekevated temp @ Arm pain at injection site.
51 2021-04-18 feeling cold Severe chills for approximately 1 hour overnight. Fatigue during the next day followed by approximat... Read more
Severe chills for approximately 1 hour overnight. Fatigue during the next day followed by approximately 30 minutes of chills the second evening, No symptoms afterwards.
51 2021-04-18 feeling hot, muscle twitching, hot flush, muscle spasms Pain at site of shot. Hot flashes, chills. Before bed got real hot from waste up. Muscle spasms. ... Read more
Pain at site of shot. Hot flashes, chills. Before bed got real hot from waste up. Muscle spasms. twitchs at shot site. Light headed, dizzy, shortness of breath. Shot should have been 2nd dose of pfizer. Pharmacist called the next day and told me to remove Janssen sticker from covid shot record card and said to write in pfizer info.
51 2021-04-18 tremor, weakness The day of the shot my lips and tongue were numb until the next morning. The next couple of weeks m... Read more
The day of the shot my lips and tongue were numb until the next morning. The next couple of weeks my tongue would go numb often. I was also feeling tired and unsteady. 12 days after the shot I became very sick for 10 days with severe diarrhea, no energy, stomach pains, weak, shaking, no more motivation. I saw a doctor and was given antibiotics to stop the diarrhea. Now 1 month after I have no diarrhea but still get nausea and shakes . I feel very anxious and will see a therapist and prescribe medication for my anxiety that I have due to the vaccine reaction. I took the vaccine so I can travel abroad much easier but now afraid to travel because of my symptoms. I will get blood tested tomorrow to see if all is ok. This vaccine is very dangerous as it has affected my DNA.
51 2021-04-19 pain in extremity left lower extremity medial thigh pain
51 2021-04-21 bell's palsy, numbness Developed left side facial numbness - presented to ER and was diagnosed with Bells Palsy
51 2021-04-21 sciatica, discomfort I received an injection in June and July 2020 to control my herniated discs problems that caused me ... Read more
I received an injection in June and July 2020 to control my herniated discs problems that caused me severe sciatic pain down my left leg. After those injections I have led a normal life. NO issues whatsoever. No discomfort, no leg pain, no back pain. Within about an hour after receiving the COVID-19 injection, I started to have discomfort and pain in my lower back. Within a few days my sciatic pain had returned. I am now scheduled for another injection in my back for 4-23-21 to get rid of the sciatic pain.
51 2021-04-22 impaired body coordination, slurring Headache Confusion/Lethargy Dysarthria and Ataxia Subsequent presentation to ER and Admission to med... Read more
Headache Confusion/Lethargy Dysarthria and Ataxia Subsequent presentation to ER and Admission to medical ICU (see below)
51 2021-04-22 pain in extremity Pain and swelling in Left Calf muscle. Treating the blood clot with Xeralto
51 2021-04-23 pain in extremity SORE ARM; This spontaneous report received from a health care professional concerned a 51 year old m... Read more
SORE ARM; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
51 2021-04-24 migraine Patient reports waking up in the morning weeks after vaccine administered with a migraine and feelin... Read more
Patient reports waking up in the morning weeks after vaccine administered with a migraine and feeling generally "same as after the vaccine", upon rising up he experienced strong nosebleed...first time in his life.
51 2021-04-27 inability to speak, slurring Onset of severe headache , slurred speech on 4/17/2021. Became aphasic with motor deficits, was not... Read more
Onset of severe headache , slurred speech on 4/17/2021. Became aphasic with motor deficits, was not a tpa candidate at hospital due to time of symptom onset. Dx with L MCA ischemic CVA
51 2021-04-30 muscle twitching BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous rep... Read more
BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
51 2021-05-03 speech disorder, mild one side paralysis R41.82 - Altered mental status R53.1 - Left-sided weakness R47.9 - Speech difficult to understand I6... Read more
R41.82 - Altered mental status R53.1 - Left-sided weakness R47.9 - Speech difficult to understand I63.9 - Cerebral infarction, unspecified
51 2021-05-04 pain in extremity Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inn... Read more
Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.
51 2021-05-04 tingling, pain in extremity Having lunch on 04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went b... Read more
Having lunch on 04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went blurry. My hands & feet started tingling. I turned very pale in facial color. Had co worker call 911, paramedics to me to ER. All my vitals showed normal, ekg, blood work, platlet count all good !! Went home and over next few days felt a little off, made regular doctor appt. follow up. Doctor said all my vitals look normal. Not sure what the cause is, had a ultra sound done of my left leg pain also. Showed no blood clots. Waiting for a heart monitor appt. On 05/03/21 woke up at 3 am drenched in sweat. Still feel a little off, for no reason . At times I feel like I might pass out. Had epilepsy as a you child. But out grew with medications. No seizures in 40 years.
51 2021-05-05 pain in extremity 4/10/2021 vaccination 4/11 or 4/12 at the latest, I started feeling a pain in my R calf. It was con... Read more
4/10/2021 vaccination 4/11 or 4/12 at the latest, I started feeling a pain in my R calf. It was constant pain for a week and decided to go to the walk in clinic. Blood work which was high and they referred me to the ER and administered a sonogram. *positive for blood clot Eloquence for 30 day starter pack. PCM is going to extend till July in which he will administer another sonogram. *COVID +; 01/2021
51 2021-05-05 pain in extremity Severe bone pain, feet, ankles, risk, hands , and especially legs pain hands everything resolve with... Read more
Severe bone pain, feet, ankles, risk, hands , and especially legs pain hands everything resolve within a week with exception being hand and fingers. Hand and fingers severe pain for a 3 weeks got better for a week and came back more severe and the sought treatment form doctor . NPN sent for blood test for inflammation and arthritis. Rheumatologist arthritis negative and inflammation factors was high. Referred Rheumatologist.
51 2021-05-08 weakness Patient started to feel nauseous, weak, and spiked a fever of 101.4 degrees F today day after vaccin... Read more
Patient started to feel nauseous, weak, and spiked a fever of 101.4 degrees F today day after vaccine.He is still experiencing these symptoms. Advised patient to rest, hydrate, and take Tylenol for the fever if safe and appropriate.
51 2021-05-12 bell's palsy Systemic: Bell's Palsy-Medium
51 2021-05-12 cold sweat After giving vaccination, while he was waiting in line on pharmacy register, he felt dizzy/lighthead... Read more
After giving vaccination, while he was waiting in line on pharmacy register, he felt dizzy/lightheaded, chill and was having cold sweats. He sat down on a chair about 30 minutes just to relax. Before the shot, he was pretty nervous about getting vaccinated (needles) and his fiance told me that he hardly gets vaccinated in the past because he is afraid of needles. She was not sure if his reaction is because of his nervousness about the vaccine or if it is an allergic reaction. I told his fiance who was with him the whole time, to take him to the ER if he is having hard time breathing or if his dizziness gets prolonged. I tried calling patient and her fiance on 5/10/21 vaccination day, and 5/12/21 again and left message to follow up but no answer/ call back.
51 2021-05-12 involuntary muscle movements, slurring Patient presented to hospital on 4/23 after experiencing stroke-like symptoms the evening of 4/22. S... Read more
Patient presented to hospital on 4/23 after experiencing stroke-like symptoms the evening of 4/22. Symptoms included slurred speech, confusion, and repetitive grasping of his L hand. Patient was diagnosed with DM2 and HTN during his hospital admit, but had not previously received treatment.
51 2021-05-14 migraine High Fever 103.5 Migraine Headache Body aches Chills Ringing in ears Exhaustion Loss of appetite
51 2021-05-16 bell's palsy headache and back and bilateral hip pain after vaccination that lingered for a month, followed by le... Read more
headache and back and bilateral hip pain after vaccination that lingered for a month, followed by left sided bell's palsy on 4/30 (26 days after injection) that was mild, and resolved with prednisone
51 2021-05-18 tingling, muscle spasms pressure on side of head tingling of face tingling of toes ear ringing leg cramps
51 2021-05-22 discomfort, feeling cold, tingling progressive skin tingling, back pain, neck pain First noted a problem 2- 2 ½ wks ago : tingling;... Read more
progressive skin tingling, back pain, neck pain First noted a problem 2- 2 ½ wks ago : tingling; touching cool surfaces would feel wet Mostly his legs at first: Tingling just in the spots where he would contact states he developed some back pain behind the lungs that he noted when he moved in a certain way would ? twisting side to side or standing up Couple days ago noted tingling was constant down the arms and legs and around the mouth: numbness around the lips like tingly cool sensation; as would feel with Novocaine Pain down the L side of his neck, mostly at night Now feels the pressure behind the muscles behind the lungs - feels it with deep breath or moving 5/22 a.m.when brushing his teeth, gargling couldn?t hold his lips together If tries to, only the R side puckers, weak on the L upper lip (in that area has less tingling) - denies any other weakness diffuse headache that he ranked as a 2 or 3
51 2021-05-23 tingling, pain in extremity, numbness He is currently hopsitalized for lack of blood flow to 2 of his fingertips. It started with his r... Read more
He is currently hopsitalized for lack of blood flow to 2 of his fingertips. It started with his right ring finger tuned white and extremely painful, then turned purple.. Then over the next week or 2 it started in pinky finger. The ring finger is now numb at times, and sometimes it tingles. The pinky finger is still very painful. He is hospitalized for this condition as they are performing tests to try to figure out the cause. The hospital isnt saying its the vaccine, but we just wanted to let you know about his symptoms. In case it does have something to do with the vaccine.
51 2021-05-24 numbness bottom lip and chin have gone numb on my left side(same side as the shot), like the effects of Novac... Read more
bottom lip and chin have gone numb on my left side(same side as the shot), like the effects of Novacaine. Started the day after vaccination and still numb 2 weeks later.
51 2021-06-01 numbness, pain in extremity Extremely exhausted, fever, chills, nausea, headaches, leg numbness and arm pain.
51 2021-06-01 unresponsive to stimuli Pt presents for COVID-19 vaccination at. Janssen vaccine given per protocol. Patient informed to wa... Read more
Pt presents for COVID-19 vaccination at. Janssen vaccine given per protocol. Patient informed to wait in observation area for 15-30 minutes. After 5-6 minutes of observation, pt reported feeling faint and appeared diaphoretic. Per facility staff, pt just admitted into rehab facility and may be going through alcohol withdrawal. Pt then started slumping over the chair and became unresponsive. Facility staff called 911. Upon waiting for paramedics, nurse and staff laid pt down onto the floor. Pt became responsive and started talking again. Respiration and heart rate within normal limits. Monitored pt until paramedics arrived. Pt taken to ER for further evaluation.
51 2021-06-06 weakness No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Naus... Read more
No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Nausea - throw up after eating Started within 7-8 hours of receiving the vaccine Took 2 Tylenol Felt better by the third day (Monday) - nausea has persisted and throat remains a bit sore and still cannot taste food
51 2021-06-10 tingling gradual onset of paresthesias beginning exactly 14 days after vaccine administration. patient was t... Read more
gradual onset of paresthesias beginning exactly 14 days after vaccine administration. patient was then admitted to hospital on 5/22 when symptoms worsened and he was ultimately diagnosed with Guilliam Barre Syndrome.
51 2021-06-26 bell's palsy, pain in extremity, tingling Intense headaches, back and hip pain and right arm pain. The pain got so bad and lasted for a few m... Read more
Intense headaches, back and hip pain and right arm pain. The pain got so bad and lasted for a few months ultimately landing me in the Emergency Room for 3 visits in 2 days. I also had Bells Palsy. They were pumping me full of morphine and it did not take away the pain. Treatment was pain management - vicodin and prednisone for the bells palsy. Severe pain is gone , but now have joint pain, weird skin sensations and dealing with fatigue and some depression. This is vaccine related - I had no issues with any of this prior to the shot.
51 2021-06-29 pain in extremity patient with chronic pain to bilateral lower extremities and is followed by wound care. During visit... Read more
patient with chronic pain to bilateral lower extremities and is followed by wound care. During visit, 6/24/21 an ultrasound of bilateral lower extremities was ordered due to the pain and wounds to both heels. The ultrasound indicated acute occlusive DVT left mid femoral vein segment.
51 2021-07-09 tingling, numbness and pain in extremities Running up a hill and became severely short of breath with significant chest pain in center of chest... Read more
Running up a hill and became severely short of breath with significant chest pain in center of chest. Had to lie on the ground to rest and catch breath. Several minutes to catch breath and about 10 minutes for chest pain to resolve. One month later had chest pain in center of chest... went to urgent care... EKG and vital signs showed normal. Two months after vaccine, started having forceful heart beat, lightheadedness, fatigue, pins/needles neuropathy in right foot... Lightheadedness and neuropathy was episodic, sometimes for hours, for a week... Fatigue was worse for a week then gradually eased but remains mild to moderate fluctuating... Forceful heart beat has continued but was worse 3 weeks ago and is always worse lying down and improves when sitting up though can be mildly present sitting up... and continues today. Seeing my primary care doctor to assess. Went to clinic 3 times in last month for this... vitals always normal and one additional EKG normal.
51 2021-07-11 numbness, weakness, tingling non stop since 6/17/2021: right arm shoulder elbow wrist thumb and first two digits numb tingle, fee... Read more
non stop since 6/17/2021: right arm shoulder elbow wrist thumb and first two digits numb tingle, feels like pinched nerve. Parasitic general energy suck.
51 2021-07-11 pain in extremity, nerve pain Nerve pain in hip and leg. Could not move for two days
51 2021-07-12 weakness, tingling, pain in extremity, burning sensation Had the expected fever within 24hrs which okay. But 5 days later out of the blue I felt shaky, diso... Read more
Had the expected fever within 24hrs which okay. But 5 days later out of the blue I felt shaky, disoriented, sweats, fatigued hardly had the energy to stand or even speak, I was fearing I was having some kind of heart attack or stroke. Something in my body was telling me something was very wrong, I have never had a feeling like this before in my life it was pretty scary. I went to a place to be alone and sit since I could hardly stand, I sat for an hour and started to feel some relief. It took almost 4 hours until some sense of normal was back. I came home and went to sleep for the event tired me out immensely. Since that days event and still ongoing I have been having random dizzy spells, I have days with absolutely not enough energy to walk out of bed and have called out of work because of it. I get the feeling I am unplugged and then plugged back in as far as energy goes almost every day. I have worse and better days with that. About 2 to 3 times a week I experience sudden pains and tingling that can go anywhere on my body but seems to focus more on all my extremities and back. Feels like fire/pins/needles and it stays with me for a few hours to an entire day the pain ranges from a 5 to an 8. My legs feel stiff every day now and at times sore yet I have done nothing exertive to cause that. With the stiffness I have trouble getting my shoes and socks on, and getting up from sitting. All these symptoms I didnt have until I took the shot.
51 2021-07-12 numbness Numbness on my right side of my face,
51 2021-07-16 pain in extremity Shot was given at max vaccination site in a shopping mall store. Shot was given in upper rear of sho... Read more
Shot was given at max vaccination site in a shopping mall store. Shot was given in upper rear of shoulder. Continuing shoulder pain that got gradually worse over time. Pain also eventually felt from shoulder down arm. Restricted range of motion. Affects daily activities and ability to sleep. .
51 2021-07-19 numbness, tingling After the initial injection site pain, I have experienced constant intramuscular pain at the site an... Read more
After the initial injection site pain, I have experienced constant intramuscular pain at the site and adjacent areas in the muscle upon movement or use. Something as simple as flexion or extension causes a sharp pain in that area. I initially put that off to the trauma of the injection itself, but now four months later with no improvement, I can only conclude that the injection caused more than normal injection trauma. I am also experiencing numbness and tingling in the whole arm after periods of immobility (such as sleeping). Getting up in the morning, that arm is moderately sore, and I experience particular pain around the injection site. There has been no injury to that arm or that muscle group. I have no pre-existing injuries or conditions that would have a bearing on this pain. I have not sought medical attention, as I feel certain that there is not enough known about this vaccine to reliably come up with a treatment plan.
51 2021-07-26 tingling, numbness Pt reports 2 days after vaccine having swelling in joints, hands, and facial area. Numbness/tingli... Read more
Pt reports 2 days after vaccine having swelling in joints, hands, and facial area. Numbness/tingling in hands b/l. Reports still having numbness/tingling in hands as well as swelling in facial area
51 2021-07-28 migraine, tingling, bell's palsy BELL'S PALSY; AFFECTING ABILITY TO THINK CLEARLY; DEPRIVATION OF SLEEP; PAIN IN THE BACK; TINGLING S... Read more
BELL'S PALSY; AFFECTING ABILITY TO THINK CLEARLY; DEPRIVATION OF SLEEP; PAIN IN THE BACK; TINGLING SENSATION OVER THE BODY BUT MORE IN THE EXTREMITIES; PERCEPTION OF HEAT AND COLD REVERSED OR DELAYED; MIGRAINE HEADACHES; MUSCLE WEAKNESS IN THIGHS AND LOWER BACK; CONTINUOUSLY EXHAUSTED WHICH IS AFFECTING ABILITY TO THINK CLEARLY; MUSCLES PAIN IN THE THIGHS AND LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 52 year old male of unknown race and ethnicity. 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: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After several weeks of vaccination on an unspecified date, the patient developed muscle pain and muscle weakness in his thighs and lower back, and the pain extended to his back. Patient experienced tingling sensation over the body but more in the extremities. He experienced perception of heat and cold reversed or delayed. The development migraine headaches increased dramatically, but as per reporter it was possible to had consequence of exhaustion from being sleep deprived. While brushing teeth patient discovered that he had partial paralysis of the left side of face and he was unable to spit, purse his lips, whistle, smile, twitch nose, or raise his eyebrow and the face area was mostly numb. Patient went to emergency room and where he had been told that he had Bell's palsy, but they did not know what to think about the non-facial symptoms and asked him to see a neurologist. The patient was prescribed with prednisone and an antiviral. By the end of the same day, he lost most sense of taste. Patient later saw a neurologist who ordered Magnetic resonance imaging (MRIs) of brain, sinuses, and upper spine to look for signs of neuronal demyelination, but there were not any significant findings. During follow up appointment on 15-JUL-2021 with the neurologist, they discussed potential association between vaccine and Guillain barre syndrome. He ordered patient to do nerve conduction test to look for evidence of peripheral nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the back, and muscles pain in the thighs and lower back, had not recovered from deprivation of sleep, tingling sensation over the body but more in the extremities, bell's palsy, lost most sense of taste, continuously exhausted which was affecting ability to think clearly, and muscle weakness in thighs and lower back, and the outcome of perception of heat and cold reversed or delayed and migraine headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210739148-COVID-19 VACCINE AD26.COV2.S -Bell's palsy and affecting ability to think clearly. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
52 2021-03-07 flushing Heart palpitations and feeling flush, extreme feeling of being tired and slight chest discomfort
52 2021-03-09 feeling hot Minor pain around shot area. Around 5 pm 3/8 started to have cold chills which became annoying to t... Read more
Minor pain around shot area. Around 5 pm 3/8 started to have cold chills which became annoying to the point my teeth were chattering. after maybe 3 hours the chills subsided and then i started feeling hot. very achy and tired at this point in time. all day 3/9 very achy and tired feeling awoke on 3/10 to almost normal feeling but after walking and going out in public became tired. evening of 3/10 safely say i am almost 100% .
52 2021-03-13 pain in extremity patient felt pain in arm, severe fatigue and aching joints
52 2021-03-13 tremor J&J vaccine, Monday at noon. About 6 1/2 hrs later I got bad chills & severe shaking, temp dropped ... Read more
J&J vaccine, Monday at noon. About 6 1/2 hrs later I got bad chills & severe shaking, temp dropped low. Then had severe diarrhea & vomiting for the nxt 12 hrs. Temp also went up to 102.5, body aches & severe fatigue. Tues morning I had to call online dr for prescription nausea meds. Then got a bad headache. Then wed, thurs & fri he just felt like i?d been hit by a truck. Was still foggy headed yesterday. Today I feel tired out easily.
52 2021-03-16 pain in extremity Fever of 106.3, chills, headache, lightheaded, dizzy, sore arm
52 2021-03-18 tremor Shakes, chills, elevated temperature - lasted 24 hours, forehead pressure, temple pain - lasted 48 h... Read more
Shakes, chills, elevated temperature - lasted 24 hours, forehead pressure, temple pain - lasted 48 hours
52 2021-03-19 feeling cold Initial symptoms began with pain at the injection site and generalized fatigue. This developed into... Read more
Initial symptoms began with pain at the injection site and generalized fatigue. This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation. I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm. There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right. The symptoms persisted over the second day albeit at less severity. Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.
52 2021-03-29 pain in extremity FELT BILATERAL LUNG CONGESTION (Lung congestion, Pulmonary congestion) BILATERAL SIDE PAIN (Flan... Read more
FELT BILATERAL LUNG CONGESTION (Lung congestion, Pulmonary congestion) BILATERAL SIDE PAIN (Flank pain, Flank pain) VOMITING (Vomiting, Vomiting) LEFT ARM PAIN (Painful L arm, Pain in extremity) DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) MISSED WORK TODAY (Loss of personal independence in daily activities, Loss of personal independence in daily activities) PAIN WHEN BREATHS (Painful respiration, Painful respiration) FEVER OF 100 F (Fever, Pyrexia) FATIGUE (Fatigue, Fatigue) This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain) , vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration) . Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever f 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).
52 2021-04-01 migraine, hypersensitivity of all senses Fever, chills, headache/migraine , extreme sensitivity to touch
52 2021-04-03 feeling cold, tremor Uncontrollable shaking/chills and slight breathing difficulty at the same time. I couldn't hold a f... Read more
Uncontrollable shaking/chills and slight breathing difficulty at the same time. I couldn't hold a full glass of water without having the water shake out of the glass. I am in good health, was fully hydrated and exercise on a regular basis. This symptom is not listed on the published symptom list and I had no idea this could possibly be the outcome of the vaccine.
52 2021-04-04 burning sensation Patient started sweating and said he felt he was burning up about 13 minutes post vaccination. He wa... Read more
Patient started sweating and said he felt he was burning up about 13 minutes post vaccination. He was slightly disoriented. We quickly checked his temperature however it was within normal range. We applied cold packs to his wrists, forehead, and face for about 12 minutes. I checked for normal capillary refill and asked him questions to assess his mental status. About 20 minutes after starting the treatment, patient started improving. He returned almost back to normal in about 30 minutes.
52 2021-04-04 pain in extremity Headache (2 days), Mental Fatigue (2 days), Arm Soreness (1 week). Treatment: 1 dose Tylenol upon ... Read more
Headache (2 days), Mental Fatigue (2 days), Arm Soreness (1 week). Treatment: 1 dose Tylenol upon onset of symptom provided temp relief.
52 2021-04-04 tingling Patient lost feeling in right arm for 10 minutes. Regained full feeling after 30 minutes per patient... Read more
Patient lost feeling in right arm for 10 minutes. Regained full feeling after 30 minutes per patient.
52 2021-04-06 tingling Patient began feeling arm tingling, throat tingling, and had redness to arm and chest. Patient denie... Read more
Patient began feeling arm tingling, throat tingling, and had redness to arm and chest. Patient denies shortness of breath but has a severe history of allergic reactions that he did not communicate to provider prior to vaccine administration.
52 2021-04-07 cold sweat Patient reported having history of syncopal episodes After vaccination patient had syncopal episode,... Read more
Patient reported having history of syncopal episodes After vaccination patient had syncopal episode, was pale, clammy and diaphoretic Patient seen by medical team, refused medical transport and signed AMA form Patient stated symptoms resolved
52 2021-04-07 flushing 10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, naus... Read more
10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, nausea, and sweating. Patient went to ER and they noted tachycardia and diaphoresis
52 2021-04-07 pain in extremity Janssen covid-19 vaccine EUA shot @ 9:30 am left arm & left leg sore chills in-between 5-10:pm fever... Read more
Janssen covid-19 vaccine EUA shot @ 9:30 am left arm & left leg sore chills in-between 5-10:pm fever & severe body aches in-between 10:pm & 2:am ( couldn't even sit up to drink water ) finally got out of bed noon the next day
52 2021-04-08 muscle spasms Headache and body ache followed by severe leg cramps.
52 2021-04-08 pain in extremity Injection site pain, spreading throughout arm on same day as shot. Next day increased site pain, min... Read more
Injection site pain, spreading throughout arm on same day as shot. Next day increased site pain, minor to mederate light headedness with vertigo that lasted severel hours. General fatigue with fever of 99.9 most of day. By 04/09 only experiancing decresed arm pain with minor fatigue.
52 2021-04-10 flushing, pain in extremity This spontaneous report received from a patient concerned a 52 year old male. The patient's height, ... Read more
This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.
52 2021-04-11 weakness I was fine Saturday after the shot. Sunday I was completely enervated. I had a bad headache and ze... Read more
I was fine Saturday after the shot. Sunday I was completely enervated. I had a bad headache and zero energy and a little bit of nausea. I started feeling better around 6:00 pm, but went to bed at 8:30 pm and slept 9 hours (which is very long for me).
52 2021-04-11 pain in extremity Johnson & Johnson Vaccine: Tired and sleepy with a headache starting at 6:45pm April 8. Then his ar... Read more
Johnson & Johnson Vaccine: Tired and sleepy with a headache starting at 6:45pm April 8. Then his arms started to have pain and aching in the body more on the arm where he did not get the shot. This happened around 8:30pm. Patient chest started to ache. He went to bed. The entire night he experienced aches and pains in his body, his stomach and hips. When he woke up at 8:00 am on April 9 his legs and the back of his thighs were aching. He could barely move. He took two Tylenol that morning. He continued to experience aching in his body all day. He said it felt like flu like symptoms. Then he took more Tylenol that evening. By 9:30pm he started feeling better. He woke up Saturday, April 10 feeling better.
52 2021-04-11 pain in extremity Approximately three weeks after receiving Johnson & Johnson vaccine, I began to get pains in legs. C... Read more
Approximately three weeks after receiving Johnson & Johnson vaccine, I began to get pains in legs. Calves were aching and throbbing. Didn't think anything of it at first....just thought achy muscles and such. The day before Easter (April 3rd 2021) decided since the pain was continuing and the internet will scare you to death - I went to a local Emergency Room in advance, I had an ultrasound on my left leg and it was noted I had DVT. (blood clot in left calf) To briefly explain: I had an achilles issue back in Nov. 2020 (slight micro tear - achilles tendonitis) I thought maybe this was related to that, as I had not been to the doctor to get it checked until early March 2021. and it bothered me off and on for a few months. I thought the calf pain may have been related to that? I explained to the emergency room doctor about my achilles and thought it was an issue related to that. They decided to perform an ultrasound on my left leg. Which noted the DVT/Blood Clot. They put me on a starter pack of Xarelto and I am to follow up with my normal doctor on April 22, 2021.
52 2021-04-12 burning sensation, numbness Swelling and numbness in legs (Burning sensation on top of
52 2021-04-13 feeling hot, muscle spasms High temperature (104-105), muscle and joint cramping. This occurred the night of the 30th. Temperat... Read more
High temperature (104-105), muscle and joint cramping. This occurred the night of the 30th. Temperature started to decrease over the next two days so did the cramping. Then starting on 4/5 I started to experience pain in the back of my head along with the sensation of heat/burning. This was accompanied by a stiff neck. This pain and stiffness persists to today. Medication prescribed by my doctor lessens the discomfort but has not rid me of the issue.
52 2021-04-13 numbness -Headache for 3 days, including the day of vaccination. -Numbness of upper extremities at night, but... Read more
-Headache for 3 days, including the day of vaccination. -Numbness of upper extremities at night, but only on the third day of the vaccine (only once), no more has been presented.
52 2021-04-13 pain in extremity, feeling cold Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still... Read more
Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still sore and the injection site. soreness site stayed sore for about another 3 to 4 days, but total top arm around site still sore and aching. Arm is hard to lift up at some times and weak to lift anything up sometimes. Arm feels week for about 2 to 3 days and then starts to fill better. Then after a day of the soreness or no weakness in the arm, it starts back hurting again. It now getting worse at night time and sometimes during the day. Some days it hurts so bad that I can't even move it. I don't bother to tell my wife, because it just last for about a 2 to 3 hours. I have been to my doctor yet. But if it keeps bothering me I will make an appointment to see him. It just my arm and hand be very weak to use at sometimes every other day.
52 2021-04-13 pain in extremity Severe headache, body aches and leg pain that persisted for 36 hours, until I started taking heavy d... Read more
Severe headache, body aches and leg pain that persisted for 36 hours, until I started taking heavy doses of Advil (800 mg every 4 hours).
52 2021-04-14 feeling hot About 11 hours after I took the shot, I start feeling very hot and my whole body started shivering v... Read more
About 11 hours after I took the shot, I start feeling very hot and my whole body started shivering very badly from toe to head, I had extremely bad headache, felt nauseous and my whole body was hurting. I took 2 Tylenol 650mg but it did not do anything. My temperature was high (reached 101). The whole thing lasted few hours non stop. After that, I have light to moderate headaches almost every day (till this day)
52 2021-04-14 tremor, seizure CHILLS WITH SEVERE TREMORS/CONVULSIONS . EXTREME HEADACHE AND DEHYDRATION. DISORIENTATION. CONTINUE... Read more
CHILLS WITH SEVERE TREMORS/CONVULSIONS . EXTREME HEADACHE AND DEHYDRATION. DISORIENTATION. CONTINUED OCCASIONAL CHILLS
52 2021-04-15 inability to speak 3/30/21, Tue. Got up and felt dizzy. Went to bed a few times to have a sleep. 3/31/21, Wed. Got up ... Read more
3/30/21, Tue. Got up and felt dizzy. Went to bed a few times to have a sleep. 3/31/21, Wed. Got up and felt better. Went to work but felt no idea of work related material. 4/1/21, Thu. Got up and felt good, but could not speak too much because of some loss of words. Called for PTO for Thu and Fri. 4/2/21, Fri. Mindset went back but still could not speak too much. 4/2/21, Fri night. After bible study at night, almost all bro & sis said that was symptom of stroke, and suggested us to see emergency doctor. On 11pm, we were at emergency room. 4/3/21, Sat. I was admitted 1-2 am into impatience room. CT diagnosed a big gray area in between speech are and spine. 4/3/21, Sat afternoon. MRI and MRA had been tested. Cardiologist said he could not rule out the last option, which was due to slow heart beat 50-60. But I have slow heart beat since I remembered things from 4-5 year-old. He suggested wearing a heart monitoring device for a 4 weeks after discharged. 4/4/21, Sun noon. Doctor admitted to discharge. They could not find cause, and would like to follow up within 1 to 2 weeks after discharging. 4/13/21, Tue night, I started wiring body monitoring device.
52 2021-04-15 numbness Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 ... Read more
Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 pain over the next several days. L shoulder pain radiating to ribs and neck w/ muscle spasms, causing HA, R hip and sacral pain, flank pain radiating down R leg. Pt reports that vision in L eye is blurry, R eye vision intact, numbness to L arm and hand, able to move. Pt reports 1in x 0.5 in blood clot when blowing nose Thursday morning, small clot subsequently about 1/2 the size, smaller clots later.
52 2021-04-15 tremor SEVERE UNCONTROLLABLE SHAKING; SEVERE UNCONTROLLABLE CHILLS; A LITTLE FEVER; BAD HEADACHE; This spon... Read more
SEVERE UNCONTROLLABLE SHAKING; SEVERE UNCONTROLLABLE CHILLS; A LITTLE FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 52 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe uncontrollable chills. On 09-APR-2021, the subject experienced a little fever. On 09-APR-2021, the subject experienced bad headache. On 09-APR-2021, the subject experienced severe uncontrollable shaking. Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe uncontrollable chills, a little fever, bad headache, and severe uncontrollable shaking on 11-APR-2021. This report was non-serious.
52 2021-04-16 tingling, tremor, numbness Around 5:00-5:30 PM (about 2 to 2.5 hours after the vaccination), I started to feel a bit tired. I ... Read more
Around 5:00-5:30 PM (about 2 to 2.5 hours after the vaccination), I started to feel a bit tired. I took Tylenol, beginning around 5:00 PM. By 8:00, I was feeling tired enough that I went to bed early. By 9:00, I had terrible chills and body aches throughout my body. The aches were worse in my chest / torso -- maybe from so much shaking. I did not watch any of the men's championship game that night. I also felt nauseous but I seemed to lack the strength to vomit. I can not remember a time when I had so much physical pain in my life. My hands felt numb / tingling. I tried to drink some ginger ale but drinking was difficult. Although I was aware that I was breathing and my heart was beating, I thought that I might die. The terrible pain continued for a few hours. Around 10:30 PM, the pain dissipated. However, after about 10 minutes of relief, the pain returned, perhaps worse than before. At around 11:30, my wife came to bed. She suggested that I try relaxing Yoga breathing. I did that and the pain stopped and I fell asleep. The next day, I woke up with a typical headache and took more Tylenol. I continued to improve the remainder of the day.
52 2021-04-18 pain in extremity Both of my feet started to really hurt, my right lower abs started to hurt.
52 2021-04-18 pain in extremity I been having a continuance pain and weakness of the left arm and shoulder.
52 2021-04-18 tingling, pain in extremity Right arm and hand severe pain and tingling
52 2021-04-19 pain in extremity LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUS... Read more
LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.
52 2021-04-20 feeling hot, pain in extremity LEFT FOOT SWELLING COMES AND GOES; LEFT FOOT SORENESS; LEFT FOOT FEELING HOT; This spontaneous repo... Read more
LEFT FOOT SWELLING COMES AND GOES; LEFT FOOT SORENESS; LEFT FOOT FEELING HOT; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced left foot feeling hot. On 30-MAR-2021, the subject experienced left foot swelling comes and goes. On 30-MAR-2021, the subject experienced left foot soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot swelling comes and goes, and left foot soreness, and the outcome of left foot feeling hot was not reported. This report was non-serious.
52 2021-04-20 pain in extremity, numbness SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATI... Read more
SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 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: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.
52 2021-04-23 weakness, numbness We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the mornin... Read more
We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the morning and he complained of numbness in his left. We thought it was related to the weather getting warm and we work the night shift, so he rested and increased his water intake. He was able to go to work on Monday night and return home and continued to rest on Tuesday. On Tuesday, there was no numbness, but there was weakness in both his legs. On Wednesday, he felt weakness throughout his body, especially in his legs. On Thursday, he collapsed. He did not lose consciences but his legs gave out under him and he was not able to get up up. He was taken to the hospital. He was diagnosed with a stroke, increased sugars (diabetes he has never had before), acute kidney injury, and uncontrolled increased blood pressure. He was hospitalized and discharged April 19, 2021. He was readmitted 04/24/2021 for another stroke.
52 2021-04-24 bell's palsy Bell's Palsy
52 2021-04-25 tingling Nose is tingling, metallic taste in mouth, perfume smell in nose
52 2021-04-28 numbness, facial paralysis Immediately after the injection patient felt a pressure like and felt a ball on the back of his head... Read more
Immediately after the injection patient felt a pressure like and felt a ball on the back of his head left side that resolved within a day. Within a week from vaccine patient started having a headache on and off with feeling of like his brain is swelling on the left side. Within another week patient experienced abdominal pain and chest pressure. went to a hospital CT abdomen was negative. On 4/28 patient had a severe headache followed by numbness to left face and left facial droop. 911 was called patient was code stroke in ED.
52 2021-04-29 tingling Three days after receiving the vaccine, he developed a headache which was intermittent with pain s... Read more
Three days after receiving the vaccine, he developed a headache which was intermittent with pain score of 5-8 out of 10. Headache became consistent around 4/11/21. Pain is in the occipital region and occasionally radiates behind the eyes. Also complains of dizziness, nausea, vomiting, and tingling in his hands bilaterally - worse in the mornings and goes away after waking up. He presented to Medical Center on 4/28/21 and transferred to Medical Center for treatment of vaccine induced thrombocytopenia and nonocclusive straight sinus thrombus. He was started on bivalirudin infusion 4/29 @ 0142 via continuous infusion. Still receiving treatment at the time of this report.
52 2021-05-02 nerve injury Tinutis - ringing in ears and loss of hearing, nerve damage - proven by a Hearing test
52 2021-05-03 tremor High fever 2 days... Uncomfortable shaking. A few hours Couldn't hold a glass of water to drink. It ... Read more
High fever 2 days... Uncomfortable shaking. A few hours Couldn't hold a glass of water to drink. It would still half full. Fatigue for 3 days
52 2021-05-05 muscle spasms SEVERE BODY ACHES ON LEFT SIDE; MUSCLE SPASMS ON LEFT SIDE LEG EYE ARM AND CRAMPING ON RIGHT SIDE; P... Read more
SEVERE BODY ACHES ON LEFT SIDE; MUSCLE SPASMS ON LEFT SIDE LEG EYE ARM AND CRAMPING ON RIGHT SIDE; PRESSURE BEHIND LEFT EYE; CRAMPING AND RIB PAIN ON RIGHT SIDE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underline health problems. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced pressure behind left eye. On 2021, the subject experienced cramping and rib pain on right side. On 30-APR-2021, the subject experienced severe body aches on left side. On 30-APR-2021, the subject experienced muscle spasms on left side leg eye arm and cramping on right side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe body aches on left side, muscle spasms on left side leg eye arm and cramping on right side, pressure behind left eye, and cramping and rib pain on right side. This report was non-serious.
52 2021-05-06 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
52 2021-05-08 numbness, pain in extremity Pt reports numbness in right hand and pain in finger tips, low back pain, fever, chills
52 2021-05-09 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: After receiving the Johnson & Johnson vaccine (Lot #204A21A), patient sat down as directed. Several minutes later, patient walked to the pharmacy counter complaining of feeling dizzy immediately before falling. No injuries were sustained. Upon examination, patient was conscious and alert, but dizzy and profusely sweating. Patient recovered within several minutes and stated it was likely anxiety that caused the fall.
52 2021-05-12 burning sensation BURNING SENSATION DOWN IN LEFT LEG; This spontaneous report received from a patient concerned a 52 y... Read more
BURNING SENSATION DOWN IN LEFT LEG; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation down in left leg. The action taken with covid-19 vaccine was not applicable. The outcome of burning sensation down in left leg was not reported. This report was non-serious.
52 2021-05-15 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe
52 2021-05-18 numbness, muscle spasms Vaccine administered Thursday, 4/1 1:15 p.m. By Sunday I experienced mild headache and upper respira... Read more
Vaccine administered Thursday, 4/1 1:15 p.m. By Sunday I experienced mild headache and upper respiratory scratchiness. By late Monday 4/5 I experienced fatigue, dizziness, upper respiratory scratchiness and increased post-nasal drip, tightness in my chest, muscle soreness and headache. By Tuesday, 4/6 around 10 a.m. in addition to the above symptoms I had a severe headache and lost feeling in my right arm for half an hour, with severe muscle cramps and loss of use in that arm. The muscle issues subsided by early afternoon leaving only fatigue, headache, dizziness and a lingering respiratory tightness and sinus issues. Concerned about vaccine side-effects I was reading about, I made a doctor's appointment for the following week (earliest available), met with a physician's assistant who prescribed an antibiotic (Doxycycline Mono 100 Mg) for the sinus issues but did not address the other issues.
52 2021-05-18 pain in extremity Arm sore for a day - and that was it. A month later, April 10, 2021. Heart Attack - they put in a st... Read more
Arm sore for a day - and that was it. A month later, April 10, 2021. Heart Attack - they put in a stent (two stents) - two of my coronary arteries had collapsed.
52 2021-05-23 numbness 1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not wa... Read more
1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99. I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.
52 2021-05-23 unresponsive to stimuli Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsi... Read more
Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsive. His eyes rolled back in his head but stayed open. His jaw became very clinched. He was sweating profusely and not aware of anything goin g on around him. This lasted somewhere between 3-5 minutes.
52 2021-05-29 weakness Chills Severe dizziness Vomiting Weakness
52 2021-05-29 pain in extremity 24 hours later, patient and wife had plans and patient stated that he was not feeling well, generall... Read more
24 hours later, patient and wife had plans and patient stated that he was not feeling well, generally. Wife then states that he did complain of leg pain since they had been driving in the car. 05/30/2021 Patient presented to ED and was found to have DVT and extensive PEs
52 2021-06-16 pain in extremity, muscle spasms In March I had a pain in my left calf muscle that I could not identify with getting hit or injuring ... Read more
In March I had a pain in my left calf muscle that I could not identify with getting hit or injuring it in any way. I called Urgent care because i read and heard about problem with the J&J vaccine that it was giving people blood clots. Urgent care said there was no need to come in that there was very little reason to believe that it was a blood clot. Then in June I woke up to very severe pain in my left leg from my foot all the way to my thigh. It was hot, swollen and I could barely bend my knee. I went to Urgent Care and they sent me across the street to the Hospital for an ultra sound on my leg. Here are the result from the ultra sound. Real time color Doppler imaging and spectral analysis were performed during ultrasound evaluation of the left lower extremity is performed. There is persistent occlusive deep venous thrombosis within the mid to distal superficial femoral vein extending nonocclusive bleed to involve the popliteal vein and exclusively within the proximal popliteal and peroneal veins of the calf. The doctor put me on 3 week of taking a blood thinner twice a day and then will go down to taking one blood thinner once a day for 6 months. I also saw MD. Here are his notes from my Drs appt. Patient is seen today, 6/14/2021, to discuss management of left leg DVT. Patient presented to urgent care on 5/20/2021. He had noticed soreness in his left leg for a couple of days and then he awoke that day and the leg was swollen. The duplex scan showed that he had occlusive clot involving left superficial femoral vein extending through popliteal vein down to peroneal vein in the left calf. He was started on rivaroxaban 15 mg twice daily. He transitions to 20 mg rivaroxaban daily tomorrow. The leg soreness has eased slightly but the swelling has not improved. He did have a repeat duplex scan on 6/7/2021 which was unchanged. Thrombus persisted but was not worse. He has not had chest pain or breathing issues or dyspnea. He does recall that about 4 weeks earlier he had a muscle spasm sensation in the left calf. He had received a Johnson & Johnson Covid immunization in late February, 2021. He was aware of the public information about venous clotting in women who had received the J&J vaccine and was also aware that it involved cerebral veins. He called his provider and was asked questions about the leg and otherwise the answers were negative. So imaging was not obtained. The muscle spasm sensation did not recur. His family history is negative for clots in his personal history for clots is otherwise negative. He is a maintenance manager. He has not had lengthy travel recently. He also denies any trauma to the legs. He has a history of GERD from which she had developed iron deficiency anemia in June 2020. He had undergone EGD has a result. He also had a colonoscopy when he turned 50 years of age and had polyps removed and then had repeat colonoscopy 6 months later. This evaluation occurred with Dr. of gastroenterology. His colonoscopy was on 12/20/2018. One of the polyps was a hyperplastic polyp. The second was a tubulovillous adenoma with high-grade dysplasia/intramucosal adenocarcinoma, 2 cm size. Polyps were excised. Had repeat endoscopy on 7/10/2019 he had a hyperplastic polyp in his rectum. Also he had a PSA checked in summer 2020. It was 0.5. He is a smoker only of very infrequent cigars, perhaps every 6 to 8 months. PAST MEDICAL HISTORY: GERD Sigmoid colon polyps, resected December 2018 and June 2019 Left leg DVT, May 2021 Sleep apnea Iron deficiency anemia related to gastritis. Diagnosed June 2020, treated with oral iron ADHD History of depression MEDICATIONS: has a current medication list which includes the following prescription(s): amlodipine, escitalopram, esomeprazole, multivit-iron-fa-calcium-mins, prednisone, rivaroxaban, unknown home medication, and tadalafil. ALLERGIES: Patient has no known allergies. PAST SURGICAL HISTORY: Vasectomy 2 colonoscopies, first in December 2018 and second in July 2019 EGD on 2 occasions, first in March 2019 and second in June 2020 FAMILY HISTORY: Father died age 66. He had a pacemaker and was on blood thinners Mother died of a throat cancer. She was a heavy smoker. Died at age 60 1 brother and 1 sister are healthy SOCIAL HISTORY: Smokes cigars, perhaps twice a year. Never smoked cigarettes Alcohol use maybe 4 beers on the weekend Previously married and divorced 3 children, 2 daughters and 1 son ranging in age from 17 through 21 REVIEW OF SYSTEMS: Significant for persistent soreness in his left leg albeit easing over the last 3 days and persistent swelling in his left leg including dorsum of his foot General: Denies weight loss, no issues with energy, denies night sweats HEENT: No mouth or throat soreness, no issues with hearing, no tinnitus, no issues with taste No epistaxis Resp: Denies cough, exertional dyspnea, sputum production. Heart: No palpitations, no exertional chest pain, no lightheadeness or dizziness when standing Gi: No dysphagia. No heartburn, Denies nausea or vomitting. Bowels are regular, no diarrhea or constipation. Denies melena or hematochezia GU Denies hematuria. No dysuria. No incontinuence. Skin: No rash, no petechiae, no dryness. No itching or burning. Musculoskeletal: No bone pains, no joint pains or swelling. No localized weakness Neurologic: Denies headaches, no double vision, no weakness, no change in sensation Psychiatric: Good spirits, sleeping well, no anxiety, normal mood Endocrine: Denies heat or cold intolerance. Heme: No easy bruising PHYSICAL EXAMINATION: BP (!) 142/99 | Pulse 95 | Temp 97.6 °F (36.4 °C) | Resp 18 | Ht 6' 3" (1.905 m) | Wt 295 lb (133.8 kg) | SpO2 96% | BMI 36.87 kg/m² Appears alert, oriented, not in distress. Well developed Psychiatric: Patient is alert oriented ×4, good spirits, interacts appropriately He has swelling in his left leg DATA: CBC: .5/20/2021: WBC 7.49 X10^3/uL; Hemoglobin 14.8 g/dL; Hematocrit (calc.) 43.4 %; Neutrophil (%) 75.4 %; MCV 98.4 fL; Platelet 141 X10^3/uL* CMP: 4/22/2021: Bicarbonate (TCO2) 25 mmol/L; BUN/Creatinine 16; Calcium, total 9.0 mg/dL; AST (SGOT) 41 IU/L*; ALT (SGPT) 38 IU/L; Alkaline Phosphatase 62 IU/L; Bilirubin, Total 0.4 mg/dL; Protein, total 6.9 g/dL; Albumin 4.3 g/dL; Albumin / Globulin 1.7 5/20/2021: Sodium 142 mEq/L; Potassium 4.6 mEq/L; Chloride 103 mEq/L; BUN 13 mg/dL; Creatinine 1.2 mg/dL; Glucose 110 mg/dL*; Calcium, Ionized 1.17 mmol/L ASSESSMENT: 1. Left lower extremity DVT. Etiology unclear. No definite provocation. He did receive a Johnson & Johnson Covid vaccine in late February, 2021. He first noticed a muscle spasm sensation in left calf in mid April, 2021 and then had onset of soreness 2 days before his visit with swelling onset the day of his urgent care visit, 5/20/2021. Currently on rivaroxaban. Transitioning now to the 20 mg daily dose. Family history negative for DVT as is his personal history. PSA was unremarkable and summer 2020. Has had prior colonoscopy in December 2018 and June 2019. Did have finding of sigmoid colon polyps with atypia in 1 and possible noninvasive adenocarcinoma. Repeat scope showed hyperplastic polyp but no additional polyps. Has also had EGDs in March 2019 and June 2020 because of GERD and iron lack anemia. Non-smoker. I discussed with patient that we would usually treat him for 6 months with anticoagulation and then reassess to determine whether it is safe to discontinue therapy. But if he has ongoing swelling and soreness in his leg it would be difficult to stop treatment because we would lose one of our early indicators of recurrence of DVT. I also suggested that we should do a lab panel to assure that he does not have any underlying inherited or acquired abnormality that predispose to this clot, since we do not have any clear-cut causative etiology. (We discussed that the Covid immunization may have been his predisposition, but that existing data suggest that this is a risk factor in females and that most of the episodes were central nervous system venous clots.) PLAN: 1. So we will draw lab panel assessing acquired and inherited predispositions for hypercoagulability. And we will plan to see him back in a couple of months to reassess his status.
52 2021-06-28 feeling cold Feverish symptoms (feeling cold), body ache, and fatigue
52 2021-06-29 speech disorder, numbness, facial paralysis Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbne... Read more
Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbness in the face (Left) droop 30mins-45mins, 05/18/2021 numbness in the face/difficulty speaking 2-3hrs, 06/12/2021 again numbness in the face05/20/2021 diagnosed with male Breast Cancer. Breast tissue removed. 06/27/2021 severe facial droop, whole numbness left-side of body, Admitted for observation. 06/28/2021 discharged TIA. Currently experiencing numbness.
52 2021-07-01 numbness, mild one side paralysis 5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to mi... Read more
5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to miss two days work. 6/18: Feelings of numbness on right side (hand, foot) while going through security at Airport. Weakness in right leg. 6/23: Went to urgent care facility. Was told it sounded like a stroke, sent to hospital for treatment. After imaging at hospital patient was told he had a minor stroke.
52 2021-07-11 bell's palsy Bells Palsy - followed by Guillain Barre
52 2021-07-11 numbness, pain in extremity Constant pain and numbness in back, legs and arms. I saw my PCP two weeks after the shot. First he p... Read more
Constant pain and numbness in back, legs and arms. I saw my PCP two weeks after the shot. First he prescribed steroid which I took for 10 days, It didn't work. I went to see him again - he told me to take magnesium malate and referred to a rheumatologist. The rheumatologist did blood tests and he said that I don't have any inflammatory disease. He didn't find anything wrong but he said that my symptoms are similar to those of fibromyalgia. he referred me to a physical therapy. I have been going to a physical therapy 3 times a week for the last two months. Nothing works so far. The pain and numbness in my back, legs and arms are as strong as before.
52 2021-07-11 migraine Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn... Read more
Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn't read anything. For the whole weekend I could not read anything. Not blurry vision, just could not read. Also on Thursday, I started to not be able to concentrate. To this day I still have trouble concentrating. I also experience dizziness after my vaccine. For the next two weeks I have had bad bout's of just feeling swimmy and weird. It has made me stay close to bed. I have been unable to do projects, I have had multiple migraines. For treatment, I have taken muscle relaxers and my migraine medicine as needed. I am going to see Dr. on 07/14/2021. I did see a doctor during a health fair on 07/09/2021 who recommended I see my doctor as soon as possible.
52 2021-07-11 pain in extremity Since I took the vaccine mre than three months ago, I have pain and numbness in my back, legs and ar... Read more
Since I took the vaccine mre than three months ago, I have pain and numbness in my back, legs and arms. I never had such a pain before. This pain is with me all the time now.
52 2021-07-12 involuntary muscle movements alot of muscle jerking can barely hold on to anything always dropping things, glitching in eyes
52 2021-07-12 facial pain, facial paralysis Started to notice facial droop left side of face about 2 weeks after receiving the Johnson & Johnson... Read more
Started to notice facial droop left side of face about 2 weeks after receiving the Johnson & Johnson (Janssen) Covid 19 vaccine. Started behind the ear and worked to the front of his face. Included eye and nostril. Couldn't chew food on that side of mouth. It has been painful, but the pain and the drooping have gotten better. Did not seek out any medical treatment as he felt nothing could be done.
52 2021-07-12 numbness, tingling Since my J&J shot on 3/20/2021 around11:45am at the drive up parking lot. I had swelling in in ankle... Read more
Since my J&J shot on 3/20/2021 around11:45am at the drive up parking lot. I had swelling in in ankles. My PCP changed my blood pressure medicine to correct those symptoms. But I've had a tingling sensation in my right arm, starting under my arm pit and goes straight down to my fingers. My right thumb, index, and middle finger is numb at the tips since my J&J vaccine shot.
52 2021-07-13 tingling face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't mo... Read more
face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't move, and constipation
52 2021-07-16 numbness, burning sensation With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day... Read more
With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to 10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving
52 2021-07-18 weakness, tremor On day of shot (April 9), I had a fever, chills and intense shaking for 45 minutes at 10pm that day ... Read more
On day of shot (April 9), I had a fever, chills and intense shaking for 45 minutes at 10pm that day of my shot. I felt better that next day and normal the following day. I had terrible diarrhea (went to bathroom every two hours), some stomach pain and low energy for four days (June 29-July 3). I received a prescription for lamotal, which helped. I was not tested for covid.
52 2021-07-18 restless legs syndrome, numbness and pain in extremities, burning sensation, coordination abnormal, pain in extremity, electric shock sensation Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Pa... Read more
Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Painful electric shock type pains from feet up calf muscles. Sensation of no circulation in legs when elevated in recliner. Stumbling/tripping, lack of coordination and balance issues. Lack of mental clarity at times. Heart palpitations or PVC sensations. Difficulty urinating, in that the flow stops and starts as if I'm involuntarily doing Koegle exercises.
52 2021-07-20 numbness NUMBNESS IN RIGHT HAND AND FINGERTIPS OF RIGHT HAND; FEELING FATIGUE INTERMITTENTLY; This spontaneou... Read more
NUMBNESS IN RIGHT HAND AND FINGERTIPS OF RIGHT HAND; FEELING FATIGUE INTERMITTENTLY; This spontaneous report received from a patient concerned a 52 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling fatigue intermittently. On 31-MAY-2021, the subject experienced numbness in right hand and fingertips of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigue intermittently, and numbness in right hand and fingertips of right hand. This report was non-serious.
52 2021-07-21 weakness, tingling FEELING TINGLING IN RIGHT LEG AND LEFT KNEE/ TINGLING MOVED TO THIGH AREA, STOMACH AND CHEST; FEELIN... Read more
FEELING TINGLING IN RIGHT LEG AND LEFT KNEE/ TINGLING MOVED TO THIGH AREA, STOMACH AND CHEST; FEELING WEIRD AFTER EACH EPISODE OF TINGLING AND WEAKNESS; FEELING WEAKNESS IN RIGHT LEG AND LEFT KNEE/ WEAKNESS MOVED TO THIGH AREA, STOMACH, AND CHEST; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre diabetes, and other pre-existing medical conditions included he had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest. On MAY-2021, the subject experienced feeling weird after each episode of tingling and weakness. On MAY-2021, the subject experienced feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest, feeling weird after each episode of tingling and weakness, and feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. This report was non-serious.
52 2021-07-22 pain in extremity Pain in arm. Felt like there was a softball size lump on my arm even though there was no lump. Pain ... Read more
Pain in arm. Felt like there was a softball size lump on my arm even though there was no lump. Pain never eased and actually has gotten worse. My left arm is extremely weak now.
52 2021-07-23 pain in extremity, weakness DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JO... Read more
DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.
53 2021-03-06 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds o... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note
53 2021-03-11 seizure, tremor The morning after he received his vaccine he started feeling sick and then started to run a temperat... Read more
The morning after he received his vaccine he started feeling sick and then started to run a temperature. By evening his temperature was 102.9. Then the seizures started, first his "left" hand up his arm and down his left side. His right hand and arm was shaking rapidly. His left leg stiffened and his toes pointed down and then the seizure traveled to his right side. He remained conscious but somewhat dazed. This went on all night. By 10:00 the next day, Thursday the seizures stopped. His temperature went back to normal Friday morning.
53 2021-03-12 tremor Hand tremors 9 hours after injection lasting for one hour. Fever starting approx. 12 hours after inj... Read more
Hand tremors 9 hours after injection lasting for one hour. Fever starting approx. 12 hours after injection. Possible contribution to fainting event approx. 15 hours after injection. Muscular aches in neck and shoulders starting approx. 17 hours after injection.
53 2021-03-25 hot flush Headache 6 hours after shot lasting 24 hours Chills and hot flashes unabated Nausea and dry heaves
53 2021-03-25 night sweats, pain in extremity Pain in the legs and feet. Same with my hands and fingers. Fatigue. Night sweats. Unable to sleep.... Read more
Pain in the legs and feet. Same with my hands and fingers. Fatigue. Night sweats. Unable to sleep. Muscle pain in the back and chest area. This started at bedtime around 11:00 pm, approximately 12 hours after the dose. Symptoms lasted a full 24 hours. Fatigue being the symptom lasting the longest. As of now, all symptoms have subsided.
53 2021-03-25 tingling, numbness Swelling and pain at injection site Itchy and. irritated skin tingling and numbness through body fat... Read more
Swelling and pain at injection site Itchy and. irritated skin tingling and numbness through body fatigue in both legs and back restlessness
53 2021-03-26 bell's palsy, pain in extremity Sore Arm immediately after shot for several days Bell's Palsy 19 days after injection (reporting thi... Read more
Sore Arm immediately after shot for several days Bell's Palsy 19 days after injection (reporting this since CDC web site specifically asked for reports of Bell's Palsy after vaccination)
53 2021-03-29 pain in extremity Sore everywhere. Lower stomach & groan is very sore. I can't hardly sit. Motrin is giving me some re... Read more
Sore everywhere. Lower stomach & groan is very sore. I can't hardly sit. Motrin is giving me some relief. I was running a fever yesterday 3-29-21. Hands are very stiff and ache.
53 2021-03-31 tremor Fever started around 6:30 pm and progressed to chills and shaking. Took two tylenol, which helped w... Read more
Fever started around 6:30 pm and progressed to chills and shaking. Took two tylenol, which helped with the chills and shaking. Experienced aches and flu-type sweats throughout the night, with sleep disrupted many times. Recovery staryed the next morning, but took day off of work due to slight headache and lingering slight fever.
53 2021-04-02 feeling cold chills, strong shivering, fever that night Next day, fever, body aches, headache, fatigue, took tyl... Read more
chills, strong shivering, fever that night Next day, fever, body aches, headache, fatigue, took tylenol through day Night, symptoms reduced and give by next morning
53 2021-04-03 tingling, numbness Patient is a * year old * who received a single dose of the J&J COVID19 vaccine in the left deltoid.... Read more
Patient is a * year old * who received a single dose of the J&J COVID19 vaccine in the left deltoid. He states that about 20 minutes following administration of the vaccine, he started to feel numbness and tingling the left side of his face, specifically in the left cheek. He has a shellfish allergy of which he gets a similar reaction if consumed. He relates that he usually takes Benadryl and the symptoms subside. He denies history of anaphylaxis requiring epinephrine. He denies a medical history. He affirms decreased sensation in the left cheek. He denies swelling and decreased movement of the left cheek. He denies chest pain/tightness, shortness of breath, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. GEN: Alert and oriented x 4, in NAD HEAD: NCAT EYES: PERRL, EOMI, no lid ptosis noted ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry MSK: FROM, MS 5/5 NEURO: Diminished light touch sensation in the left CN 5 distribution. Motor function intact. Alert and oriented x 4, CN 2-4 and 6-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Facial Numbness, r/o Bell's Palsy. Patient was observed for 20 minutes following his 30 minute wait period. Patient was offered EMS services, but patient did not feel as if it was necessary. Patient was re-evaluated and did not display signs/symptoms of anaphylaxis. Facial sensation symptoms had stabilized by the time patient asked to leave with his wife, who would be driving their vehicle home. Vital signs stable. Patient asked to follow up with PCP and to inform them of the post-vaccination reaction. Patient instructed to go to the emergency department should he develop chest pain, shortness of breath, and swelling of the face/lips/mouth/tongue/throat, as these could be possible signs of anaphylaxis that require immediate attention. Medications administered: None. Patient self administered OTC Benadryl. Disposition: Home
53 2021-04-04 weakness Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a b... Read more
Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a bit in his chair. In addition to this he felt pain in Right Pectoral Muscle. Patient was noticed with pale and diaphoretic appearance but within few minutes felt better with increased ventilation and cold compress.
53 2021-04-05 tremor Symptom onset: Friday 03/26/2021 no time reported. Patient presented to dialysis on 03/27/2021 with ... Read more
Symptom onset: Friday 03/26/2021 no time reported. Patient presented to dialysis on 03/27/2021 with fever 103.5, shakes, chills, tachycardia.
53 2021-04-06 seizure Patient received vaccine approx 5-10 minutes patient fainted in his chair. A cardiac nurse was wait... Read more
Patient received vaccine approx 5-10 minutes patient fainted in his chair. A cardiac nurse was waiting to receive their vaccine and rushed over to help too. Patient began to convulse. We tried to get patient to respond approx 2 min later patient woke up and complained about being thirsty. We gave him Apple juice and placed a cold pack on his neck. Called 911, We took BP it was 77/49 pulse 45, we laid patient down and retook BP 123/73 Pulse 68. After 5 more min BP 135/85 pulse 72. EMS arrived and took patient away
53 2021-04-07 numbness, tingling, pain in extremity, flushing about 3 hours after injection i noticed i was flushed neck ears face, about 5 to 6 hours my ears sta... Read more
about 3 hours after injection i noticed i was flushed neck ears face, about 5 to 6 hours my ears started ringing, trouble sleeping legs pricing over night., 2 degrees elevated temperature from normal. this lasted for almost exactly 24 hours. my leg pain is in the same location as a severe blue of shingles i had two years ago. it is now 96 hours after injection and my legs are still tingling and occasionally feel prickly and painful. this is manifesting into right toes. there is an odd numbness to my right thigh. i was worried somehow i might have triggered another shingles type outbreak.
53 2021-04-09 tremor Severe vomiting, diarrhea, fever, nausea and severe headache. Significant Trembling and chills follo... Read more
Severe vomiting, diarrhea, fever, nausea and severe headache. Significant Trembling and chills followed by high fever, disorientation and dizziness and fatigue. Symptoms started approximately 5-6 hours after shot - began with trembling followed by severe chills and dizziness - followed then another 4 hours later by fever, significant nausea and extreme vomiting and diarrhea - then loss of appetite, fatigue, dizziness. After 24 hours the severe symptoms stopped and there was just another 15 hours of fatigue. 40 hours later everything felt back to normal. Hour 6 to hour 30 after vaccination were horrible.
53 2021-04-10 weakness NIGHTMARES; TALKING IN HIS SLEEP; RESTLESSNESS AND THRASHING ABOUT/ ASLEEP, HE THRASHES AROUND LIKE ... Read more
NIGHTMARES; TALKING IN HIS SLEEP; RESTLESSNESS AND THRASHING ABOUT/ ASLEEP, HE THRASHES AROUND LIKE FISH OUT OF WATER; NO ENERGY; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 53 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nightmares. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced talking in his sleep. On 03-APR-2021, the subject experienced restlessness and thrashing about/ asleep, he thrashes around like fish out of water. On 03-APR-2021, the subject experienced no energy. Laboratory data included: Body temperature (NR: not provided) 102 F. 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 fever, nightmares, fatigue, talking in his sleep, restlessness and thrashing about/ asleep, he thrashes around like fish out of water, and no energy. This report was non-serious.
53 2021-04-10 feeling cold, weakness Woke at 4 am on 4/11/21 freezing, weak nauseous, dizzy and tried to go to bathroom, stumbled back on... Read more
Woke at 4 am on 4/11/21 freezing, weak nauseous, dizzy and tried to go to bathroom, stumbled back onto bed as I was passing out
53 2021-04-11 tremor Extreme chills and severe shaking lasted 4hrs tapering off after 230AM without medicine. Body aches... Read more
Extreme chills and severe shaking lasted 4hrs tapering off after 230AM without medicine. Body aches and severe headache (not migraine) lasted almost 24hrs; took 500mg Tylenol at 5am with little relief, took 240mg baby Aspirin approx 8am, took 10mg Maxalt at 9am with some more relief, but headache persisted. Took 325mg Aspirin about 3pm and felt near total relief by 5pm. Body aches also relieved by afternoon. No issues the next day (Sunday).
53 2021-04-12 numbness heavy numbness in right side of face, mouth and jaw, right arm and right side of torso. Pain on side... Read more
heavy numbness in right side of face, mouth and jaw, right arm and right side of torso. Pain on side of right thigh. Symptoms lasted around 15-20 minutes and subsided. Symptom of numbness in right side of face, mouth and jaw resurfaced on March 12th which prompted me to visit my primary doctor.
53 2021-04-12 pain in extremity Headache, Body Ache. Raise in Blood Pressure. Sore legs
53 2021-04-12 pain in extremity vaccine given on 3/30/2021-no pain till 4/6/2021- on 4/6/2021 patient started having pain in left a... Read more
vaccine given on 3/30/2021-no pain till 4/6/2021- on 4/6/2021 patient started having pain in left arm after lifting something one week after injection. 4/7/2021 states that pain radiates from the injection site to the back of the arm when he rises his arm to shoulder level-- arm feels weak after carrying something pain level 8/10 when he lifts his arm. No pain otherwise.
53 2021-04-12 tingling TINGLING IN THE FINGERS; This spontaneous report received from a pharmacist concerned a 53 year old ... Read more
TINGLING IN THE FINGERS; This spontaneous report received from a pharmacist concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced tingling in the fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in the fingers. This report was non-serious.
53 2021-04-13 hot flush, feeling cold, burning sensation, weakness Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immed... Read more
Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.
53 2021-04-13 tenderness Very bad headache that started on Monday night... progressed all day on Tuesday. I started feeling... Read more
Very bad headache that started on Monday night... progressed all day on Tuesday. I started feeling better when I woke up on Wednesday. The pain was in the left temple. It was also hurt to touch it. My face and teeth also felt some pain. On Wednesday morning, the headache started to go away but I could still feel it very slightly
53 2021-04-14 weakness 11.30 PM chills lasted one hour , treated w/Tylenol 1:30 AM racing heart, 110 bpm, lasted one hour ... Read more
11.30 PM chills lasted one hour , treated w/Tylenol 1:30 AM racing heart, 110 bpm, lasted one hour , treated with Tylenol and controlled breathing Following day headache and no energy
53 2021-04-15 bell's palsy, numbness, tingling BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN A... Read more
BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN ARM, LEGS, FEET AND HAND; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 240 (unit unspecified), and height was 182.88 centimeters. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included patient had family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced bell's palsy, numbness in arms, legs, lower abdomen and buttlocks, itching throughout, tingling in arm, legs, feet and hand. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing out of range, CT scan (NR: not provided) negative, Chest X-ray (NR: not provided) negative, and Urinalysis (NR: not provided) nothing out of range. Treatment medications (dates unspecified) included: hydrochlorothiazide/lisinopril. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching throughout on 23-MAR-2021, was recovering from numbness in arms, legs, lower abdomen and buttlocks, and tingling in arm, legs, feet and hand and bell's palsy. This report was serious (Other Medically Important Condition). Additional information was received from patient on 31/03/2021. The following information was updated and incorporated into the case narrative: Reporter (HCP), Patient demographics (Gender, weight, height, Concomitant condition), Event (Bell's Palsy), Lab Test : CT Scan (Head and Torso), Blood work, Urinalysis, Chest X-ray- negative, Suspect product: (Route of administration), drug used to treat AE (Lisinopril) was added.; Sender's Comments: V1: Additional information received in this version is regarding patient demographics, serious event Bell's palsy, lab test, medical history of the patient. This information changes the seriousness of the case from V0 nonserious to V1 serious. 20210357779-Covid-19 vaccine ad26.cov2.s-Bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
53 2021-04-15 pain in extremity, muscle spasms Bad headache in morning. Very unusual for me. In my eyes. Hard to concentrate on work at computer. A... Read more
Bad headache in morning. Very unusual for me. In my eyes. Hard to concentrate on work at computer. After an hour took a short nap and completely went away. Several days before had sharp pain in my calf but thought it could be a muscle cramp. That was also very unusual.
53 2021-04-15 pain in extremity HARDLY MOVE; VERY SORE OR PAIN IN THE ARM; CAN NOT SLEEP; This spontaneous report received from a co... Read more
HARDLY MOVE; VERY SORE OR PAIN IN THE ARM; CAN NOT SLEEP; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 04-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 can not sleep. On 04-APR-2021, the subject experienced hardly move. On 04-APR-2021, the subject experienced very sore or pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore or pain in the arm, and hardly move, and the outcome of can not sleep was not reported. This report was non-serious.
53 2021-04-20 flushing SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTI... Read more
SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees. 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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.
53 2021-04-21 night sweats COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKIN... Read more
COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
53 2021-04-22 weakness Bodily aches and pains, Fatigue, Lightheadedness, Fever, Acute and extreme weakness (Rushed to Hosp... Read more
Bodily aches and pains, Fatigue, Lightheadedness, Fever, Acute and extreme weakness (Rushed to Hospital) Dehydration
53 2021-04-22 cold sweat, muscle spasms Blood clot in each lung. Started in legs, spread through heart and settled in lungs. This occured ab... Read more
Blood clot in each lung. Started in legs, spread through heart and settled in lungs. This occured about 3 weeks AFTER J&J/Jansen vaccine. Immediate symptoms were painful leg cramps on both sides back pain, fever sweating, nausea, clammy skin, headache, neck pain.
53 2021-04-22 facial pain, tenderness Patient describes right side of face became red/purplish and swollen roughly 3 days after vaccine. S... Read more
Patient describes right side of face became red/purplish and swollen roughly 3 days after vaccine. Symptoms were accompanied by sinus pressure on right side of face. Eye was also red and mildly itchy. Facial symptoms were accompanied by arm pain and tenderness. Symptoms resolved after roughly 3 days
53 2021-04-25 pain in extremity Received the vaccine on 4/4/2021. On 4/8/2021 started having pain in lower left leg. Pain off and ... Read more
Received the vaccine on 4/4/2021. On 4/8/2021 started having pain in lower left leg. Pain off and on for two weeks. Pain intensified on 4/23/2021. I went to the emergency room where they performed on ultra sound examination of my left leg. Confirmed that I have a deep vain thrombosis (DVT) behind my left knee. Prescribed Eliquis. Saw Dr. today. He could not confirm that DVT was caused by vaccine, but I thought I should report it. I am to stay on Eliquis for six months at which time I will be evaluated for a blood clot disorder.
53 2021-04-28 facial paralysis, bell's palsy facial swelling, facial drooping, complaints of left ear pain Emergency department visit diagnosed w... Read more
facial swelling, facial drooping, complaints of left ear pain Emergency department visit diagnosed with Bell's palsy treated with valtrex prednisone
53 2021-05-01 feeling cold Body ache, headache, chills/shakes/lightheadedness, lethargy, increased pain in back and other exist... Read more
Body ache, headache, chills/shakes/lightheadedness, lethargy, increased pain in back and other existing condition area- frozen shoulders, trigger fingers thumb tendon.
53 2021-05-05 tremor CUT HIMSELF WHILE SHAVING; CHEST RASH; SHAKING; HEADACHE; LETHARGIC; ACHEY; This spontaneous report ... Read more
CUT HIMSELF WHILE SHAVING; CHEST RASH; SHAKING; HEADACHE; LETHARGIC; ACHEY; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included lamotrigine for epilepsy, and levetiracetam for epilepsy. On 04-MAR-2021, the subject experienced lethargic. On 04-MAR-2021, the subject experienced achey. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced shaking. On 10-MAR-2021, the subject experienced chest rash. On 16-APR-2021, the subject experienced cut himself while shaving. Treatment medications (dates unspecified) included: loratadine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cut himself while shaving on APR-2021, chest rash on 13-MAR-2021, and headache on MAR-2021, and the outcome of lethargic, achey and shaking was not reported. 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.
53 2021-05-06 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: BP 117/74 HR 62, second reading 122/111 HR 64, 3rd reading 142/81 HR 63. Patient was loss consciousness within 3 minutes of vaccine. I called the paramedics but he regained consciousness after 1 minute so we cancelled the call. He continued to complain of feeling dizzy so I had him stay for an additional 15 minutes. He has history of fainting with IVs/blood draws.
53 2021-05-09 pain in extremity, weakness - Occasional fatigue ranging from mild to moderate. - Occasional "drained" feeling like I pulled m... Read more
- Occasional fatigue ranging from mild to moderate. - Occasional "drained" feeling like I pulled man G's. - Mild brief dizziness (1-2 times a day), - Constant soreness in hands with mild sensation of having held something that vibrates (e.g., power tool) - Occasional arthritis-like pain in joints (fingers and knees). A few notes: - All of the above sensations have increased noticeably in intensity/frequency since 5/5/21. - I tested negative for Covid-19 on 5/8/21 (PCR). - I have been diagnosed with arthritis in my pinkies. - I am under doctor's care/monitoring for kidney stones which may give rise to some common symptoms such as the fatigue.
53 2021-05-12 feeling hot TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received fr... Read more
TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included cold sores. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A 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 unexpected therapeutic benefit. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced lips got warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, and the outcome of lips got warm and unexpected therapeutic benefit was not reported. This report was non-serious.
53 2021-05-13 pain in extremity Soreness in shoulder/neck/back/arm on the injected side of body (right side). No worse than annoying... Read more
Soreness in shoulder/neck/back/arm on the injected side of body (right side). No worse than annoying, but enough to make me avoid any heavy lifting or other physical exertion with that arm (or turning my head too far). The pain started decreasing after about two weeks, and was mostly gone in around a month.
53 2021-05-19 weakness A 53-yo male patient with a nonsignificant past medical history presented to the hospital with worse... Read more
A 53-yo male patient with a nonsignificant past medical history presented to the hospital with worsening generalized muscle pain, and weakness. Patient reported that he received the Jannsen COVID-19 vaccine 3 weeks prior to admission and symptoms began 8 days later. On the morning of admission the patient also developed pressure-like and pleuritic chest pain. EKG findings showed ST elevations in V5-V6 with depression in aVL. D-dimer was found to be elevated however PE evaluation was negative. Troponins were also found to be elevated. The patient was diagnosed with acute pericarditis and underwent left heart catheterization, selective coronary angiography and left ventriculography. The coronary angiography revealed no significant obstructive coronary artery disease, and left ventriculography revealed normal LV size and function. Patient was subsequently initiated on colchicine therapy for acute pericarditis. He remains admitted at hospital.
53 2021-05-19 mild one side paralysis Left side stroke;severe headache;blindness;treatment was TPA;no significant finds in any test;curren... Read more
Left side stroke;severe headache;blindness;treatment was TPA;no significant finds in any test;currently being treated as a cardiac patient
53 2021-05-20 unresponsive to stimuli Had a stroke on May 12, 2021. Found unresponsive while at work, while at work and sent to ER at Hosp... Read more
Had a stroke on May 12, 2021. Found unresponsive while at work, while at work and sent to ER at Hospital. Hospital sent him to Hospital, due to Stroke on the same day. On 5-15-21 sent to Acute Rehabilitation. Still in Rehab doing PT, OT and speech therapy. Many test completed and unknown to how stroke happened. Health prior to vaccine was healthy with no concerns.
53 2021-05-23 feeling hot The patient lost consciousness a few minutes after receiving the shot while walking back to his seat... Read more
The patient lost consciousness a few minutes after receiving the shot while walking back to his seat for monitoring. He came too after just a minute and we gave him a ice pack. His blood pressure was normal and his pulse was also within range. Patient was very warm to the touch.
53 2021-05-27 night sweats PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUG... Read more
PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.
53 2021-05-31 pain in extremity I took aspirin, tylenol and I ate soup, took 2 days off from work to rest. Vision got blurry Upset ... Read more
I took aspirin, tylenol and I ate soup, took 2 days off from work to rest. Vision got blurry Upset stomach Left arm in pain Ever since I took the shot I've been tired.
53 2021-06-01 pain in extremity Best use date recorded by HD as 3 months from receiving. Received on 3-2-2021. Marked to discontinue... Read more
Best use date recorded by HD as 3 months from receiving. Received on 3-2-2021. Marked to discontinue use on 6-2-2021. Maintained in cold chain management 36 to 46 degrees F. Administered on 6-1-2021 Vial opened for the client. The other 4 doses were discarded at the end of the clinic. On 6-2-2021 an e-mail from DH was noted with expiration of Lot 1802068 on 5-25-2021. Johnson & Johnson was contacted and reported to Pharmacist. Reference ID EZR20210078918(VO) case # 02242111. Client has a Developmental Disability. His guardian (mother) was contacted expiration date reported. The mother states that client c/o sore arm 6-1 with difficulty sleeping. Today he is feeling back to normal. No problems or concerns.
53 2021-06-02 pain in extremity I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four... Read more
I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four days with pain in my left leg. On the 19 I was not able to move my left leg with a lot of pain and a little discomfort on my right leg. Rush to the hospital and right away the found blood clots on my left leg, The ER did not check my right leg and two weeks later they found clots on the bottom part of my right leg. They gave me blood thinner and now Im taking Eliquis twice a day. Symptoms continue, I have the same pain, I dont see any improvent. I did went to work yesterday and I realize that I can do any lifting or be sitting down for at least one hour.
53 2021-06-03 burning sensation Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by ... Read more
Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.
53 2021-06-03 cold sweat I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had... Read more
I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had a bad taste in my mouth approximately 3 days.
53 2021-06-08 numbness, pain in extremity, cold extremities, sensory loss On 5/20/21 patient arrives to hospital via EMS for leg pain and numbness. Left lower extremity coole... Read more
On 5/20/21 patient arrives to hospital via EMS for leg pain and numbness. Left lower extremity cooler to the touch. Unable to palpate pulses. Unable to Doppler pulses. Cap refill is slow, around 3 to 4 seconds. Patient reports he is unable to feel a sensation. Able to wiggle toes. 5/20 CT angiogram reveals dissecting aneurysm. 5/20 COVID-19 positive 5/20 cardiothoracic surgery : MEDIAN STERNOTOMY for REPLACEMENT, AORTA, ASCENDING (HEMASHIELD PLATINUM 34MM), AND TEE Intubated or the surgery and of typical uration post-operatively On high flow NC oxygen Critical care MD notes: Not symptomatic due to COVID No COVID treatment(s) were ever needed. Discharged to home
53 2021-06-10 pain in extremity shortly after (few weeks) receiving the vaccine, I experienced a large amount of pain in my right fo... Read more
shortly after (few weeks) receiving the vaccine, I experienced a large amount of pain in my right forearm which resulted in a painful lump later identified as a thrombosis which had to be removed. It was removed on 5/27/21.
53 2021-06-11 involuntary muscle movements Patient was nervous/agitated prior to shot. Patient told vaccinator that is was all psychosematic a... Read more
Patient was nervous/agitated prior to shot. Patient told vaccinator that is was all psychosematic and to not to worry. About 3 minutes after injection, patient stated he felt faint. Another staff member noticed he was bobbing his head around. Patient got up from chair and laid on the floor. Staff raised his feet. Once patient was feeling more stable, we moved him to a lift chair in the flat position. Patient stated he gets faint with other vaccines.
53 2021-06-13 unresponsive to stimuli Claimant alleges he was given a Johnson & Johnson vaccine after already receiving both Moderna vacci... Read more
Claimant alleges he was given a Johnson & Johnson vaccine after already receiving both Moderna vaccines. Claimant stated he was feeling ill and became unresponsive. He fainted and was transported to hospital.
53 2021-06-20 cold sweat patient alerted the technician that the patient stated he felt like he was going to pass out. He was... Read more
patient alerted the technician that the patient stated he felt like he was going to pass out. He was visually sweating, clammy, and bending over. The pharmacist then instructed the patient to lean back in his chair and to breathe. next he started to lean to his side to pass out so the pharmacist grabbed him and held him up, the patient was unaware that he passed out. the patient was passed out for about 20 seconds and may have had a small seizure with no history of seizures on file. we applied a cold pack on the patient to help with the nausea he then dry heaved into the trash can. ems arrived and took patient to the hospital.
53 2021-06-21 pain in extremity Patient reported pain and swelling in left leg 5 days after receiving the Janssen vaccine. Patien... Read more
Patient reported pain and swelling in left leg 5 days after receiving the Janssen vaccine. Patient was seen in clinic for symptoms and was evaluated by PCP.
53 2021-06-29 hot flush Had immediate hot flash with lots of sweating and fainted. Unconscious for 1 minute and woke up feel... Read more
Had immediate hot flash with lots of sweating and fainted. Unconscious for 1 minute and woke up feeling better and more cooled. Used ice packs and wet cloth to cool down. Took blood pressure and pulse - BP: 95/60 Pulse: 59; is on blood pressure meds and was told this was his normal by his wife.
53 2021-07-02 burning sensation, pain in extremity, tingling Immediate pain in left arm. Pain continued to get worse over the weekend with burning and tingling ... Read more
Immediate pain in left arm. Pain continued to get worse over the weekend with burning and tingling in arm and front and rear shoulder. Sought treatment at an urgent care. Later sought treatment with primary physician. By this time I was experiencing what felt like a deafness in the forearm as well as some tingling. Sunlight, air from fan or cold air from a/c worsens the pain. I was prescribed gabapentin. Dose was increased at a later date. Meds do hope somewhat but not completely. Was sent to a neurologist with in office test done. I am currently scheduled for more tests in August.
53 2021-07-11 muscle twitching, pain in extremity, nerve pain Pain and weakness in left arm. Constant twitching of muscles in left arm for long periods of time. ... Read more
Pain and weakness in left arm. Constant twitching of muscles in left arm for long periods of time. Pain in my toes to my fingernails. Lots of nerve pain. Feels like an inflammation around heart or chest cavity (that has mostly subsided at this time).
53 2021-07-11 tingling, numbness About a month ago I started experiencing (3) distinct symptoms 1- Bladder control issues 2-Numbness... Read more
About a month ago I started experiencing (3) distinct symptoms 1- Bladder control issues 2-Numbness/tingling in my left arm which has spread to my hand and is consistently spreading 3-Trouble walking sometimes, my left leg feels out of my control
53 2021-07-13 feeling hot At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain ... Read more
At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months plus high blood pressure weakness
53 2021-07-13 pain in extremity Shoulder and upper arm pain that is persistent. Cannot sleep on that side due to pain.
53 2021-07-14 pain in extremity, tingling I experienced feelings of easily fatigued muscles in forearms within about 1 week of vaccine. I hav... Read more
I experienced feelings of easily fatigued muscles in forearms within about 1 week of vaccine. I have experienced ongoing periodic feelings of sharp needle-type sensations in lower legs. Starting ~mid-June I have a pain in my right index finger between first and second joint, similar to as though a piece of glass is in my finger. But when i push on it, i sense there is no foreign object in there. I sometimes have experienced tingling in my right hand and up my right arm. I have had intermittent slight headaches.
53 2021-07-16 cold extremities, pain in extremity, sensory loss, numbness AORTIC DISSECTION; AORTIC ANEURYSM REPAIR; ARTERIOGRAM CORONARY ABNORMAL; ASYMPTOMATIC COVID-19; CAP... Read more
AORTIC DISSECTION; AORTIC ANEURYSM REPAIR; ARTERIOGRAM CORONARY ABNORMAL; ASYMPTOMATIC COVID-19; CAPILLARY NAIL REFILL TEST ABNORMAL; ECHOCARDIOGRAM; ENDOTRACHEAL INTUBATION; HYPOAESTHESIA; PERIPHERAL COLDNESS; PULSE ABSENT; SARS-COV-2 TEST POSITIVE; SENSORY LOSS; STERNOTOMY; PAIN IN EXTREMITY; This spontaneous report received from a health care professional via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) concerned a 53 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included heart failure, concurrent conditions included ex-smoker, hypertension, obesity, and asthma and type A dissecting thoracic aortic aneurysm measuring up to 6.1. The patient's pre-existing medical conditions included that he had no allergies to medications, food, or other products. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 total was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Docusate, Ibuprofen, paracetamol (Acetaminophen), and salbutamol (Albuterol) for an unknown indication. On 20-MAY-2021, the patient went to hospital via EMS (emergency medical services) for leg pain (pain in extremity) and numbness (hypoaesthesia). The patient's left lower extremity was cooler (peripheral coldness) to the touch. The patient's pulses were absent, and abnormal (difficult to palpate and doppler). The patient had capillary nail refill test which was slow and around 3 to 4 seconds. It was reported that he was unable to feel a sensation (sensory loss) but was able to wiggle his toes. The patient had arteriogram coronary which was abnormal, CT angiogram (computerized tomography angiography) which revealed dissecting aneurysm (aortic dissection) and had echocardiogram whose results were not reported. The patient had cardiothoracic surgery for aortic aneurysm repair. The patient underwent to median sternotomy for replacement of aorta with ascending hemashield platinum 34 mm. The patient had TEE (Transesophageal echocardiography) incubation (endotracheal intubation) and was postoperatively on high flow NC (Nasal cannula) oxygen Critical care. The patient had SARS-CoV-2 and Covid-19 test which came out positive and he experienced asymptomatic Covid-19. The patient was discharged to home. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aortic dissection, aortic aneurysm repair, arteriogram coronary abnormal, asymptomatic covid-19, capillary nail refill test abnormal, echocardiogram, endotracheal intubation, hypoaesthesia, pain in extremity, peripheral coldness, pulse absent, sars-cov-2 test positive, sensory loss and sternotomy. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183696. The suspected product quality complaint has been confirmed not to be voided based on the PQC evaluation/ Investigation performed. It was reported that a valid lot number was unavailable and due diligence to obtain product identification information and field sample availability was performed as applicable. In lieu of a batch specific review, an overall review of the manufacturing and packaging process, release process, and product quality review results was performed. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Additional information was received from central complaint vigilance on 08-JUL-2021. The following information was updated and incorporated into the case narrative: investigation result added, event of clinical vaccination failure deleted.; Sender's Comments: V1: Additional information updated in this version includes deletion of event clinical vaccination failure and investigation results of PQC. This information doesn't alter causality of previously reported events. 20210640575-Covid-19 vaccine ad26.cov2.s -aortic dissection, aortic aneurysm repair, capillary nail refill test abnormal, hypoaesthesia, peripheral coldness, pulse absent, sensory loss. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210640575-Covid-19 vaccine ad26.cov2.s - arteriogram coronary abnormal, asymptomatic covid-19, echocardiogram, endotracheal intubation, sars-cov-2 test positive, sternotomy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210640575-Covid-19 vaccine ad26.cov2.s -pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.
53 2021-07-17 muscle spasms, seizure 1st of 5 known seizures was an hour after the injection, the 2nd was 2 1/2 hours after the injection... Read more
1st of 5 known seizures was an hour after the injection, the 2nd was 2 1/2 hours after the injection, the 3rd was 5 hours after the injection, the 4th was 22 hours after the injection the following day, the 5th was 40 hours after the injection. These seizures were different in nature. His muscles and body tightened heavily for up to 2 minutes, he turned blue and was combative. Muscle spasms for up to 10 minutes after seizure. Aggressively hyper focused and moving around unaware of reality for 20-30 minutes.
53 2021-07-18 tremor Pt.'s sister states after receiving the J&J 06/01/2021, started experiencing nervousness, nauseous, ... Read more
Pt.'s sister states after receiving the J&J 06/01/2021, started experiencing nervousness, nauseous, vomiting, anxiety, memory loss, and constant shaking. Weight lost (estimated 15lbs), loss of sleep. Physician visit (07/15/2021) Blood test ran still awaiting results. Cognitive Test 07/15/2021, recommendation for MRI.
53 2021-07-19 feeling hot Patient felt lightheaded, warm 5 minutes after getting the vaccine. It appeared as he was unconsciou... Read more
Patient felt lightheaded, warm 5 minutes after getting the vaccine. It appeared as he was unconscious for few seconds in and out for about 2-3 minute. Upon spouse's request we did call paramedics for help. Patient was doing fine by the time paramedics arrived,. Patient did mention he was very anxious to get vaccines. He did not have any underlying health conditions, His last vaccines was in high school. Patient also mentioned he had no meals the entire day and probably led to lightheaded. Paramedics did not administer any medications.
53 2021-07-21 bell's palsy, facial paralysis Diagnosed with Bells Palsy 6 weeks after vaccine. Facial paralysis on the left side of my face
53 2021-07-25 nerve injury, pain in extremity, numbness tired, entire body aches, and bad pain in both feet. persistent numbness in body extremities. The p... Read more
tired, entire body aches, and bad pain in both feet. persistent numbness in body extremities. The pain in one foot has remained until present which has slowly subsided. It has caused nerve damage in that foot.
54 2021-03-08 weakness I had Covid in June - and felt the same - fever (not real high - 101), chills, nausea, no energy, he... Read more
I had Covid in June - and felt the same - fever (not real high - 101), chills, nausea, no energy, headache - lasted from 7pm ish until sometime around 5am woke up sweating and only had slight headache that went away after some fluids - it was not fun at all, but didn't last too long - I didnt take any Advil until about 2 am, then could sleep. Stayed home Monday because I could, but by noon felt nearly 100%, by 6pm felt 100%.
54 2021-03-09 tremor Chills, uncontrolled shaking, headache, body aches
54 2021-03-12 weakness 10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, diz... Read more
10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, dizzy, eyes fluttering and 102.0 fever. 645pm - Took 3 Tylenol and BP 144/85 HR 83. Bed rest with Gatorade and water. 1100pm - Took 2 Tylenol. Fever reduced to 99.8. Headache and extremely tired. No energy. Bed rest with fluids. 24 hours after vaccination : Fever almost gone, 11am 2 more Tylenol, extremely tired and weak. Low energy. Ringing in ears. Minor headaches. 48 hours after vaccination; No fever, extremely tired and weak. Low energy. Ringing in ears.
54 2021-03-18 tremor, seizure On Friday, March 19 around 9:10am I had seizures - loss of awareness, very pale, shaking (but not qu... Read more
On Friday, March 19 around 9:10am I had seizures - loss of awareness, very pale, shaking (but not quite convulsions). This happened before 25 years ago and is likely unrelated to the vaccine. Expected cold/flu-like symptoms did occur on March 14 and part of March 15 but things have been fine since then. I've followed up with my GCP and am scheduling a Neuro appointment for followup.
54 2021-03-19 tremor Reddish skin, a lot of yawning, fever, red eyes, chills and uncontrolled shaking.
54 2021-03-20 burning sensation SEVERE RASH: large, unabated, red to dark red, raised welts. The initial rash started under arms cov... Read more
SEVERE RASH: large, unabated, red to dark red, raised welts. The initial rash started under arms covering from underarm to hip as circular patterns. Then spread into the back. Covered sides, back, neck, into scalp, upper arms, buttocks, knees (front and back), thighs. Rash appeared mostly as one large/connected reddish glob. Spread occurred within 2 hrs from initial onset at 8pm. SEVERE RASH Lasted 8 hrs and would lessen but then new lesser rash would appear and is still present to lesser degree. Rash itched and burned. Treated self with a Claritin pill and cortisone cream all over rash. Took a Benadryl tablet the following day. Rash decreased each day. Rash still present to a lesser degree on 3rd day after it started with the rash appearing more as reddish dots. **Pictures are available upon request**
54 2021-03-22 feeling cold, night sweats i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headach... Read more
i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headache around my head and muscles pain with temp and shivering cold i could not sleep all night after also with stomach pain too and at one time i felt short of breath i did not take anything until 12:00noon the day with tylenol and i drank lots of Gatorade, i night sweat a lot and i slept all night after taking another two pills of tylenol 500 mg each, i sweat all night and I woke up good thanks god i feel much better
54 2021-03-22 numbness, mild one side paralysis pt presented to ER 0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed a... Read more
pt presented to ER 0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed and use bathroom and couldn't bear weight or move his right leg. NIH stroke scale score-2, Glasgow coma score =15 183/105, HR 103, RR 18, 02 saturation 95% RA 98.7 oral temp 0/10 pain. clonidine po tablet 0.1mg. EKG=tachycardia 106 normal P waves, normal PRI, normal QRS complex, normal ST and T waves. labs=SARSCoV2 RNA negative, CT head WO=no acute intracranial abnormality by CT criteria. UA=negative, glucose 359
54 2021-03-22 muscle spasms Symptoms were severe headache, leg cramps, low fever, chills. These lasted approximately 16 hours.
54 2021-04-03 migraine, numbness During the night after the vaccine, woke up and was not able to breathe very well. Also experienced ... Read more
During the night after the vaccine, woke up and was not able to breathe very well. Also experienced a painful migraine/headache and the left side of my face lost feeling. Still mildly numb today.
54 2021-04-04 migraine After about 10 hours, migraine headache started, took prescription pain meds but was not helping. ... Read more
After about 10 hours, migraine headache started, took prescription pain meds but was not helping. By 9a.m. my blood pressure taken at home was 180/110 and started having chest pain on left side. Went to urgent care where they felt it was a cardiac reaction to vaccine and they sent me to ER. Underwent EKG and chest xray. Blood pressure still at same level 180/110 and not going down, migraine still at an 8 out of 10, chest pain still present. I was given an IV to treat for migraine pain and within a few hours all symptoms had went away. We started with Urgent Care at about 10a.m. on 4/3/21 and then by the time all was done I was released from the ER at 6:30p.m. on 4/3/21.
54 2021-04-04 pain in extremity Sore arm between shoulder and elbow since the vaccine was administered 3 weeks ago.
54 2021-04-05 numbness, bell's palsy, facial paralysis Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and nu... Read more
Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and numbness, left eye dryness (does not close) Treatment: ketorolac (TORADOL), followed by 10 days predniSONE 20 mg and 5 days valACYclovir 1gram 2 weeks later, still have all symptoms... some improvement with facial droop. Numbness remains, headache neck and jaw pain remain fairly constant... Ibuprofen and Naproxen used for treatment.
54 2021-04-05 unresponsive to stimuli, seizure, unresponsive to stimuli, seizure Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
54 2021-04-06 pain in extremity FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; AR... Read more
FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15 in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.
54 2021-04-08 cold sweat Pt c/o dizzy, light headed, diaphoretic and clammy. V/S obtained with b/p 132/68 HR 55 O2 99%. Pt wa... Read more
Pt c/o dizzy, light headed, diaphoretic and clammy. V/S obtained with b/p 132/68 HR 55 O2 99%. Pt was assissted to floor to prevent falling. Given water and cool compress for neck. Pt was held for 30 minutes after time. Pt refused EMS. After time pt was released to go home. A/Ox3.
54 2021-04-08 cold sweat Pt started to get dizzy, light headed, diaphoretic, clammy upon assessement. Vital signs obtained wi... Read more
Pt started to get dizzy, light headed, diaphoretic, clammy upon assessement. Vital signs obtained with b/p 132/68 HR 55 O2 99%. Pt was assissted to floor to prevent falling. Given water with cold compress applied to head. After extra 30 min wait time pt no longer complain of dizziness, light headness or being diaphoretic. A/Ox3. Left w/o any difficulty.
54 2021-04-08 feeling hot Patient stated feeling little light headed, strange, weakness, feeling warm, sweaty, without visual ... Read more
Patient stated feeling little light headed, strange, weakness, feeling warm, sweaty, without visual problems wanted to lay down. Patient awake and alert without anxious. Does not like needles/shots. Felt better after 15 minutes. Patient better after 15 minutes. Patient did not have SOB without swelling without rash. Breathing ok without nausea. 11:45 am- 126/90 HR 59
54 2021-04-08 feeling hot About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I b... Read more
About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I began to feel "hot" and very fatigued. Then my temperature went up to 101.9 degrees F, taken by an electronic touchless digital thermometer. Then, the L Deltoid vaccination site began to feel very sore. As the day went on, I felt increasingly fatigued and exhausted, and had trouble concentrating. I felt better the 2nd day after vaccination, but felt intermittent myalgias, increasing L Deltoid soreness, and hot and chilled at the end of the day. Today, I felt better in the morning, exceptfor persistent L deltoid soreness, and fatigue. This evening, I am feeling cold, tired, and myalgias again.
54 2021-04-08 muscle twitching FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP F... Read more
FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP FROM LYING DOWN/LIGHTHEADEDNESS; HAVE NOT BEEN ABLE TO SLEEP; UNCONTROLLABLE STIFFNESS IN THE LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN THE LEFT SHOULDER JOINT; UNCONTROLLABLE MUSCLE TWITCHING IN THE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included right shoulder surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced uncontrollable muscle twitching in the left arm. On 17-MAR-2021, the subject experienced uncontrollable stiffness in the left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in the left shoulder joint. On 19-MAR-2021, the subject experienced have not been able to sleep. On 29-MAR-2021, the subject experienced dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness. On 29-MAR-2021, the subject experienced room spinning. On 01-APR-2021, the subject experienced fell. 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 uncontrollable pain in the left shoulder joint, uncontrollable stiffness in the left side of neck, uncontrollable pain in left side of neck, have not been able to sleep, dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness, uncontrollable muscle twitching in the left arm, and room spinning, and the outcome of fell was not reported. This report was non-serious.
54 2021-04-09 feeling cold, feeling hot Headache, sinus headache symptoms, hot and cold chills, fatigue, hives next day Recovered 24 hrs
54 2021-04-09 migraine ELEVATED BLOOD PRESSURE; CHEST PAIN; SHORTNESS OF BREATH; VOMITING; NAUSEA; HEADACHE MIGRAINE; This ... Read more
ELEVATED BLOOD PRESSURE; CHEST PAIN; SHORTNESS OF BREATH; VOMITING; NAUSEA; HEADACHE MIGRAINE; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and tension headache, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to left arm, on 02-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included atenolol for high blood pressure. On 02-APR-2021, the subject experienced headache migraine. On 03-APR-2021, the subject experienced elevated blood pressure. On 03-APR-2021, the subject experienced chest pain. On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg, and EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, chest pain, shortness of breath, vomiting, headache migraine, and nausea on 03-APR-2021. This report was non-serious.
54 2021-04-09 tingling Polyneuropathy with paresthesia and motor weakness of bilateral upper and lower extremities started ... Read more
Polyneuropathy with paresthesia and motor weakness of bilateral upper and lower extremities started about 10-11 days after receiving vaccine. Currently hospitalized, undergoing studies MRI, lumbar puncture for definitive diagnosis.
54 2021-04-10 pain in extremity, muscle spasms Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and... Read more
Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and pain in my lower back right side, upper right thigh, behind my right knee and down into my right calf. I figured that the pain would go away but the pain increased and my leg started swelling and the pain increased making it very difficult for me to put my leg down on the ground and put pressure on my right leg.
54 2021-04-11 pain in extremity Arm pain and swelling began immediately. Later in the evening on same day of shot, I began to experi... Read more
Arm pain and swelling began immediately. Later in the evening on same day of shot, I began to experience nausea. Next morning pain, swelling and nausea persisted. Medium intensity body aches and headache began late morning. By mid afternoon body pain increased to the point that I was no longer able to function and needed to lie down. Took a 4 hour nap. Side effects persisted after waking up. At time of writing, 28hrs after vaccine, I am still feeling the side effect although less severe. Ibuprofen and Tylenol do seem to help.
54 2021-04-12 weakness c/o of weakness, lightheaded. Placed on stretcher. V/S BP 98/60, HR 60 SAO2 99 color good, skin war... Read more
c/o of weakness, lightheaded. Placed on stretcher. V/S BP 98/60, HR 60 SAO2 99 color good, skin warm and dry. Patient had fasted for lab work prior to receiving vaccine. Serial v/s done, drank ginger ale and felt better. Discharge BP103/67, HR 72 SAO2 96%
54 2021-04-12 pain in extremity Unusual painful swelling of toes of left foot. (NOT entire leg or entire foot.) Pain like that aft... Read more
Unusual painful swelling of toes of left foot. (NOT entire leg or entire foot.) Pain like that after foot "falls asleep" then "wakes up." Symptoms started ~5 days after vaccination Took Ibuprophen for pain. Swelling faded after ~24 hours.
54 2021-04-12 pain in extremity 10 days later I had Hip pain 11 days later I had Pain in Right Leg
54 2021-04-12 pain in extremity I had a small lump appear at or near the site of injection past the 2 week period. My arm was stiff ... Read more
I had a small lump appear at or near the site of injection past the 2 week period. My arm was stiff and sore. My spouse massaged my shoulder and the lump seemed to disappear. Arm felt better. The next day the same thing happened. My spouse massaged my arm and it went away again. I haven't had any other issues beyond that. I'm not completely sure it is related to the vaccine. I was also in the hospital during this time for an unrelated health issue. I had an obstructed bowel that required surgery. My surgeon assured me that they did nothing to my left arm during the surgery and treatment of the bowel obstruction. After a few conversations with the medical staff and my spouse we thought that the arm issue may have been a side effect of the vaccine shot. That's why I'm submitting this to you now. So far I haven't experienced anything else at the injection site. My spouse also had the same vaccine at the same time as me. He hasn't experienced any of the same effects as I have.
54 2021-04-13 weakness 4/6/21 - got bloody nose at 10:00 A.M, which would not stop. Nose still bleeding 2 hours later, got... Read more
4/6/21 - got bloody nose at 10:00 A.M, which would not stop. Nose still bleeding 2 hours later, got dizzy, so lied down. Vomited blood and could not stop the bleeding. Went to the ER at 2:00 PM, to have them stop the bleeding 4/6/21- E.R. - Fainted n the lobby while waiting. Taken back to room and given IV and gave multiple tests. E.R. doctor put packing in nose to slow bleeding. Still The Diagnosis was Epistaxis and Vasovagal syncope, and advised to follow up with my doctor and otalaryngologist. 4/8/21- Nose bleeding finally cam to stop in the evening, but had fatigue, weakness, irregular heartbeat, and shortness of breath 4/9/21- ENT and Allergy removed packing, completed nasal scope. Nose still felt like it was stuffed with blood clots until 4/13/21
54 2021-04-13 numbness, tingling, pain in extremity, burning sensation Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, sw... Read more
Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, swelling, numbing, burning, tingling that started 4.13.2021 (Friday at around 1700 hrs). In our ED now, awaiting to be seen by our Hospitalist for possible admission to the hospital.
54 2021-04-13 muscle spasms MUSCLE SPASM; MILD FEVER; This spontaneous report received from a consumer concerned a 54 year old m... Read more
MUSCLE SPASM; MILD FEVER; This spontaneous report received from a consumer concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced mild fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasm, and the outcome of mild fever was not reported. This report was non-serious.
54 2021-04-13 night sweats Fever, constant headache, SOB, slight coughing, body aches, night sweats, fatigue.
54 2021-04-13 pain in extremity Charlie horse pain in left calf . Subsided 3 days later.
54 2021-04-14 weakness Fever, chills. nausea, fatigue, weakness, headache,
54 2021-04-14 pain in extremity DIAGNOSIS: 1. Superficial thrombophlebitis MEDICAL DECISION MAKING/DIFFERENTIAL DX: Differential dia... Read more
DIAGNOSIS: 1. Superficial thrombophlebitis MEDICAL DECISION MAKING/DIFFERENTIAL DX: Differential diagnosis includes DVT, superficial thrombophlebitis, muscle strain, tendinitis. The patient presented to the emergency department with atraumatic left leg pain. An ultrasound reveals a fairly large blood clot in the greater saphenous vein. Although this is a superficial clot, given its extent, I think it warrants anticoagulation. Per the trial, the patient would benefit from 45 days of 10 mg Xarelto treatment. The patient was given good precautions regarding bleeding risk while on a blood thinner. He will schedule follow-up appoint with his primary care doctor. He will also use Tylenol and warm packs to help with the discomfort from the superficial thrombophlebitis. He was discharged in satisfactory condition.
54 2021-04-15 discomfort Very low symptoms i.e., Low grade fewer ~97F, Fatigue and Body discomfort during the day after the ... Read more
Very low symptoms i.e., Low grade fewer ~97F, Fatigue and Body discomfort during the day after the the inoculation. Jus rest, No treatment. Everything was normal two days after the inoculation.
54 2021-04-15 tingling, pain in extremity Left leg pain, swelling, and tingling. Patient was found to have DEEP VEIN THROMBOSIS of LEFT LOWER ... Read more
Left leg pain, swelling, and tingling. Patient was found to have DEEP VEIN THROMBOSIS of LEFT LOWER EXTREMITY - POPLITEAL VEIN.
54 2021-04-16 feeling hot, hot flush Janssen COVID-19 Vaccine EUA Within the first minute after injection, I started to feel dizzy and I... Read more
Janssen COVID-19 Vaccine EUA Within the first minute after injection, I started to feel dizzy and I felt like I was having a hot flash. For a few minutes I continued to get warm and at about the 10 minute point I was taken to the waiting room where I got a drink of water. After drinking the water I felt much better and soon felt normal with the exception of discomfort at the injection site. (My left upper arm just below my shoulder) After six days now, I still feel fine overall however, if I message the injection site, I can still feel a little bit of discomfort.
54 2021-04-20 tremor SHAKES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned ... Read more
SHAKES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 227 pounds, and height was 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, and chills on 10-APR-2021, and had not recovered from fever, headache, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
54 2021-04-21 pain in extremity SWELLING ON LEFT TOE; ARM HURT A LOT; VERY TIRED; This spontaneous report received from a patient co... Read more
SWELLING ON LEFT TOE; ARM HURT A LOT; VERY TIRED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure abnormal, and blood thinner. On 06-APR-2021, the subject experienced arm hurt a lot. On 06-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced swelling on left toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on left toe on 11-APR-2021, and arm hurt a lot, and very tired on 07-APR-2021. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures.
54 2021-04-22 pain in extremity ARM SORENESS; This spontaneous report received from a consumer concerned a 54 year old male. The pat... Read more
ARM SORENESS; This spontaneous report received from a consumer concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness. This report was non-serious.
54 2021-04-22 pain in extremity Patient presented to ED on 4/22/2021 with non-productive cough, mild shortness of breath x 10 days.... Read more
Patient presented to ED on 4/22/2021 with non-productive cough, mild shortness of breath x 10 days. Acute onset chest pain x 1 day. Chronic bilateral leg swelling, but worsening leg pain. Hx of DVT and PE, not on anti-coagulation.
54 2021-04-23 weakness Evening after getting vaccination I developed fairly loud tinnitus in both ears. The ringing was lo... Read more
Evening after getting vaccination I developed fairly loud tinnitus in both ears. The ringing was loud enough to keep me awake, even though I felt pretty weak and achy from the vaccine. It subsided after about a week but is still present to some extent. I've noticed it off and on before the vaccination, but never so steady or strong. About one month after the vaccine I'd say it's a little worse than before, but not terrible.
54 2021-04-26 cold extremities I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, ... Read more
I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.
54 2021-05-02 pain in extremity Arm is still sore after 5 weeks
54 2021-05-15 muscle spasms, pain in extremity pain in left foot and left calf feels like cramping...has continued since 3 days after the shot. sti... Read more
pain in left foot and left calf feels like cramping...has continued since 3 days after the shot. still happening.
54 2021-05-24 muscle spasms FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLI... Read more
FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 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: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.
54 2021-05-24 tingling Chills starting in upper left quadrant of back and feeling of sunburn hypersensitivity starting on 5... Read more
Chills starting in upper left quadrant of back and feeling of sunburn hypersensitivity starting on 5/13/21, Dailey spread across back then chest, then stomach and down legs. No rash no fever, then aches and pain feeling in same areas. Then spread sunburn feeling up neck to bask of skull with aching pains on both sides of neck. Scalp now painful to touch and have chills radiating through body when exposed to cold air. Skin hyper sensitive to shower (hot or cold)with pain like needles
54 2021-05-25 pain in extremity Experienced severe headache, leg pain, shortness of breath. Was admitted to Hospital on 4/11/2021. ... Read more
Experienced severe headache, leg pain, shortness of breath. Was admitted to Hospital on 4/11/2021. Discharged 4/12/2021. Follow up w Primary doctor
54 2021-05-26 pain in extremity April 13 (I had been traveling before it and came back) and I was preparing for work and my foot hur... Read more
April 13 (I had been traveling before it and came back) and I was preparing for work and my foot hurt. I hobbled around that day and noticed my foot was swollen. The next morning, I went to Piedmont Hospital ER( on the 14th) - they gave me a starter dose of blood thinners and I was able to schedule appt with Dr. Shamm -my hematologist - Zeralto - was what she prescribed. Everything is "back to normal." But based on my health history - the doctor care will be ongoing and I'll continue to see this doctor for treatment.
54 2021-05-27 bell's palsy, facial paralysis Stroke-like symptoms of headache and left-sided facial droop/paralysis began around 3:30pm on 5/21/2... Read more
Stroke-like symptoms of headache and left-sided facial droop/paralysis began around 3:30pm on 5/21/2021. Went to Emergency Room. CT scan ruled out blood clot and stroke. Diagnosed with Bells Palsy. 15 day course of treatment of Prednisone is currently underway, starting with 60 mg on days 1-5, followed by 50mg day 6-7, 40 mg day 8-9, 30 mg day 10-11, 20 mg day 13-14, and 10 mg day 14-15. (As of today, 5/28/2021, I am on 50mg day 7). Paralysis has not yet subsided.
54 2021-05-28 numbness, pain in extremity Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg an... Read more
Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg and butt area.sever joint pain in lower back and hips and knees hands and feet.at 5 hrs of injection. Sore throat and inside if ckeeks and swellind of lower lip1 sat after injection. Joint pain in knees and lower back pain was severe and lasted 3 days. Numbness in fingers at 1 day - oresen confysen in thinkinj
54 2021-05-31 pain in extremity DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 ye... Read more
DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 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: unknown, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-APR-2021, the patient had sore arm. On 17-MAY-2021, the patient noticed that his left leg got bigger and ignored it, he measured his calf which was 2 inch wider and elevated his feet. On 24-MAY-2021, it was really big and then the doctor sent him to urgent care and it was confirmed a case of deep vein thrombosis (DVT) and he was treated with blood thinner. Still his calf, ankle and foot looks bigger. The patient's wife did not have the lot number. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 28-APR-2021, and had not recovered from DVT in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556854 -Covid-19 vaccine ad26.cov2.s - DVT IN LEFT LEG . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
54 2021-06-01 unresponsive to stimuli At 12-00pm the pharmacist gave patient a J & J Covid Vaccine. He asked him to sit down for 15 minut... Read more
At 12-00pm the pharmacist gave patient a J & J Covid Vaccine. He asked him to sit down for 15 minutes. At approximately 12-10PM Patient yelled for assistance. At the time the pharmacist ran over to the chair. Patient siaf that he was going to pass out. His eyes rolled back and it seemed like a seizure, at that point he began to pass out. The pharmacist assisted him to the floor. He was unresponsive on the floor for 10 seconds. After 10 seconds he regained consiouness. He said he felt fine. We called the ambulance. They came 15 minutes later. The pharmacist did his vitals pulse: 60 respirations:16 blood pressure 115/70. At that time the ambulance came and assisted him to the hospital.
54 2021-06-03 migraine Headaches, migraines, sensory issues.
54 2021-06-08 weakness About 8 hours after the vaccine at 2:30am I had a fever and bad sweats, back and stomach pain, diarr... Read more
About 8 hours after the vaccine at 2:30am I had a fever and bad sweats, back and stomach pain, diarreha, lost of bowel control, achy all over. Which prompt me to call for an ambulance. I went into the ER I had to get 3 bags of IV fluids for dehydration, anti-nausea medication, pain medication for back pain because I passed out and hurt my back and cut my face. I also had swollen in my left foot. I am still having fatigue feeling. I still don't have my energy levels back from before the adverse event.
54 2021-06-15 migraine Had migraine headaches for about 3 weeks, following Johnson and Johnson injection.
54 2021-06-16 weakness Patient reported that he has been experiencing decreased range of motion (limited range past shoulde... Read more
Patient reported that he has been experiencing decreased range of motion (limited range past shoulder height), increased pain and soreness with movement, and decreased strength to lift weights that were previously easily lifted. Stated that these symptoms started 2-3 days after he received the vaccine. Stopped by the pharmacy counter 6/12/21 to inquire as to whether this could be related to the vaccine.
54 2021-06-24 feeling cold During the 15-minute observation period, the patient had a fainting episode. He was briefly not awar... Read more
During the 15-minute observation period, the patient had a fainting episode. He was briefly not aware of his surroundings and felt cool and sweaty to the touch. After a couple minutes, the patient slowly started regaining his mental status and was able to tell us his name, date, and the name of his kids. The EMTs arrived and did a thorough assessment; they determined that because the patient had not had anything to eat or drink all day up until his vaccine appointment, coupled with the fact that the patient had walked 5 minutes to the pharmacy and the weather was warm, the patient's blood pressure and sugar likely bottomed out and caused him to faint. The patient was given an ice pack to cool down and orange juice to normalize his blood sugar. After waiting in the pharmacy for another 15 minutes, the patient was deemed fit enough to walk back home. He was advised to have something to eat and take a cool shower.
54 2021-07-07 numbness and pain in extremities, face paralysis, bell's palsy, pain in extremity, tingling, numbness To begin, I have always been a healthy, middle-aged male, with no history at all of neurological pro... Read more
To begin, I have always been a healthy, middle-aged male, with no history at all of neurological problems. What follows is a comprehensive summary of all that happened to me shortly (7 days) after getting the Janssen COVID vaccine and the supporting documentation to support the diagnosis of my having developed Guillian-Barre' Syndrome (GBS) as a direct and obvious consequence of the vaccine. THURSDAY, 5/13/21: Received the J&J vaccine at 10:00 AM (LOT NUMBER 205A21A). FRIDAY - THURSDAY, 5/13 - 5/20/21: No obvious reaction to the vaccine, at all. FRIDAY, 5/21/21: During the day, I noticed deep-muscle pain/soreness in both shoulders (deltoid muscles) that increased throughout the day. It felt as if I had been doing heavy-weight presses with the resulting soreness. I attributed it to a delayed reaction from the vaccine (as I'd heard muscle pain, particularly in the shoulders, is a common reaction symptom), as I had no injury or other possible cause and chose to ignore it. It may have even started a day or two before Friday, but wasn't of such consequence as for me to recall it; the only vivid memory I have is the discomfort on Friday, 5/21/21. SATURDAY - SUNDAY, 5/22 - 5/23/21: I had continued shoulder pains, but ignored them because they were not acute and just attributed them to a short-term vaccine reaction. MONDAY, 5/24/21: In the evening, while sitting in the bleachers attending a sporting event, I noticed my buttocks was pretty sore. The bleachers are not normally comfortable, but this was a dull, serious ache across my entire buttocks. I didn't know to what to attribute it (not yet at that time associating it with the shoulder pain), so ignored it. In retrospect, I realized later that the soreness I was feeling at that time was similar to the shoulder pain and was the pain felt from a deep numbness across the buttocks, akin to when a body part (hand, foot, etc) "falls asleep" so deeply that it's numb, but is still very, very sore. Later that night, my upper back began to feel sore, from shoulder to shoulder, down to my mid-back. As the night progressed, this pain increased exponentially to a "Level 10", leaving me unable to sleep but in 15-minute increments, wandering the house to find a spot -- sofa, chair, floor, anywhere -- to give me some comfort to sleep; I slept 2 hours, total, that night. The pain across my back felt equivalent to someone beating me with a baseball bat all over my upper back -- it wasn't an acute, localized pain, but very deep and broad across the area. Normally, Aleve quickly resolves any pain issues I have, but overnight, it did nothing to reduce the pain. TUESDAY, 5/25/21: I began to piggyback Aleve and Extra Strength Tylenol, and that seemed to help abate a little of the most intense pain, but it was still painful and precluded sleep and much of my working. I think it was at this time that I began to notice the pain and numbness going beyond my buttocks, down the backs of my legs, and into my feet, leaving my feet (and toes, in particular) numb and tingling. I also began to notice a problem with balance and gross motor controls (stumbling when walking, nearly falling several times in the shower) -- all symptoms I have never experienced in any capacity. Additionally, I had considerable pain down the backs of my legs, leading me to feel as if my calves and hamstrings had been through a heavy workout the day before and desperately needed stretching -- however, any attempts to do so led to excruciating, stabbing pains in those muscles. I also noticed that the pain in my upper back was becoming more acute and localized in my cervical vertebrae area. Having taken care of a father who has had many back surgeries and suspecting I have my own degenerative cervical disc issues (I've had past neck pains), I began to believe that all the pain and numbness throughout my body might be due to a cervical issue (e.g., bulging disc, stenosis, etc), and so tried to treat the area as such, with hot shower, heating pad, better neck support, etc. I continued to piggyback the two pain meds that day, but the upper back and neck pain and numbness and gross motor issues came back in full that night, again leaving me no relief for sleep -- I could only doze in 15-minute increments and found no position or place to sleep that was comfortable; I was in tremendous pain 10) across my entire back and down my legs. By 2:00 AM, I knew there was going to be no relief, and I couldn't wait until the morning; I drove myself to the nearby ER, again still believing/expecting at the time that this was a spinal issue. In the ER, I was met by a PA who reviewed my situation, determined that cervical imaging was unnecessary, and prescribed Percocet. My blood pressure was recorded at 160/94. I was released after two hours and returned home. Despite the meds, I was still in considerable pain that night and found myself unable to sleep in more than 10- to 15-minute increments. WEDNESDAY, 5/26/21: During the day, the Percocet seemed to abate the pain, somewhat, although it tended to flare up much more at night during the prior 2 nights, anyway. However, I noticed I had an upset stomach by midday, and as the day progressed, the pain in my abdomen grew considerably. By the evening, the pain across my abdomen was unbearable, as bad as it was in my back and legs. Late in the evening, I researched Percocet and saw that abdominal pain and nausea are two prominent side effects. I stopped taking the pain medication immediately, knowing that my back pain would return in full through the night; again, I slept in 15-minute increments in considerable back and abdominal pain for a total of about 3 hours. It was also during the day Wednesday that I noticed considerably worse gross motor skills (e.g., walking, ascending/descending stairs, standing up straight, writing), balance, and increased numbness and tingling in my legs, feet, and hands. At one point, I tried to walk by my daughter in a hallway in the house, and in trying to go around her, I fell against the wall. She thought I was joking; I wasn't. It happened several more times that week. Also, this day or the next, I started noticing additional problems with urinating and defecating. It felt as though I had no control over my abdominal muscles, so could not strain or push when going to the bathroom. When trying to have a bowel movement -- and I knew needed to -- I felt as though I had no control to push; when urinating, I had no muscle support for pushing out the urine. THURSDAY, 5/27/21: Still believing these pain, numbness, and other neurological, problems to be related to cervical vertebrae/disc issues, I had an appointment with a spine orthopedist. He ordered cervical X-Rays and confirmed that I do have disc compression/degeneration, but not excessive and nothing that could explain the pain and numbness persisting all over my back, down to my hands, across my buttocks, and down my legs to my feet. The message: the cervical discs were not the problem. This is when I reconsidered all I had been through, tying back to the initial pain I felt in my shoulders the prior Friday. This is when I realized that my body had been reacting to the vaccine. Never before in my life had I had neurological problem. Never before had I experienced pain, numbness, and tingling across my entire body that way, so until that moment, I hadn't considered the vaccine to be a possible vector for all that was going on with me. The coincidence of these events was FAR too great to be anything but a causal relationship. The likelihood of these symptoms arising on their own is infinitesimal in comparison to a causal effect. The vaccine had triggered a serious and painful neurological response in my body. The orthopedist, knowing I had responded poorly to the Percocet, prescribed oxycodone. I took that pain medicine that day and into the evening, but once again, my stomach and abdomen began to bother me and the abdominal pain returned. Once again, I looked at the side effects of the medicine, and the first two I saw were stomach pain and nausea. I stopped taking the pain medicine immediately. That night, I slept a total of 2.5 hours. FRIDAY, 5/28/21: I was still in considerable pain, and that combined with very little sleep (and none of it good) for 4 days led me to having trouble thinking clearly. My wife insisted I needed to go back to the ER in the morning to see what could be going on. My blood pressure upon being seen was initially approximately 185/140, but what was finally recorded after a second test was 191/112. I waited to be seen for about 2 hours, but I finally met with the ER physician and described my history of problems that week, including my then-belief that this was a vaccine reaction. She ordered full bloodwork, chest X-Ray and CT scans (without contrast) of lumbar and thoracic spine and CT scan with contrast of chest/abdomen. Nothing strikingly abnormal was found in these scans, but doctors (ER physician and neurologist) noted bliteral weakness in lower and upper body. The doctors wanted to order MRIs, but I am unable to have an MRI due to a piece of metal in my left eye. The morphine I was administered helped reduce my pain and my blood pressure upon leaving had abated, somewhat (don't recall my final BP). Both doctors seemed not to believe that these symptoms could be the result of an adverse vaccine reaction, but they were unable to explain a cause. On my inquiry, at my friend's recommendation I ask to verify, the neurologist disagreed that these were symptoms of a presentation of Guillian-Barre' Syndrome (GBS). The ER doctor asked if I was interested in being admitted, but I felt some of my more extreme symptoms (blood pressure and pain -- thanks to the morphine) had abated sufficiently to allow me to leave. After 8 hours in the ER, I left and returned home. My numbness, tingling, some pain, balance, and motor skills issues persisted, but were blunted somewhat (probably from the morphine?). It was either this day or the next, that I was standing outside, and knowing I had problems walking and with balance, I decided to try to run a few steps to see how weak my legs were and bad my motor skills and balance were. Immediately, it was clear that things were worse than I had considered. I had very poor control of my legs -- they flew off to the sides, out of control, as I tried to step; I stumbled a couple times and almost fell; and I couldn't proceed in a straight line, veering off at an angle. I earnestly tried several times, with the same results each time. That night, while the pain was still there, it was tolerable enough that I was able to sleep for a total of about 5 hours. SATURDAY, 5/29/21: Early in the AM, I noticed I was unable to smile. Having a friend who had had Bell's Palsy, I recognized the signs immediately. The left side of my face sagged, I was unable to smile (left side of my mouth sagged), and I was unable to close my left eye. My wife took me to the ER, and we were met by the same ER physician who had seen me the day before. She was shocked about my return so soon after my prior visit. My blood pressure, on being admitted, was 151/102, but as with my other visits, asymptomatic other than the problems described before (pain, numbness, and tingling, in my back, arms, legs, and abdomen; gross motor movement; lack of coordination; and lack of clarity in thinking); no other signs of infection or illness. The Dr ordered a CT scan (without contrast) of my head and other bloodwork. Of note, the CK came back at 712 U/L. The CT scan came back normal. Again, I was administered morphine, which abated my pain and allowed me to relax. After 3 hours, I was released, with prescriptions for Amlodipine for the high blood pressure and Prednisone and Valtrex (Valacyclovir) for the Bell's Palsy. The morphine helped reduce my back and abdominal pain and give me some comfort, such that I could sleep another 5 hours that night, although all other symptoms persisted. SUNDAY - WEDNESDAY, 5/30/21 - 6/2/21: I continued to experience the numbness and tingling in my back (primarily), abdomen, legs/feet, and arms/hands, but my severe pain began to abate, such that I could sleep a bit more easily. I taped my eye shut at night, as my Bell's Palsy eyelid would not close fully, and it teared constantly. WEDNESDAY, 6/2/21: Not having a GP, I finally found an Internist to review my case and symptoms, but primarily to extend my meds (Blood Pressure and antiviral and steroid for the Bell's Palsy), as the ER doctor had only given me a 5-day prescription. The doctor review my situation and continued the meds. Having been prompted regularly by my friend to confirm a GBS diagnosis, I asked this doctor about a possible GBS-vaccine link and after a cursory review, he said he did not think so. THURSDAY, 6/3/21: With the weakness in my left eyelid, my desire to find a resolution to it, and my concerns about its effect on my vision, I had an appointment with my opthamologist, who recommended eye drops until the eye improved and instructed me to stop taping the eye shut. She noted no other problems with my vision. FRIDAY - MONDAY, 6/4/21 - 6/7/21: During this time, the medicines for my Bell's Palsy seemed to take effect, and the paralysis symptoms abated mostly (with some residual weakness in my left eyelid). I continued to experience the other neurological symptoms, however. TUESDAY, 6/8/21: Having been unable to get a timely appointment with a trusted neurologist, a friend with a contact at medical school head of neurology was able to get me an appointment with a neurology faculty member. I met with Dr. that afternoon, and he was the first to really listen to the symptoms I had and understand some of the possible triggers and consequences of them. I started the conversation explaining that I'm a reasonable, rational, and science-based person, an engineer by training and career, and that I firmly believed all the symptoms I was presenting were a direct consequence of my getting the vaccine. Additionally, at my friend's continued urging, I asked if these symptoms could point to a Guillian-Barre' diagnosis. He was at first skeptical of my proposition of the vaccine cause, but was quick to say he was glad I had raised the question of GBS, because he had that diagnosis in mind, as I discussed my symptoms. He believed that the symptoms I had and the way and speed with which they had progressed pointed to a likely GBS diagnosis. He scheduled a follow-on appointment to have an Electromyogram (EMG) and Nerve Conduction Study to assess the extent of the neurological damage and prognosis for resolution, as I am unable to get an MRI and he seemed to feel a lumbar puncture was unnecessary. FRIDAY, 6/11/21: I had my scheduled EMG and Nerve Conduction Study with Dr. The results showed some abnormal neuropathy, but mostly normal in my extremities and indicative of some recovery from symptoms. Although I still had considerable numbness, tingling, and some pain down my legs into my feet and down my arms into my hands, my most prevalent issues at that point were numbness and tingling across my entire upper back and abdomen, but the doctor indicated these tests don't identify issues very well, that they are better designed for testing neurological issues in the extremities. We agreed to reconvene over the phone in several weeks, unless problems worsened. TUESDAY, 6/29/21: During a follow-up appointment with the doctor, I indicated that some of my neurological issues were abating and that my blood pressure had returned to near-normal range. My energy was returning to a degree and my motor skills and balance and control had improved. However, I continued to have significant numbness and tingling across my back and abdomen, and of greater concern, I had increasing tingling and pain going down my left arm to my index finger when I stretched out my arm. This was a new symptom and increased in pain in frequency in the following days and raises the question of what other symptoms might arise. AS OF 7/8/21: CURRENT STATUS: I have continued numbness and tingling in my feet and hands and back and abdomen, although they are reduced from their earlier state. However, I have increased shooting pain in my left index finger when stretching out my left arm. Additionally, I have a mild increase in weakness in my left eyelid, after prior improvement from the Bell's Palsy. My dangerously high blood pressure at the early onset of these symptoms has returned to near-normal levels, although my GP continues to keep on blood pressure medicine (Amlodopine) for now. Finally, a lot of the issues I had thinking clearly and regularly making mental mistakes, all noticeable and commented on by my family, have lessened, although I still find myself making mental mistakes and forgetting information that would have been MUCH less likely prior to this adverse GBS event caused by the J&J vaccine.
54 2021-07-09 muscle twitching Patient has staring to develop a twitching in the left eye followed by pressure and a gritty feeling... Read more
Patient has staring to develop a twitching in the left eye followed by pressure and a gritty feeling with redness.
54 2021-07-11 weakness May1,2021 Loss of strength in arms legs and hands. June 4, 2021; Diagnosis CIDP. Being treated w... Read more
May1,2021 Loss of strength in arms legs and hands. June 4, 2021; Diagnosis CIDP. Being treated with IVIG.
54 2021-07-15 muscle twitching congestive heart failure, left bundle branch blockage, left ventricle wont dialate, EF of 20%. wate... Read more
congestive heart failure, left bundle branch blockage, left ventricle wont dialate, EF of 20%. water pills 160mg a day, beta blocker, 1/2 a day. muscle twitch while sleeping or rest.
54 2021-07-16 weakness COUGH; COMMON COLD; EXTREME FATIGUE/ LEG FATIGUE; FUZZY MIND (FOR COUPLE OF WEEKS); BONES HURT; HEAD... Read more
COUGH; COMMON COLD; EXTREME FATIGUE/ LEG FATIGUE; FUZZY MIND (FOR COUPLE OF WEEKS); BONES HURT; HEADACHE; FELT WEAK; HEAT GLOW (FEELING LIKE HASN'T SLEPT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced heat glow (feeling like hasn't slept). On 14-MAY-2021, the subject experienced felt weak. On 15-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fuzzy mind (for couple of weeks). On 21-MAY-2021, the subject experienced bones hurt. On 21-MAY-2021, the subject experienced extreme fatigue/ leg fatigue. On 30-JUN-2021, the subject experienced common cold. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fuzzy mind (for couple of weeks), bones hurt, headache, felt weak, and extreme fatigue/ leg fatigue, was recovering from common cold, and heat glow (feeling like hasn't slept), and had not recovered from cough. This report was non-serious.
54 2021-07-16 weakness TROUBLE GETTING UP; COULD NOT FEEL ANYTHING; BRUISED HIPS ARMS AND BUTTOCKS BRUISES HAD SWOLLEN TO B... Read more
TROUBLE GETTING UP; COULD NOT FEEL ANYTHING; BRUISED HIPS ARMS AND BUTTOCKS BRUISES HAD SWOLLEN TO BE SIZE OF A FOOTBALL ON RIGHT BUTTOCKS AND HIP AND FEW SMALLER BRUISES ON RIGHT SHOULDER; DISCOLORATION ON THE BRUISES/BRUISES WERE EXTREMELY DARK; FELT WEAK FROM WAIST DOWN; AS WERE WALKING BUCKLED OVER/ FELTS LEGS BUCKLED COMPLETELY; FELL TO FLOOR BUT DID NOT LOSE CONSCIOUSNESS; BRUISED HIPS ARMS BUTTOCKS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 245 pounds, and height was 76 inches. The patient's concurrent conditions included back issues, and spinal cord stimulator implant, and other pre-existing medical conditions included 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced as were walking buckled over/ felts legs buckled completely. On 19-JUN-2021, the subject experienced fell to floor but did not lose consciousness. On 19-JUN-2021, the subject experienced bruised hips arms buttocks. On 19-JUN-2021, the subject experienced felt weak from waist down. On an unspecified date, the subject experienced trouble getting up, could not feel anything, bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder, and discoloration on the bruises/bruises were extremely dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from as were walking buckled over/ felts legs buckled completely, fell to floor but did not lose consciousness, and felt weak from waist down on 19-JUN-2021, and bruised hips arms buttocks, and bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder on 04-JUL-2021, was recovering from discoloration on the bruises/bruises were extremely dark, and the outcome of trouble getting up and could not feel anything was not reported. This report was non-serious.
54 2021-07-21 numbness, tingling, face paralysis, slurring, weakness The patient's wife called the pharmacy July 19,2021 to inform of the problem. She reported that her ... Read more
The patient's wife called the pharmacy July 19,2021 to inform of the problem. She reported that her husband was feeling excrutiating generalized pain,weakness,numbness and tingling of arms and legs,speech slurring,weakness of left side of the face causing his left eye to remain opened. She reported that they visited the emergency room and his doctor's office several times but was discharged with no diagnosis.
54 2021-07-21 tingling, pain in extremity in mid-June 2021 I started experiencing pain in my feet. They started swelling and feeling tingly..... Read more
in mid-June 2021 I started experiencing pain in my feet. They started swelling and feeling tingly... almost like they had fallen asleep. Minor tingling also started occurring in my hands. On certain days the discomfort in my feet was enough to limit my walking. I noticed on certain days my shoes fit tightly and my calfs were very tight with the ankles showing signs of swelling. The symptoms continue through the date of this filing...sometimes better/sometimes worse.
54 2021-07-25 numbness middle finger on left arm has been slightly numb ever since the day of vaccination
55 2021-03-06 weakness High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but co... Read more
High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto-Bismol. Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21
55 2021-03-08 inability to speak Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported n... Read more
Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported not knowing what he was doing and where he was. Father brought him to ED after having breakfast together and son didn't know how to pay or what foods he liked. Was unable to recall his father's name. Treatment: DAPT with ASA and plavix x21 days and then transition to plavix 75mg daily, atorvastatin 80mg (stroke treatment) Outcome: TBD
55 2021-03-08 feeling cold, hot flush Fever/chills and slight nausea overnight (24 hours post-shot). Temperature check is normal, but swea... Read more
Fever/chills and slight nausea overnight (24 hours post-shot). Temperature check is normal, but sweated through night and general malaise 36 hours after shot still. Hot and cold flashes persist 36 hours after.
55 2021-03-09 feeling hot About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body ... Read more
About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body aches, head ache, and eyes hurt. This is a similar reaction to what I have with the flu vaccine. I no longer get the flu vaccine because of this.
55 2021-03-10 cold sweat Fever, cold sweats for about an hour in the middle of the night (2AM). I took an Aleve and was bett... Read more
Fever, cold sweats for about an hour in the middle of the night (2AM). I took an Aleve and was better in the morning (7AM).
55 2021-03-11 seizure Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presente... Read more
Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain
55 2021-03-12 tingling, discomfort, weakness Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine ... Read more
Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.
55 2021-03-13 muscle spasms, weakness Woke up next morning with headache. Neck began to ache through the day. By 4pm had 102 fever and mus... Read more
Woke up next morning with headache. Neck began to ache through the day. By 4pm had 102 fever and muscle aches and cramps in neck, arms, legs, feet, and back. For the next 8 hours had fever and chills. And sweated profusely soaking the bed. Fever broke around 2 am and now just feel sore and weak.
55 2021-03-13 seizure Seizure
55 2021-03-16 pain in extremity 3-15-21 headaches, running a 101.8 fever Monday night. Tuesday ran a fever of 100.5. 3-16-21 Legs hu... Read more
3-15-21 headaches, running a 101.8 fever Monday night. Tuesday ran a fever of 100.5. 3-16-21 Legs hurting on Tuesday and body sore. Wednesday feeling extremely tired but no fever. I went back to work today Wednesday 3-17-21
55 2021-03-18 discomfort I experienced pain in my right side of my back. It was not back pain, it felt like my kidney. The ... Read more
I experienced pain in my right side of my back. It was not back pain, it felt like my kidney. The intense pain began March 10, on a scale from 1-10, the pain was a 6. I was uncomfortable when I tried to sleep, lasting throughout the day time hours. and lasted until March 15, 2021. I was prescribed Metocabamol and Meloxican. Also, I applied heat which was not affective, ice, worked at 50%.and I used a portable muscle stem for 1-2 hours at a time. This treatment worked the best. doctor diagnosis was a sprain ligaments of lumbar spine.
55 2021-03-20 burning sensation, pain in extremity I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple o... Read more
I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple of hours after the vaccine, later pain in the legs in the afternoon. At night I had a mild fever, chills, body aches (everywhere) unbearable headache (still going on 24 hours after the shot), pain at the vaccination site (left shoulder, still strong after 24 hours), pain in the lungs (I sneezed a couple of times). I took Tylenol every 4 hours, but did not improve, only brought the fever down a bit. Today after 24 hours, I still have headache, muscular aches, and fatigue.
55 2021-03-22 feeling cold Feeling cold, body aches, headache, extremely tired, sleeplessness
55 2021-03-22 pain in extremity Severe leg pain onset approximately 7 hours after vaccination. Patient was unable to go to work toda... Read more
Severe leg pain onset approximately 7 hours after vaccination. Patient was unable to go to work today.
55 2021-03-26 pain in extremity Arm is still sore two weeks after shot. I had all the signs of Covid a week after the shot. Tast... Read more
Arm is still sore two weeks after shot. I had all the signs of Covid a week after the shot. Taste is still off.
55 2021-03-28 cold sweat Patient in at 1026 reporting dizziness, clammy, pale. Had not eaten yet. 0 CP, 0 palpitations, VS: 1... Read more
Patient in at 1026 reporting dizziness, clammy, pale. Had not eaten yet. 0 CP, 0 palpitations, VS: 101/57, 65, 94%. 0 Meds, 0 PMH. Patient has hx of vagal reactions with shots and blood draws. patient provided snack and water, feeling better after eating and lying down.
55 2021-03-31 pain in extremity I shortly after the shot I having had random pains in arm, including joints [like when the pressure ... Read more
I shortly after the shot I having had random pains in arm, including joints [like when the pressure changes ... don't think I have arthritis]) but they only lasted a few minutes and then would go away. About 10 hours later I started feeling sick. One of the first things I noticed besides a headache was my heart rate jumped up to over 100 beats per minute (it is normally below 84). I started getting chills and fever. It was worse than any flu fever I ever had and I could not sleep. Worst part was my heart rate would not go down, remaining above 100 but below 110-115 beats per minute. I considered calling 911 but after looking online decided not to as long as it remained below 120 bpm. I don't know my maximum temperature - I did not think to take it until after the peak had passed by 20 minutes or so (was 99.4 at that point - normal temperature runs 97.2 (low 96.8, high 98.2)). Heart rate finally started to drop around 3:30 am.
55 2021-04-01 discomfort, tingling Janssen COVID-19 Vaccine EUA Prickly itchy rash appeared on thighs; discomfort waned after ~ 15 min.... Read more
Janssen COVID-19 Vaccine EUA Prickly itchy rash appeared on thighs; discomfort waned after ~ 15 min. Similar rash appeared on arms, legs, & back after showering same day at ~ 5 pm. Again, discomfort waned after ~20 min. Rash appeared on thighs again this morning at ~ 7:30 am. Again, discomfort waned after ~20 min. I have not yet sought medical attention since symptoms have been intermittent rather than persistent since first appearing.
55 2021-04-05 coordination abnormal incoherent uncoordinated unstable unable to perform daily task at all
55 2021-04-05 flushing, feeling cold, discomfort Relaxing watching TV wearing shorts and t-shirt, A/C on at 77, suddenly overtaken with extreme cold ... Read more
Relaxing watching TV wearing shorts and t-shirt, A/C on at 77, suddenly overtaken with extreme cold and body aches about 8:30pm. Sat outside in 85 degrees for awhile to try to warm up. About 9pm got in the walk-in shower and sat on bench super hot water. Got out of shower at 9:40pm my skin beet red mostly my chest. Still freezing and body aches. Put on sweatpants and long sleeve t-shirt. Now have A/C off and windows open, 82 degrees outside. My temp taken before I started this form was at 98.7. I ache all over and am freezing. Not shivering though. But have goosebumps on arms under sleeves. I am very uncomfortable. It is now 10:35pm.
55 2021-04-05 flushing, tingling The patient received the vaccine at 12:20pm. He was observed per protocol for 15min until 12:35. A... Read more
The patient received the vaccine at 12:20pm. He was observed per protocol for 15min until 12:35. At 12:35pm he denied feeling any response to the vaccine and ambulated away with a steady gait. At 12:41pm the patient reported back to the nursing area c/o "dizziness" and feeling like he does when he "drinks too much caffeine" and his left arm felt "tingly." Pt was asked to lay down. Vitals were checked at 12:45pm while patient was laying down. BP 180/90, Spo2 96%, HR 69 and regular rhythm per palpation, Temp 97.7, RR 16. Pt was AO x 4. At 12:50pm BP was reassessed 186/100. At 12:55pm pt reported still feeling "dizzy." His face was flushed. His left arm still felt "tingly." He reported feeling "nauseous" and described "heart palpitations." Pt was asked to sit up and given 50mg of Benadryl PO per policy and 911 was called at 12:56pm. Patient laid back down. At 1300 temp 98.5, pulse 63 and RN noted irregular rhythm by palpation, Spo2 97%, RR 16. The ambulance arrived at 1303 and the paramedics resumed care of the patient. The paramedics noted PVCs on their rhythm strip and BP 170/90. At 1311 patient started reporting "epigastric pain" 5/10 pain. At 1313 the paramedics transported the patient to a hospital (unknown which hospital).
55 2021-04-06 numbness, slurring Started with normal type symptoms aches and pains and then by weds had bad headache and by Thursday ... Read more
Started with normal type symptoms aches and pains and then by weds had bad headache and by Thursday face become numb and slurred speech. On steroids for 7 days. Went to neurologist and getting MRI 4/7/21. Some improvement. Numbness now entire face and now spread through hands and legs "feel like jello".
55 2021-04-06 unresponsive to stimuli Pt wanted to test BP prior to shot. Rph said pt BP was a little high so they waited and took BP agai... Read more
Pt wanted to test BP prior to shot. Rph said pt BP was a little high so they waited and took BP again a minute or 2 later. BP had gone down some, so they agreed to proceed. After dose, pt was dizzy, sweaty, unresponsive for a short time. Once he was more responsive, we helped him sit on the floor against the wall as he was quite dizzy. We called 911 and pt refused transport to hospital, but was evaluated.
55 2021-04-07 pain in extremity Moderate left deltoid pain the day after vaccine - pain is persisting through today 4/8/21 - a month... Read more
Moderate left deltoid pain the day after vaccine - pain is persisting through today 4/8/21 - a month later. Olecranon Bursitis in left arm - same as vaccine - 4/2/21 - seen at ER and given IV antibiotics, then outpatient oral antibiotics
55 2021-04-09 pain in extremity Diarrhea, Sweating, sore arm.
55 2021-04-10 pain in extremity Extreme left arm and shoulder neck pain and tightness within a week of shot and has persisted for ov... Read more
Extreme left arm and shoulder neck pain and tightness within a week of shot and has persisted for over a month. Treated with Methocarbamol and Diclofenac Sodium. Within two and a half weeks of the shot, on March 23rd, sudden loss of peripheral vision in right eye. Doctor diagnosed as NAION, non-arthritic anterior ischemic optic neuropathy. Vision loss in one eye is blurred from varying angles and grayed out and is considered permanent. Eye problem caused pain down neck and jaw. Also, a rash developed over chest with symptoms similar to shingles.
55 2021-04-11 weakness Patient reports feeling dizzy, weak, could not stand. Pt was removed from car and placed on stretche... Read more
Patient reports feeling dizzy, weak, could not stand. Pt was removed from car and placed on stretcher. Pt Vital signs were take and within normal limits. Pt recovered and was sent home via personal vehicle.
55 2021-04-11 weakness Fatigue, chills, moderate weakness, headache. Fever rising to 100.5 by 8 hours after the reaction be... Read more
Fatigue, chills, moderate weakness, headache. Fever rising to 100.5 by 8 hours after the reaction began.
55 2021-04-11 feeling cold Fever of 103 F. Sweating. Cold. Aching.
55 2021-04-12 muscle spasms Headache everyday Cramps Joint pain Muscle pain Tired legs
55 2021-04-13 weakness Approximately eight hours after receiving the shot, I started getting a headache, body aches, and ch... Read more
Approximately eight hours after receiving the shot, I started getting a headache, body aches, and chills (April 3rd, 8 p.m.). I went to bed and had severe chills and body sweats for the entire night. The primary symptom to report is that my heart raced all night. It felt like it was beating at about 140 to 150 Hz or higher. When I woke up in the morning, it felt like my chest had been pounded on all night. The pain was in my sternum area. The headache and body aches took a little over a day to go away. The chest pain took a couple of days to die down. On April 12th, I walked my dogs in the morning and felt out of breath, which isn't normal for me. In the afternoon, while working at my desk at home, I started getting more and more severe chest pain and then started getting dizzy and felt weak. I drove myself to the local ER and they tested me for a heart attack. All tests came back negative. They suggested going to another facility to get checked for clots or to make an appointment with a cardiologist. The next day, after talking to a doctor friend, he suggested going to the ER facility to get imaged for clots and to get fully checked out. No cardiologist appointments were available till the next week. I went to the ER facility and was there for seven hours getting tested. They came back and said all test results were negative and that my heart looked fine. They did not have any suggestions for what might be causing the pain in my chest.
55 2021-04-13 muscle spasms cramp in both legs for about 20 minutes from thigh down
55 2021-04-13 pain in extremity Patient developed pain in both knees and pain and swelling of calves about 36 hours after receiving ... Read more
Patient developed pain in both knees and pain and swelling of calves about 36 hours after receiving the J&J COVID19 vaccine. His Allopurinol dose had been increased to 300 mg. daily a few days before that but no other change in health status. Now his left calf still feels a little swollen and he noticed a bruise there without history of trauma.
55 2021-04-14 pain in extremity Pt reports right leg pain, slight warmth, no redness
55 2021-04-16 numbness SEVERE HEADACHES, LEG NUMBNESS, CHRONIC FATIQUE SYMPTOMS STARTED WITHIN 24HRS AND PROGRESSED
55 2021-04-19 pain in extremity 3-20-21: The day after the shot I had a miner swollen lymph node inner elbow area which went away. ... Read more
3-20-21: The day after the shot I had a miner swollen lymph node inner elbow area which went away. 4-18-21: Perfect health. No pain in left arm. 4-19-21 to 4-20-21 : Over 24 hours sudden increase of swollen lymph node of the inner elbow area of my left arm. Constant pain which increases sharply with arm movement. Unable to lift arm without high level pain. Can't put left arm through coat sleeve without assistance. No medical assistance yet, as this just occurred. Waiting this week to see if it gets better.
55 2021-04-19 seizure SEIZURE; HIT HIS HEAD ON THE CONCRETE; This spontaneous report received from a consumer concerned a ... Read more
SEIZURE; HIT HIS HEAD ON THE CONCRETE; This spontaneous report received from a consumer concerned a 55-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) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the patient was sitting with his wife after receiving the JANSSEN COVID-19 vaccine, when he had started to slump over. Patient experienced seizing (passed out and slipped out of his chair and started). It was reported that the patient hit his head on the concrete. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure (pass out and slumped over) and hit his head on the concrete was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210414732 and 20210414751.; Sender's Comments: V0 20210415021-Covid-19 vaccine ad26.cov2.s-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
55 2021-04-21 pain in extremity Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19.... Read more
Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19. LE ultrasound revealed extensive DVT. Does report a 4 hour plane ride 4 weeks ago.
55 2021-04-22 feeling jittery ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEAD... Read more
ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. 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, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
55 2021-04-22 tingling, discomfort, pain in extremity On 4/15/21 client contacted public health office to report adverse effects of COVID Vaccines. Repor... Read more
On 4/15/21 client contacted public health office to report adverse effects of COVID Vaccines. Reports late afternoon on 4/6/21 he felt "heavy", had a HA, tired, nausea, body aches, high fever (did not take his fever), sweating, only drank water for 3 days, under arm swelling in the right arm. On 4/7/21 reports right shoulder and arm pain all the way down his arm to his hand began with tingling and sharp pain in his hand. On 4/12/21 he was tested for COVID and tested negative. Denies any rash, redness, or swelling at the site of the actual injection. On 4/15/21 was seen by MD for ongoing arm and shoulder pain.
55 2021-04-23 weakness Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vacc... Read more
Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vaccination. pt complained of left leg swelling.
55 2021-04-26 pain in extremity Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. ... Read more
Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. On 3/22 went to urgent care for left elbow swelling which had never occured before in this joint visit deteremined was olecranon bursitis. The very next day began complaining about leg pain around 3/23 and by 3/26/2021 pain was unbearable in the leg and went to ER where patient was then admitted for DVT and pulmonary embolisms.
55 2021-04-27 facial pain Facial muscle soreness and tension. Lockjaw.
55 2021-04-28 seizure Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme hig... Read more
Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues
55 2021-04-28 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after administration pt began to sweat and fainted. Pt regained conciousness after 3 seconds and then remained under observation of the rph until pt was confident they would be able to make it home on their own. #4 benadryl was given to take home but instructed to take if symptoms came back.
55 2021-04-29 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Approximately 10-12mins after the J&J shot was administered, the patient got our attention to let us know he wasn't feeling well and might faint. I quickly tended to him as he slowly passed out. I craddled his head to make sure he did not hit it on the countertop. Pateint was seated. After approximately 30 second the patient started to come to. We gave him some water, took his bp, had him wait 30mins and took his bp again before he left with his wife.
55 2021-04-30 unresponsive to stimuli, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe
55 2021-05-02 tingling, pain in extremity, cold extremities 7 days after my first shot into my left arm. my pointer finger turned white / purple and was tinglin... Read more
7 days after my first shot into my left arm. my pointer finger turned white / purple and was tingling numb and cold. that would come and go and then about day 14 my middle finger experienced the same thing as my pointer got worse and more painful. , by day 20 my ring finger started to experience it but never as bad as the pointer and middle. I went to the DR at that time and it was presenting as Raynaud's. and i was prescribed amLODIPine (NORVASC). after a week of this seams not to help.
55 2021-05-03 tingling, numbness, pain in extremity Numbness in nose and upper lip shortly after receiving shot. Both arms pain and numbness and tinglin... Read more
Numbness in nose and upper lip shortly after receiving shot. Both arms pain and numbness and tingling. Back and neck pain. Arm swelling.
55 2021-05-04 muscle spasms BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report rece... Read more
BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
55 2021-05-06 mild one side paralysis Lt sided weakness, subjective fevers, body aches, seen in the ER, continues to have symptoms
55 2021-05-11 bell's palsy New onset Bell's palsy L face on 5/8/2021. Confirmed on examination 5/12/2021
55 2021-05-12 weakness LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old... Read more
LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced light headed. On MAY-2021, the subject experienced fatigue. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, light headed and weak was not reported. This report was non-serious.
55 2021-05-12 feeling hot, weakness, facial pain, night sweats Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front... Read more
Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all, since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021
55 2021-05-14 pain in extremity Sore left arm, also felt like I had a fever of 101 deg but was actually normal. Headache and body a... Read more
Sore left arm, also felt like I had a fever of 101 deg but was actually normal. Headache and body aches
55 2021-05-15 numbness, facial paralysis facial numbness/drooping, flare up of bell's palsy
55 2021-05-16 pain in extremity On March 28th, started noticing symptoms. There was pain in my entire right leg, shin swelling; calf... Read more
On March 28th, started noticing symptoms. There was pain in my entire right leg, shin swelling; calf- swelling and skin discoloration; and right foot - swelling. On 4/1, I went to Urgent Care where I was seen, evaluated and treated by Dr. She ordered blood tests and an ultrasound within 20 minutes. I had 4 blood clots in 3 veins in my right leg/DVT. My blood platelet value was 267 and the standard range is 130 to 400. They didn't consider it low, but it's still an issue. I was given an injection of Enoxaparin Sodium Injection--1 ml injection twice a day for 5 days, which was started in the ER. I then switched to Pradaxa 150mg pill twice a day. I took that until around the 6th of this month when I noticed my right leg had gotten worse. I was instructed to go back to the urgent care. Another ultrasound was ordered and it showed I still had the 4 blood clots in 3 veins that seems to have worsened, so the meds were not working. He consulted with a vascular surgeon and they put me back on the injection once a day, which I am currently still on. I was told to follow up with my PCP in two weeks and that appt is on Thursday with Dr.
55 2021-05-17 involuntary muscle movements After 5 minutes from giving the vaccine. Patient started to say he was getting dizzy. He lost color... Read more
After 5 minutes from giving the vaccine. Patient started to say he was getting dizzy. He lost coloration at first, but could speak just fine. Then a few seconds later he appeared to lost consciousness, his head fell back, and he started to have jerking movements. He was making noises that almost sounded like a snore to me right at first, but it was more than likely him gagging on saliva. 911 was called, and his symptoms continued for roughly 30-60 seconds. EMS took him to hospital where they diagnosed it as vasovagal syncope and just gave him some fluids.
55 2021-05-21 tremor, bell's palsy Bell?s Palsy, muscle pain, muscle tremors, recurring headaches
55 2021-05-22 muscle spasms My deltoid will knot up (spasm) if I stretch or reach forward as to work on something or lift anythi... Read more
My deltoid will knot up (spasm) if I stretch or reach forward as to work on something or lift anything from an awkward position where that muscle needs to contract significantly. I have to lower my arm and massage it to try to get it to relax again. Symptoms developed within a week of the vax and are focused precisely at the injection site. Pain and intensity of the spasm depends on how quickly I back off but if I am holding something I can drop and can't back of fast enough it gets fairly intense.
55 2021-05-24 migraine The participant woke up with a severe migraine headache. He couldn't focus on anything everything lo... Read more
The participant woke up with a severe migraine headache. He couldn't focus on anything everything looked blurry, He went to work and couldn't focus on numbers, every time he tried to read everything was blurred, He had a constant headache for 2weeks and his eyes are still experiencing blurred vision. He heard that several others also experienced reactions who were vaccinated at his job. He missed 2 days of work and went to urgent care, where he was advised to go to the ER immediately. He had someone take him to ER because he was advised not to drive. To this day he still has a hard time focusing on numbers, When reading the shelf tags at his job everything needs a lot more focus to help with blurriness.
55 2021-05-24 pain in extremity pt started having pain in his left foot. He now has to limp since he has trouble putting any weigh... Read more
pt started having pain in his left foot. He now has to limp since he has trouble putting any weight on it. He has some pain in the calf and chin also. He states he has never had any pain or problems with this foot in the past. Pt will make an appt to see a doctor regarding his foot.
55 2021-05-28 pain in extremity I woke up and had a fever of 103. also had chills felt like I had covid. I couldn't walk on my right... Read more
I woke up and had a fever of 103. also had chills felt like I had covid. I couldn't walk on my right leg , my calve in my right leg was super red. I called my Doctor and he told me to take Tylenol. I felt better about 2 days later but my right calve was sore for a week.
55 2021-06-03 pain in extremity, numbness, tingling NUMBNESS IN BOTH ARMS; TINGLING IN ARM; PAIN IN RIGHT ARM ALL THE WAY TO THE WRIST; INJECTION SITE S... Read more
NUMBNESS IN BOTH ARMS; TINGLING IN ARM; PAIN IN RIGHT ARM ALL THE WAY TO THE WRIST; INJECTION SITE SORE; HEADACHE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, and concurrent conditions included cataract, teeth problems, nerve condition, penicillin allergy, marijuana abuse, non-alcohol user, and cigarette smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced numbness in both arms. On 30-MAY-2021, the subject experienced tingling in arm. On 30-MAY-2021, the subject experienced pain in right arm all the way to the wrist. On 30-MAY-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on MAY-2021, had not recovered from pain in right arm all the way to the wrist, tingling in arm, and numbness in both arms, and the outcome of injection site sore was not reported. This report was non-serious.
55 2021-06-05 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild
55 2021-06-07 pain in extremity Tinnitus in left ear which is severe and still there. Sore arm
55 2021-06-07 pain in extremity Severe chills and fever and sweating started at 7pm and continued until around 6am. Severe pain in... Read more
Severe chills and fever and sweating started at 7pm and continued until around 6am. Severe pain in right calf muscle started at 3am on 6/3 and lasted for 24 hours. At the direction of my dr, i was seen in the ER at hospital. The hospital checked for blood clot but ultra sound showed no clots.
55 2021-06-09 numbness and pain in extremities, burning sensation One week after injection, periphery neuropathy. Significant burning sensation in both ankles, top of... Read more
One week after injection, periphery neuropathy. Significant burning sensation in both ankles, top of feet, and lower calves. The following day, today, doing much better. It may have built up in the preceding days, but by day 7 it was overwhelming. It is not day 8, symptoms are mild to non existent.
55 2021-06-10 facial paralysis LEFT SIDE FACIAL PARALYSIS INCLUDING EYE; This spontaneous report received from a consumer concerned... Read more
LEFT SIDE FACIAL PARALYSIS INCLUDING EYE; This spontaneous report received from a consumer concerned a 55 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient had no medical problems before the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown), dose was not reported, 1 total, administered on 28-MAY-2021 to left arm as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included unspecified blood pressure medication, an unspecified diuretic, aluminium hydroxide/magnesium hydroxide (Maalox) for stomach issue, and vitamin b nos. On 29-MAY-2021, Saturday around midnight the patient experienced left side facial drooping. On 30-MAY-2021, the patient was hospitalized. The patient did not have a stroke, but was on medication now with facial paralysis, taking multiple medications including unspecified steroids. The patient was getting blood work every 10 days now and was seeing a neurologist for the paralysis. It was also reported that the patient could not see out of left eye due to drooping but seemed to be looking better after a week with steroids. On an unspecified date in 2021, Laboratory data included: Blood test (NR: not provided) Not reported. The patient was hospitalized for 1 day and was discharged on 31-May-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left side facial paralysis including eye. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:20210608311 -COVID-19 VACCINE AD26.COV2.S-Left side facial paralysis including eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
55 2021-06-10 unresponsive to stimuli Johnson & Johnson COVID Vaccine EUA J&J Dose 4/9/21 NOT COVID POSITIVE 5/25/21: The patient is a 55... Read more
Johnson & Johnson COVID Vaccine EUA J&J Dose 4/9/21 NOT COVID POSITIVE 5/25/21: The patient is a 55-year-old male presents to the emergency department via EMS today after calling 911 with acute shortness of breath and being found unresponsive and pulseless at home, subsequently requiring cardiopulmonary resuscitation on route to the ED. the patient has a past medical history significant for gout, which he takes indomethacin as needed, and recently went to another state in March. His significant other reports that COVID-19 infection went throughout the house in December, although he did test negative, they believe he had it due to his symptoms. He did have that Johnson and Johnson COVID-19 vaccination at the beginning of April of this year. Apparently the patient was speaking with the 1st responder right up until for minutes prior to EMS arrival and when fire department arrived on the scene the patient was found unresponsive, pulseless, and apneic, and subsequently they performed 1 round of CPR administering epinephrine and Narcan, when the patient regained a pulse. The patient lost a pulse again, requiring subsequent CPR and airway tube was placed. The patient arrived in the ED at 10:02 a.m., epinephrine was administered x7 rounds, patient was intubated with a 7.5 ET tube, Lucas device on patient, at 1053 the patient was awake, opening his eyes, squeezing nursing staff hand. At 10:59 a.m., nursing staff reported patient trying to pull his ET tube out. The patient received at least 1 hour 15 minutes CPR including time on scene, on route to ED, and in ED. At 11:10 a.m. patient's O2 saturation decreased to 79%, patient became diaphoretic with decreased responsiveness. At 11:13 a.m., cardiology was at the bedside. The patient's laboratory studies were significant for platelets 44, INR 1.2, CO2 16, AGAP 24, glucose 475, BUN 17, CR 1.55, ALT 248, AST 274, ALP 123, mg 2.9, lactate 15, troponin negative, 1st ABG: PH 7.11, pCO2 39.4, base excess -17, PO2 46, HC03 12.6, O2 saturation 100%. EKG showed right bundle-branch block with ST elevation in lead 3, V1, V2, V3, and V4 leads with ST depression in 1, aVL, and lead II. Limited stat bedside echo showed akinetic septum and hypokinetic right ventricle. The patient was taken to the cath lab. Dr. completed a pulmonary arteriogram and found bilateral massive emboli subsequently undergoing thrombectomy. Patient was on epinephrine, norepinephrine, IV fluids, heparin, and propofol. The patient was seen postprocedure in the intensive care unit while mechanically ventilated and sedated. The patient's sedation was stopped and the patient woke up, moved all extremities, and followed some commands. The patient's significant other was at the bedside. He is currently on norepinephrine at 20mcg/min, epinephrine 20mcg/min, heparin per PE protocol after receiving bolus in CCL, propofol 25mcg/kg/min, and IV NS fluids. The patient's wife reports that he has a history of chewing tobacco, but quit over 20 years ago. She believes that he has a family history of blood clots in his sister's and maybe his dad, but she is not completely sure about that. 6/8/21: 56-year-old man who called EMS with complaints of acute onset shortness breath, was found unresponsive, apneic and without a pulse on arrival of EMS. ACLS protocol was initiated, he was brought to the emergency department where CPR was continued with Lucas device. He was intubated, required administration of 7 rounds of epinephrine, a total of 1 arm 15 minutes of resuscitation was required prior to return of spontaneous CT circulation. Cardiology was emergently consulted, he was taken to the cath had last cath lab with only mild nonobstructive CAD noted. He then underwent pulmonary angiography with the finding of saddle pulmonary embolism as well as bilateral main pulmonary artery thrombosis. He underwent mechanical thrombectomy of the right and left main pulmonary trunk, right upper middle old and lower lobe pulmonary artery, left lower lobe pulmonary artery. Therapeutic anticoagulation was initiated with IV heparin then transition to oral Eliquis. He was treated with empiric antibiotic therapy for presumed aspiration pneumonia. Tunneled hemodialysis catheter was placed secondary to legal Rhea and acute kidney injury, renal replacement therapy was initiated with CRRT. Clinical response was favorable, he was subsequently extubated and transitioned to intermittent hemodialysis. He was assessed by Physical and Occupational therapy and recommended for acute rehabilitation placement. His been discharged today in stable medical condition to continue hemodialysis as scheduled per Nephrology at the acute rehabilitation unit.
55 2021-06-15 pain in extremity My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard t... Read more
My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard to put on and take off t-shirts. Hard to lift with my arm and it is weaker now.
55 2021-06-28 pain in extremity Left arm pain, angina equivalent, woke up after going to bed with left arm pain, radiating from shou... Read more
Left arm pain, angina equivalent, woke up after going to bed with left arm pain, radiating from shoulder down the arm.
55 2021-07-05 pain in extremity, numbness I started to suffer from a numbness in my left hand that radiated into a deep pain and increasingly ... Read more
I started to suffer from a numbness in my left hand that radiated into a deep pain and increasingly became intense. That pain radiated up to my shoulder and into the left quadrant of my chest. I started experiencing shortness of breath and a hypersensitivity to the heat. I went to Hospital ER and they ran a bunch of tests. I was diagnosed with a blood clot in my arm. I was given Eliquis. I was on that medication for about 2 weeks and after my second week of being on Eliquis, I started to suffer from the same symptoms. I decided to go to the Hospital. When I went there they admitted me and ran through blood tests to check for a heart attack or stroke or anything relating to the pain I was experiencing. Now I am back home and I am still taking Eliquis. As of today, I am still experiencing the symptoms. The symptoms are mild, but it's still scary. I would like to add that I have had an increase in dietary intolerance.
55 2021-07-08 cold sweat Patient passed out for about 15 sec., he became nauseated and vomited. States that he does this ever... Read more
Patient passed out for about 15 sec., he became nauseated and vomited. States that he does this every time he gets his blood drawn. When he was easily awakened by touching him and stating his name. He was then able to answer questions appropriately. Blood pressure was 100/68. Heart rate was 100. He was clammy to the touch. After about 15 min stated that he felt better. Stated that he ate only a banana for breakfast. Wife drove his home.
55 2021-07-11 bell's palsy trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise... Read more
trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness
55 2021-07-13 weakness, pain in extremity Lower body muscle fatigue, hip/knee/feet skeletal pain, body joint inflammation, energy loss.
55 2021-07-13 burning sensation, nerve injury, tingling, pain in extremity June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs. Dizziness ... Read more
June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs. Dizziness and fatigue.
55 2021-07-13 paralysis, weakness, pain in extremity Adverse Events: Headache, Fever, Diarrhea, Nasal Congestion, Leg Pain, Weakness, Paralysis Dx. Guill... Read more
Adverse Events: Headache, Fever, Diarrhea, Nasal Congestion, Leg Pain, Weakness, Paralysis Dx. Guillain Barre Treatment: Immunoglobulin, Sodium Chloride 0.9%, Respiratory Bypass, Oxygen Outcomes: Patient actually in Intensive Care Unit at Hospital receiving treatment. Continue with oxygen by nasal cannula, whole body paralysis with urinary and feccal incontinence (foley and diaper). Symptoms begin since June 10,2021. Admission to Hospital on June 17, 2021 to present.
55 2021-07-15 numbness, tremor, pain in extremity, migraine No effect for approx. 6-weeks; then, headache, complete body fatigue and muscle weakness developed o... Read more
No effect for approx. 6-weeks; then, headache, complete body fatigue and muscle weakness developed overnight. A "charged-nerve"/anxious-energy feeling developed throughout body. Then- over the next couple-weeks- numbness in hands/fingers, feet/toes, tremors in head, neck, face hands and fingers and shakiness in arms and legs, developed and continue until today. The headache and charged-nerve feeling has continued, and pain in neck and mid/lower-spine has developed. Muscles in legs especially continue to be weak and some pain has developed in thighs. A ringing in ears is continuous and fasciculations have developed throughout entire body.
55 2021-07-16 bell's palsy GUILLEN BARRE SYNDROME; BELLS PALSY/FACE DROOPING; CHILLS; HEADACHES/EXCRUCIATING HEADACHES; FEVER; ... Read more
GUILLEN BARRE SYNDROME; BELLS PALSY/FACE DROOPING; CHILLS; HEADACHES/EXCRUCIATING HEADACHES; FEVER; This spontaneous report was received from a consumer and concerned a 55 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included drug allergy. Other relevant history included general good health and a marathon runner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced fever, chills and headaches. On 14-APR-2021, patient thought he had eaten something that had burned his lip. On 18-APR-2021, the patient experienced bells palsy/face drooping. His "lip going numb" then "face started drooping". He went to the emergency room. The doctors proceeded with an MRI and "all sorts of bloodwork." Patient also had "leg started to have twitching" and then started to have excruciating headaches ", "back started hurting on around the 22nd or 23rd of April" and "his legs and feet were numb" and "just couldn't get his utensils", "body weakness and headaches." He went to a neurologist and had a nerve conducting study and "it looked like it was GBS and chronic inflammatory." On 27-MAY-2021, Guillen Barre syndrome was diagnosed. Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions to help with GBS. At the neurologist, the patient had 5 treatments of plasma. He was having reactions with the infusion including "light headedness or headaches." He was given saline and the doctors told him to "stay hydrated and also was suggested acetaminophen and ibuprofen." He was also having "extreme weakness" with the plasma therapy. The neurologist was looking into the diagnosis and determined as it "is a reaction to the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillen Barre syndrome was not reported. The patient recovered from Bells Palsy/face drooping on 23-APR-2021, and fever and chills on an unspecified date, and had not recovered from headaches/excruciating headaches. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210726629.; Sender's Comments: V0: This spontaneous report received from a consumer concerns a 55 year old male, who was noted to have bell's palsy and diagnosed with Guillain-Barre syndrome (GBS) 32 and 71 days, respectively, after receiving the Janssen Covid-19 vaccine. Patient's height and weight were not reported. The patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information on smoking history, illicit drug use and alcohol abuse were not provided. Patient has drug allergy, unspecified. Patient had fever, chills and headache one day after receiving the vaccine. Thirty-two (32) days post vaccine, the patient's face started to droop and was noted to have bells palsy. He sought consult at the emergency room and was worked up on. No results provided. Patient started experiencing twitching of his legs, excruciating headaches and back pains. Later, his legs and feet started to get numb, described as not being able to get his utensils. His body started to get weak and he still was experiencing headaches. He went to a neurologist and had a nerve conducting study. Seventy-one (71) days after receiving the vaccine, patient was diagnosed with Guillain-Barre Syndrome (GBS). Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions. Information regarding other potential etiologies was insufficient, and the occurrence of Bells Palsy and GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
55 2021-07-16 flushing, feeling hot Patient stated he gets anxiety when getting any vaccinations or at the dentist office. Patient state... Read more
Patient stated he gets anxiety when getting any vaccinations or at the dentist office. Patient states he feels hot. He looked flushed and sweaty. His blood pressure at 12:48pm was 159/84. Two ice packs were used. One was placed on his neck while other one was used on his forehead. He was given couple of water bottle. Blood pressure was taken at 12:58pm 132/82. He stated ?I feel much better and this always happens to me when I get vaccinated? He was observed for additional 10 minutes.
55 2021-07-16 numbness, pain in extremity, tingling PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING A... Read more
PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
55 2021-07-16 numbness two weeks after shot I starting having pain in my right shoulder. thought I over worked it, but wee... Read more
two weeks after shot I starting having pain in my right shoulder. thought I over worked it, but week by week it continue to get worse. To the point that it wakes me up 4-5 times a night. While on vacation it hit a tipping point in pain and my pinky finger and ring finger started going numb on my hand. I started to research and thought it might be a nerve issue... from top of shoulder blade to my fingers I get pain. Pain to the point I have a hard time moving my arm in certain directions. two day prior to returning from vacation I called the doctor to have it checked out. On July 12th I saw my doctor (knowing nothing about J&J) and he thought I just needed a steroid shot for inflammation and was given the shot. watching news I heard about these nerve issue with J&J, men over 50 and everything they were saying fit me perfect. The next day I followed up with my doctor (Put a call into him) and a nurse called me back and informed me it probably had nothing to do with the J&J shot. I called the location that gave me the shot and they recommend that I complete this from. Today, 7/17/21 I am still in pain with numbness in my fingers.
55 2021-07-18 tingling paresthesia of right hand, left face, left/right leg
55 2021-07-27 pain in extremity CHEST PAIN; FEVER; LETHARGIC; ARM SORENESS; This spontaneous report received from a patient concerne... Read more
CHEST PAIN; FEVER; LETHARGIC; ARM SORENESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to weeds, allergic to grass, allergic to dust, allergic to pollen, allergic to dairy products, asthma, high blood pressure, type 2 diabetes, and alcoholic, and other pre-existing medical conditions included 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: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil. On 21-MAY-2021, the patient experienced lethargic and arm soreness. On 22-MAY-2021, the patient experienced fever. On 14-JUN-2021, the patient experienced chest pain, and was hospitalized for 1 day. Patient experienced some side effects. He did some medical tests and it all came back negative. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAY-2021, and had not recovered from arm soreness, lethargic, and chest pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210748476-Covid-19 vaccine ad26.cov2.s - CHEST PAIN . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
56 2021-03-07 weakness Fever, chills, headache, body aches came on on suddenly at 11pm. Took ibuprofen at 5 a.m. Fever and... Read more
Fever, chills, headache, body aches came on on suddenly at 11pm. Took ibuprofen at 5 a.m. Fever and chills gone by 7a.m. Then felt low energy, tired on 3/6 fine by 6 p.m.
56 2021-03-12 hot flush I started having very itchy feet and it gradually got hot and made it's way up my legs and on to my ... Read more
I started having very itchy feet and it gradually got hot and made it's way up my legs and on to my back and buttocks. I had extremely itchy, angry, red, hot raised skin rash. I have never had a rash like that. Luckily, I did not have any problem with breathing. I took a cool shower and took 2 Claritin. I also put Caladryl on my skin. This was 5 days and a couple of hours after taking the vaccine. It seem "Janssen COVID-19 Vaccine EUA"
56 2021-03-23 weakness, muscle spasms Chest Pain Chest Tightness Lightheadedness Headache Pressure in Head Cough Swelling in Ankles Leg We... Read more
Chest Pain Chest Tightness Lightheadedness Headache Pressure in Head Cough Swelling in Ankles Leg Weakness Tiredness starting from day after shot until today.
56 2021-03-24 numbness Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing ... Read more
Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing to include bilateral legs up to knees and bilateral arms up to mid forearm. He also had mild leg weakness bilaterally. He has absent reflexes. His lumbar puncture showed albuminocytologic dissociation. He was diagnosed with Guillan-Barre syndrome and is being treated with IVIG.
56 2021-03-26 tremor Beginning 6 hours after shot I had chills and shaking for 6 hours. Then fever of 102 for the next 6 ... Read more
Beginning 6 hours after shot I had chills and shaking for 6 hours. Then fever of 102 for the next 6 hours then ok. I took ibuprofen for the fever.
56 2021-03-28 tremor, unresponsive to stimuli patient reported at 1525 with a hx of vagal rx to injections. NKA and mild COPD. 0 CP, 0 SOB, 0 N/V,... Read more
patient reported at 1525 with a hx of vagal rx to injections. NKA and mild COPD. 0 CP, 0 SOB, 0 N/V, 0 tightness. Patient diaphoretic, shaky, not answering questions, pale. HR 89, SP02 93%, 105/65. Patient felt better supine, color improved, drink and snack were offered but declined. patient was released to care of wife who was driving home with HR 73, and BP 145/67.
56 2021-03-31 weakness Fever, chills, dizzy, nausea, fast heart beat, headache, very tired , and weakness. Taking Tylenol. ... Read more
Fever, chills, dizzy, nausea, fast heart beat, headache, very tired , and weakness. Taking Tylenol. It?s been 4 days and still ongoing.
56 2021-03-31 pain in extremity Depression and pain in the arm.
56 2021-04-02 night sweats March 31st aches all over body, stiff muscles, extreme night sweats, nights sweats lasting 2 days. A... Read more
March 31st aches all over body, stiff muscles, extreme night sweats, nights sweats lasting 2 days. All other symptoms on going. Extremely Fatigued.
56 2021-04-05 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out for a short time.....told me he normally has a vagal response to shots and not to be surptrised of he passes out.....patient fully recovered prior to leaving....he was monitored closely
56 2021-04-07 weakness I got dizzy had projectile vomiting weakness tired
56 2021-04-07 cold sweat Clammy skin, thready pulse, shaky, and anxious
56 2021-04-07 migraine Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red s... Read more
Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red spots on leg that looked similar to a heat rash and over the next 24 hours entire legs were covered in red dots and feet were almost solid purple. On the morning of 16th day constant nose bleed and multiple blood blisters in mouth inside cheeks and all over tongue. Blood was coming from mouth. At that point legs were covered in dark red almost purple and spreading to chest, back, and arms.
56 2021-04-08 weakness Pt became dizzy and called for help. Upon arrival ambulance was called and pt was ALOC w/bilateral w... Read more
Pt became dizzy and called for help. Upon arrival ambulance was called and pt was ALOC w/bilateral weakness slowly progressing and sweating profusely. Pt was A&O x 3 to self and location. Then patient seemed to have lost consciousness completely for about a minute. Pt was still breathing normally, and was tachycardic. Left sided drooling was present. By the time the ambulance arrived patient regained consciousness and strength. Pt stated this happened before when he had a root canal fixed. Stated he seems to have anxiety induced seizures. Pt VS were taken by EMTs and where stable, Pt refused to go to the hospital. He called his wife to pick him up and pt was monitored until she arrived.
56 2021-04-08 muscle spasms Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and finger... Read more
Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and fingers. Cramps in legs. Skin sore to touch almost felt like sunburn. Gastrointestinal discomfort that included loose stools and gas. Frequent urination possibly due to water intake, but was unusual. Fever lasted about 24 hours. All symptoms starting to subside around the 24 hour mark.
56 2021-04-08 night sweats Night chills/sweats, pain in area of shot, headache, and fatigue
56 2021-04-09 cold extremities Client brought to observation area after J & J vaccination to left deltoid. C/O dizziness, nausea, ... Read more
Client brought to observation area after J & J vaccination to left deltoid. C/O dizziness, nausea, sweating. Initial O2 sat of 87% (note extremities cool to the touch. Placed on 10 LPM NC at 100% At 1028 am 98/69 blood pressure 100% O2 sat on 10 LPM 1031 am 98/69 Client then on RA and continued at 100% Client c/o mild dizziness. Later ambulated to bathroom without aide He works at the college and will rest in his work room. He reported very mild dizziness, MAEW, NAD, Speaking in full sentences. 1103 am VS of 113/72 64 22 Client directed to call 911 for difficulty breath and f/u with a health care provider as needed. Note client stated he does not have health coverage presently Client DCd home at 1105
56 2021-04-10 pain in extremity Sore throat, runny nose, extreme fatigue. Started around 12 hours after shot. Lasted all through t... Read more
Sore throat, runny nose, extreme fatigue. Started around 12 hours after shot. Lasted all through the following day and night. Felt much better 48 hours after shot. Mild soreness in left arm.
56 2021-04-13 bell's palsy extreme headache bells palsy
56 2021-04-13 mild one side paralysis Headache, dizziness, left side weakness, vertigo
56 2021-04-13 muscle spasms I developed a high pitch ringing in the ears the morning after the vaccine. It was noticed when I w... Read more
I developed a high pitch ringing in the ears the morning after the vaccine. It was noticed when I woke up. I did have a low fever, high chills, and significant neck muscle "cramping" during the night when this reaction developed. The ringing (Tinnitus) is pretty loud and bothersome. The volume has not changed since the day after my vaccine shot (two weeks now).
56 2021-04-13 unresponsive to stimuli Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, p... Read more
Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, phlebitis) 13 April; treated for dehydration and prescribed ASA. Tachycardia on exam, resolved with resuscitation. Asymptomatic 4 hours later, and expired overnight in his sleep. Found unresponsive in the morning, time of death 09:57.
56 2021-04-14 weakness, muscle spasms severe chills all night went away around 6 am. Vomit with dry heaves at 1:15 am last round at 5:30 a... Read more
severe chills all night went away around 6 am. Vomit with dry heaves at 1:15 am last round at 5:30 am. Very severe at times. Shortness of breath started in the afternoon or the 6th of March, lasted for 14 days. Cramps in my legs periodically still get them not as often now. Still don't have the same energy I had before the shot. I still tire easily.
56 2021-04-16 facial paralysis, slurring At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, sl... Read more
At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, slurred speech. Called plant nurse. She said my face was drooping, I couldn't smile or stand. She called Ambulance. Ambulance arrived and decided symptoms of stroke and called for helicopter to take me to medical center. When I arrived they did CT and I was later told it showed possible areas of no oxygen to brain. They gave me TPA drug and almost immediately I could see improvement - my headache cleared. Throughout the next couple hours I regained movement on right side and all functionality returned except weakness in right arm. I stayed in ICU for 24 hours as required after receiving TPA and while additional tests were ran then was discharged on Friday, April 16, 2021
56 2021-04-19 numbness Patient is a medical doctor. . patient reports at 10pm April 11, 2021 , he was reaching into a clo... Read more
Patient is a medical doctor. . patient reports at 10pm April 11, 2021 , he was reaching into a closet when his entire right side fell asleep/was numb. He reports that sitting temporarily help relieve symptoms, however when he stood, symptoms returned. patient sought care at ER. His BP was 183/110. However, nothing was found to be wrong except B-12 level was low. Patient reports that symptoms lasted 45 minutes.
56 2021-04-19 muscle twitching, numbness I began to feel numb around my mouth and nose. It spread to most of my face, then chest, then arms,... Read more
I began to feel numb around my mouth and nose. It spread to most of my face, then chest, then arms, mainly left arm and leg, then to both legs. General weird feeling / numbness, no pain. I had trouble with limb control, not bad, but enough to notice. Mainly left side, but noticeable on both sides. From the onset on face numbness to the chest leg spread was just a matter of a few, maybe 5 minutes. I looked at my face in the car mirror, and appeared to have facial control. I was driving to a relatives house, and it worried me. On the way, I also noticed a lump in my right neck, about the size of a pea. When I got to my relatives house I told them I thought I had a small stroke, but wasn't sure. The numbness lasted until the next day, then slowly went away. It took about 2 days before the numb twitchy feeling went away from my left eye/upper cheek area. The lump in my neck also went away. rubbing on it actually made the numbness slightly go away. I did not go to a hospital, or seek any treatment. I think I should have. I do believe that l had a small stroke / blood clot, and that it should be reported. I think I am OK now,
56 2021-04-19 pain in extremity, weakness slight headache within hours, disappearing within 36 hours. arm soreness beginning next morning, co... Read more
slight headache within hours, disappearing within 36 hours. arm soreness beginning next morning, continuing for 5 days, escalating for the first 2 1/2, then decreasing in similar intensity. Yesterday, however, I started to have a bad headache at 4 a.m., then felt generally more ill to a level of almost incapacity by evening - bad headache, general weakness, dizziness, some muscle pain, bad nausea. Used Aleve and Ibuprofen and by 11pm started to feel normal again. By the next morning, I felt fine - tired like I just got over something, but fine. Not sure it was injection related, but wanted to share.
56 2021-04-19 pain in extremity Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. ... Read more
Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. The pain improved then around 4/10 he developed significant pain/swelling to rt calf. Venous US confirmed DVT. Pt started on Eliquis. Pt has h/o superficial thrombosis, not h/o DVT.
56 2021-04-20 limb paralysis 56 years old male called to report an adverse reaction after he received his jhnson and jhnson vacci... Read more
56 years old male called to report an adverse reaction after he received his jhnson and jhnson vaccine on 04/11/2021 @1230. patient reported 30 mins after receiving his vaccine he developed arm pain, diarrhea, and chills. patient reported sinus allergies. patient reported that he takes advil for his allergies. and amlodipine for his high blood pressure. patient was instructed to take advil to help with his symptoms. patient was instructed to seek medical attention if the symptoms got worse.
56 2021-04-20 muscle spasms Patient started having leg cramping on 4/13/2021, presented to the emergency department on 4/18/2021... Read more
Patient started having leg cramping on 4/13/2021, presented to the emergency department on 4/18/2021 with increasing shortness of breath and chest pain.
56 2021-04-21 migraine SORE THROAT; MIGRAINE; DRY MOUTH; This spontaneous report received from a patient concerned a 56 yea... Read more
SORE THROAT; MIGRAINE; DRY MOUTH; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dry mouth. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced migraine. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, and had not recovered from dry mouth, and migraine. This report was non-serious.
56 2021-04-22 numbness I started having bad headaches the day after the vaccine. A few days later I saw blood in my stool. ... Read more
I started having bad headaches the day after the vaccine. A few days later I saw blood in my stool. I have experienced blood in my stool seven times up to this point. I have been feeling slight numbness in my biceps and calves. I have also been very sleepy and fatigued. Another thing is also pain around my rib cage area. I have also experienced some shortness of breath.
56 2021-04-24 cold sweat, tingling, feeling cold, weakness Freezing ,hot ,cold, sweets disy ,lack of appetite constipation no energy inside feel like burning a... Read more
Freezing ,hot ,cold, sweets disy ,lack of appetite constipation no energy inside feel like burning and boiling ,weak general stomach ache bad ,heart palpitations , tingling legs and feet , dehydrated
56 2021-04-27 tingling Tingling, thoracic sensory level loss, urinary retention. CSF protein elevated to 90. Started app... Read more
Tingling, thoracic sensory level loss, urinary retention. CSF protein elevated to 90. Started approximately 3 weeks from time of vaccine. Drug store provided vaccine 04/06/2021 Admitted to hospital 04/27/21
56 2021-05-02 pain in extremity, numbness Patient stated on 04-18-21 that he had pain underneath the upper arm, under the biceps, and numbness... Read more
Patient stated on 04-18-21 that he had pain underneath the upper arm, under the biceps, and numbness in the tip of the left index finger. Symptoms started simultaneously. On good day, patient pain underneath the upper arm is minimal and there is no numbness in the tip of the left index finger. On bad days, the pain is 7/10 underneath the upper arm and there is numbness that he rates as a 4. He did not take any medications to alleviate symptoms.
56 2021-05-04 flushing Systemic: Flushed / Sweating-Severe
56 2021-05-06 pain in extremity, weakness, numbness Immediately after vaccines had headache and soreness of the arm. on 5/6 numbness of the arm and loss... Read more
Immediately after vaccines had headache and soreness of the arm. on 5/6 numbness of the arm and loss of strength, dry mouth.
56 2021-05-18 migraine BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from ... Read more
BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced body ache. On 07-MAY-2021, the subject experienced migraine headache. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced extreme fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAY-2021, had not recovered from fever, extreme fatigue, and body ache, and the outcome of migraine headache was not reported. This report was non-serious.
56 2021-05-18 pain in extremity, tingling BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE R... Read more
BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
56 2021-05-18 pain in extremity Pain in right lower leg lead to hospitalization for a blood clot. Patient discharged on Eliquis.
56 2021-05-19 pain in extremity My health was great before my vaccine. I was able to have a normal full day five days out of the fir... Read more
My health was great before my vaccine. I was able to have a normal full day five days out of the first 60 without health issues. This week I haven't had one day where I haven't had something going on. I woke up day after vaccination and started feeling feverish, but going into bad chills, extreme headache, a different kind of headache than my migraines, abdominal had pain, heart rate and breathing, heart rate was elevated, breathing not normal, out of breath, deep pain right thigh at bone, did not bruise. I called cardiologist 03/25/2021, about thigh, thought it might be DVT, I followed up 03/29/2021 since I did not hear back, we spoke on the 30th, I had very high blood pressure, doc presumed I had a tress fracture of right thigh bone and that other things were related to my chronic intro viruses. I saw my infectious disease doctor on April 13th he said this could be a major conflict with either current viruses, meds taking in conjunction with vaccination. All of my major lymph nodes were inflamed. I do have non Hodgkin's lymphoma, but they told me it is slow growing. Visited ER on 04/14/2021. Dr met me there.
56 2021-05-19 pain in extremity Nausea, fever/cold chills, Upper right arm and shoulder stiffness and pain discomfort. Lasting over ... Read more
Nausea, fever/cold chills, Upper right arm and shoulder stiffness and pain discomfort. Lasting over a month until I seeked medical attention from my doctor.
56 2021-05-22 pain in extremity Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks. Ge... Read more
Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks. General body aches - mostly in feet and in upper right arm, shoulder, and neck area (C1-down to mid-shoulder), fogginess of thought, and overall tiredness and lack of sharpness since about 2-3 days post injection.
56 2021-05-24 tingling, pain in extremity Fatigue and low grade fever started 5/21 about 24 hours. Arm sore as well. Felt tingly skin n chest ... Read more
Fatigue and low grade fever started 5/21 about 24 hours. Arm sore as well. Felt tingly skin n chest and stomach for 3 days. That has quit now. 5/24. Continued having low grade temp between 99 and 101 still on 5/25. No real appetite but probably due to fever. Can smell and taste. Just curious as to how much longer temp will continue to come and go? Assume fatigue is tied to fever.
56 2021-05-28 weakness I received my shot and two days after I felt weak and sick. I fine for a few weeks and then I went o... Read more
I received my shot and two days after I felt weak and sick. I fine for a few weeks and then I went outside to cut grass and all of my joints started to ache really bad. I came back inside and checked my temperature. I laid on my couch for a couple hours while running a high temp of 100.7. My eyes started to get really hot. I woke up at 12:30am and it was 90.7. I was checking my blood pressure and it was 110/64. I went to the doctor and it was discovered that I have pneumonia.
56 2021-06-01 tremor, pain in extremity, tingling, weakness BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE T... Read more
BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
56 2021-06-10 migraine 4/13 awoken at 6am with a sharp severe headache on the right side of the head. I had blurry vision t... Read more
4/13 awoken at 6am with a sharp severe headache on the right side of the head. I had blurry vision the entire day and a little the next day. Since 4/13 I have had almost daily light headaches and light to moderate nausea. I had several doctors appointments after that who treated me for migraine. Since the symptoms persisted into June I was sent for an MRI on 6/1. I received a call on 6/2 stating that I had suffered a stroke. I followed up with an MRA on 6/9. I met physician on 6/10 and stated that there were no issues reported in the MRA, however they confirmed that I had suffered a stroke. I After presenting the physician information that the symptoms described in Jansen vaccine were similar to mine they ordered an MRA scheduled for today and blood tests also today.
56 2021-06-13 numbness, pain in extremity Left arm started hurting. It hurt for 2 days. Then my right and left arm started hurting. this went ... Read more
Left arm started hurting. It hurt for 2 days. Then my right and left arm started hurting. this went on for another 2 days. then both my arms ,across my back and both hands went numb. Went to emergency room. They did test. Said i had blocked heart artery. They removed blockage. I was in serve pain, It felt like my bones was breaking. I end up going to the doctor 2 days in a row. The doctors think that the vaccine may have trigger that reaction.
56 2021-06-15 grand mal seizure Pt had tonic-clonic seizure after covid-19 vaccine Janssen
56 2021-06-19 weakness Weak. Chills. Fever. Body aches.
56 2021-06-24 weakness, unresponsive to stimuli About 5 minutes after vaccination, patient complained of dizziness/spinning. It continued for severa... Read more
About 5 minutes after vaccination, patient complained of dizziness/spinning. It continued for several minutes when he became syncopal and briefly unresponsive. Heart rate 40. Glucose 103. BP 108/60. Respiratory rate 20 and sonorous. Placed on monitor which showed sinus bradycardia. 20 minutes after vaccination, patient recovering and able to talk but diaphoretic and weak. Taken to ER by paramedics.
56 2021-07-05 pain in extremity FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING ... Read more
FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 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: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.
56 2021-07-11 numbness, pain in extremity, tingling Shingles (Herpes Zoster) symptoms began just over 24 hours following the administration of the vacci... Read more
Shingles (Herpes Zoster) symptoms began just over 24 hours following the administration of the vaccine. Initial symptoms were pain and numbness radiating from right hip / gluteal area down right leg. Pain/tingling/numbness spread across belly area in the following days. Patient remained unaware it could be shingles until June 1, 2021 when multiple patches of blisters appeared down lower right leg. Medical help sought the following day June 2, 2021. Acyclovir 800mg (5 times daily) was prescribed for 7 days. To date, some soreness remains at the initial site as well as some sensitivity across belly area.
56 2021-07-12 tingling Planter facialitis like symptoms Julianne barre like pin and needle pain on feet Knee pain
56 2021-07-13 numbness, weakness 7.8.21: Patient reported weakness, lightheadedness, fever, possible numbness/tingling (also s/p hear... Read more
7.8.21: Patient reported weakness, lightheadedness, fever, possible numbness/tingling (also s/p heart cath) 7.9.21: Presented to ED - fever, headache, myalgia, neck stiffness, weakness in lower legs, difficulty walking, numbness - left AMA 7.9.21: Presented to ED - with generalized weakness - He was discharged on 7/7. He had noted BLE weakness during his admission and noted worsening of his weakness following his discharge. He returned to the ER on 7/8 but left AMA. He presented to ER on 7/9 with right arm and BLE weakness and MRI showed numerous small acute ischemic foci bilaterally. CTA was negative for significant stenosis or occlusion. He was evaluated by Neurology and felt that there was a high likelihood of cardioembolism as the etiology of his strokes vs cocaine. They recommended cardiac monitoring for evidence of afib as well as DAPT x 21 days followed by ASA monotherapy. He was noted to have an elevated troponin on admission and was placed on a Heparin drip. Cardiology did not feel that repeat cardiac cath was warranted. An Echo with bubble study was performed and showed EF 45-50%, diffuse hypokinesia, mild DD and no evidence of shunting. He has been accepted at hospital with plan for transfer there today. Assessment / Plan Multifocal stroke - suspect shower embolism vs r/t cocaine use - Echo - no evidence of shunt - per Neuro - DAPT x 21 days followed by ASA monotherapy - 30-day cardiac monitor at discharge Elevated troponin Recent IWMI CAD Ischemic CM - EF 45-50%, diffuse hypokinesia Cocaine use with possible vasospasm - s/p Heparin drip - no indication for repeat cardiac cath per Cardiology - ASA, Plavix, Metoprolol, Lisinopril, Lipitor - Norvasc - counseled on cocaine cessation
56 2021-07-15 pain in extremity Had right knee pain on 5/21/21 then had right leg pain/ swelling/elevated labs starting on 6/11
56 2021-07-16 pain in extremity, numbness PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND ... Read more
PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND THE CALF, BETWEEN ANKLE, KNEE AND HIP; LIGHTHEADEDNESS; SORE ARM; MUSCLE ACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient takes no prescription or over the counter medications and has no medical conditions and describes self as healthy. the patient had no known allergies and was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. On APR-2021, the subject experienced lightheadedness. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) within range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, and sore arm, and muscle aches on 12-MAR-2021, and had not recovered from persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. This report was non-serious.
56 2021-07-18 hot flush Hot Flashes
57 2021-03-08 tremor Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasti... Read more
Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body rash still in progress
57 2021-03-09 tingling, numbness Headache, nausea, chills, rigors, numbness and tingling body wide... HORRIBLE for about an hour, unc... Read more
Headache, nausea, chills, rigors, numbness and tingling body wide... HORRIBLE for about an hour, uncomfortable for another 12hrs, still present 20hrs from onset. Hope it will be over by morning of 3/11. Have had reactions to vaccinations in the past. This was a bad one. Glad I don't have to repeat the dose.
57 2021-03-10 feeling cold, feeling hot, muscle spasms extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper tors... Read more
extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate headache , cold all over .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep.
57 2021-03-10 tingling pt. experiencing pin and needle on the L arm the vaccine was administered. pt. not in any distress ... Read more
pt. experiencing pin and needle on the L arm the vaccine was administered. pt. not in any distress and states that the pins and needles are fading.
57 2021-03-14 night sweats Very bad headache overnight first night after injection. Night sweats and fever 2nd and 3rd night ... Read more
Very bad headache overnight first night after injection. Night sweats and fever 2nd and 3rd night after injection.
57 2021-03-15 weakness After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, A... Read more
After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, Along with chills as well. This continue throughout the weekend. I remained at home and did not have any energy to go out and be around people. The next day, I also got diarrhea and was very dehydrated. Immediately, after I left the vaccine shot location, like within 5 minutes, I started to smell fish and my mouth tasted like salt for three days. I also had excruciating headaches that did not go away with advil. So I rested a lot and had no real big appetite what so ever!. Today, I am concerned that on my left side below my left clavicle, I feel a big bump what appears to be possibly a lymphatic swelling of node? I am concerned because I did not have this swelling before and do not know if it's a reaction to the vaccine. Pls contact me via phone, this is urgent. Thanks
57 2021-03-18 tingling Approximately 10 hours after the injection (about 2 weeks prior to this ER visit) the patient starte... Read more
Approximately 10 hours after the injection (about 2 weeks prior to this ER visit) the patient started experience paresthesias of the right arm and face. Evaluation in the ER on today's date did not show objective findings of the paresthesias, nor identified cause, including evaluation for stroke.
57 2021-03-21 cold sweat, seizure, unresponsive to stimuli Following covid 19 vaccine client reported sweating with obvious pallor. He was cold and clammy. H... Read more
Following covid 19 vaccine client reported sweating with obvious pallor. He was cold and clammy. He was unresponsive prior for approximately 30 seconds with mild seizure activity with spontaneous movement of eyes with jerking. He was monitored by EMS and evaluated by a Dr. His car seat was reclined, no Epi pen given . Blood Pressure was 82/48 initially with pulse 65 and RR 12. He was transported to EMS vehicle on site and monitored then released home. He was advised to follow up with ER for further treatment if needed.
57 2021-03-21 night sweats, pain in extremity Ears are ringing. Sore arm, night sweats, tired.
57 2021-04-01 weakness Patient presented to ED via ambulance with fatigue weakness, poorly controlled Diabetes, hyperglyce... Read more
Patient presented to ED via ambulance with fatigue weakness, poorly controlled Diabetes, hyperglycemia and abdominal pain. still in hospital on this date
57 2021-04-02 paralysis, numbness Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre... Read more
Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine
57 2021-04-03 hot flush Patient had syncope related symptoms. Main symptoms were dizziness and hot sweats.
57 2021-04-05 hypersensitivity of all senses onset of hives all over the faces..converted to rashes all over the body in next two days with itchi... Read more
onset of hives all over the faces..converted to rashes all over the body in next two days with itching, chills and nightly low grade fever. lastly the red patches moved to the extremities with touch sensitivity and itching.
57 2021-04-07 hot flush, flushing LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; Thi... Read more
LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain behind his eyes. On MAR-2021, the subject experienced flushed. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced low grade fever. On 29-MAR-2021, the subject experienced minor or brief headaches. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, flushed, hot flashes, fatigued, and minor or brief headaches, and the outcome of pain behind his eyes was not reported. This report was non-serious.
57 2021-04-07 tingling Patient started complaining of extreme back pain and trouble walking within days after receiving the... Read more
Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator.
57 2021-04-07 tremor, migraine First 4 hours post injection no serious side effects, slight headache was settling in. At approx. 8... Read more
First 4 hours post injection no serious side effects, slight headache was settling in. At approx. 8PM (7 hours after shot) I had fairly a severe reaction of horror for the next 16 hours - all night long. Heart racing/energy beyond, deep chills and severe whole body shaking to the point of my back going out (dont' have a bad back), fever, migraine headache so bad (i dont get headaches) and body aches from a horror movie. I'm a jock, run daily, healthy, no smoke, drink or drugs. This lasted all night long well into the morning. At 3Am i considered going to the ER, but didnt. By 2pm the following day most of it went away. Two days later (today) i am dizzy, heart feels fast or racing, naseuous earlier , and exhausted. I can deal with it now, but it's very uncomfortable. Frankly, I regret getting the vaccine, wish i had not. I had covid last March, it was no big deal beyond what a flu would have done...with some shortness of breath on and off for a few months. The reaction to the vaccine is viccious compared to covid itself (for me, just my experience). Hope this all stops and goes away. Thank you for your work!
57 2021-04-09 slurring, tingling Patient reports: 3/20/21 began experiencing tingling feeling in all four limbs at different times 3/... Read more
Patient reports: 3/20/21 began experiencing tingling feeling in all four limbs at different times 3/28/21 experienced slurred speech 3/30 experienced what he describes as near blindness-was driving down road and all of a sudden most of visual field went black and could only see the white line of the road. Was close to hospital and was able to see enough to get himself to the hospital. Patient reports he was hospitalized at Hospital from 3/30/21-4/1/21 and was diagnosed as having a stoke
57 2021-04-11 weakness, restless legs syndrome - general sense of feeling weaker than normal. - feeling of tense and restless muscles (especially l... Read more
- general sense of feeling weaker than normal. - feeling of tense and restless muscles (especially legs), a sense that my body was struggling. - inability to sleep. That lasted about 30 hours. I realize this is probably a mild symptom, and probably a normal reaction. But you might need to know that.
57 2021-04-11 flushing Janssen COVID-19 Vaccine EUA Passed out while seated, 3-4 minutes after receiving vaccine. Fast onse... Read more
Janssen COVID-19 Vaccine EUA Passed out while seated, 3-4 minutes after receiving vaccine. Fast onset of extreme nausea followed by blackout. Duration of blackout unknown. Woke up on floor not knowing how I got there. Sat up, nausea and lightheadedness returned, then dissipated with no further blackout. Felt rush of blood from head to toe and felt okay after that. Pharmacy staff took blood pressure, readings were close to normal (slightly elevated). Paramedics were called by pharmacy, and their BP readings were also close to normal. After all that, aside from some fatigue, no other appreciable side effects over the next 48 hours. No nausea, flu-like symptoms or fever, and very little soreness at injection site.
57 2021-04-12 difficulty speaking Hoarse voice. Started about 24 hrs after the Johnson shot, I still have it.
57 2021-04-12 numbness, facial paralysis, speech disorder Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallo... Read more
Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallowing on 3/16/21 around 11pm. Had facial drooping of the mouth and eye on my left side of face. Went to Hospital ER around 5:30 am on 3/17/21 as symptoms did not subside. I was later placed in stroke observation unit. I had 2 MRI's, CT scan and Echo tests ran. i was diagnosed with TIA. All test were negative for a cause. I sent a total of about 26 hours hospitalized.
57 2021-04-12 pain in extremity, feeling hot 4/10 - after 4 hours, (14:00) felt hot and my face was in red color. Generally OK 4/11 - Generally ... Read more
4/10 - after 4 hours, (14:00) felt hot and my face was in red color. Generally OK 4/11 - Generally felt hot, red face, and then around 16:00, arm and let joins started to ache and mild pain occurred. 4/12 - After having a dinner around 17:00, with in 30min, chest pain started at left chest. felt more like heart burn sensation. 19:00 pain stopped by drinking some hot tea. 22:00 took my meds, Brilinta, Carvedilol and Atorvastatin 23:30 chest pain came back instead of left side, in the center of chest. took some tums and drank some hot water 26:00 no more pain and was able to go sleep. 4/13 - 07:00 no pain but off and on with discomfort in the chest area from last night chest pain.
57 2021-04-12 tremor Fainted twice, some body shakes when waking up, glazed over eyes
57 2021-04-13 weakness Felt weak and tired by late afternoon. Chills in the early to late eve. Then acute nausea from midni... Read more
Felt weak and tired by late afternoon. Chills in the early to late eve. Then acute nausea from midnight till 2pm. Finally broke a sweat around 330am. Was fine by 6 am.
57 2021-04-13 slurring the day after the shot, started feeling unwell (approx 24 hours post shot). Slurring words, stumblin... Read more
the day after the shot, started feeling unwell (approx 24 hours post shot). Slurring words, stumbling around and general unwell feeling with a fluttery feeling in chest. No previous heart issues of any kind. After it continued for an hour or so, I took him to the ER and it was discovered that he was in AFIB. 2 rounds of meds and tests, but stayed in that rhythm. They ended up doing a cardio version and it went back into normal sinus rhythm. Follow up with dr, placed on Eliquis, EKG, stress test and sleep study have found no other contributing factors atthis point.
57 2021-04-13 muscle twitching Contraction on lower lip on my mouth
57 2021-04-13 pain in extremity Patient seen in ED with CC of unilateral leg pain x3 days. Pt attributes the leg pain developed shor... Read more
Patient seen in ED with CC of unilateral leg pain x3 days. Pt attributes the leg pain developed shortly after receiving the J&J COVID Vaccine. Ultrasound demonstrates superficial thrombis of greater saphenous vein. Hemodyanimcally stable. Pt prescribed Eliquis 10mg bid x7 days followed by 5mg po bid. Cannot confirm pt has been administered J&J vaccine -not documented in medical chart, pt only self-reports. Also with sedintary lifestlye/bed-bound.
57 2021-04-13 pain in extremity Patient reports: pain and swelling in left leg below knee and calf tender to touch. Patient is curre... Read more
Patient reports: pain and swelling in left leg below knee and calf tender to touch. Patient is currently admitted into hospital for treatment.
57 2021-04-14 weakness Some weeks after vaccination I started feeling shortness of breath. When I walked from the parking l... Read more
Some weeks after vaccination I started feeling shortness of breath. When I walked from the parking lot to my work desk it was hard and when I arrived at work my co-workers could hear me grasping for air, I felt winded, and it never happened before. Also, another episode when the elevator broke down I could not go the flight of stairs without having to stop and catching my breath. Since the weather is better I decided to start walking in the park for exercise but I realized I did not have the strength nor the capacity to breathe. I amafraid at night because sometimes when I lay down I can't breathe.
57 2021-04-14 pain in extremity Patient with pain and swelling on articulations, cannot close right fist
57 2021-04-15 severe one side paralysis Patient had a CVA, no left side movement. Unknown date of occurrence, discharged from hospital 4/15/... Read more
Patient had a CVA, no left side movement. Unknown date of occurrence, discharged from hospital 4/15/2021. Patient works for DOT who held a clinic at their site. DOT HR Director informed us of this event. Unable to share much information.
57 2021-04-15 hypersensitivity of all senses, coordination abnormal SMOOTHER AND CLEARER SKIN; INCREASED SENSITIVITY IN FINGERS AND TOES; HEARING INCREASED; INCREASED C... Read more
SMOOTHER AND CLEARER SKIN; INCREASED SENSITIVITY IN FINGERS AND TOES; HEARING INCREASED; INCREASED COORDINATION IN HANDS, FINGERS, ARMS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included completely Paralysed, and concurrent conditions included Guillain-barre syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased, and increased coordination in hands, fingers, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased and increased coordination in hands, fingers, arms was not reported. This report was non-serious.
57 2021-04-15 pain in extremity On 4/16/2021 patient reported left leg pain began on 4/12/2021. Pharmacist recommended the patient s... Read more
On 4/16/2021 patient reported left leg pain began on 4/12/2021. Pharmacist recommended the patient seek medical attention at the nearest emergency room.
57 2021-04-18 pain in extremity I received the vaccine on 3-12-21 and woke up 3-15-21 with pain in the bottom of my left foot. I sch... Read more
I received the vaccine on 3-12-21 and woke up 3-15-21 with pain in the bottom of my left foot. I scheduled an apt with my PCP on 3-16-21. My PCP scheduled an ultrasound on 3-24-21 where the nurse discovered blood clots in my lower left leg. I started taking Eloquis later that afternoon. I then had an apt with a blood dr. on 4-9-21 where she drew blood for tests. I was experiencing my heart racing and she scheduled me an apt with a cardiologist on 4-13-21 where the cardiologist suspected that the clots had moved into my lungs. The cardiologist did an EKG on the same day. I have a heart echo scheduled for 5-7-21. I am experiencing side effects from Eloquis so 4-19-21 I switched to Xeralto.
57 2021-04-18 tremor FEVER OF 101.4; CHILLS; SEVERE HEADACHE; ICHY RASH AT INJECTION SITE; SYMPTOMS OF RASH; SHAKING; Thi... Read more
FEVER OF 101.4; CHILLS; SEVERE HEADACHE; ICHY RASH AT INJECTION SITE; SYMPTOMS OF RASH; SHAKING; This spontaneous report received from a consumer concerned a 57 year old male. The patient's weight was not reported and height was 73 inches. The patient's concurrent conditions included no alcohol use, and nonsmoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNWON) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever of 101.4. On 09-MAR-2021, the subject experienced shaking and chills. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced ichy rash at injection site. On 09-MAR-2021, the subject experienced symptoms of rash at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 101.4, shaking and chills, severe headache, and ichy rash at injection site, and the outcome of symptoms of rash at injection site was not reported. This report was non-serious.
57 2021-04-20 numbness FATIGUE AND NUMBNESS IN THE LEFT ARM AND FINGER TIPS
57 2021-04-20 pain in extremity Extreme lower Extremity pain; like running a marathon; Red swollen lumps in legs; fever; chills and ... Read more
Extreme lower Extremity pain; like running a marathon; Red swollen lumps in legs; fever; chills and sweats This has been currently going on for 12 days with fever everyday up to 103
57 2021-04-21 weakness WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a 57 year old male. The... Read more
WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included prostate enlargement, and concurrent conditions included over sized bladder, and compressed nerve in neck, and other pre-existing medical conditions included no known allergies, no illicit drug use/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21/JUN/2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210428579.
57 2021-04-21 weakness CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report receive... Read more
CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report received from a patient concerned a 57 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced feeling fatigue. On APR-2021, the subject experienced being weak. On 10-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 97.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, feeling fatigue, and being weak, and the outcome of severe nausea was not reported. This report was non-serious.
57 2021-04-23 pain in extremity BROKE OUT IN HIVES ALL OVER BODY; SORE ARM; This spontaneous report received from a patient concern... Read more
BROKE OUT IN HIVES ALL OVER BODY; SORE ARM; This spontaneous report received from a patient concerned a 57 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced broke out in hives all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-MAR-2021, and was recovering from broke out in hives all over body. This report was non-serious.
57 2021-04-23 pain in extremity My dad has been experiencing what seem to be definite blood clot symptoms since the vaccine but he r... Read more
My dad has been experiencing what seem to be definite blood clot symptoms since the vaccine but he refuses to go to the dr. Shortly after the vaccine he experiencing stabbing headaches that came on quickly and went away in an instant. I thought they were gone after that but he later told me the stabbing headaches continue, along with horrible pain in his legs, and ringing in his ears. He told me recently that the symptoms stopped exactly two weeks later but his legs are hurting again.
57 2021-04-25 myelitis transverse Transverse Myelitis - being treated with steroids and IVIg
57 2021-04-27 weakness LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR A... Read more
LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR ABNORMAL 319; URINATION PROBLEM; MALE GLAND (REALLY BIG) WAS SWOLLEN/ RED; FEELING OF PASSING; LIGHT HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 57 years old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes (did not take any medication). Patient was assaulted before getting the Covid-19 vaccine and was cut in the neck and needed blood transfusion last OCT-2020. Patient got several vaccinations. Last vaccination he received was in 1980. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, 1 day after vaccination, patient experienced light headache, feeling of passing and weakness. On 11-APR-2021, after 2-3 days of vaccination, patient was suffering from urination problem which included swollen male gland/ redness (peeling of the skin /flesh is visible /getting worse) and pain during urination. He had pain upon pulling back his foreskin (he was not circumcised and never had such problems). On unspecified day, he had trouble in vision. He visited two doctors regarding the problem who stated that patient had left eye trauma (cataract). On unspecified date. he also had rashes all over the body (specifically arms) referred as eczema. On an unspecified date, he had shoulder pain/soreness/wound on both shoulders right as well left. Skin of the left shoulder was peeled and flesh was visible. He stated that peeling of the skin was moving towards the back of his shoulder and was getting worse. He had tattoos on his left and right shoulder/arm. As per patient, he was given a lot of shots in his right during his profession. Patient has abnormal blood sugar level. On 23-APR-2021, Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 319. Treatment medications (dates unspecified) included: bismuth subsalicylate and took 7 up to alleviate symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye trauma/ cataract, urination problem, rash all over body arm/eczema, weakness, feeling of passing, light headache, and male gland (really big) was swollen/ red, and the outcome of shoulder pain/sorenes/wound and blood sugar abnormal 319 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210448488 - COVID-19 VACCINE AD26.COV2.S - left eye trauma / cataract . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210448488-COVID-19 VACCINE AD26.COV2.S-BLOOD SUGAR ABNORMAL 319 .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
57 2021-04-27 muscle spasms, burning sensation, pain in extremity Severe muscle spasms and leg pain currently Initially it was in knee and hip joints as well, I was ... Read more
Severe muscle spasms and leg pain currently Initially it was in knee and hip joints as well, I was treated with steroids for 5 days, that made the joints feel better. Still having terrible burning type pain in my right thigh muscles
57 2021-04-27 pain in extremity Two blood clots in right leg below the knee, calf pain, swelling of lower leg and foot, painful to w... Read more
Two blood clots in right leg below the knee, calf pain, swelling of lower leg and foot, painful to walk
57 2021-04-30 slurring, tingling SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous repor... Read more
SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System;) a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included history of CABG (Coronary artery bypass grafting), and concurrent conditions included diabetes mellitus, congestive heart failure, and diabetic retinopathy, and other pre-existing medical conditions included the patient had no known allergies to medications, food, or other products and did not had other illnesses at the time of vaccination and up to one month prior. The patient did not have an adverse event following any previous vaccination. The patient, at age of 57 years, received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin and insulin lispro for drug used for unknown indication. On 20-APR-2021, the patient began experiencing tingling feeling in all four limbs at different times. On 28-MAR-2021, patient experienced slurred speech. The patient experienced what he described as near blindness. The patient was driving down road and all of the sudden most of visual field went black and could only see the white lines of the road. The patient was close to hospital and was able to see enough to get himself to the hospital and was diagnosed as having a stroke. The patient had CT, MRI, and ultrasound of heart (results unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling feeling in all four limbs, slurred speech, vision decreased and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210440193-covid-19 vaccine ad26.cov2.s-Stroke, Vision decreased, Tingling sensation in all four limbs, Slurred speech. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY: history of CABG, UNDERLYING DISEASE: congestive heart failure, and diabetic retinopathy
57 2021-04-30 feeling cold, weakness The night after the COVID vaccine had fever 101.4, feeling cold, until the follow day. Went to the... Read more
The night after the COVID vaccine had fever 101.4, feeling cold, until the follow day. Went to the Emergency Department the following night because I noticed that I was drooling, feeling very dizzy and weak.
57 2021-05-03 pain in extremity Mild to moderate arm pain for first 2 weeks. Progressed to severe arm and shoulder discomfort with d... Read more
Mild to moderate arm pain for first 2 weeks. Progressed to severe arm and shoulder discomfort with decreased mobility during 3rd week.
57 2021-05-05 pain in extremity The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12... Read more
The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12/2021 my left leg was swollen and painful. I was already taking blood thinner. I went to the Emergency Room the next day and they found a blood clot in my leg. The Thrombosis was behind my left knee. My leg was swollen from the knee down and my ankle was very swollen. My Eliquis dosage has been increased from 2.5mg to 5mg twice daily. I did not have a repeat sonogram but my leg is no longer swollen.
57 2021-05-06 weakness, pain in extremity, numbness, tingling, facial paralysis, bell's palsy Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a g... Read more
Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a gait issue. Developed Bell?s palsy. Weakness and at times severe pain in shoulders and arms. Tingling sensations in hands. Decreased feeling in legs and feet. These weaknesses are bilateral. Started with general feeling ?off? approx April 1, progressed to severe back pain April 13, visit to ER April 16 diagnosed with pneumonia sent home with antibiotics. Back to ER April 21 with severe back pain and beginning to have difficulty walking and weakness. Sent home with naproxen and muscle relaxers. Back to ER on April 24 fearing a stroke due to face droop. Admitted. Several tests run to R/O stroke,myasthenia gravis, lymes disease. Diagnosed with Bell?s palsy. Sent home on April 28. Still extremely weak. Using a walker. Still in pain. Sent back to ER per physician for another brain MRI on may 4. Not done due to argument between ER staff and physician who sent him in.
57 2021-05-07 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: 3 minutes post vaccination patient was pale, experiencing diaphoresis, felt funny. Immediately he drank apple juice and right after still felt like he was going to faint. As he was sitting upright in chair talking his eyes rolled back in his head and he became unresponsive. I had him lie down and propped up his feet. Called 911 and took his blood pressure. He regained consciousness but was still not coherent. He attempted to sit in chair again and immediately felt like he was going to pass out
57 2021-05-09 seizure Systemic: Seizure-Mild, Additional Details: Patient experienced seizure within 20 minutes of adminis... Read more
Systemic: Seizure-Mild, Additional Details: Patient experienced seizure within 20 minutes of administration that did not last for more than 5 minutes. Patient was able to sit back in chair to await ambulance.
57 2021-05-12 weakness, pain in extremity History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplast... Read more
History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.
57 2021-05-13 pain in extremity, numbness, tingling 3 weeks ago pt. felt numbness/ tingling in RLE, swelling in RLE has increased & 5 days ago pt. felt ... Read more
3 weeks ago pt. felt numbness/ tingling in RLE, swelling in RLE has increased & 5 days ago pt. felt increased pain and tightness.
57 2021-05-17 weakness Low energy ever since
57 2021-05-17 weakness DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneou... Read more
DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.
57 2021-05-17 numbness, tingling WHOLE RIGHT ARM STARTED TINGLING FROM SHOULDER TO FINGERS; FINGERS NUMB; BICEP HURTS ALL ON THE INNE... Read more
WHOLE RIGHT ARM STARTED TINGLING FROM SHOULDER TO FINGERS; FINGERS NUMB; BICEP HURTS ALL ON THE INNER SIDE OF ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health and did not have any symptoms before the vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole right arm started tingling from shoulder to fingers. On APR-2021, the subject experienced fingers numb. On APR-2021, the subject experienced bicep hurts all on the inner side of arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from whole right arm started tingling from shoulder to fingers, fingers numb, and bicep hurts all on the inner side of arm. This report was non-serious.
57 2021-05-17 pain in extremity 5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib... Read more
5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib cage. It was determined by testing that I had a blood clot in left leg and one in each lung. There was also heart arrhythmia. I was given blood thinners for the clots which I am still taking. I was also given medication to help with high blood pressure and to help with heart beat.
57 2021-05-19 cold sweat, feeling hot lightheadedness when standing up, heachache, upper back stiffnesss, hot and cold sweats, vomiting
57 2021-05-23 pain in extremity Extreme dizziness/ vertigo. Room spinning. Started this morning. Had muscle soreness yesterday. Recu... Read more
Extreme dizziness/ vertigo. Room spinning. Started this morning. Had muscle soreness yesterday. Recurring pain down right leg. I need to call Dr.
57 2021-05-23 pain in extremity Overly tired, severe coughing, flu-like symptoms, sore arm
57 2021-05-24 flushing headache front and back and neck, face feels flushed and hot, slight cough, breathing is slightly... Read more
headache front and back and neck, face feels flushed and hot, slight cough, breathing is slightly labored, chest feels tight. Some body ache's. Tylenol given.
57 2021-05-27 pain in extremity First few days severe headaches and neck aches. These were gone after a week. Intense pain in legs... Read more
First few days severe headaches and neck aches. These were gone after a week. Intense pain in legs and knees. VERY difficult to walk and stand from getting up in the morning until mid day. Painful most of the days and evening. I wake up multiple times at night with pain. I wake up about 5 or 7 times/ night. Very difficult to walk up and down stairs.
57 2021-05-29 pain in extremity I had pain in my left leg primarily in my calf that was pretty constant. I went to Urgent Care two w... Read more
I had pain in my left leg primarily in my calf that was pretty constant. I went to Urgent Care two weeks later. They were not concerned about a blood clot since the time had passed. I contacted my Doctor and he did not feel that it was necessary to be concerned because I am male which was no cause to worry.
57 2021-05-31 tingling, numbness He got the vaccine, had no issues with it other than being tired and lethargic for 2 days. Then aft... Read more
He got the vaccine, had no issues with it other than being tired and lethargic for 2 days. Then after 9 days the shoulder muscle was sore as if he had just gotten the vaccine. He then had tingling, prickling sensations up and down his arm to his fingertips with occasional slight numbness. He has not gone to his doctor, but it has not gotten any better.
57 2021-06-01 weakness, numbness Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started fe... Read more
Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started feeling numb. I went into my kitchen and all of a sudden I started feeling dizzy. I lost all strength in my legs and in my left arm. I really couldn't move my arms or my legs and I felt really light headed. I had to have my 5 year old boys get me some water to drink. My son noticed that my heart was beating really strong and really fast. I saw water boiling over in the pot on the stove and I couldn't even get out of a chair to turn it off. I couldn't stand up. I finally managed to go back by my bed from the chair and slowly moved around. I tried holding my phone and it dropped out of my hands a couple of times because I couldn't hold it. A couple hours later, I felt a little better, but I had to fight to get around. We fell asleep and when I woke up, I still felt bad. I took my children to school and told them that I was going to the hospital to get checked out. At the hospital they performed multiple tests and they back showing I had stroke. I was treated for suffering from a stroke.
57 2021-06-09 pain in extremity Both feet swollen, right toe hurts, heels hurt. First few days was hard to walk. It is better now bu... Read more
Both feet swollen, right toe hurts, heels hurt. First few days was hard to walk. It is better now but still a little swollen and heels and right toe hurt
57 2021-06-11 muscle spasms, numbness LOW LEVEL INFLAMMATION IN PERICARDIA; LOW LEVEL INFLAMMATION IN MENINGES; HIGH BLOOD PRESSURE; ACUTE... Read more
LOW LEVEL INFLAMMATION IN PERICARDIA; LOW LEVEL INFLAMMATION IN MENINGES; HIGH BLOOD PRESSURE; ACUTE INFLAMMATORY RESPONSE; MUSCLE CRAMPS (LEGS); COULD NOT SLEEP; MILD BRONCHITIS; HALF SIDE OF THE FACE COMPLETELY NUMB; END OF THUMB GOING NUMB; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 57 year old White and Caucasian male. The patient's height, and weight were not reported. The patient's concurrent conditions included cholesterol, and the patient always had healthy lifestyle, never had heart problems or blood pressure before, was not taking any medication. The patient experienced intolerance to medication when treated with Nurofen (ibuprofen) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fish oil for cholesterol. On 07-APR-2021, around at 01:00 AM, the patient started having headaches and flu-like symptoms that he could manage without medication. On 14-APR-2021, in morning, he had severe muscle cramps (calves and feet), end of thumb going numb and left side of the face completely numb (bottom half of the cheek and underneath the throat). Also had severe headaches (scale 8/10), which was very unusual for the patient. The patient called his PCP who referred him to a local clinic, they drew blood and did a chest X-ray based on the symptoms. Chest X-ray revealed mild bronchitis. Doctor suggested him to go home and stay hydrated. On 14-Apr-2021 (during the night) , patient woke up with muscle cramps in legs and feet, could not sleep because of the severity of the cramps (scale 7 to 8/10) and severe headaches (scale 8/10), could not stay laying down. On 15-Apr-2021, patient visited physician's office. Physician prescribed him steroids (prednisolone) and told him he had an acute inflammatory response to the vaccine and now has low level inflammation in pericardia and meninges (verbatim "inflammation in the bag around the brain and bag around the heart"). Patient's blood pressure (BP) was at 148/130 (his BP baseline was around 120/75) and heartrate was around 96 bpm (baseline 52-55 bpm). Doctor prescribed propranolol. Heart rate went down with propranolol, but Blood pressure was still high, so Doctor switched to losartan 25 mg. He was diagnosed with tachycardia (heart pounding out of chest). On 21-APR-2021, Doctor has scheduled a MRI to rule out blood clots which was normal and also Fibrin D dimer, result was unknown. On 22-APR-2021, patient went to the emergency room, because blood pressure (BP) was 195/138. After receiving treatment, blood pressure was 130/85 and patient went home. Couple of days later, BP was high again, doctor added amlodipine 5 mg to losartan 25 mg and referred the patient to a cardiologist who then increased the dosage to amlodipine 10 mg. Patient now takes losartan 25 mg and amlodipine 10 mg. On 27-May-2021, the patient visited cardiologist and Scheduled Computed tomography scan and electrocardiogram on Monday. Primary care physician had prescribed magnesium supplement for the cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from muscle cramps (legs), and the outcome of end of thumb going numb, half side of the face completely numb, mild bronchitis, acute inflammatory response, low level inflammation in pericardia, high blood pressure, could not sleep and low level inflammation in meninges was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210608039 -covid-19 vaccine ad26.cov2.s- low level inflammation in pericardia, low level inflammation in meninges, high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
57 2021-06-12 weakness, cold sweat extreme version of COVID 19 symptoms: extremely hard to breathe only able to take short breaths; vom... Read more
extreme version of COVID 19 symptoms: extremely hard to breathe only able to take short breaths; vomiting; dry-heaves; coughing; no appetite; fever; cold sweats; chills; lethargy; tired; no energy 15 lb weight loss. This continued from Mid May to June 10, 2021.
57 2021-06-17 numbness, nerve pain Neuropathic pain and numbness
57 2021-06-21 pain in extremity PT STATES THAT HE HAS HAD ARM PAIN NOT JUST AT THE INJECTION SITE BUT HIS WHOLE ARM SINCE 2 DAYS AFT... Read more
PT STATES THAT HE HAS HAD ARM PAIN NOT JUST AT THE INJECTION SITE BUT HIS WHOLE ARM SINCE 2 DAYS AFTER BEING VACCINATED
57 2021-06-21 pain in extremity 3 days after the vaccine, I felt pain in the left leg; I thought I had torn my angle/foot (I have no... Read more
3 days after the vaccine, I felt pain in the left leg; I thought I had torn my angle/foot (I have not kicked anything nor made a wrong step, but there was a bit of pain: since I hike a lot in the City and the country, I could have slightly sprayed my ankle without really recalling it), but I have never had such swelling: I could put my finger in the foot from the ankle down and it would leave a 1/3rd of an inch depression in a puffed-up skin/subcutis. I am a pathologist myself and found it unnecessary to bother anyone with the trouble. So I took aspirin which controlled the swelling somewhat. It took a good 4 weeks for the swelling to fully subside, with a few occasional episodes of worsening. It is all good now.
57 2021-06-24 weakness, night sweats Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue,... Read more
Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.
57 2021-06-28 nerve injury Burning of underarm and left part of stomach. This went on for 1 week before my PCP. They took X-ray... Read more
Burning of underarm and left part of stomach. This went on for 1 week before my PCP. They took X-ray scans because of the stabbing pain. They came back negative and ran blood tests for internal bleeding. Then they scheduled an MRI which came back negative too. I got with a neurologist and they said I have nerve damage. This has been over the course of 3 months.
57 2021-06-30 slurring, inability to speak Initially inability to move the left arm to put it into the jacket. Then bouts of labile hypertensio... Read more
Initially inability to move the left arm to put it into the jacket. Then bouts of labile hypertension, inability to find his word and then slurred speech and global problems moving his limbs and fine motor issues
57 2021-07-01 weakness 24 hours after getting the vaccine I started feeling sleepy and groggy. 48 hours after the vaccine I... Read more
24 hours after getting the vaccine I started feeling sleepy and groggy. 48 hours after the vaccine I felt very groggy and off balance, like I was half asleep or had been drugged with a sedative. I also had low energy and exerting myself (with long walks, etc) made me feel wiped out and exhausted . After one week I started to feel better, but still felt slightly groggy and off balance, like I was drugged with a mild sedative. Now on July 1 -- one full month since getting the vaccine -- I still feel slightly groggy and off balance, no matter how much sleep or rest I get. I also still have lower than normal energy and muscle soreness. The grogginess and off balance is most noticeable when walking or moving my head quickly.
57 2021-07-01 numbness RINGING IN BOTH EARS; NUMBNESS UPPER GUMS/TEETH; INCREASED SALIVATION; This spontaneous report recei... Read more
RINGING IN BOTH EARS; NUMBNESS UPPER GUMS/TEETH; INCREASED SALIVATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug use, no significant medical history, no prescription medications, no caffeine use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A) dose was not reported, administered on 22-JUN-2021 10:13 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced ringing in both ears. On 22-JUN-2021, the subject experienced numbness upper gums/teeth. On 22-JUN-2021, the subject experienced increased salivation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from ringing in both ears, numbness upper gums/teeth, and increased salivation. This report was non-serious.
57 2021-07-11 numbness, facial paralysis, tingling, speech disorder 7/5/2021 he started to notice numbness in his neck and shoulders, which he related to a possible pin... Read more
7/5/2021 he started to notice numbness in his neck and shoulders, which he related to a possible pinched nerve. On Tuesday, 7/6 he noticed increasing numbness to neck a.m. shoulders with new onset left fingers tingling as well as bilateral feet, at which time he started taking Excedrin. On Wednesday, 7/7 he noticed increasing neck pain and numbness with his "entire spine "painful. On Thursday, 7/8 he noticed increase BL feet numbness. Today, 7/10 he woke up with numbness to the left side of his face, facial droop, mumbled speech and continued numbness to left fingers and BLE feet, for which he came to the ED for further evaluation management. Patient is currently hospitalized in ICU at the time of this report.
57 2021-07-11 numbness Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness an... Read more
Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness and unbalance Malaise with any kind of physical exertion Stiffness/pain in the lower back of head
57 2021-07-11 muscle spasms, numbness, tingling 6/28/21 - J&J vaccine administered in right arm 6/29/21 - left calf cramp notice first thing in the... Read more
6/28/21 - J&J vaccine administered in right arm 6/29/21 - left calf cramp notice first thing in the morning, assume potassium issue, took supplement - no change 6/30/21 - intermittent numbness left calf, cramping still present 6/30/21 - MD Visit to walk in clinic - ultrasound - for DVT - results negative - doctor diagnosis - likely pulled muscle - ordered prescription for cyclobenzaprine (FLEXERIL) 10 mg tablet 7/1- 7/6 - cramping spread to ball of foot, hamstring, and quad, all left leg. occasional short stinging like bee, on outside of calf, numbness and pins and needles intermittently - flexeril results no benefit 7/7/21 - Visit to PA -D-Dimer test .27 (>.50 indicates blood clot) negative DVT ultrasound. Summary - Ultrasound of legs negative for DVT. Leg cramps likely due to to recent vaccination. Please call the office if there is no improvement after taking ibuprofen as instructed.
57 2021-07-12 numbness, pain in extremity, tingling Tingling Numbness, Restricted movement and pain all in the left arm
57 2021-07-12 muscle spasms Cramping in.legs 5 fays
57 2021-07-12 tingling, slurring Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortn... Read more
Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortness of breath, some slurring of words, unusual stutter, abdominal pain, pressure in chest front to back, soreness at shot location, later - a very high blood glucose reading. 6/25/2021 - glucose reading of 225, HBA1c reading of 8.8%! Later diagnosed with LADA because of glucose readings, AND because lifestyle is vegan vegetarian and active workouts, AND no prior high glucose readings. subsequent tests for auto immune, negative.
57 2021-07-12 tingling Tingling in arms and legs. Muscle weakness on arms ,legs and shoulders. Lasted for three weeks. In t... Read more
Tingling in arms and legs. Muscle weakness on arms ,legs and shoulders. Lasted for three weeks. In the 4th week had weakness in left leg and tingling. Tingling also on both thumbs. Progressive reduction in thr 5th week. Looks back to normal in the 6th week
57 2021-07-12 paralysis Short temporary paralysis in right hand and fingers lasting a minute or two on 3 separate occasions.... Read more
Short temporary paralysis in right hand and fingers lasting a minute or two on 3 separate occasions. Not sure if related to vaccine. Happened to receive vax in right shoulder. Only reporting cause of recent story of Guillain-Barré syndrome. Didn?t connect it to inoculation, but never had the sensation before shot. Haven?t really felt it again for last month or so. May be nothing related.
57 2021-07-12 tremor Fatigue, stomach bloating, shortness of breath, nerve problem-shaking, rash, was provided antihistam... Read more
Fatigue, stomach bloating, shortness of breath, nerve problem-shaking, rash, was provided antihistamine by healthcare professional.
57 2021-07-13 nerve pain 2 weeks after vaccination, seemed that every nerve in my body has been damaged. I've never had wide ... Read more
2 weeks after vaccination, seemed that every nerve in my body has been damaged. I've never had wide spread nerve pain in my whole body like this before. I've got an appointment with Dr. which is my doctor tomorrow.
57 2021-07-13 paralysis blurred vision, paralysis all over body. Time of occurrence was about 12:30 am 7/13/21. No treatment... Read more
blurred vision, paralysis all over body. Time of occurrence was about 12:30 am 7/13/21. No treatment has been given since vaccine. Has had cuts in ligament on ankle (work related injury) the day before covid shot.
57 2021-07-14 numbness, weakness Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted... Read more
Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.
57 2021-07-14 numbness, tingling Approximately 2.5 to 3 weeks after shot felt a noticeable and annoying tingling/numbness in fingers ... Read more
Approximately 2.5 to 3 weeks after shot felt a noticeable and annoying tingling/numbness in fingers of both hands. This sensation has diminished over time but can still slightly feel it at times. Assumed it was a coincidence until J&J warning was issued several days ago.
57 2021-07-14 numbness, tingling About 1 month after receiving the J&J Covid vaccine patient noticed numbness/tingling in the smaller... Read more
About 1 month after receiving the J&J Covid vaccine patient noticed numbness/tingling in the smaller 3 fingers of his right hand. Around the same time, he noticed weakness in his right hand also. He received his vaccine in his left deltoid.
57 2021-07-16 pain in extremity PAINFUL SORE ARM; BAD HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned ... Read more
PAINFUL SORE ARM; BAD HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 57 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: 025A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 12-JUL-2021, the subject experienced painful sore arm. On 12-JUL-2021, the subject experienced fatigue. On 12-JUL-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad headache, fatigue, and painful sore arm. This report was non-serious.
57 2021-07-20 tingling, numbness I started having numbness and tingling in the left foot and left hand after taking the shot along w... Read more
I started having numbness and tingling in the left foot and left hand after taking the shot along with headaches. I mention to my primary doctor during my physical and he has referred me to a neurologist that I have scheduled an appointment to further evaluate.. I continue to experience this and I'm awaiting my appointment with the neurologist.
57 2021-07-25 pain in extremity Approximately 2 months after the vaccine the patient began to have pain in his right calf. No treatm... Read more
Approximately 2 months after the vaccine the patient began to have pain in his right calf. No treatment at that time. About 2 weeks later the pain came back, an ultrasound was done and blood clots were seen. Zorelto was started however patient had a reaction to that of( lips swelling and nausea). At that time Eliquis was started at 5mg BID until current.
57 2021-07-27 pain in extremity About 6-8 hours after receiving injection was having chills, sweating and shivering. Hands and feet ... Read more
About 6-8 hours after receiving injection was having chills, sweating and shivering. Hands and feet were very sore and stiff. All areas of past trauma painful and continue to be so.
58 2021-03-08 muscle spasms Muscle cramps, nausea , headache, chills, fever 100.4
58 2021-03-08 tremor fever over 102, chills and shakes. chills went away around 4:00 am, fever was gone when I woke up..... Read more
fever over 102, chills and shakes. chills went away around 4:00 am, fever was gone when I woke up....Slight headache during the day Saturday, headache was gone on Sunday when I woke up.
58 2021-03-11 weakness Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak... Read more
Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak, face turned white. I was close to passing out but didn't. I requested attention after about 10 minutes. While being treated by medics they mentioned color had returned to my face. I felt better enough so I refused to go to hospital and was driven home. Later that morning, 03/08/2021 about 10 AM, I developed a fever and body aches with sharp pains thru out my body and joints. First temperature check was 100.5. My fever, pains/weakness increased thru out that day and overnight with chills. Highest temp check was 102.8 that evening prior to bedtime. I don't know if it could have been higher at some point overnight. It felt like I had a moderate to bad case of the FLU. The next morning, 03/09/2021 the fever broke down to about 101. By 03/11/2021, aside from a little residual weakness I felt more like myself. However, as of the writing of this report my temp seems to fluctuate between normal and 99.8. Will report this to my Doctor on next visit. Worth noting that I haven't had any Flu like symptoms to that degree in many years.
58 2021-03-15 tremor, weakness ABOUT 4 HRS AFTER SHOT(THAT FRI. NIGHT), LIGHTLY FEELING WEAK, GRADUALLY OVER THE NEXT 6 HRS WEAKNES... Read more
ABOUT 4 HRS AFTER SHOT(THAT FRI. NIGHT), LIGHTLY FEELING WEAK, GRADUALLY OVER THE NEXT 6 HRS WEAKNESS STRONGER 3 FULL DAYS. MONDAY MORNING WEAKNESS EVENED OFF. TUESDAY MORNING FEELING SICK,WEAK, NAUSEA, SHAKY, HARDER BREATHING, COUGHING, WIERD TASTE IN MOUTH, DRY MOUTH, LIGHT HEADACHE, SLEPT VERY HEAVY, SWEATY
58 2021-03-19 feeling cold vaccine 12:30 PM 8:30PM felt very cold. Soaked in hot bath for awhile, went to bed. Sometime later v... Read more
vaccine 12:30 PM 8:30PM felt very cold. Soaked in hot bath for awhile, went to bed. Sometime later very had high fever that lasted for hours and was accompanied by high heart rate and aches. After I had cooled a bit I took my temperature--103. Heart rate over 100, maybe up to 120 my resting pulse is typically in the l 50s )Suspect fever at peak was over 104. Fever and elevated heart rate lasted for hours. . At 2:30 AM took 3 ibuprofen, returned to bed and drifted off. An hour or two later woke up completely drenched and dripping with sweat but no longer feverish. Drifted back to sleep. By 9 AM felt almost normal, but (not surprisingly) a bit wrung out.
58 2021-03-21 muscle spasms chills, fever, muscle contractions/seizures, severe headache, joint pain, sweats,muscle weakness, ac... Read more
chills, fever, muscle contractions/seizures, severe headache, joint pain, sweats,muscle weakness, acid reflux- time course: began approx 8 hrs after shot (12:15am) and continued until 5am,-acetaminophen 1000mg q8h, naproxen 220mg q12h, gaviscon liquid 10ml, the headache, muscle pain has continued at a lower intensity until 12noon on monday 3/22/21
58 2021-03-22 tremor Headache, fatigue, body aches and flu like symptoms lasting about 24 hours. Chills and shakes for ab... Read more
Headache, fatigue, body aches and flu like symptoms lasting about 24 hours. Chills and shakes for about 20 minutes, 10 hours after injection.
58 2021-03-23 weakness About 30-45 minutes after the vaccine was administered, I began to experience a thickening of the mu... Read more
About 30-45 minutes after the vaccine was administered, I began to experience a thickening of the mucus in my throat and some slight+ wheezing, perhaps an increase in heart rate. This lasted for about 10-15 minutes. Next day very mild flu symptoms and lack of energy--this continued through the following day but milder.
58 2021-03-23 seizure Seizures 4 days after the vaccine
58 2021-03-26 feeling hot Patient stated arms felt warm and then started to develop hives 2 to 3 minutes after receiving vacci... Read more
Patient stated arms felt warm and then started to develop hives 2 to 3 minutes after receiving vaccine. Then stated arms, shoulder and back felt achy. Patient was given 50mg or Benadryl orally and monitored.
58 2021-04-01 numbness Initially (20 minutes after shot) felt numbness in toes on both feet. Chills were next felt within ... Read more
Initially (20 minutes after shot) felt numbness in toes on both feet. Chills were next felt within approx an hour. Intense muscle aches were later (approx 6-8 hrs after shot) along with overall fatigue. A medium grade headache began 8-10 hrs after shot and continued throughout night - lowering to a slight headache within 24 hrs after shot. Headache ended 28-30 hrs after shot. Developed a post nasal drip and mild congestion in sinuses about 1.5 days after shot (and continues). Numbness in toes appears to have returned with some stiffness felt in my calf muscles.
58 2021-04-07 migraine Patient had Covid in late November/early December. Same side effects as then. Severe migraine like ... Read more
Patient had Covid in late November/early December. Same side effects as then. Severe migraine like stabbing headache, fever, chills , body ache and nausea.
58 2021-04-08 tremor I became nervous and started shaking (no chills). The quaking/shaking lasted about an hour. My hea... Read more
I became nervous and started shaking (no chills). The quaking/shaking lasted about an hour. My heart rate was accelerated for a few hours and I had difficulty sleeping.
58 2021-04-08 tremor Chills and body shakes.
58 2021-04-09 numbness NASAL DRIP; MILD CONGESTION; INTENSE BODY ACHES; WEAKNESS BEHIND KNEES WORST ON LEFT SIDE; CHILLS; M... Read more
NASAL DRIP; MILD CONGESTION; INTENSE BODY ACHES; WEAKNESS BEHIND KNEES WORST ON LEFT SIDE; CHILLS; MEDIUM GRADE HEADACHE; FATIGUE; LOW GRADE FEVER; MUSCLE ACHE; NUMBNESS IN BOTH FEET - FRONTAL FROM BUNION OUTWARD MAINLY ON BOTTOM; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 150 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no allergy to vaccine, drug, or food and no history of drug abuse. the patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no family history of any disease or allergy relevant to vaccination and hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on right arm muscle for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced numbness in both feet - frontal from bunion outward mainly on bottom. On 31-MAR-2021, the subject experienced intense body aches. On 31-MAR-2021, the subject experienced weakness behind knees worst on left side. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced medium grade headache. On 31-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced low grade fever. On 31-MAR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nasal drip. On 01-APR-2021, the subject experienced mild congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, was recovering from medium grade headache, intense body aches, nasal drip, mild congestion, low grade fever, and muscle ache, had not recovered from numbness in both feet - frontal from bunion outward mainly on bottom, and weakness behind knees worst on left side, and the outcome of fatigue was not reported. This report was non-serious.
58 2021-04-10 facial paralysis, numbness the patient was admitted with severe headache and backpain. over the course of 3-4 days, he develope... Read more
the patient was admitted with severe headache and backpain. over the course of 3-4 days, he developed progressive neurologic symptoms (bilateral facial nerve palsies, numbness and dysesthesia of the lower extremities, bilateral lower extremity weakness and loss of reflexes) consistent with acute inflammatory demyelinating polyneuropathy.
58 2021-04-10 unresponsive to stimuli Within 5 minutes of receiving the vaccine patient's blood pressure bottomed out and he became catato... Read more
Within 5 minutes of receiving the vaccine patient's blood pressure bottomed out and he became catatonic (like state). He was not responding to his wife or I calling his name. He was not able to move his body and just kept staring down/ off into the distance. He would come in and out as time went on he was slowing coming back to us as his BP started to elevate. He was not having trouble breathing/ we did not use any medication. Paramedics were called since patient was not responding. They evaluated him in the rescue. result of patient unknown at this time were not available to follow up when phoned on Sunday
58 2021-04-12 numbness Numbness in two fingers on left arm (ongoing for over one month after dose), rash on site of injecti... Read more
Numbness in two fingers on left arm (ongoing for over one month after dose), rash on site of injection (ongoing for over one month)
58 2021-04-12 pain in extremity Next day left arm was sore .Two day later felt sick ,head hurt, leg pain late more than usual, was r... Read more
Next day left arm was sore .Two day later felt sick ,head hurt, leg pain late more than usual, was real tired sleeped most of next few day
58 2021-04-12 tremor Blurred vision, dizziness, nausea and shakes.
58 2021-04-13 weakness This spontaneous report received from a consumer concerned a male of unspecified age. The patient's ... Read more
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, severe vomiting, and severe exhaustion. The action taken with covid-19 vaccine was not applicable. The outcome of the severe vomiting, diarrhea and severe exhaustion was not reported. This report was non-serious.
58 2021-04-13 muscle spasms Have had constant nausea, diarrhea, cramping, sometimes burning sensation in stomach since getting t... Read more
Have had constant nausea, diarrhea, cramping, sometimes burning sensation in stomach since getting the shot.
58 2021-04-14 unresponsive to stimuli Patient was given vaccination and asked to sit in observation area for a minimum of 15 minutes. Wit... Read more
Patient was given vaccination and asked to sit in observation area for a minimum of 15 minutes. Within the first 5 minutes, the pharmacist was alerted to the patient dropping his phone and glasses to the floor and staring off into space. The pharmacist proceeded to make contact with patient by calling their name and giving them gentle taps on the shoulder and knee. The patient "came to" within a few minutes stating that they could hear and see but felt as though they were "off in space" . Once the patient "came to" they were coherent but perspiring a bit. The patient was offered water and a cool damp cloth. The patient was offered EMT services which they declined. The patient was made to wait another 15 minutes in the observation area. The patient did have a spouse with them who would be driving them home. The patient was called later in the day to by the pharmacist to see how the were feeling. The patient stated they were fine and appreciated the follow-up call.
58 2021-04-18 bell's palsy Bells Palsy, other nerve problems, body aches, body pain
58 2021-04-18 pain in extremity After my J&J vaccine, I experienced left hip and joint pain. I could not lift my left leg up. The ne... Read more
After my J&J vaccine, I experienced left hip and joint pain. I could not lift my left leg up. The next morning after my J&J vaccine, my left leg started hurting more and I could not ambulate. My left hip was hurting so bad I could not sleep at night. I went to the doctor 03-17-2021 to get monitored and he said it could be arthritis. I was prescribed by Dr. cyclobenzaprine 10mg and naproxen 500mg. I feel that my pain is inside the joint, hip pain region and to this day, I still have sleeping problems due to my pain in my left leg and left hip pain since the J&J vaccine. I will have a follow up with Dr. in the coming weeks.
58 2021-04-20 pain in extremity PASSED OUT; LIGHT HEADED; VERY SLEEPY; ARM PAIN; This spontaneous report received from a patient con... Read more
PASSED OUT; LIGHT HEADED; VERY SLEEPY; ARM PAIN; This spontaneous report received from a patient concerned a 58 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: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient was very sleepy and experienced arm pain. On 08-APR-2021, the patient passed out in shower and felt light headed, he awoke in shower with no known duration and with no injuries The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, and the outcome of light headed, arm pain and very sleepy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210420738-covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
58 2021-04-20 pain in extremity About 36 hours after the injection I started to feel some fairly profound fatigue, and had aching jo... Read more
About 36 hours after the injection I started to feel some fairly profound fatigue, and had aching joints throughout my body for about 36 hours after the onset. I also had some lingering mild pain in the backs of my thighs for about 12-18 hrs after the aches went away.
58 2021-04-21 night sweats, weakness, feeling hot FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZ... Read more
FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.
58 2021-04-21 pain in extremity NECK PAIN; ARM PAIN; LEFT SIDE BODY PAIN; HEADACHE; This spontaneous report received from a patient ... Read more
NECK PAIN; ARM PAIN; LEFT SIDE BODY PAIN; HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced left side body pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, arm pain, and left side body pain. This report was non-serious.
58 2021-04-21 pain in extremity Extreme tightness in neck muscles and pain in hips and left leg
58 2021-04-21 pain in extremity BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE... Read more
BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. This report was non-serious.
58 2021-04-22 weakness, feeling hot Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the fl... Read more
Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.
58 2021-05-02 pain in extremity Patient is a 58-year-old male with history of DM2 on insulin, bovine aortic valve replacement, nonis... Read more
Patient is a 58-year-old male with history of DM2 on insulin, bovine aortic valve replacement, nonischemic cardiomyopathy (unknown EF), hypertension, obesity, presented to Medical Center on 4/26/21 for left leg pain and swelling. Symptoms began about 2 days ago when he drove to visit some friends and started to " feel under the weather" hence drove back yesterday. He then had acute onset of left leg swelling and pain which prompted him to present to the ED. He was reportedly concerned about " having a clot" as he just received the Johnson & Johnson Covid vaccine this past week.
58 2021-05-05 feeling hot Vasculitis Both Lower Legs - Red Rash and Red Spots Warm to Touch
58 2021-05-12 feeling of insects crawling on skin, weakness GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATI... Read more
GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.
58 2021-05-12 numbness BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous repor... Read more
BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021 The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported. After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday. As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
58 2021-05-17 pain in extremity Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after... Read more
Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after injection dizziness. 48 hours after injection neck and head pain on left side, arm soreness, and swollen lymph node on left side of throat. Minor pain in mouth and throat with fatigue and dizziness. Neck and head pain decreasing on day 3 with all other effects resolving but injection site is still fairly sore. Overall, I would say this was probably a normal response associated with my immune system reacting to the injection. I had the virus the first week of December 2020. I would classify my infection as moderate. I was sick with fever, chills and severe body aches and it lasted for 10-14 days.
58 2021-05-17 pain in extremity 03/23 Sore arm after shot for three days and general soreness in left shoulder. No other side effect... Read more
03/23 Sore arm after shot for three days and general soreness in left shoulder. No other side effects, Soreness fade within a weeks 05/10 /2021: Woke up with what was felt like a closed eustachian tube (right side). Teble, high end hearing muted all day. Minor post nasal drip. 05/11/2021 No nasal drip, sounded better in the morning. By 12pm, hearing in my right ear is completely gone. 05/12/2021 Visit to GP : clean out ear with not relief. Simple Test confirms hearing loss is not viral but sensorinrual loss.
58 2021-05-19 weakness DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous re... Read more
DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.
58 2021-05-19 difficulty speaking, pain in extremity THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MU... Read more
THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.
58 2021-05-20 pain in extremity Pain in left upper arm about 10 days after injection, shooting down arm to hand, reduced mobility of... Read more
Pain in left upper arm about 10 days after injection, shooting down arm to hand, reduced mobility of the arm, didn't improve for 3 weeks thus saw my own doctor. She referred to orthopaedic doctor. Saw him on 5/12/2021, he diagnosed adhesive capsulitis in left shoulder possibly caused or exacerbated by the swelling due to the vaccination in that same area. Revisit in 3 weeks after dr. visit. Taking ibuprofen to reduce inflammation.
58 2021-05-21 slurring Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, inc... Read more
Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, increased heart rate, decreased kidney functions, blood clots in both arms and jugular vein, slurred speech, severe pain in right side, fluid in right lung and around heart. Admitted to MICU from emergency room. Intubated for 12 days. Chest tubes both sides, central line, Hickman Catheter. Discharged and admitted to hospital. Currently home receiving outpatient therapy.
58 2021-05-22 burning sensation At 12 hours after application: Headache, left lobe. At 24 hours of application: skin rashes, with so... Read more
At 12 hours after application: Headache, left lobe. At 24 hours of application: skin rashes, with some burning, but remains 4 days later. No other effect.
58 2021-05-24 weakness Within a couple hours, I felt very tired. At about 9pm, I went to bed and started experiencing chil... Read more
Within a couple hours, I felt very tired. At about 9pm, I went to bed and started experiencing chills, sweating, intense body aches and pains, a headache, nausea and abdominal pain. This lasted thru the night. When I woke up, the chills, sweating and intense body aches and pains were less in severity. I took my temperature and it was 101. The temperature was elevated on and off for the next two days. The other symptoms lessened. The abdominal pain remained. I continued to have a headache for over one week. On the 14th (five days after) I felt like I was finally getting better. However, on the night of the 14th, the fever returned and the abdominal pain worsened. I made an appointment with my PCP on the 15th. I was still experiencing a fever, tiredness, body aches and pain, nausea and abdominal pain. I also had loose stools. My PCP requested I be tested for COVID (came back negative) and treated me with antibiotics for diverticulitis. I finished the treatment and shortly after started experiencing issues with a tooth where I had a root canal several years ago. I am still experiencing issues with the tooth and am taking amoxicillin. I have not felt well since the injection on the 9th. I feel tired, do not have the energy that I would expect to have and still have this nagging tooth issue. I'm 100% convinced this is all related to the vaccine on the 9th.
58 2021-05-26 numbness, tingling May 10 started to experience numbness and tingling in both hands and feet. May 20 got in to see a ne... Read more
May 10 started to experience numbness and tingling in both hands and feet. May 20 got in to see a neurologist symptoms worsened became difficult to walk. May 20 admitted into hospital.
58 2021-05-30 weakness Fatigue, weakness, headaches, nausea continued for at least 8 weeks post-vaccine (to date), with som... Read more
Fatigue, weakness, headaches, nausea continued for at least 8 weeks post-vaccine (to date), with some improvement over time.
58 2021-05-31 numbness BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOUR... Read more
BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication. On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung, bilateral hands and legs swollen and bilateral feet and hand numb. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
58 2021-06-08 pain in extremity A few days after the vaccine my left arm began to hurt approximately where I received my flu shot se... Read more
A few days after the vaccine my left arm began to hurt approximately where I received my flu shot several months before. I went into the doctor and told him where it was hurting and he felt it was a shoulder impingement and gave me a shot. That was a week ago and it still hurting so I making this report because of that.
58 2021-06-09 cold sweat, weakness Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pai... Read more
Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pain from hips up back to neck, and ribs front and back still continue. Periodic cold sweat mainly in the mornings and sense of unsteadiness in my head.
58 2021-06-23 pain in extremity On Friday June 11 I woke up with itching hands; as the day went on the condition worsened; I applied... Read more
On Friday June 11 I woke up with itching hands; as the day went on the condition worsened; I applied Aveeno and Benadryl cream; Saturday June 12th I went to urgent care and received a Steroid shot which did help the rash and hives. On Sunday June 13th I noticed my hands starting to hurt ; by Monday the the pain was severe; I saw my family Dr on Tuesday June15th on he prescribed oral steroids. Wednesday the pain had moved to my shoulders and hands where it continues. The pain is not as severe but it still hurts to move my shoulder or to grip things with my hands.
58 2021-06-28 weakness, inability to speak I am finding my ability to stand, walk, or hold my arms above my head for any period of more than a ... Read more
I am finding my ability to stand, walk, or hold my arms above my head for any period of more than a few minutes difficult. Yesterday I was unable to hold myself upright sufficiently to sit in a kayak (never got to find out for how long could I try to paddle). Mentally I am constantly having short-term memory challenges, for example just recalling the word fatigue to describe my situation I have had to write on a note paper as I repeatedly forget the term until I read it. Bringing groceries from our vehicle into the house I am finding near impossible (what used to take 1-2 minutes has taken me over 15 in the past 3 weeks on multiple occasions). I find myself falling asleep repeatedly during work, even though I am sleeping well at night. Some days are better than others, with a strong correlation to temperature.
58 2021-06-29 brain damage Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome... Read more
Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome in the mechanical cardiac valve, leukipenia, thrombocytopenia, encephalopaty, acute kidney injury, respiratory failure, tachycardia, new onset afib. Patient is currently still hospitalized and declining in status- on ventalator
58 2021-07-01 pain in extremity, tremor TREMBLING; BODY ACHES; NIGHTMARES; SEVERE CHILLS; SORE / PAINFUL ARM; This spontaneous report receiv... Read more
TREMBLING; BODY ACHES; NIGHTMARES; SEVERE CHILLS; SORE / PAINFUL ARM; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative. On 28-JUN-2021, the subject experienced sore / painful arm. On 29-JUN-2021, the subject experienced trembling. On 29-JUN-2021, the subject experienced body aches. On 29-JUN-2021, the subject experienced nightmares. On 29-JUN-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trembling, nightmares, and severe chills on 29-JUN-2021, and body aches on 30-JUN-2021, and had not recovered from sore / painful arm. This report was non-serious.
58 2021-07-02 facial paralysis, speech disorder Stroke, treated at hospital with blood thinners. Outcomes - 85% within a year. Patient has memory ... Read more
Stroke, treated at hospital with blood thinners. Outcomes - 85% within a year. Patient has memory and speech issues. Facial paralysis on right side.
58 2021-07-07 tremor I got a prostate infection and experienced severe chills and shaking and I also had a fever.
58 2021-07-09 discomfort (4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; ... Read more
(4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; no other symptoms. (4/30) Rapid fever onset with chills from 98.6 to 102.7 within four (4) hours; increased pain in right side; . Seen at urgent care: blood pressure normal; elevated heart rate (130); sub-normal SpO2; urinalysis negative; chest x-ray negative; COVID test negative. Referred to ER. (4/30) ER: increased pain; no coughing or symptoms beyond extreme chills/fever; two additional COVID tests negative; extremely high white cell count (25K), CT showed small pneumonia on right side. Treated with multiple antibiotics and released. (5/1-5/7) Continued elevated (99-100F) fever; occassional lethargy; no coughing or other symptoms. (5/8) Temperature normal; occassional lethargy; no coughing; increased pain on right side at night. ( through 7/10) increasing pain on right side; present constantly but worse at night; radiates front to back on right side below rib cage; no other symptoms. (5/12,6/23,7/1) Follow-up visits with PCP; additional chest x-ray negative; CT scheduled for 7/14.
58 2021-07-11 slurring 2-3 weeks after vaccination patient started with weakness in both legs, general fatigue, progressive... Read more
2-3 weeks after vaccination patient started with weakness in both legs, general fatigue, progressive weakness in both arms, progressive dysarthria, and fasciculations in both upper arms. Patient followed up with neurologist but did not improve. Patient now has pending appointment with Neurology.
58 2021-07-12 tingling, bell's palsy Bells Palsey 02May2021 Low grade fever and fatigue 12May2021 Breathing issues started 14May2021 Covi... Read more
Bells Palsey 02May2021 Low grade fever and fatigue 12May2021 Breathing issues started 14May2021 Covid 19 Positive Test 15May2021 Covid related pneumonia 19May21 Hospital admitted 19May2021 to 24May2021 Tingling in fingers and toes started 30Jun2021 to present.
58 2021-07-12 unresponsive to stimuli "Chills and aches" the day and evening of the shot. After a couple of weeks, Pt began to experience... Read more
"Chills and aches" the day and evening of the shot. After a couple of weeks, Pt began to experience various pains at different points of his body. He developed severe indigestion resulting in him visiting his physician on April 19th where he was put on a 7-day steroid regimen. One week later, early on Monday morning, April 26, 2021, Pt collapsed in his bathroom at home, was unresponsive, and pronounced dead by the paramedics who responded.
58 2021-07-13 weakness, pain in extremity Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, p... Read more
Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, post vaccine fever, hyperkalemia, anemia, vomiting, weakness, hypoxia, hypervolemia; Pt rcvd J & J and next day seen in ER with leg pain, N, V, diarrhea and shortness of breath. Mult stool antigens neg. Lactic acid and WBC elevated. Initial fever resolved as did hyperkalemia and hypervolemia state after urgent dialysis.
58 2021-07-16 facial paralysis, numbness Presented with generalized malaise, fever, chills on June 23. Had headache and cough on and off afte... Read more
Presented with generalized malaise, fever, chills on June 23. Had headache and cough on and off after receving vaccine. On July 8 admitted to hospital with rash concerning for erythema migrans. Positive Lyme IgM. Started doxycycline. Discharged 7/10. Came back on 7/11 with bilateral facial nerve palsy. noted to have severe back pain of unclear cause as well. Started on Ceftriaxone. Discharged again on 7/13. On 7/14 presented to oupatient ID clinic with increasing back pain and numbness on trunk and upper thighs. Sent back to hospital. CT head, MRI thoracic and lumbar spine normal. LP done normal cell count, mildly elevated protein on CSF. Increasing muscle weakness of extremities (proximal muscles of lower extremities first). Impression: Guillain Barre. Started on IVIG
58 2021-07-19 tingling When patient woke up the morning after the vaccine (given on 7/19; symptoms started 7/20), he experi... Read more
When patient woke up the morning after the vaccine (given on 7/19; symptoms started 7/20), he experienced tingling feet; body aches; shortness of breath; chest tightness.
58 2021-07-21 burning sensation, tingling, bell's palsy COVID-19 RELATED PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; AS... Read more
COVID-19 RELATED PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ASTHMA AGITATED; BURNING SENSATION IN FINGERS; TINGLING OF FINGERS AND TOES; BELL'S PALSY; This spontaneous report received from a 58-year-old male patient. The patient's height and weight were not reported. The patient's concurrent conditions included high cholesterol, high triglycerides, mold allergy, alcohol use (6 to 8 beers in the weekend) and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 08-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient started experiencing bell's palsy. His mouth was dropping on the left side and he didn't have any feeling or nerve feeling on that area of mouth. His eyes and rest of the body was fine. He visited the physician. On an unspecified date in MAY-2021, Laboratory data included: CT scan result was Negative and Blood test was Negative. Patient was given a Steroid shot as treatment and it resolved. On 12-MAY-2021, he experienced low grade fever, fatigue and kind of illness. On 15-May-2021, he visited hospital with breathing problem and coughing. In the hospital patient was tested positive for covid-19 (suspected clinical vaccination failure). The chest X-ray showed that the lungs were clear. On 19-MAY-2021, he again had trouble breathing and was unable to breathe despite trying hard and was hospitalized for 5 days. Patient had another X-ray and was diagnosed with a COVID-19 related Pneumonia. He was put on Remdesivir and oxygen as treatment. Laboratory data included: Oxygen saturation was around 80. After 3 and half days, he was able to breathe on his own and was taken off oxygen. On an unspecified date in MAY-2021, while at hospital, patient experienced asthma agitated and was prescribed prednisone also. On 24-MAY-2021, he was discharged from hospital for 5 days. Non-company suspect drugs included: tyrosine (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUN-2021 for mental alertness. Since 29-JUN-2021, he experienced tingling in his fingers and toes. He reported that the physician had put him on D-Tyrosine for last one month and has experienced the event since then. On 08-JUL-2021, he stopped the supplement as the physician had asked him to stop but still have the event and symptoms were getting worse. On JUL-2021, he experienced burning sensation in fingers. He stated that it was not all the finger and toes in general but noticed more issue on the left side than the right side. The left side was worse for the toes but for the fingers issue progressed from right index to his left hand. At the time of reporting, He had tingling and burning sensation in both hands and was continuing and not getting any better. Physician was aware but did not prescribe him any medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bell's palsy, suspected covid-19 infection, covid-19 related pneumonia and asthma agitated, had not recovered from tingling of fingers and toes, and burning sensation in fingers, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000185884. The suspected product quality complaint had been confirmed to be not voided.; Sender's Comments: V0: 20210727746-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS V0: 20210727746-covid-19 vaccine ad26.cov2.s-Bell's palsy, Covid 19 pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210727746-covid-19 vaccine ad26.cov2.s-Asthma aggravated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
58 2021-07-25 tingling, slurring, nerve injury PATIENT REPORTED TO PCP DR ON 05/08/21 AFTER FEELING TIRED AND NERVE TINGLING SENSATIONS IN BODY, FO... Read more
PATIENT REPORTED TO PCP DR ON 05/08/21 AFTER FEELING TIRED AND NERVE TINGLING SENSATIONS IN BODY, FOLLOWED UP WTH NEUROLOGIST ON 06./03/21 AS SPEECH WAS SLURRED
59 2021-03-08 feeling hot Body ache, chills and headache and feeling hot
59 2021-03-09 pain in extremity, numbness 21 hours after injection, lethargy and tired. Approximately 40 hours after injection, loss of motor... Read more
21 hours after injection, lethargy and tired. Approximately 40 hours after injection, loss of motor function on left side, specifically, could not lift left leg to climb stairs, combined with soreness in left hip and shoulder. Hip pain is mild to severe, and deep, mostly around the top of the femur. Approximately 8 hours later had sharp, shooting pains deep in the left leg/. Felt like it was in the femur, paint started at the top of the leg and shot down to the knee. Pain duration approximately 1 second, with multiple, sporadic occurrences over the next several days. Approximately 3.5 days after injection, numbness in left hand - small (pinky) finger and radiating along side of hand to wrist. Loss of motor function on left side resolved after approximately 8 hours, pain in hip, pain in shoulder and shooting pain in leg and hand numbness continue. Shooting pain is intermittent, shoulder pain is intermittent, hip pain and numbness in hand are constant.
59 2021-03-10 weakness Chills sweats vomiting diarrhea body aches no energy slept for most of day
59 2021-03-13 cold sweat, unresponsive to stimuli, weakness PATIENT GIVEN VACCINE AFTER ALL PROCEDURAL ITEMS WERE COMPLETED ANDWAS LEFT SEATED IN A CHAIR ASSIGN... Read more
PATIENT GIVEN VACCINE AFTER ALL PROCEDURAL ITEMS WERE COMPLETED ANDWAS LEFT SEATED IN A CHAIR ASSIGNED FOR COVID 19 MONITORING . PATIENT STARTED SNORING/GURGLING AND I LOOKED OVER TO SEE IF PATIENT WAS CATUALLY SNORING . PATIENT WIFE CALLED HIM BY NAME HE DID NOT ASWER RIGHT AWAY, I RAN TO TO ATTEND TO HIM AND I NOTICE HE WAS PALE , SWEATLY AND CLAMY ALSO WARM TO TOUCH. I CALLED HIS NAME HE ASWERED I THEN TOOK HIS PULSE WHICH WAS NORMAL AND GAVE HIM SOME WATER TO SIP AND ALSO GAVE PATIENT A CANDY WITH MENTHOL THEN HE STARTED GAINING BACK COLOR . HE FELT WEAK BUT STARTED FELLING BETTER. HE SEEM TO HAVE DIZZY ,LIGHTED HEAD SPELLS RIGHT AFTER VACCINE WAS ADMINISTERED. I MONITORED PATIENT FOR 45 MINS HE WAS ABLE TO GET UP AND WALK AND SAID HE FELT BETTER. ITS SEEM LIKE IT WAS MORE OF A FAINTING SPELL BUT BECAUSE HE WAS SEATED AND BEING MONITORED HIS RECOVERY WAS GOOD. PATIENT GOT UUP AND WALK AROUND AFTER RECOVERY AND I TOKK HIS NUMBER SO THAT I CAN FOLLOWUP AFTER CLOSING
59 2021-03-24 weakness Couple minutes after receiving the vaccine patient was: diaphoretic heart rate mid 30's did drop to ... Read more
Couple minutes after receiving the vaccine patient was: diaphoretic heart rate mid 30's did drop to high 20's, weak, diazzy. Blood pressure 149/80. Incident lasted approximately 15-20 minutes and symptoms resolved. Action took was monitor patient.
59 2021-03-30 discomfort I'm not sure if this related to the vaccine, but I suspect it is. Starting about 10-14 days after re... Read more
I'm not sure if this related to the vaccine, but I suspect it is. Starting about 10-14 days after receiving the vaccine (IM into my deltoid), I have been experiencing a regional (almost dermatomal) distribution itchiness and hypersensitivity in my left infrascapular and upper lateral back region. It's a superficial (dermal/epidermal) discomfort, not deep. I have observed NO associated rash or hives; nothing is visually evident. I am still experiencing this at day 19 post vaccine. I've not taken any medication, have not applied any topicals, etc.
59 2021-04-02 feeling hot, feeling cold Coldness, then slight chills, then chills with shivering, then extreme chills and shivering. No feve... Read more
Coldness, then slight chills, then chills with shivering, then extreme chills and shivering. No fever until 8 hours after shot. Skin extermely warm heart rate increased from 64 to 110 for over 6 hours.Chills started to reduce around 11 hours after shot Fever of 101.2 at 9 hours after shot Fever of 101.6 at 10 hours. Chills stopped and extereme hotness began. Fever and hotness slowly began reducing until 14 hours after dose. Fatgue set in.. note during chills also felt extreme hotnwss at same time in all parts of body
59 2021-04-05 numbness A week after the patient had the vaccine he developed weakness with numbness in the lower extremitie... Read more
A week after the patient had the vaccine he developed weakness with numbness in the lower extremities. Patient continued to get worse and was admitted on 04/03 with concerns for Guillain-Barré syndrome ( GBS). Patient is currently getting treatment for GBS.
59 2021-04-09 feeling cold, weakness Started to feel weakened after about 6 hours. Woke up about 12 hours later with very sore muscles, ... Read more
Started to feel weakened after about 6 hours. Woke up about 12 hours later with very sore muscles, headache, and significant cold shivering. Was unable to go back to sleep.
59 2021-04-09 pain in extremity MILD PAIN IN LEFT LEG; RIGHT ARM WAS SORE WHERE HE GOT THE VACCINE; This spontaneous report received... Read more
MILD PAIN IN LEFT LEG; RIGHT ARM WAS SORE WHERE HE GOT THE VACCINE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies, had no bad medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm was sore where he got the vaccine. On 02-APR-2021, the subject experienced mild pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild pain in left leg, and right arm was sore where he got the vaccine. This report was non-serious.
59 2021-04-11 cold sweat Client reported prior to vaccination, that it is common for him to become faint and possibly "pass o... Read more
Client reported prior to vaccination, that it is common for him to become faint and possibly "pass out" when receiving injections, having blood draws completed, and IVs started. Verified that client was feeling well and had eaten breakfast and was hydrated prior to injection. Client sitting in chair and tolerated injection well. About 5 minutes after injection given, client reported that he was feeling faint. Client was clammy and pale, and lost consciousness for about 30 seconds. Wife present and held his head and stood next to him in the chair. Client did not fall, and stayed seated in the chair. He slowly regained consciousness, and when able to sit and speak, client was offered water, which he accepted. VS collected - BP sitting in RUE - 108/78, P - 64, R - 16, O2 sats - 96%. Client started to regain color, and report that he was feeling better. Granola bar offered and client ate. Wife reported that this is a common event for client, when having blood drawn, IVs started, or injections given. Client states that he has "passed out many times before." Client stayed seated in chair, with RN and wife in room with him. By 0945, client states that he was feeling "back to normal." No s/s of allergic reaction. Wife to drive home and stay with husband for the rest of the day. Discussed s/s of allergic reaction, and other s/s that require immediate medical attention. Wife and client verbalized understanding.
59 2021-04-11 cold sweat Johnson-Johnson Covid 19 vaccine EUA- patient arrived 0845 completed paperwork and taken back guard,... Read more
Johnson-Johnson Covid 19 vaccine EUA- patient arrived 0845 completed paperwork and taken back guard, at 0858 client stated he was not feeling well and asked if he could lay down. Guard held his hands on shoulder to support client. Client became unconscious , code blue called , laid client to floor, client, pale, skin clammy and cold. Vital taken 0900 BP 92/60 pulse 52 resp. 20. As soon as client placed on floor he became responsive. He stated his pulse runs 52 and that was normal for him. He stated he has no medical history or medications, not diabetic. He stated he usually faints when he gets shots but it had been 20 years ago since he fainted so he thought he was over it. Stated he has fainted multiple times after shots. EMT arrived at 0904 client awake, alert and oriented, VS 112/68. EMT checked client over well. 0910 BP 147-86 HR 54. Client refused to go to hospital staff stayed with client approx. 15-20 more minutes in break room, he had beverage and snack. He stated he was much better and felt comfortable to leave,
59 2021-04-12 weakness Individual called LHD to report adverse reactions to vaccine including, SOB, dizziness, weakness, v... Read more
Individual called LHD to report adverse reactions to vaccine including, SOB, dizziness, weakness, vomitting, headache and chills lasting 8 - 10 hours.
59 2021-04-12 flushing, weakness 3min 16s after injection: dizziness, weak and extremely tired, nauseous; flush face and headache (fo... Read more
3min 16s after injection: dizziness, weak and extremely tired, nauseous; flush face and headache (forehead) drank power ade (10oz), moved to cool/cold area; remained inactive; after several minutes (3-6min) symptoms improved, then repeated (symptoms returned but less severe, then mitigated) two more times over next 18 min stayed at dr. office for another 20 minutes with no more adverse reactions (mild headache and slight tiredness; no other symptoms)
59 2021-04-12 numbness, numbness and pain in extremities Shortly after injection right hand finger tips presented with peripheral neuropathy. Patient believe... Read more
Shortly after injection right hand finger tips presented with peripheral neuropathy. Patient believed this would shortly go away and didn't report it. Following day neuropathy had spread down fingers. Currently fourth day, numbness has continues in fingers and into palm of right hand. Patient has been living with peripheral neuropathy in his feet for over 15 years is well versed with neuropathy and its symptoms. This is new. Very similar to allergic reaction to Ciprofloxacin which according to CDC can cause permanent damage to the CNS after one dose.
59 2021-04-13 feeling hot, pain in extremity left leg pain and swelling, redness, increased warmth worsening over 1 week
59 2021-04-13 muscle spasms, unresponsive to stimuli, weakness Mother called health department today, 4/14/21, to report reactions son experienced after receiving ... Read more
Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A "scan" showed blood clots in brain and heart. This individual passed away on 4/4/21.
59 2021-04-13 pain in extremity Patient noticed symptoms of nausea and pain in legs about 24 hours after receiving the J&J COVID-19 ... Read more
Patient noticed symptoms of nausea and pain in legs about 24 hours after receiving the J&J COVID-19 vaccination. On Friday, April 9th, a pounding headache developed and is still currently ongoing. Patient visited their doctor soon after symptoms began to check if there were underlying conditions requiring medical attention. Doctor did not find any issues. Patient has been taking ibuprofen 800mg every 4 hours as needed but without relief for the headaches. Headaches still persist even now.
59 2021-04-13 pain in extremity Chills, fever, leg pain, nausea, headache.
59 2021-04-14 weakness Abdominal pain, low fever, headache, muscle and joint soreness, fatigue/ weakness, nausea, diarrhea,... Read more
Abdominal pain, low fever, headache, muscle and joint soreness, fatigue/ weakness, nausea, diarrhea, congestion.
59 2021-04-14 flushing SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report re... Read more
SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 194 (unit unspecified), and height was 71 inches. The patient's concurrent conditions included gout, alcohol use, non-smoker, cipro allergy, high cholesterol, and high blood pressure, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 in left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, febuxostat for drug used for unknown indication, losartan for drug used for unknown indication, pravastatin for drug used for unknown indication, probiotics nos for drug used for unknown indication, selenium for drug used for unknown indication, vitamin d nos for drug used for unknown indication, and calcium. On 08-MAR-2021, the subject experienced swollen lips. On 08-MAR-2021, the subject experienced swollen throat. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced flushed face. On 08-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, swollen throat, dizziness, and flushed face on 08-MAR-2021, and flu-like symptoms on 10-MAR-2021. This report was non-serious.
59 2021-04-14 migraine Severe neck pain; migraine headache; muscle aches; nausea; upper body joint pain
59 2021-04-14 pain in extremity pain in the calves, tiredness, stiff neck
59 2021-04-14 pain in extremity Patient had LLE swelling and pain, went to see PV provider the next day who recommended pt go to ER.... Read more
Patient had LLE swelling and pain, went to see PV provider the next day who recommended pt go to ER. Pt was diagnosed with nonocclusive SVT in the L short saphenous vein via ultrasound. Good prognosis, no CP or SOB.
59 2021-04-15 numbness Patient presented 5 days after vaccine administration with a lacunar stroke. He had numbness in his... Read more
Patient presented 5 days after vaccine administration with a lacunar stroke. He had numbness in his right face and right hand which he woke up with on day 5.
59 2021-04-15 pain in extremity The night after the shot, I started feeling some pain in my right leg from about the hip down the th... Read more
The night after the shot, I started feeling some pain in my right leg from about the hip down the thigh. It got progressively worse and I was actually having difficulty standing. It peaked around Monday, but as of today (Friday 4/16/2021) it is definitely still there. However, it is diminishing in pain. I think it will go away with time so I haven't seen a doctor yet. I don't experience leg pain so this was a surprise. I thought maybe I perhaps slept in a wrong position but I would assume it would go away. I don't see any discoloration in the area.
59 2021-04-16 seizure seizures starting 8 days after vaccine, unable to c ok control with medication
59 2021-04-18 weakness On 4/14/2021 patient woke up with stomach cramps and diarrhea. states he could not walk, and had no... Read more
On 4/14/2021 patient woke up with stomach cramps and diarrhea. states he could not walk, and had no energy from dehydration. patient states he had SOB. Patient has emergency alert system, so he pressed the button and an ambulance took him to the ER.
59 2021-04-18 muscle spasms Leg Cramps every few nights, more than I have had in last 5 years
59 2021-04-18 pain in extremity Extreme pain in legs & feet Pain in chest with deep breaths
59 2021-04-19 muscle spasms 59-year-old. 3 male see Johnson & Johnson vaccine March 23. A few days after receiving the vaccine, ... Read more
59-year-old. 3 male see Johnson & Johnson vaccine March 23. A few days after receiving the vaccine, he reports he developed left-sided neck pain and right-sided lower back pain. The left-sided neck pain radiating down left arm and right-sided low back pain radiates down right leg. He denies any injury, car accident, or any sort of heavy lifting. He does drive a limousine many hours per days and remains sitting most of the day. However, he has been performing this order work for many months and never had this order musculoskeletal problem before the vaccine. He has been taking Advil with no improvement. Cervical radiculopathy at C7 Start Medrol (Pak) Tablet, 4 MG, as directed, Orally, AS DIRECTED WITH FOOD, 6 days, 1 Pack, Refills 0 Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet, Orally, every 8 hours as needed for muscle spasms, 10 days, 30, Refills 1 Notes: Neck Strain or Sprain: Rehab Exercises material was printed.
59 2021-04-19 pain in extremity left lower leg pain extremity swelling
59 2021-04-21 weakness, pain in extremity FELT HUNGOVER; LOSS OF ENERGY/DIDN'T HAD GUMPTION TO DO ANYTHING; FELT-LIKE DRUNK/BUZZED; TROUBLE GO... Read more
FELT HUNGOVER; LOSS OF ENERGY/DIDN'T HAD GUMPTION TO DO ANYTHING; FELT-LIKE DRUNK/BUZZED; TROUBLE GOING BACK TO SLEEP; FEELING OF LIKE BEATEN UP/ FELT DEAD; TIREDNESS; INJECTION SITE BURNING; ARM SORENESS; This spontaneous report received from a patient concerned a 59 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: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site burning. On 12-APR-2021, the subject experienced arm soreness. On 13-APR-2021, the subject experienced trouble going back to sleep. On 13-APR-2021, the subject experienced feeling of like beaten up/ felt dead. On 13-APR-2021, the subject experienced tiredness. On 13-APR-2021 05:30, the subject experienced felt-like drunk/buzzed. On 15-APR-2021, the subject experienced felt hungover. On 15-APR-2021, the subject experienced loss of energy/didn't had gumption to do anything. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning, and arm soreness, had not recovered from tiredness, felt-like drunk/buzzed, felt hungover, loss of energy/didn't had gumption to do anything, and feeling of like beaten up/ felt dead, and the outcome of trouble going back to sleep was not reported. This report was non-serious.
59 2021-04-21 discomfort Went emergency after noticing one of my veins had turned red and was hardening. Vein pulsing in lef... Read more
Went emergency after noticing one of my veins had turned red and was hardening. Vein pulsing in left leg. Emergency room doctor diagnosed "superficial thrombophlebitis." The pulsing in lower leg (calf) continues and in elbow and wrist joints. The pain is not an issue. I've been feeling a bit of but most of my discomfort has been anxiety about what's going to happen next and what are the throbbing. The vein is no longer red, is slightly hard, pain is a 1 on scale of 10. Doctors have not contacted me since the evening after I was seen and I reported to them I felt better than I did at the hospital.
59 2021-04-21 pain in extremity SORE ARM; This spontaneous report received from a consumer concerned a 59 year old male. The patient... Read more
SORE ARM; This spontaneous report received from a consumer concerned a 59 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-APR-2021. This report was non-serious.
59 2021-04-21 pain in extremity ITCHY PATCH ON FEET/ ON SHINS/SIDE OF KNEES; PATCHY BURNING RASH ON LOWER BACK/TOP OF BUTTOCKS; SORE... Read more
ITCHY PATCH ON FEET/ ON SHINS/SIDE OF KNEES; PATCHY BURNING RASH ON LOWER BACK/TOP OF BUTTOCKS; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was very healthy, does not have skin, breathing problems and also not taking any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 12-APR-2021, the subject experienced fatigue. On 16-APR-2021, the subject experienced itchy patch on feet/ on shins/side of knees. On 16-APR-2021, the subject experienced patchy burning rash on lower back/top of buttocks. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, sore arm, patchy burning rash on lower back/top of buttocks, and itchy patch on feet/ on shins/side of knees. This report was non-serious.
59 2021-04-23 pain in extremity Muscle pain in both arms/shoulders, headache for 3 days, fatigue, stomach aches for 3 days (since 4/... Read more
Muscle pain in both arms/shoulders, headache for 3 days, fatigue, stomach aches for 3 days (since 4/21/21)
59 2021-04-24 pain in extremity Left lower extremity swelling and pain for 1 week, right lower extremity normal.
59 2021-04-26 weakness BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO... Read more
BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
59 2021-04-26 feeling cold Fever, Mucles pain, cold, headache
59 2021-04-26 mild one side paralysis RIGHT OPHTHALMIC STROKE; LEFT SIDED WEAKNESS; CHILLS; This spontaneous report received from a physic... Read more
RIGHT OPHTHALMIC STROKE; LEFT SIDED WEAKNESS; CHILLS; This spontaneous report received from a physician concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced chills, tremor. On 10-APR-2021 15:00, the patient presented to hospital he was hunched over, gait was unsteady, and stated that over the past day left side gotten weaker, unable to decide the feeling, reports of numbness, decreased strength to left side, shuffling gait. On the same day, 10-Apr-2021, patient was hospitalized with symptoms of stroke, and was diagnosed with right ophthalmic stroke. The patient was in the hospital for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210427690-covid-19 vaccine ad26.cov2.s -RIGHT OPHTHALMIC STROKE, LEFT SIDED WEAKNESS . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
59 2021-04-26 numbness Left side facial / body numbness & tingling.
59 2021-04-27 mild one side paralysis, speech disorder, numbness This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27... Read more
This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27/2021 with sudden onset of left upper and lower extremity weakness and left-sided numbness of his face. The patient stated he may have had some weakness the previous night (04/26/2021), but mostly noticed it when he woke up around 0900 on 04/27/2021. The patient stated he may have also had some transient speech changes which he felt were improved upon emergency department presentation. The patient stated he took an 81 mg aspirin prior to hospital arrival. The patient was overall hemodynamically stable in the emergency department. Past medical history is only significant for benign prostatic hyperplasia. This patient has no history of previous CVA or TIA, no smoking history, no history of clotting disorders, no recent trauma or other injury. CT head revealed a small right frontal subarachnoid hemorrhage with no midline shift and concern for clot. CTA head and neck perfusion study was significant for ?perfusion abnormality involving the right frontal lobe in the region of known subarachnoid hemorrhage, likely related to dural venous sinus thrombosis involving the posterior aspect of the superior sagittal sinus, left greater than right transverse sinus, and left sigmoid sinus.? This patient is noted to have recently received his Johnson and Johnson vaccine on 03/20/2021. The patient was admitted to the intensive care unit. Neurology and hematology were consulted.
59 2021-04-27 numbness 10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdom... Read more
10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet.
59 2021-05-01 pain in extremity Left lower leg pain and swelling for 1 day. DVT
59 2021-05-02 numbness ON 4/4/21 PT EXPERIENCED SHOULDER PAIN, HEADACHE AND ANKLE PAIN AND NUMBING ON HANDS, ON 4/27 PT WEN... Read more
ON 4/4/21 PT EXPERIENCED SHOULDER PAIN, HEADACHE AND ANKLE PAIN AND NUMBING ON HANDS, ON 4/27 PT WENT TO URGENT CARE MD PRESCRIBED MEDROL DOSE PACK, AND MOTRIN. PT WAS INSTRUCTED TO FOLLOW UP WITH DR AND RECOMMENDED TO GET AN MRI 4/29 PT DEVELOPED COUGH
59 2021-05-03 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS WAITING IN THE OBSERVATION A... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS WAITING IN THE OBSERVATION AREA WHERE HE FELL DOWN AND LOST CONSCIOUS FOR FEW SECONDS.911 WAS CALLED. HE WAS COHERENT, NO OTHER SYMPTOMS, VITALS WERE FINE, HE WAS NOT HOSPITALIZED. HE GOT A SCRATCH ON HIS LEFT EAR.
59 2021-05-04 feeling cold Fever, Chills, Cough, Dizziness, Stroke
59 2021-05-04 cold extremities Pt. called his daughter on Sunday April 18 and told her was not feeling well and said it was from th... Read more
Pt. called his daughter on Sunday April 18 and told her was not feeling well and said it was from the effects of the (one shot) COVID-19 vaccine. You would have to contact her directly for more information. He was found dead in his room by the manager around 5 pm on April 22nd. Manager told me his body was cold to the touch so she thought he may have passed the previus day on April 21st. Daughter todl me earlier today that a doctor is running some tests to try to determine the cause of death. You would need to contact her for the doctors name. My own inpression is that the emphysema was not severe enough to have d=caused his death as he could walk up to half a mile.
59 2021-05-11 bell's palsy G51.0 - Bell's palsy
59 2021-05-13 pain in extremity Pain at left Under Arm, Chest pain and neck area And Both Calves behind knee.
59 2021-05-16 pain in extremity, burning sensation a severe pain in my left leg inside thigh. A bright red dot was there. My arch of my foot was burnin... Read more
a severe pain in my left leg inside thigh. A bright red dot was there. My arch of my foot was burning and then the burning moved up my shin. Pain is not continuous, but moves to my calf and back to my thigh. I had a ultra sound done, my doctor told me I have a blood clot and put me on Eliquise on 4-21-21.
59 2021-05-17 weakness I woke up the next day with a fever , the fever went and then I had trouble breathing with congestio... Read more
I woke up the next day with a fever , the fever went and then I had trouble breathing with congestion I went to urgent and went on antibiotic the congestion cleared up then I had extreme tiredness for 3 days I am still having trouble with my left arm and cannot reach it above my head the energy level has returned to normal around Thursday and Friday of last week but the rotation of the left arm is still difficult
59 2021-05-18 weakness Patient experienced syncope less than 5 minutes after receiving the Janssen COVID-19 shot. We alert... Read more
Patient experienced syncope less than 5 minutes after receiving the Janssen COVID-19 shot. We alerted store management and called 911. He regained consciousness after about 15 seconds or so. We laid him on the floor and got cold, wet paper towels to hold on his head. He felts weak but was alert. EMS arrived and checked his vitals. His vitals were ok. He refused to go with EMS when he was asked. We called his wife and she came and picked him up.
59 2021-05-18 night sweats No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to... Read more
No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.
59 2021-05-18 pain in extremity I received my vaccine six weeks ago. My arm still hurts as if I got the vaccine yesterday.
59 2021-05-18 unresponsive to stimuli, depressed level of consciousness, feeling hot, speech disorder Upon administration of vaccine, patient became unresponsive with regards to decreased speech and ale... Read more
Upon administration of vaccine, patient became unresponsive with regards to decreased speech and alertness. Patient did not faint/pass out, but experienced sweating, feeling hot and pallor appearance. No treatment necessary as patient slowly regained responsiveness.
59 2021-05-19 feeling hot, pain in extremity FELT RUNDOWN; FELT TIRED; NO ERECTION; WARMTH SENSATION IN THE RIGHT ARM AND WRIST; PAIN IN THE RIGH... Read more
FELT RUNDOWN; FELT TIRED; NO ERECTION; WARMTH SENSATION IN THE RIGHT ARM AND WRIST; PAIN IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 59-year old male. The patient's height and weight were not reported. The patient's past medical history included open heart surgery in 2018, and he had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose was administered on 06-MAY-2021 on the right arm as prophylactic vaccination. Concomitant medications included Atorvastatin, Clopidogrel, Diltiazem, Losartan, and Pioglitazone. On 6-MAY-2021 the patient felt a warm sensation of the vaccine when it was administered in the arm and wrist. He felt soreness in the Right arm that evening. On 7-MAY-2021 his arm felt achy but not as painful. He felt "rundown" until the date of May 10th, or the 11th. On 10-MAY-2021 he observed that he was not able to obtain an erection; however, he was able to ejaculate. From 10-MAY-2021 to 17-MAY-2021 the patient still is not able to obtain an erection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth sensation in the right arm and wrist, pain in the right arm, felt rundown, and felt tired, and had not recovered from no erection. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210532159-covid-19 vaccine ad26.cov2.s-No erection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
59 2021-05-23 pain in extremity, muscle twitching 10 days of almost constant muscle twitching below the injection site at the elbow area/ top of forea... Read more
10 days of almost constant muscle twitching below the injection site at the elbow area/ top of forearm. This uncontrollable muscle movement is almost constant. I have strong pain and fatigue if I use my arm. Additionally, the injection site bled and remains bruised after 10 days.
59 2021-05-24 muscle twitching Pt experienced right upper chest "muscle twitch". Vitals 188/92, HR 92, OxSat 91. Pt stated that it... Read more
Pt experienced right upper chest "muscle twitch". Vitals 188/92, HR 92, OxSat 91. Pt stated that it lasted about three minutes no longer can feel it. No other complaints at this time. Oriented x 4. No distress noted.
59 2021-05-24 tremor CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY... Read more
CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.
59 2021-05-27 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient became unresponsive with gasping but remained with normal pulse, pt came to within a minute
59 2021-06-02 cold sweat 103.7 Fahrenheit fever next day, chills, waking up in cold sweats, severe headache, was regaining ta... Read more
103.7 Fahrenheit fever next day, chills, waking up in cold sweats, severe headache, was regaining taste and smell from Covid-19, then the taste and smell went away again, metal taste. About 3 days long. Took tylenol, which helped with fever. Metal taste has not gone away. Needed to increase his intake on oxygen tank.
59 2021-06-08 weakness PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient con... Read more
PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, controlled high cholesterol, stroke like symptoms in MAR-20219, however he was not diagnosed as having stroke because all tests were negative but he still had the symptoms, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021 after vaccination, the patient felt weak but it was not significant. On 05-JUN-2021, the patient felt weak while doing daily activities. The patient had not felt anything and had breakfast. He got in the sun and got dehydrated as not had water for three hours during the day. Later, he got water. The patient had taken one drink of alcohol, sat down and got light headed then passed out for less than a minute. It was reported that, upon contacting emergency services advised patient to visit emergency room to check him as a precaution but the patient denied. It was reported that, the patient's heart, blood pressure, and blood glucose were normal. The patient was fine at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 05-JUN-2021, and light headed, dehydrated, and felt weak on JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210613161-covid-19 vaccine ad26.cov2.s-passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
59 2021-06-14 paralysis Pt received shot, went home, within 1 hour of having shot he felt extremely high. The feeling escal... Read more
Pt received shot, went home, within 1 hour of having shot he felt extremely high. The feeling escalated quickly, lasted about a 1/2 hour, and then subsided. He described his symptoms as feeling paralyzed, as he couldn't move, even to reach his phone to call for help, but his mind was alert. He felt tired and achy and slept for 3 hours.
59 2021-06-16 numbness Next day after the vaccination I had numbness on the left side of the face, felt like it was droopin... Read more
Next day after the vaccination I had numbness on the left side of the face, felt like it was drooping but with no visual indication of drooping. Eye, cheek and chin were affected. I felt fine otherwise and didn't think anything more, this happened intermittently over the next two months and now along with the face numbness I am starting to feel a numb feeling in my left side by the breast and the opposite side of the back. I saw my doctor today and he told me to report this, as he didn't see any difference in the facial appearance from one side to the next.
59 2021-06-18 tremor, feeling hot VIOLENT SHAKING OF THE WHOLE BODY; FEVER 101.1 DEGREE F THEN 102.1 DEGREE F; BODY ACHES; FEELING WAR... Read more
VIOLENT SHAKING OF THE WHOLE BODY; FEVER 101.1 DEGREE F THEN 102.1 DEGREE F; BODY ACHES; FEELING WARM; CHILLS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and viral pneumonia, and concurrent conditions included asthma, alcohol use, non-smoker, and seasonal allergy. The patient was previously treated with for asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 14-JUN-2021, the subject experienced body aches. On 14-JUN-2021, the subject experienced feeling warm. On 14-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced violent shaking of the whole body. On 15-JUN-2021, the subject experienced fever 101.1 degree f then 102.1 degree f. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102.1 degree F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violent shaking of the whole body on 15-JUN-2021, and feeling warm, and chills on 16-JUN-2021, and had not recovered from fever 101.1 degree f then 102.1 degree f, and body aches. This report was non-serious.
59 2021-06-20 pain in extremity, feeling hot When he got the shot he felt hot and sweaty and it cleared and a few day later he had a bad reaction... Read more
When he got the shot he felt hot and sweaty and it cleared and a few day later he had a bad reaction having chills, chest pains, pains in left arm and on left side, and nausea and lower back pain
59 2021-06-23 weakness Pt was hospitalized from 6/3-6/7 for severe hypercalcemia and diagnosed with diffuse metastatic rena... Read more
Pt was hospitalized from 6/3-6/7 for severe hypercalcemia and diagnosed with diffuse metastatic renal cell cancer. He received his J and J vaccine on 5/14/21 and reported "everything went to downhill" with development of nausea, constipation, weight loss, weakness, poor appetite resulting in hospitalization with new severe hypercalcemia and acute functional decline and dx with metastatic renal cell cancer. pt was dx with a bladder tumor 3/19, underwent TURP with bladder biopsy and fulguration and cyctoscopy on 5/19/21. Prostate bx reveals benign nodular hyperplasia, bladder bx revealed urothelial dysplasia felt to be pre neoplastic. Urine Cytology from 4/14/21 negative for high grade urothelial cardinoma. with pamidronate treatment, lasix and ivf and calcitonin his hypercalcemia improved and he was discharged to follow up with oncology and urology as out pt. He has since been readmitted on 6/22/21 with recurrent hypercalcemia and progressive decline. biopsy with I.R. of left renal mass confirmed RCC, biopsy of LN was non-diagnostic. per urology: Given the small size of the renal mass, it would be surprising if this was truly metastatic RCC, this could be metastatic urothelial carcinoma given his history of high grade T1 disease, although the primary site and the urinary tract has presumably been eradicated of disease, metastatic disease prior to initial tumor eradication in the bladder remains a possibility.
59 2021-06-23 pain in extremity NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PA... Read more
NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
59 2021-06-24 pain in extremity Cubital tunnel syndrome in injected arm. Hands "fall asleep" occasionally, but this time it did no... Read more
Cubital tunnel syndrome in injected arm. Hands "fall asleep" occasionally, but this time it did not resolve, resulting in weakness in hand and arm that have only partially recovered in the weeks following. Unable to use left hand since onset to use most tools, turn a valve, etc. Uncertain at this point whether full recovery is possible, but progress seems to be stalled at perhaps 50%-75% capacity. Icing helps with pain, along with regular acetaminophen and occasional ibuprofen. Exercise (including ulnar nerve "flossing") helps with recovery but has plateaued.
59 2021-06-25 feeling hot Pt came in for the Jansen COVID shot around 11:00, after receiving it he went to the waiting area an... Read more
Pt came in for the Jansen COVID shot around 11:00, after receiving it he went to the waiting area and a few minutes later seemed to momentarily pass out in his chair, his wife called us over and Pt described feeling warm and dizzy. He drank some water and ate a candy bar over the next few minutes. Pt continued to feel dizzy and was sweating. After a few minutes Pt appeared to continue having extreme syncope and we called 911. Paramedics arrived a few minutes later.
59 2021-06-28 weakness Patient called on 6/29 around 10:30 am stating that he has muscle aches, no energy, and trouble bre... Read more
Patient called on 6/29 around 10:30 am stating that he has muscle aches, no energy, and trouble breathing since 5/21 (2 days after his vaccination). Pharmacist advised patient to see a doctor immediately since he is very trouble breathing and to rule out any infection or other issues related or not related to vaccine.
59 2021-07-04 flushing, tingling Skin flushing on neck, chest and back. Heart pounding, lightheadedness, 60 pt spike in systolic B... Read more
Skin flushing on neck, chest and back. Heart pounding, lightheadedness, 60 pt spike in systolic BP lasting over 1 hour. Tingling sensation on upper body including both arms.
59 2021-07-08 feeling hot Patient had stated that he tended to pass out after giving blood. After shot was given pharmacist s... Read more
Patient had stated that he tended to pass out after giving blood. After shot was given pharmacist stayed with patient in case something happened. Patient almost immediately said he didn't feel right. Patient started to lose color and was very hot. Pharmacist got up and stayed next to patient. Patient slowly lowered his head and started to breathe heavily. Pharmacy technician then came over with a cool towel to place on patients head. The pharmacist couldn't tell if patient had in fact passed out because patients head was down and pharmacist was holding patient in place so he didn't fall. The pharmacy tech was asked if patient passed out and she saw his eyes were open. Patient then asked how long he was out for. That was for a total of roughly 5 seconds. Patient then stayed at pharmacy for around 45 minutes. He regained his color and his body temp returned to normal. He did say he was drowsy but felt he was fine to go home. Patient was called later in the day and he said he was drowsy but feeling much better.
59 2021-07-11 tingling Weakness and tingling in your extremities Issues maintaining body temps. Blood sugar hitting crazy... Read more
Weakness and tingling in your extremities Issues maintaining body temps. Blood sugar hitting crazy numbers on 12 hour fast Tired and sore, left rear neck tingling with head aces
59 2021-07-12 tingling Patient is reporting tingling in right fingers and on right side of body that appeared after vaccine... Read more
Patient is reporting tingling in right fingers and on right side of body that appeared after vaccine administration.
59 2021-07-13 tingling Patient notified us today that he just recently started having tingling in different parts of his b... Read more
Patient notified us today that he just recently started having tingling in different parts of his body and requested we report this information to you.
59 2021-07-16 tingling, nerve pain, weakness TINGLING IN LEFT ARM FROM LEFT ELBOW TO LEFT HAND; WEAKNESS; DULL NERVE PAIN; This spontaneous repor... Read more
TINGLING IN LEFT ARM FROM LEFT ELBOW TO LEFT HAND; WEAKNESS; DULL NERVE PAIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced dull nerve pain. On 01-JUN-2021, the subject experienced tingling in left arm from left elbow to left hand. On 01-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and tingling in left arm from left elbow to left hand, and the outcome of dull nerve pain was not reported. This report was non-serious.
59 2021-07-17 numbness, pain in extremity, tingling Constant muscle pain, muscle weakness, especially in legs. Initially, no pain in arms or feet. all... Read more
Constant muscle pain, muscle weakness, especially in legs. Initially, no pain in arms or feet. all other muscles affected; lower back, upper back, chest, abdomen, groin. Eventually, tingling in finger tips & toes then numbness in hands and feet, and pain in arms.
59 2021-07-22 tremor, weakness within 2 weeks of injection, patient feels he had worsening Fatigue, Weakness, Tremulousness, confus... Read more
within 2 weeks of injection, patient feels he had worsening Fatigue, Weakness, Tremulousness, confusion.