Johnson & Johnson

March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache

Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)

Eight hours after the shot, I quickly became very chilled with total body aches and pains and extremely tired. My mouth became very dry. This lasted most of the night. The next morning approaching 24 hours after the shot, the initial side effects were gone but I then had a headache and a bit of nausea. Again was extremely tired and pretty much rested all day. All side effects were gone the next day. I felt no need to call my healthcare provider and did not take any over the counter pain medication.

headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that began to climb. Fever peaked at 104.8 and stayed there for approx 6 hours. Vomiting started around 7pm. Rapid hear rate for approx 4 hours. Pulse was over 120 beats for approx 2 hours with chest pain.

Horrendous headache starting 13 1/2 hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the 24 hr mark, just tired and had to stay in bed. Today 3/9, all good.

I had the most peculiar taste in my mouth. It wasn't entirely a metal taste, but it was strong enough it overwhelmed the taste of everything else for about 6 hours. I could still taste other things, but the primary taste and the one that remained in my mouth was this odd, almost metal taste. The next day (after the taste was gone)- it would have been almost 24 hours from the time of the injection - I was hit with a bad headache and body aches like I haven't had in many years. The body ache was gone the next morning, and the headache lingered another day past that. Today, Tuesday March 9, is the first day I feel like myself again.

Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.

It started about 11 hours after the shot: malaise, then severe shivering (almost locking my jaw). Fever got to 101.8 after a few hours and would not go down with ibuprofen or aspirin. It got down to 100 by morning. Then it hovered around 99 the next day after taking Aleve.

9 hours after injection, woke up with chills, body aches, head ache, and extremely dizzy. Lasted 8 hours then all symptoms were gone except the continued dizziness I still have whenever sitting up or rolling over when I'm laying down. Been 7 days now and hasn't subsided.

Headache, lasted 27 hours. starting 15 hours after injection Fatigue starting 10 hours after injection lasting 40 hours

c/o headache- IDDM- ate breakfast 0930 other and nothing since. Denies any of adverse symptoms. does self report. high anxiety R/T being here, getting vaccine & "emtional" as has not seen spouse who underwent liver transplant 2 months ago & contracted meningitis. 173/94- 72 given water & banana. Rested & relaxed w/ fresh air flow x 15 additional mins. w/ resolution of symptoms.

The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a "rash" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area encompassing her entire breast. Axilla excluded. No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation.

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash.

Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.

Chills at about 8pm on 3/6/2021. The woke with a rapid pounding heart rate just after midnight 3/7/2021. I went to the Hospital emergency room. They ran tests; ekg, blood tests, chest X-ray. They gave me fluids and Tylenol. My heart rate and blood pressure were fluctuating when I first went to the ER but then they went back to normal and I was released around 6:00pm 3/7/2021.

At 9pm I started to feel tired and went to bed. At 3am I woke up with nausea, headache, and arm very sore at site of injection. I was also a bit dizzy when I got up. By 10am, I just had a bit of a heachache and fatigue.

Approximately 6 hours after receiving the injection, chills began. Then headache, low grade fever, neck ache. Then nausea and vomiting. I couldn't keep anything down. About 24 hours after the side effects began, I started to feel better.

About 5pm after I began feeling achy and fatigued. The next day after I developed the tingly, pins and needles sensation that came and went in both legs, my face, arms and both hand area which I am still experiening today but not as frequent as it was when it began. When it happens its not always in the same spots and doesnt occurs at the same times its as if it alternates and now I also get a hot sensation at the top of my ears periodically which doesnt last very long but it does occur

Shortness of breath, fatigue, dizzy, aches. 1 week out and still have listed symptoms. May be improving slightly but not gone

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Frequent runny stools 11. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely cold - teeth chattering, chills and fever at 11:30pm - approx. 8 1/2 hours after injection. After that vomiting, soreness, headache body aches, fever of 100 degrees. When awaking the next morning, still had fever of 99.8, chills, nausea, headache. Finally felt like myself by 3pm on Tuesday, March 16. I am not a chronic complainer. After receiving my flu shots every year for many years, this was the first reaction I've ever had to any immunization - ever.

Chills, fever ranging up and down between 100 and 105. 105 @ midnight 12 hours after vaccine. The rest of the time during first 24 hours temp fluctuated between 102 and 104 along with chills, body aches, severe headache and nausea. Hours 24-48 were similar but with slightly lower temps finally ending about 3rd days post vaccine. Nausea and diareah 3rd and 4th day post vaccine

Fatigue (10 hours post), headache (3+ days) , severe pain under right armpit (10 hours post--lasting 2 days), dull pain under right arm 3+days, chills 36 hours post vaccine

Six hours after vaccine, extreme muscle aches; splitting, nauseating headache across the forehead. All symptoms resolved 30-36 hours post vaccine

March 13, 2021 - Upset stomach; headache; fever & body aches March 14, 2021 - Fever; headache and tired March 15, 2021 - Tired & slight cough March 16, 2021 - Slight cough & minor rise in body temperature

6 pm chills 10 pm tired, needed to sleep 2 am awoke with extreme headache, nausea, fever, chills. lasting 2 hours, husband wanted to call 911, thought I was going to die, was able to take 2 Advil then sleep in 30 minutes, slept till 11 am

1 -500mg Tylenol taken at 3pm. At 8pm Chills started along with headache. 9pm Fever reached 101.5 and 1-500mg Tylenol taken. Slept under 2 blankets & fever broke at 12:45am. 3:30am woke up & headache was better & no chills. Got up at 8am. Slight headache & tired. 8:15 am 1-500mg Tylenol taken. 12:30pm no headache.

severe chills, exhaustion, nausea, constipation, urinary discomfort, odor in urine - most symptoms lasted until Tuesday 3/16. However, that evening I developed a red bumpy itchy rash on both my legs (front only from knee to upper thigh). I took a Benedryl and it was gone this morning. The discomfort while urinating has returned this morning 3/17 and my primary doctor is sending me for lab work.

fever to 100.4, headache, neck pain for 10 hrs then 3 days later developed fever 100.6 and abd pain, diarrhea,

Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days. The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath. I was coughing up a lot of mucus. The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme. 8 days after the vaccine I started to have pain at the injection site. My upper hurt if I touched it. Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them. This seems like a muscle pain from the injection site to my shoulder.

Almost received an instant headache within minute's Extreme fatigue the following day. Got vaccine on a Friday and on Sunday started to experience pretty tense stomach pain and nausea. Now its Monday and still tired, with headache and stomach pains and nausea I wanted to report but not sure if this is due to the vaccine or not?

It hurt momentarily and I stayed for 15 min as required. I went to work at 2pm. At around 8:30pm, I started feeling like I ran a marathon. I felt like I hit a wall. My body just ached. I took some Ibuprofen and continued my shift. I woke up the next day with a headache so bad that I couldn't lift my head off of the pillow. I took Tylenol and that continued the entire day. I stayed in bed all day. The next night, I woke up in the middle of the night with chills, but no temperature. The following Monday, I still had the chills along with nausea. By Tuesday, I felt normal again.

Dizziness, vertigo, nausea3 days post vaccine 24 hour after vaccine chills shoulder pain on side of injection

Family noted route post vaccination symptoms including fatigue, fever shortly after vaccination and within first 24 hours. >24 hours patient began having increase in activity level, emotional lability, hyperactivity, flight of ideas, auditory and visual hallucinations, etc.

Within a minute of receiving the vaccine, pt reported itchy/tingly sensation in her mouth and throat. Initially stated she could breathe/swallow just fine but very quickly stated the swallowing was getting more difficult. 911 was called followed by 0.3 mg EpiPen in her right outer thigh and 50mg of oral Benadryl. Her BP was then taken around 4:45 and it was 162/93 at which point EMT arrived and took over.

8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot. Dizziness and fever persisted for almost 12 hours. Patient waking up in the morning felt lose of appetite due to nausea.

Around 13 hours later 7AM didn't sleep well. Woke up with dull headache and back of neck muscle aches. This lasted all day and evening. Today 3/26/21 I woke up feeling much better, dull headache pretty much gone. That was all that I had for side affects.

Worst headache ever - intense pain when walking or moving head, nausea. Dr told me to take 4 ibuprofen 3 times per day. I took 2 3 times per day. The headache and nausea lasted 4 days. Headache is milder but still present, especially with head movements. Ringing in ears, moderate tinnitus from the day I got the shot and it still remains.

Fever and chills began around 3 am following vaccination at 6:45 PM. Upon arising around 7 am, fainted in bathroom and was dizzy when upright for about thirty minutes. Bruised ribs secondary to falling.

Approximately, 11 hours after the shot Severe cold chills, so severe my teeth would not stop chattering. I was shaking so hard my body ached from shaking. Goosebumps, a crazy headache. I thought i was having an anurysm. Not a normal headache. Cold sweats so bad you could just about wring out my sheets and clothes. Nausea, some vomiting. On a scale of 1-10 of these symptoms is was an 11-12. These symptoms changed as the days went on. In the moring of the first night. I was ok. Woke up with a bad headache, still nauseas and still cold but not like at night tollerable. About 5PM day 2 it started all over again, just as severe. Next moring ok. This pattern kept reapeating for 4 days. Food now getting repulsive. No way I could eat anything. On day 5 the symptoms continue now throug the day, however the teeth chattering not happeing and the cold chills a bit less severe. I would say by day 5 on the scale of 1-10 i am now about a 9. This was so horrible for so long. Every single night i would wake up soaked in my own sweat. This is still happening 11 days later. I am still experiencing headaches. I never have headaches. I did not go to a Doctor because i figured what are they going to do, i have to ride this out. Also a strange thing is took my temparture daily and seveal times. Zero temprature. by day 5 I could not get out of bed for 3 days. Day 8 things getting better, still cold chills and headaches but not as bad. Day 9 way better, now getting hungry. Daytime cold chills now gone mostly less headaches. Oddly headaches and cold chills start about 4-5pm and continue through the night. In the morning i wake up with a headache still today.

Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all senses including proprioception to the point of not being able to move from standing or sitting. By hour seven, all sensory inputs were too overwhelming to do anything but shut down and sleep. 911 was not an option because they don't let you sleep, and ERs are overwhelming already, before maximizing all inputs. 7.5 mg hydrocodone for overwhelming pain and sensitivity, allowed sleep. On waking, sensitivity was lessened, but the pain started, 18 hours after the vaccination. Emotional lability for three days. Average aching of arm and injection site were not above expected levels. "Brain fog" and lack of ability to articulate (another autism symptom) started within that first seven hours, and diminished over next ten days. Not yet gone as of today Dry mouth; overproduction of thick 'chunky' mucus that wouldn't cough out, treated with guaifenesin, lasted three days. Shortness of breath and cough associated with that mucus also diminished after three days. Not completely gone ten days later. Excessive thirst, onset two hours after vaccine, lasted two days. Hyperalert (can't sleep without drugs), hyperactive despite weakness, and hypervigilant (extreme startle reflexes) lasted three days as well. Sleep was achieved with hydrocodone and THC. All over body pain, feelings of immune mobilization (coming down with) for two days were not above expected levels. No fainting or other collapse at time of injection, or later. Knowing that severe over-stimulation is exacerbated in a medical setting, it was decided not to seek medical support for three days of systemic symptoms that would have easily merited hospitalization.

Chills and fatigue for 3 days,fatigue and lightheadedness x10 days. Seen at the walkin 3/15/21 sent to ER for two units of blood. Acute anemia-seen at Hospital 3/15-3/16/2021. 3/24/2021 stool tested and no blood found. Next test is on 4/22/21-endoscopy

Shot immediately started stinging. My upper arm swelled with a hard ridge about 3 inches long and 1 inch wide. Extremely painful. Could barely raise my arm and could not sleep on that side or tolerate even soft touch of my entire upper arm. No other reaction that seemed like an allergic response. I did get very sick for 2 days with severe flu symptoms and strange shooting pains in random parts of my body. Enough pain to wake me from a sound sleep. Bad chills, but no fever. I did. I give my legs seemed swollen for about 3 days. I got the J&J vaccine on 3-6-21 and my arm is still swollen with a slightly smaller hard and painful ridge at the injection site and it sometimes throbs and itches severely. Today is 4-2-21. Starting to wonder if it will ever go away. I still cannot sleep on that side. The pain overall is less, but it still throbs and itches periodically throughout the day.

Started 6 hours after injection and lasted 24 hours that included - Chills, Nausea, Muscle & Joint aches, Severe headache, Fatigue. I didn't take any course of action other than rest and sleep.

Got really tired at 10pm, 11 hrs after shot, but couldn't sleep until 4:30. Was slightly nauseous. Vomiting then started around 7:30 am and continued. Last vomit was around noon today, April 4, but am still nauseous and not sure I'm done vomiting. Been in bed since 10 pm on April 2. Fever today is 99.0. Also have been experiencing a lot of nasal congestion off and on.

FLU LIKE SYMPTOMS/ TIREDNESS; COLD SYMPTOMS/ NASAL CONGESTION; RIGHT SIDE NOSE BLEEDS; RIGHT SIDE EAR ACHE; This spontaneous report received from a patient concerned a 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to Vectrum, Keflex. 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 11-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced right side nose bleeds. On 18-MAR-2021, the subject experienced right side ear ache. On 18-MAR-2021, the subject experienced cold symptoms. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold symptoms, had not recovered from right side nose bleeds, and right side ear ache, and the outcome of flu like symptoms 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

I couldn?t get warm, cold to the point of shivering for approximately 16 hours. I have fully recovered.

Approximately 12 hours after receiving the vaccine I experienced severe chills and couldn't get warm. I didn't take my temperature. The chills lasted approximately 5-6 hours. The day after receiving the vaccine I experienced fatigue and minor muscle aches.

RASH ON LEGS AND ARMS; SORENESS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced soreness. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 22-MAR-2021, and fever on MAR-2021, and had not recovered from soreness, tiredness, and rash on legs and arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 60 year old female. 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: 1805029, expiry: not reported) dose was not reported, once a total administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore underneath the arm. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, extremely tired, and sore underneath the arm. This report was non-serious.

Swollen lymph nodes in neck, stiff and painful neck, headache,fever,chills, Excessive fatigue x 9 days and to present

fever of 101, achy, tired, dizzy, lightheaded. Took two naps and slept 10 hours that night. Felt a bit better the next day.

Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - skin was sensitive to even my clothes. Headache started in the front of my forehead by late evening, and I literally couldn't even walk up to my bed. Restless sleeping with all the sweating and chills. Woke up with headache remaining and feeling very "wiped out" and still light-headed. No more chills or sweats the next day, but I was weak for about 48 hours. Honestly - I'm very healthy and getting Covid directly from another person couldn't have been worse than getting the vaccine. :( And I am even saying that as a 35 year professional Research Scientist. Thank you

1. Soreness at injection side immediately after administration, duration around 6 hours 2. Significant headache presented in front and sides of head (near temples), beginning day 1 after injection, with duration of 4 days. 3. Fatigue presented on day 1 after injection, duration of 4 days. 4. Mental health symptoms after day 1, with duration of 5 days, presenting as feelings of sadness and depressive ideation. The last symptom (#4) is difficult for me to correlate specifically to the vaccination, as I am a 60 year-old and in my first year in a rigorous doctoral program at a hospital. The negative physical symptoms experienced by the injection could have added an extra layer to the sadness that I reported from the daily app check-ins. I already operate (since fall 2020) in an overwhelmed state (while beginning a difficult academic program via Zoom). Could the physical fatigue and headaches from the vaccine lead to the feelings of sadness? Or were the feelings of sadness a third symptom of the vaccine? I cannot answer, and therefore cannot provide this correlation link with any reliability. I did speak to my therapist via Zoom, and reached out via email to my general physician (who recommended OTC meds.

Fever of 100 for 2 days, muscle pain, chills 1.5 days after shot. swelling and painful arm from shoulder to elbow, bruise a quarter large at injection site for 5 days. Lymph nodes swollen along left clavicle and under arm. Felt fluish. Severe fatigue beginning in evening first day thru morning of 2nd day after shot.

7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided. Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.

for 12 hours fever 102 degrees, severe chills/fever, aches pains, cough, chest pressure, headache, fatigue,...now 48 hours later still fatigue, weakness, aches, cough and do not feel very well

FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. 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).

Shortly after I felt really tired and went to bed. Had chills and a fever of 101 during the night. I developed a headache and felt fatigued all throught out the next day and after about 24hrs all symptoms dicipated. For the next 2 days after I felt run down but was still functional and by the 3 day I was fine.

A few hours after the Thursday afternoon injection, my temp shot up and stayed right around 102, my heart rate was 135- just sitting, and my oxygen level was 93%. I shook uncontrollably the first 10-12 hours, and had chills. Tinnitus. Nothing inproved until the middle of Friday night- I sweated through sheets. Still had fever, high heart rate, and up and down oxygen for 18-20 days. My heart rate (I'm on 2 anti-arrhythmia drugs so my rate is rarely above 65) was still high but better by day 22. Fever is also better but not gone. Exhausted.

Sunday 04/04/2021 started itching on right side next to breast, no redness or rash. itch got more severe over nigh. 04/05/2021 morning lips dry and burni,g throat and back tongue scratchy. 04/06/2021 severe itching from head to toe still no rash or redness. took benedryl called fam. doctor, told me to continue benedryl till itch subsides. evening severe pain in upper stomach near breast, felt like big bubble /knot, started vomiting and diarhea all night . 04/07/2021 entire body rash and hives, went to ER. said it was severe alergic reaction. gave me prednisone shot, and told me to contact allergist. taking prednisone for 4 days also pepcid and benedryl. it is now 04/09/2021 still itching all over , and diarhea

Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen

FULL BODY ACHES; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:20 to left arm deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 02-APR-2021 05:00, the subject experienced full body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, chills, and headache on 02-APR-2021. This report was non-serious.

Chills - severe, mild headache, body aches, high heart rate (124 resting rate) began at 9 hours post injection. Took Tylenol to reduce body ache and chills. Took 5 mg diazepam to lower heart rate. Still chills and body ache at 30 hours post-injection Heart rate has returned to normal range

Headache, fatigue, chills, intermittent shooting nerve pain at the left angle of my mandible. I went to work on Tuesday because my work was short staffed but was allowed to go home 3 1/2 hours early. I took Advil every 4-6 hours on Tuesday and half of Wednesday. I came straight home and slept until dinner, ate and then went back to bed and slept until midnight, took more Advil and drank a full glass of water, and slept the rest of the night. Wednesday I felt a bit better, headache not as bad and jaw pain not as frequent, still pretty tired. I went to bed straight after dinner and then felt great on Thursday.

FEVER; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.2 C. On 26-MAR-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle pain and fatigue was not reported. This report was non-serious.

extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite eye focus issues dizziness brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day

Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking completed. Had mild reactions originally. Pain in arm, and fever next day that rose to 100.9. No chills, no major problems, no rash. A couple nose bleeds on second day which were not typical for me. Returned to work on third day. Now on day 10 I'm convinced I'm having a delayed reaction. Still mild but present. Low temp 99.5, headache, fatigue, feeling of not being normal. Not allowed to work today. Reason for report of such mild symptoms is my surprise of this delayed reaction 10 days later. There is a bruise on my injection arm now, opposite side of arm, that also is puzzling, but not really worrisome. Know to monitor for platelet issues.

Woke up with body aches, headache, low grade temperature. Stayed in bed most of day(thu) That evening finally took a couple tylenol because the aching was preventing me from sleeping. Fri I felt better maybe a little tired. Friday evening I started vomiting, and had diarrhea. Fever was at 202 at highest. Brain fog. Had severe chills for a couple hours. Fever hung around 100 most of Saturday. Have slight tightness in upper chest. Occassional dry cough. Occassional diarrhea. Weak. Sunday. Still have occassional diarrhea. Temp has been around 99.5. Weak. But a little more energy. Still have tightness in chest.

Within 5 minutes of receiving the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.

The second day after the shot I was really tired. I also had a strange sensation on my face. A couple of weeks after I started to have insomnia. I kept waking up scared. I started to have a flare up of my Arthritis. I still have feelings of tiredness, headaches and my back has been really flared up. I have a disability with my spine being crooked. The pain has been a lot worse than normal. I have been visiting the Chiropractor frequently three weeks after my shot. I did not have as much back pain before the vaccine.

Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs

Mild pain and redness at injection site. General wide-spread muscle soreness and fatigue after 12 hours and continuing into second and third day. Symptoms consistent with very mild flu vaccine reaction or very mild case of flu. Symptoms lessening on third day after vaccine with some continued muscle fatigue, particularly after activity.

Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.

I woke up at 2AM on the 03/29/2021 with a severe headache, nausea and chills. I went to get a RAPID test at CVS which was a NEG result.

Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.

Extreme chills & shaking. Blood pressure hyper (160/90]and hypotensive (90/65), erratic pulse, fever (102.4), headache, nausea.

Patient reports shortness of breath, fevers, chills, diffuse myalgias along with right-sided back and chest pain since receiving the COVID vaccine. Symptoms began a few hours after receiving the vaccine. She reports localized pain to the injection site but denies redness or swelling. She reports she had fevers for 2 to 3 days, highest being of 101. She presented to the ED on 4/10/21 because of worsening shortness of breath with mild cough and pain in her back. This is exertional along with pleuritic. She reports she has overall improved from the myalgias but is generally not feeling well and continues to have dyspnea.

1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.

Chills, lasting approximately 4 hours. Low grade fever (range 99 to 101), fatigue, lasting approximately 22 hours. Nausea and vomiting for approximately 2 hours--cumulatively. The day after inoculation at about 10:00 pm, everything back to "normal".

Severe to moderate headache, fever (unknown first night and feverish feeling since), large joint and abdominal pain, very fatigued, thirsty, increasingly redness and tenderness at 8njection site and surrounding area over the past 2 days.

Approx 31 hours after the vaccine, I ran a 99.9 temp. Ran than for about 30 hrs. I also got diareah within 30 hours after shot. That lasted about 24 hrs. I had a slight headache for about 24 hrs

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

The day after the vaccine was administered (April 5, 2021) I woke up with headache, fatigue and I developed ringing in my ears. I went to urgent care, as I had pain in my ears. They washed out my ears because they had wax, the pain was relieved, and the tinnitus diminished, but I still have the ringing in the ears a week after the vaccine. It has subsided some, and is most noticable at night.

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu-like symptoms

Shortly after the vaccine I fainted which came on quite quickly and upon waking within a minute I felt sick and vomited.

Headache, neck soreness, Itchy all over, fever, and dizziness. Patient stated the headache started around 1:00pm on 4/12/21 and the itchy all over started about 4:00pm. All other symptoms started later that afternoon. Patient called to report this issue and stated he fever is now gone and so is it itchy all over feeling but the sore neck and dizziness are still present.

on 4/11 she developed fever and chills, on 4/13 itching started at ankles, by morning she had a red rash from neck to toes. Appeared small raised rash, very itchy.

Started on Monday morning at 8:30 am started feeling cold chills. Took 800mg of Ibuprofen and after an hour felt better. When going to bed around 9:00pm I noticed that my skin was soaking wet and that I had a hot feeling. When I woke up in the morning (tuesday April 13, 2021) around 7am I could not fully open my eyes. I looked in the mirror and noticed that my entire face was swollen and was red in different areas. I took some benadryl as I thought this was an allergic reaction and went back to bed. A litter later I started getting cold chills and then hot flashes. Around noon time I took another benadryl. By 2:30 I was not feeling any better and I also had body aches and pains and called my doctor. I was able to get in to the office. I was told that I was having a reaction to the shot and that I was boarder line for the hospital. They gave me a shot steriod shot and prescribed Metheylprednisolon tablets (24) to be taken as directed and to continue to take benadryl. It's now Wednesday morning April 14, 2020 and the swelling has gone down but not fully gone and I have stated on the prescription. I now have redness in my chest area. I still have a some chills and hot flashes.

One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER

Ears plugged. Then at 8:45 pm started severe back pain. (Lasted 3 weeks). Headaches off and on. Tired/fatigue.

FEVER; FATIGUE; ARM SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of this reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: not reported) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm soreness. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on APR-2021, and had not recovered from fever, and fatigue. This report was non-serious.

SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.

At time of injection:Burning and pain at injection site 11 hours later:Fever of 101, nausea, stomach pain, chills and other flu-like symptoms Appx. 8-10 days later: terrible deep /aching cramp-like pain in upper left arm. Limited range of motion due to pain. Sporadic head aches-unusual for me as i do not hget headaches unless it's sinus which this isn't.

Starting the 10th, patient has had bad headache, severe muscle pains more than usual, SOB more than normal and severe fatigue. She thought it would go away but the symptoms got worse with each day. No fever. She had been taking Ibuprofen and Tylenol around the clock. Symptoms had not improved Also had been nauseated since Monday 4-12-21. The site was sore and her arm felt heavy and she could hardly lift it.

Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia making it impossible to sleep. Palpitations seemed to get better by 11 am the next morning but my heart rate was still elevated ( pulse 106-112). Shortly after that ( around 11:45 am) I became extremely light headed and dizzy and felt like I was going to pass out. I also started to feel nauseous and sweaty. I rested lying down for two hours before hearing back from my doctor's office. I was able to control the lightheadedness and dizziness by lying down. The feeling of passing out / nearly fainting went away. I continued to feel nauseous and my heartrate was still elected. I started to get a headache as well. On the advise of a nurse at my doctor's office, my husband took me to the ER. My EKG was normal . My heartrate was elevated. Due to the overcrowding at the ER that day I was made to wait at least an hour and half for further evaluation. I continued to feel light headed and slightly dizzy. My nausea and headache got much worse . I was finally taken back to a treatment room and received IV fluids, Zofran and Tylenol. My heartrate went back to normal and my headache and nausea improved with treatment and I was discharged around 7pm. I continued to feel very tired and slightly lightheaded that evening. The next morning I was much more nauseous again and still very weak feeling and slightly lightheaded. I have continued to feel weak, very fatigued , unwell and nauseous on and off until today, April 14, which is 6 days after I was vaccinated.

Approximately 24 hours after the administration of the vaccine the patient experienced a fever of 110.6, and left work and remained out for 24 hours. The patient proceeded to experience GI symptoms which presented as diarrhea for 10 days post vaccination. The fever resolved after 24 hours. The patient experienced pain in joints, this has continue and not yet resolved, the patient has made an appoint with their primary physician to address the matter. The patient is currently taking ibuprofen to treat the pain.

April 13: Diarrhea, nausea in morning. Fever of 100 at 4 pm, muscle aches. Fever morning of April 14 with Diarrhea, fever gone by 3 pm.

Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied by chill, fatigue, body heaviness, Treatment was rest. Recovered by 3rd day. Vaccination shot site of arm extreme soreness the day after the shot for 2 days

Report she got the vaccine on 4/10/21 and started having achiness, fatigue shortly after. 3 days later pt developed diarrhea (watery), cough, SOB. Reports SOB worse with exertion, talking.

Warm, itchy red patch approximately 2 inches below vaccine site. Swollen, itchy, erythametous, and warm to touch, painful. Tired.

Patient's daughter called on her behalf to translate from Spanish. She reported that her mother was having "flu-like" symptoms approximately 3 weeks after receiving the J&J vaccine. She also mentioned that she was having a headache in the back of her head and neck which are known to be possible indication of a cerebral venous sinus thrombosis which has been rarely associated with the J&J vaccine. I advised the daughter to take the mother to the emergency department for further evaluation and she agreed that she would take her right away.

My vision had 5-7 water bubbles that appeared with blood-stained edges. They would move as I looked at things for about 10 minutes. Was on a walk and went home and sat in a chair. 4 hours after injection my neck and upper back was killing me. I have had a previous injury from a car wreck 40 hears ago. I slept in the chair that night and the next days on a heating pad. My back felt like a horse kicked me. The next day my eyelids were too heavy to lift for about the duration of a movie. I could not fall a sleep, but could not lift my eyelids. I had vaccination on Friday night. I could not stand any sunlight until Sunday. My sinuses were killing me and the back of the head. On Sunday afternoon I could eat chicken broth and drank lots of water. By Sunday night, I felt fine and ran 5 miles on the treadmill. Feel great now.

initial symptoms- rash, itching, elevated BP, headache, ankle swelling ultrasound on 4/6/2021 - bilateral DVT CBC low platelets - 16 thousand CT chest - moderate burden PE Pt. was hospitalized

Headache that lasted until 4/14/21, was seen by her provider as a virtual visit and told to treat with flonase and ibuprofen and to go to ED if headache doesn't go away after that treatment. Headache got better night of 4/14/21, but returned again 4/15/21 in AM.

elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of breath confusion.

BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 25-MAR-2021. This report was non-serious.

BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and smoker (5-6 cigarettes/day), 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: 0421A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced headache. On 11-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 body aches, headache, and fatigue. This report was non-serious.

FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A 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 achy arm. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced feeling very tired. On 11-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced feeling woozy or dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy arm, and muscle ache on 11-APR-2021, and feeling very tired on 12-APR-2021, and had not recovered from heart racing, feeling woozy or dizziness, and headache. This report was non-serious.

ACHE MOSTLY ON THE FACE AREA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A 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 ache mostly on the face area. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache mostly on the face area, chills, headache, and fever on 08-APR-2021. This report was non-serious.

I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my heart. Could not sleep on Saturday night extreme anxiety feeling. Extreme hyper active feeling!!! Felt like if I had a surge of energy. Very restless, legs felt jittery! Left lymph node in my neck was swollen and slight headache.

BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS MOSTLY INSTEP AND CALVES; MIGRAINE TYPE HEADACHE LIKE STEAK THROUGH THE HEAD; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine type headache like steak through the head. On 06-APR-2021, the subject experienced cramps in calves/leg cramps mostly instep and calves. On 06-APR-2021 03:00, the subject experienced bone ache. On 06-APR-2021 03:00, the subject experienced body aches. On 06-APR-2021 03:00, the subject experienced very high fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, and very high fever on 06-APR-2021, and migraine type headache like steak through the head, cramps in calves/leg cramps mostly instep and calves, and body aches on 07-APR-2021. This report was non-serious.

Immediate pain upon injection. Rapid heart beat . Sore arm at injection site. Later flu like symptoms: headache, chills, slight fever, body aches Later terrible leg cramps and numbness in both legs which sent me to emergency room 4/12/2021 Continued pain in nerves in arms and legs, muscle cramping. Nerve sensitivity on left side(shot arm) of face

Janssen COVID-19 Vaccine EUA Chills, fever and headache for approx 40 hours. Controlled with Tylenol. Fine after that.

Pt received her 1st and only needed dose of the Janssen COVID-19 vaccine on 4/2/2021. After the 2 weeks needed to be considered fully vaccinated, She presented to the ED with cough, SOB, and chest discomfort on 4/17 and was diagnosed with COVID pneumonia. She was treated but not admitted.

On 4/16/21, patient reported that following vaccination on 4/8/21 around 9:45 am: ..."The feeling of being light headed began around 10:30 am while I was sitting at my computer. Six days after the vaccine, I actually went to bed with severe cold chills which lasted several hours. I am still experiencing intermittent periods of "brain fog" or at times feeling a little light headed. Last Saturday was the only day that I haven't experienced feeling this way. Again, it does not happen all of the time but it is bothersome. I am hopeful that after this Thursday (2 weeks will have passed since the vaccine) that symptoms will disappear. If not, I will follow up with my family practitioner. Thank you!"

FEELING WEAK; MUSCLE ACHE; FEVER (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.

All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.

DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report. On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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

SORE THROAT; SWOLLEN FACE; TINGLING LIPS; FATIGUE; FLUSHED FACE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obstructive sleep apnea, hbp, bipap at night, non-smoker, abstains from alcohol, and seasonal 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included colecalciferol for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, hydrochlorothiazide/triamterene for drug used for unknown indication, loratadine for drug used for unknown indication, metoprolol for drug used for unknown indication, orlistat for drug used for unknown indication, and paracetamol. On 12-APR-2021, the subject experienced flushed face. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced swollen face. On 13-APR-2021, the subject experienced tingling lips. On 14-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen face, tingling lips, and fatigue on 13-APR-2021, was recovering from flushed face, and had not recovered from sore throat. This report was non-serious.

This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no 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 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.

3/16 vaccination 4/4 extreme HA, tired, High BP, dizzy. 4/6 went to the ER. Shot for headache. Tramadol for HA if got worse. I took Tylenol. I saw PCM on Friday Meloxicam 7.5 1 per day. Will go to 2 tablets per day if continues. Not consistent HA as of yet. Scheduled echocardiogram on 4/29/2021 *Usual BP runs 115-120 range. Never had issue with BP. Knee replacement sx 12/1/2020 and no issues with BP then. Since vaccine my BP has been in the 150's. My BP has been consistently high since vaccine. Lowest has been 141 on 4/12/2021. I feel like I am out of breathe.

Pt has a history of DM2, HTN, HLD, HCV cirrhosis (sp treatment, Child Pugh A), CKD3 with baseline Cr 1.5 who presented to the ER after a syncopal episode and with headaches. She has no history of a positive COVID test. She reported receiving the J&J vaccine on 3/6 and reports headaches since then. She also had a syncopal episode that prompted her presentation to the ED. She underwent MRV of the brain looking for sinus thrombosis. The brain portion was normal but she was found to have a LIJ thrombus. She denies prior history of VTE. It is overall unclear if this thrombus is related the her symptoms, to the vaccine, or completely incidental. Pt was started on a heparin drip in the hospital...

constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.

BODY ACHES; HEADACHE; LOSS OF APPETITE; CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced extreme fatigue. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, loss of appetite, extreme fatigue, chills, body aches, and headache. This report was non-serious.

SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and normally had to take anti-histamines in the spring. 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine. On 13-APR-2021, the subject experienced shortness of breath. On 13-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 shortness of breath, and fatigue. This report was non-serious.

FOGGY FEELING IN HEAD; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clindamycin. 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced foggy feeling in head. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, nausea, and foggy feeling in head. This report was non-serious.

I took 1 Benandryl about 1 hour before the injection of the vaccine prior to leaving my home. My son took me as I would anticipate some type of reaction given my history. J&J was the one my doctor recommended in hopes that I could handle the response better and only need 1 dose. I had options to get pfizer or moderna, but my dr wanted J&J so I waited several weeks longer to get this one. Within 10 minutes of having the injection, my ears swelled up, and felt like I was on a bad plane and could not burst clear. Then my throat on left side, the same side I got the shot swelled. My face was full of red and rash and my son mentioned he was concerned how I looked. I told him my symptoms and then took another Benadryl before we left the store. I told the pharmacist that I was having a reaction, they wanted to call 911-I said please no. I am used to having reactions and would want to see if I can manage it with Benadryl at home. I came home and took my Alegra (as I take my alegra at night before bed to help with congestion). Going forward every 2-3 hours I would take another benadryl rotating the time frames and slept as much as possible. It took several hours for the swelling to subside, longer than I was used to. Over the next several days, I would have times when my ears, throat would swell, my face would be red and rashed, especially at night my face will get red, rash and ears and throat swell late at night. It waxes and wains depending on how I feel. After the main allergic reaction of 12-24 hours later, I stared with the COVID symptoms, fever, chills, body ache, the joints that I have trouble with hurt so much more (knee, foot, arms, hands) I was so thankful I did not catch COVID. I don't think I would have survived. On Friday, March 19, 2021 was the first day I started to feel better except for the late night episodes of allergic reaction. I take Alegra or when needed Benadryl. It seems to lower my swelling response.

SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious

Patient presented to the ER on 4/16/21 for dyspnea and wheezing, diagnosed with acute COPD exacerbation/chronic bronchitis and discharged home. Pt presented to ER 4/22/21 with worsening symptoms and was admitted to the hospital for acute kidney injury, dehydration and COPD exacerbation.

Headaches, fever, loss of appetite, diarrhea, fatigue for 24 hours then daily headaches x?s 4 weeks. Taking Aleve for headaches, discussed symptoms with the provider

SWOLLEN LYMPH NODE; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and 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 swollen lymph node. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, fatigue, nausea, and swollen lymph node. This report was non-serious.

DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, and headache on 27-MAR-2021. This report was non-serious.

Rapid heartbeat 24 hours severe stomach pain two weeks muscle and joint pain two weeks extreme high blood pressure two weeks. Extreme fatigue two weeks. The vaccine triggered an auto immune response. It triggered a flareup in my body and I was very ill for several weeks. Because of my severe stomach pain and blood pressure soaring my doctor ordered a CAT scan and blood work up. I am now three weeks post vaccine and my body seems to be calming down my blood pressure has returned to normal and the stomach pain has stopped. The extreme fatigue muscle and joint pain is still present but much better.

Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms continued for a few days, I started to feel a bit better, did not take any pain reliever medications because I didn't want to mask symptoms. On 4/14/21, 7 days post vaccination, my leg pain in both legs worsened including numbness and a burning sensation in both feet. Back pain continued, arm pain started in both arms with numbness in both hands however the pain on my left side with legs and arms is worse. I've had intermittent shooting pains in my left ear, left jaw, left temple and across the left side of my face. I've also experienced shoulder and neck pain. The abdominal pain is intermittent and mild. On 4/15 - 4/18 the pain in my legs was so bad that it was waking me up at night and my arm pain was occurring more frequently. I decided to go to the ER on 4/18, day 11 post vaccination, due to my concern of a possible DVT or other type of blood clot. The ER physician's assistant did not look at my legs but did several blood tests and other tests.

While I had nausea and fatigue Saturday morning after the vaccine, this report is about my nasty shingles outbreak. Rash started on left hand and calf and spread up my leg. Started with itching, not so much pain as in my prior outbreak which when I was 19 was local on my left arm. This is a bigger rash are, blistered red swollen, oozing, burning...the usual.

AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.

I woke up from almost like a pop in my brain and fluid started pouring down my throat and I started choking. I woke up and was able to spit some of it out. It was clear and also tinged with blood. It stopped once I stood up. I immediately thought my brain was leaking. I told my daughter about this the next day. My balance was off and I had a weird flapping in my head for the next few days. As well as a headache. A few days after I heard about the blood clots. I am not 100% sure if it was from the shot but it was literally hours from when I received it. It was very scary.

weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eating , patient was dehydrated . went to hospital , got out now

BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events 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 events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.

HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, 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: 1805022, 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 sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.

DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 the left arm, on 27-MAR-2021 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 left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious

SINUS INFECTION; CHILLS; FOGGY FEELING IN HEAD/ DID NOT FEEL LIKE HERSELF; DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, anxiety, seasonal allergies, and drug intolerance. 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 01-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 foggy feeling in head/ did not feel like herself. On APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sinus infection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, had not recovered from foggy feeling in head/ did not feel like herself, and dizziness, and the outcome of sinus infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

Itching, rubbing, nausea, dry heave, stridor, heavy breathing, cough, swelling of uvula Given Benedryl - Patient declined EpiPen, EMS and ER. Remained tired and itchy for the rest of the day.

CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-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, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

Janssen COVID-19 Vaccine EUA 24 hours of SEVERE pain in every muscle and especially neck, eyes, head, face, jaw. Also fever, nausea, vomiting, inability to sleep, intense tiredness. After 24 hours, all symptoms continued but were milder for 2 more days. Couldn't eat at all for 3-4 days.

Patient developed cold symptoms with heavy drainage on 4/15/21. Patient took a whole package as directed but continued to get worse. Used Vicks Vapor Rub and took a couple doses of sinus medication after the Coriidin was gone. Started severely hurting with difficulty breathing and chest pain on 4/27/21. Went to The Hospital on 4/28/21. Was diagnosed with pneumonia, pulmonary embolism in left lower lobe pulmonary arterial branches. Patient was admitted. Patient placed on Rocephin 1 gram IVPB daily and azithromycin 500 mg IVPB daily. Patient was started on therapeutic dosing of Lovenox and then transitioned to Eliquis 10 mg BID for 7 days then 5 mg BID. See hos.

Patient experienced nausea, vomiting, diarrhea, headache and fever (101 F) from 10:00 pm 03/18/21 to 12:00 pm 03/19/21.

Patient reports potential side effects for 2 weeks post dose. She has been having diarrhea, chills, body aches, and fatigue. She stated that the symptoms started the day after the vaccine and continue still 2 weeks later.

From what I understand the night of the dose she had chills and a headache. She had several bad headaches since that vaccine up until her death on April 21st. She was given the J&J vaccine on April 8th at the CVS. Died on April 21. at home. I just saw an article today, May 4th that about 1-2 hours from her death, another female in her 30's got the J&J vaccine on the SAME DATE April 8 and she died on APRIL 19th. Pretty close in deaths and same vaccine. IS IT CONNECTED?

BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine. 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 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.

4/11/21 (evening) - Headache. Called doctor on Monday. Took 1 aspirin with doctor's approval and was fine. 5/4/21 (approximately 1 a.m.) Awoke feeling nauseous. Went to bathroom and proceeded to vomit four times over the next 90 minutes. Last episode was just vomiting water that I'd sipped and could not hold down. No sore throat, fever, chills or diarrhea. Just vomiting. Able to handle crackers, ginger tea & ginger beer. Plan to try soup today. Still more tired than normal (though 16-18 hour workdays don't help here), and stomach still feels a little unsettled. 5/4/21 - Present - Headache. Afraid to take aspirin as it might upset stomach that has already had a tough time. NOTE: Regarding question on next page about adverse reactions to vaccines, I haven't had a vaccine since childhood. My parents, who were typically never sick, became terribly ill for months after receiving their first and only flu vaccine. One of my sister's had a similar reaction. For that reason, my other sister and I have never opted for vaccines in adulthood, until now. I just took it now because I don't want to die, my employer is pushing for us to return to campus, and I know my high school students will not vaccinate or wear masks if they can avoid it.

DULL HEADACHE; INJECTION SITE ARM PAIN; FATIGUE; ACHY; DIZZY; This spontaneous report received from a patient concerned a 60 year old female. 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: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced injection site arm pain. On 09-APR-2021, the subject experienced felt fatigued. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine was not applicable. The patient recovered from achy, dizzy, injection site arm pain, and felt fatigued on APR-2021, and had not recovered from dull headache. This report was non-serious.

SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sporadic nose bleeds. On APR-2021, the subject experienced leg cramps in calves like charlie horse. On APR-2021, the subject experienced constant headache. On APR-2021, the subject experienced extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headache, and the outcome of sporadic nose bleeds, leg cramps in calves like charlie horse and extreme fatigue 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.

Fever,coughing,sob,severe weakness over 4day perios,went into resp distress,unable to raise up became no strength

I felt fine after the vaccine and I took a walk. Three hours later I got a massive headache. I was nauseous with vomiting and diarrhea. I felt like had bubbles going up my spine when I was lying down about a week after the vaccine. The nausea and vomiting went on for ten hours. After five weeks my arm is still a little slow I still have headaches intermittently, and sometimes daily.

I experienced after my J&J vaccine headaches for two days. Then on 04-16-2021 upon waking up I had a red rash which was warm, hot sensation when touching my arm. This hot sensation radiated up to my neck, trachea and down my forearm. I got concerned about the red rash and because I felt my arm hot sensation and I went to see my doctor who asked me if I had trouble breathing or if I had any chest pain. I told him I could breathe and I was concerned about my rash. He prescribed Prednisone medication which I took several days to go away. To this day I still continue with the headaches that come and go and I take 2 acetaminophen to relieve the pain. I do not know if my headaches are related to the J&J vaccine and the rash has gone away.

Adverse event started the same night. Extreme body aches, low grade fever, extreme anxiety, fatigue and headaches. Fever subsided with 24 hours but the body aches, anxiety, fatigue, and headaches continue to date. Just not feeling well since I received the vaccine. I am going on 4 weeks post vaccine.

AFTER REVIEWING PRE-VACCINATION CHECK LIST, DISCUSSED WITH PATIENT ALLERGY TO PENICILLIN AND INQUIRED INTO DETAILS OF FLU VACCINE REACTION. PATIENT DISCUSSED BOTH "ALLERGY/REACTIONS" WITH PHYSICIAN AND HE ADVISED PATIENT TO GO AHEAD WITH VACCINE. PATIENT NOTIFIED OF 30 MINUTE WAIT TIME. THE JANSSEN COVID VACCINE WAS ADMINISTERED IM AT 2:05 PM. 5 MINUTES LATER WHILE DISCUSSING SIDE EFFECTS THE PATIENT EXPERIENCED LIGHT HEADNESS, FOLLOWED BY DIZZINESS, THEN NAUSEA. PATIENT PLACED HEAD DOWN TO KNEES BUT UPON RAISING HER HEAD THE SYMPTOMS RETURNED, ALONG WITH SWEATING AND A HEADACHE. PATIENT ASKED TO LAY DOWN ON CARPETED FLOOR AND , 911 WAS CALLED. A PHYSICIAN IN OUR MEDICAL BUILDING NOTICED AND ASSISTED BY CHECKING BLOOD PRESSURE (122/77) AND PULSE WHICH WAS STRONG AND REGULAR.. HE REMAINED AT HER SIDE UNTIL THE FIRESTATION MEDICS ARRIVED FOLLOWED BY EMS. BY THIS TIME . PATIENT SAID THIS TYPE OF REACTION HAS OCCURRED BEFORE AND LASTS 30 MINUTES WITH A FULL RECOVERY. PATIENT WAS PUT INTO A CHAIR TO SIT UPRIGHT, THEN ALLOWED TO WALK AROUND UNASSISTED. EMS GAVE PATIENT OPTIONS OF GOING TO THE ED TO BE EXAMINED, OR RELEASED TO HER HUSBAND. SHE CHOSE THE LATTER OPTION AND LEFT VIA CAR. AT 3:45 PM

Patient described intractable vomiting, dehydration, blood sugar over 800. Patient went to hospital and was admitted to ICU for approximately 4 days. Patient has been discharged from the hospital.

LINGERING MEDICINAL/ IRON TASTE IN MOUTH; MILD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine for prophylactic vaccination. 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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced lingering medicinal/ iron taste in mouth. On MAY-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering medicinal/ iron taste in mouth, and the outcome of mild headache was not reported. This report was non-serious.

HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021. I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.

As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that my inhaler was filed with pepper spray. On wed going home had bad cough. Then Thursday , left work early, had to go home. On the way there was like a circle of fire going around my heart to include that part of lungs. Had to bed rest till Monday. Dr. at Emergency gave a prescription of Antibiotics and a cough prescription, my son had to pick it up for me. Then a bout a week later I had finished dinner, taking my plate to the kitchen, body/brain completely quit. No time to get dizzy, speak out or say anything. JUST QUIT. My husband said I was in/out for about 10 minutes as he was trying to help me up. Right side of nose/head still has problems.

Janssen COVOD-19 Vaccine EUA. I had a fever, terrible headache, muscle aches, tired, chills, soreness in upper abdomen and not being able to take a very deep breath. These lasted for a little over 24 hours, but I still have some tenderness in upper abdomen and cannot take a deep breath.

4/7/21 Chills, Body Ache 4/12/21 Cough , Blood Tinged Sputum 4/16/21 Chest Pain (seen in emergency room - admitted to hospital)

Severe Headache, Triggered Trigeminal Neuralgia, Rash, Fever, Large swelling at vaccine site, Short of Breath

CHILLS; FEVER; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. 's medical history patient gave tylenol 500mg (a total of 2 tablets were given in the past day, 1 at 9am and 1 at 2am).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-MAY-2021 13:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced injection site pain left arm. Laboratory data included: Body temperature (NR: not provided) 99.4 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and injection site pain left arm. This report was non-serious.

LIGHTHEADED; HEADACHE THAT GOES FROM NECK AROUND THE SKULL, AROUND FACE AND HAIR AREA; NAUSEA; FATIGUE; DOESN'T FEEL LIKE HERSELF; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced doesn't feel like herself. On 13-MAY-2021, the subject experienced lightheaded. On 13-MAY-2021, the subject experienced headache that goes from neck around the skull, around face and hair area. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fatigue. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and lightheaded, had not recovered from headache that goes from neck around the skull, around face and hair area, and fatigue, and the outcome of doesn't feel like herself was not reported. This report was non-serious.

Fever and cold-like symptoms on Saturday afternoon; woke to red itchy hives all over my neck, both arms, face, forehead, scalp, fingers, and ankle.

Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tylenol, Meloxicam, and Sumatriptan with mild improvement after medication but HA returns later. Diarrhea has improved. No improvement in body aches or fatigue

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.

Patient positive for COVID-19 on 04/08/21 after completing vaccination. Loss of taste and smell, headache, runny nose, sore throat, and fatigue.

I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events 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 events. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

Heart rate seemed much higher than normal. I felt pressure on my chest, especially on the upper right side of my chest, all day. Breathing was also more difficult than normal. These symptoms lasted all day and were very concerning, but they seemed to have subsided by the next day (Monday May 17th), so I did not seek medical attention. On Monday May 17th, I had a headache from the time I awoke and for hours thereafter. But that went away shortly after I took an aspirin. This is my third reaction event to this vaccine. The first was a headache 3 days after the vaccine. The second was severe vomiting 3.5 weeks after the vaccine. This increased heart rate, chest pressure, difficulty breathing, and headache is the third event.

Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck pain,weakness,tired, coughing, pain in back. Using Tylenol doesn't help much..I will feel fine for a day then it comes back

2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my left arm swelled. The shot location in my left arm itched a lot. I scratched it, it bled. It became a large hole. 3 days later approximately, I start feeling very very tired. It got progressively worse . I then developed " brain fog". I have barely been able to work since then.. I believe I started to recover yesterday but not completely sure yet. I also developed a painful tumor in my right arm pit that lasted for a few days. It has since gone away. It was approximately 3/4 " in size. It developed overnight.

Substantial body aches, unrelenting headache, fatigue, negative thinking, general malaise. Had to close my shop and lose business (would only do that if it knocked me off my feet)!

cardiomegaly, with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia

Five hours after vaccine around 8 PM I started with chills and shakes and then fever. I think I had a fever of over 100. No body aches or anything like that, of coarse there was a little bit of soreness in arm but it wasn't so bad. 3 weeks later is when I started with headache which I recognized as sinus so I started medical treatment I went to see a doctor about a month later on 05/03/2021 and that is when I was put on antibiotics for 10 days and steroids. It ended up going away maybe halfway through taking the antibiotics, about 5 days in using antibiotics around 05/08/2021 I started feeling better.

I noticed a large lump, it started as a rush that was itchy and painful. I had some joint and muscle pain. The lump is still there and painful. I did have diarreha and fatigue.

I have had a low-grade fever for 4-6 weeks, always between 99.4 and 100. I am also experiencing aches and stomach issues. I had some type of a lung issue/bronchitis starting about May 1st or so, which has not resolved. In treating that, I tested negative for COVID, had a normal CBC and had a normal chest x-ray.

Patient started coughing, and said that her throat was tingling. She said it was getting hard to breath. Staff gave her some water and took vitals. 1:30 BP 130/92, 81. 1:35 Denies throat tingling. 1:36 reviewed when to seek medical attention and if she reacts after she leaves here. BP 113/77, Pulse 57. 1:41 Patient states she feels fine, no tingling in throat, and no coughing. patient leaves Health Department.

HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.

ABDOMINAL CRAMPING; EXTREME CHILLS; SHOULDER PAIN IN BOTH SHOULDERS; REALLY BAD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A 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 abdominal cramping. On 02-JUN-2021, the subject experienced extreme chills. On 02-JUN-2021, the subject experienced shoulder pain in both shoulders. On 02-JUN-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramping, and had not recovered from extreme chills, really bad headache, and shoulder pain in both shoulders. This report was non-serious.

Injection was extremely painful. Injection site was itchy and sore for a few days. Fever of 101 for about 36 hours starting day after injection. Round, hard lump (chick pea size) developed at injection site a week or so after injection. Lump faded over 3-4 weeks. Left a quarter size indentation about 1/4 inch deep. My primary physician said there is muscle atrophy and the chemicals in the injection likely killed muscle cells. Left arm is slightly sore.

PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.

I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.

Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and patient transported to hospital. Upon exam it was determined the patient had a bleed on the ride side of the brain. After 4 or 5 days she was transferred to Rehab. She was then sent back to hospital after complications. Patient began having kidney problems and was undergoing dialysis. 06/16/2021 patient began having bad headaches, CT scan showed multiple previous strokes(clots). Patient currently still in hospital.

LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.

The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.

Redness at the injection site and has swelled and became large over time, about the size of a quarter. Fatigue and dizziness. Severe pain under rib.

Get tire extremely fast when walking daily Shortness of breath daily Swollen ankles daily Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine

patient presented to ER with myalgias/arthralgias, flu like symptoms including fever, congestion, sore throat. Pt had COVID vax 6/9. In ER, noted to have leukocytosis of 36k with neutrophil predominance. Admitted and no infectious source identified. COVID negative on 6/22. Pt transferred to higher level of care due to concern for hematologic malignancy. All tests unremarkable so far. Ferritin was > 11k. Pt case reviewed by rheumatology who suggested adult onset Still's disease which could be vaccine related. Starting Anakinra asap in effort to see improvement

ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced tenderness on top of the head. On 18-JUN-2021, the subject experienced sore arm. On 19-JUN-2021, the subject experienced achy. On 19-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on top of the head on 21-JUN-2021, achy, and chills on JUN-2021, and sore arm on 26-JUN-2021. This report was non-serious.

Sore throat and headache. Runny nose, sneezing and Productive cough next. And Had a fever once and 02 went down to 95 and then to 92 and then back up. I got Tylenol (took it around the clock - until the week after the hospital due to headaches); Vit D; and I took herbal teas Ginger/Turmeric and water. I had Telehealth visit the whole time. I went to ER when 02 went to 92 and I couldn't smell. I couldn't lay down - had to sit up due to not being able to breathe. I couldn't bend down without being out of bed. I still was short of breath for about three weeks after. Fatigue lasted that long, too. They gave me some (Received Oxygen for breathing at ER). My sense of smell has now returned - not sure when. I'm back to going to gym now - I can walk around and not get out of breath.

Within the first 6 days after taking the vaccine a bump appeared on the right thumb. Chronic pain increased, right shoulder, wrist and elbow sore. Has a cough currently.

BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. 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).

FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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).

FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was not reported and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.

11:30PM - Chills late that night and up for an hour for them - went to go to bed with a lot of clothes and lots of blankets but I fell asleep. Morning they were gone. Slightly after that, I had some fatigue but nothing major. I was pretty normal. Then I noticed a few weeks later some swelling under my arms - lymph nodes swollen. I was very aware that they were touching. That seemed to last for a couple of months. I have just become aware the last few weeks that those symptoms with the swollen lymph nodes are gone. About 6 weeks to two months ago - I have been getting pounding heart and a bit of difficulty breathing. May be related stress. It comes and goes and then about a month ago I started a stress reduction supplement protocol and started doing meditation but they were still there and so I went to the doctor. She did an EKG and general physical and she didn't find anything that showed up abnormal with heart. The heart pounding and the breathing issues I'm still noticing.

Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, earache, nausea felt like had the flu for several days was on a liquid diet of broth no medicines. 07/07/2021 started feel better with still scratchy though, no nausea or diarrhea.

No symptoms whatsoever except about 5 days later I started getting headaches and three months later they?ve never subsided.

2 weeks after getting the vaccine I experienced a horrible headache that lasted 2 weeks. None of my migraine meds worked on this headache. It was constant, for 2 weeks. It then started letting up, but I woke up with half my face being numb. It starts at my lips and moves up my face to my lower eye lid. My upper teeth are also numb on that side. The left side, When that happened I went to the ER as advised by my doctor (4-12-21). My blood pressure was very high so they treated me for that and did a CAT scan of my head and found nothing. I was sent home. Saw my Neurologist the next day 4-13-21, She ordered an MRI which was done on 4-17-21. Nothing significant was found. I also saw my Primary care doctor that same week. He did bloodwork to rule out auto immune diseases. Bloodwork was good. I also went to see my dentist that week to rule out dental problems. He did an xray and did not think it was dental related. The numbness is still there. It has not gone away

My head hurt really bad shortly after injection and continued for at least 2 weeks, trouble with body shakes, also had trouble when taking walks with urinary isues, and exusted climbing stairs, caused pressure in my chest which is still there. Finally did Ultrasound of heart because of the pressure in chest, it came back ok. Having alot of junk in throat daily, constantly trying to clear it, I have to use fexofenadine daily instead of ocasional with Asthma flair ups., with shortness of breath it almost fells like emphysema, very sensetive to all smells worse then before.

Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to focus. Mind foggy. Tested for antibodoes for covid and vaccone resulted negatives after one month of vacconation and then again after 3 monthz. However had high autoinmune response. Headache and neck pain continued. Had N mri and neurologiat evaliation but nothing founf. Headaxhe continued and leg pain and stiffness also. Now also continuous ringing in my ears abd hot ears. Veins in my arm are unusually darker abd more visiblw.

VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.

Night 1-severe chills Days 2-3-4 -flu like symptoms-diarrhea Chronic diarrhea has continued to this day

LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.

After receiving the shot I have had headaches every day since receiving the vaccine. I also sweat more profusely they I did before. Water just runs off of me.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm

2 days later nausea, vomiting, diarrhea, palpitions, tachycardia, fatigue, general malaise. Still have occassional palpitations.

First 3 days - headache, nausea, body pain, chills, sweats,fatigue. About 3 weeks to present. Memory loss, brain ?fog? Using the wrong word when speaking. ( not the word I was thinking ? , doing stupid things that I wouldn?t normally do , not thinking clearly. Forgetting where I?m going and what I?m doing with a long effort to recall where I am / what I?m doing.

Well I felt like I had a cold, or allergies, post nasal drip, cough, then I had a low grade fever of 99.7 that made me concerned so I went to get tested for Covid and got the results that I was positive. But before I got those results I called my PCD on 7/27/2021 and they told me to go in and get examined as well, even though I did have a test in progress. They put me on an antibiotic (clarithromycin), then after getting my results I told them I got them and I was positive. They told me ok, to drink plenty of fluids and rest. I also called my Rheumatologist and they wanted me to stop a medication I was taking for two weeks. I have been feeling a little better, right now I just feel like I have a bad cold and today is 7/29/2021, again this all started 7/25/2021. On July 12, I did feel like I had a cold and I saw my DR then as well, that was just the post nasal drip and the cough and she just told me to take Z-Pak which helped immediately and then I was fine until it started again on the 25th of July, the cough, post nasal drip and fever.

Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 hours after. Next day generally just cold and body tired. No arm pain.

day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea

Within 4 hours: extreme fatigue, headache, loose stools continued until 8am 3/7/2021. Itching all over body, without hives, from 2pm 3/7/2021 until 6:45pm 3/7/2021 - unsure itching is over.

Complained of chills 10 minutes after vaccine administration. EMS checked blood sugar but machine could not read. It was either too low or too high.. BP 219/89, EKG was unremarkable. Patient was advised by EMS and NP to be transported to ER but decline. Preferred to be transported to by the husband to PCP.

Friday , March 5 - Received shot at approx. 9:30am. 10:00 am feeling very tired. By 3:00pm feeling achy and feverish, 6pm full chills, headache, and fever and very achy. At 7:00pm took my temp. It was 100.4 degrees. I took 3 -200mg Advil and went to bed. Saturday, March 6 - woke at 6:30am feeling washed out. By 8:00am was feeling a bit achy, took 3- 200mg Advil and by 10:00am was feeling much better. Symptoms were completely gone by noon and have not recurred since.

Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache.

Rapid heart rate for several hours (about 10). Bad headache which is now a sinus headache on the right side.

About 12 hours after vaccine I had Uncontrollable shivering and mild body aches. Only lasted about 2 hours

-severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection

3/9/21- chills muscle aches, joint pain, tired for about 4 hours 3/10/21-4:00 pm- chili?s, joint pain, aches, headache, fever-99.8

Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea

4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0

Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches and shaking all night. Fever broke at 5:30 am-19.5 hours after injection. It?s 24 hours after injection and fever has broke but nausea has returned. Comes in waves. Extra tired and sick feeling just like the flu.

24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday-Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping.

fever of 101.6, chills, aches, and headache, began the morning after the shot and lasted until about midnight.

Jansen COVID-19 Vaccine EUA After waiting 15 min post vaccination, I got in my car to drive home. I started to see arcs of color in the peripheral vision of my left eye. Later this became more prominent. Overnight, I developed a headache and saw wavy colored/blurred lines in my left eye for about 10 min that obstructed my vision. I saw an ophthalmologist as I was very concerned. They suggested that as my eyes looked healthy under examination that it might be an ocular migraine. I still have a painful headache 26 hrs post vaccination. I?ve never had an ocular migraine previously.

Fatigue, Moderate body aches Intermittent Fever first 24hours Headache Red & soreness around injection site. Persisted for 48hours. Took Motrin, hot showers & herbal teas. Bed rest

3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea

Three hours after injection I fell fast asleep. 7 hours after injection I had mild body aches and chills that lasted about an hour. I have had a dull headache for about 15 hours. I ended up sleeping for 14 hours

Janssen COVID-19 Vaccine EUA 3/11/2021 - 8pm very sore lymph nodes under armpits, sore chest muscles - sore all the way around my torse from one armpit to the other. Start getting the chills. Went to bed at 10pm. 3/12/2021 - 12am woke up with VERY Intense headache (forehead area and temples) - never had a headache this bad in my entire life, back of neck very sore, couldn't sleep, relax or focus. 3/12/2021 - 3am Diarrhea and nausea started, mouth very dry, tried to drink water but couldn't due to nausea, Headache still intense, haven't slept since midnight and couldn't relax or focus. In and out of bed, up and down stairs just didn't know what to do. 3/12/2021 - 7am diarrhea and nausea ended but still very intense headache. No sleep since midnight and just kept pacing , trying to sit, tried breathing learned in childbirth, but nothing was relieving the headache or letting me relax and sleep. Husband thought I looked like death. 3/12/2021 - 9:30am I finally broke down and took 2 Tylenol and was able to sleep for 2 hrs. 3/12/2021 - 11:30am body still ached and headache was now tolerable. Able to finally focus and relax. Symptoms were now tolerable as compared to 12am-9:30am, prior to taking Tylenol. 3/12/2021 - 5:00 pm beginning to feel better and eat a regular dinner. 3/13/2021 - 8:00 am woke up and felt 100% normal injection site was never sore or red, didn't have a fever

Severe chills, fever highest 101.4°, Pulse ran 80-100, fell to do that I think I fainted Blood pressure 93/49,94/41,99/50,77/46,92/44,

Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, back aches, legs and feet ached. Hurt the balls of my feet when I walked. My eyes felt like they had sand paper in them. I did not run a fever but my body felt like I had. I had Flu B January of 2018, my syptoms after Janssen Shot were as severe as Flu B, but the duration was not as long! Approximately 24 hrs after injection I starting experiencing a headache, along with neck and shoulder aches. And I experienced fatigue for 3 days after injection along with the headache and neck, shoulder and back ache. On the fourth day following the injection I only feel tired. Aches, pains and headache are gone.

Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day after the vaccine shot

Janssen COVID-19 Vaccine EUA I developed severe chills (no fever) 8 hours after receiving the vaccine. Taking Aleve helped to ease the chills. For the next 6 days, I had a headache, flu-like symptoms, light-headedness and nausea. Four days after receiving the vaccine, I had a nose bleed, which is a very rare occurrence for me.

Shot received at 11:15 a.m. Saturday. Fever of 102f at 7:00 pm same day. Took 350 mg Tylenol at 8:30 pm, very strong chills throughout night, low fever into Sunday. Had low grade fever until about 4:00 pm Sunday. Overall flu like body soreness, extreme tiredness and overall not feeling well all day Sunday until about 7:00 pm. Body soreness all through Monday. Tuesday - fine.

Janssen COVID-19 Vaccine EUA; at 4:15 a.m. I took a tylenol for the headache I'd had since around 8 pm; ate a few crackers with it; then as I was going back to bed I immediately felt weak/dizzy and then I passed out on the floor. My life partner started calling my name and check my pulse (which he said was strong) ; then I came to but was really dizzy; I was nauseous and vomited for a few minutes; extremely hot/sweating; and after I stopped vomiting, then had a bowel movement (He had to aid me in getting to the bathroom). About 20 - 25 minutes later I felt much better; everything calmed down. I was ultimately able to fall back to sleep.

headache, sore throat, body aches, fatigue starting 12-24 hours after shot; development of oral ulcers 72 hours post vaccine

Extremely tired, headache for 24 hours, loss of appetite & fever for 8 hours ....Highest fever went was 100.1 ....Would do it again !!!! Worth it to be protected from a deadly infection of Covid 19 !!!!

weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.

DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK.

The day after I took the vaccine I awaken with a terrible headache and remained in bed all day. The next day I noticed a goose egg shape on my left arm in the area of the vaccine site, with soreness in my arm and shoulder throughout the entire week. Called the pharmacy who suggested I complete the form online and contact the doctor. Called the nurse line.

Chills, 103 fever, nausea, dizziness,aches, headache, fatigue. Came and went within 24 hours. Red face. On and off since vaccine Elevated blood pressure. Ongoing Tinnitus. Noticed last night, getting worse.

Severe chills/fever/body aches/nausea/headache/fatigue/closed eye hallucinations/sweating/mediciney aftertaste/sweat smelled like medicine/dizzy. All were severe and lasted for 3 days and I was unable to even function for 2.5 days. Dizziness has lasted longer.

Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood thinners (TNK and Heparin), Stent in coronary artery. outcome: hospitalization 3 days and then recovery and fatigue ongoing...

Severe Headache, took Tylenol every 4 hours. Did not help. Went to bed early and woke up feeling fine.

Was out shopping with friends and feeling fine but when driving home I noticed a high pitch sound in my left ear that abruptly started for no known reason. I have pollen allergies to trees and due to staying indoors and wearing a mask I was having no bad allergy symptoms and never had tinnitus on my worse pollen day. The tinnitus symptom was loud enough to notice over all other noise and very irritating in a quiet room. The high pitch sound was non stop and constant. I went to sleep that night and woke up Saturday morning still hearing it. I felt that morning like I was having a very mild cold with very mild congestion. I felt likeI had swelling under my ears I was not tired but I did feel like staying in bed and sleeping as if my body was mildly requesting it. I slept most of the day. Woke up with the high pitch sound but it seemed a little bit lower in volume. Around 8 pm the sound left as quickly as it came

Patient with 2 Emergency Department visits after vaccination. (3.19.21 & 3.22.21) 3.19.21: Symptoms: Patient had the J&J vaccine on Tuesday, and felt fatigued on Wednesday. Today she is more short of breath than normal and states she has chest pain. Daughter has suggested an ambulance, but patient, who is A&O X 3, declines. Daughter will bring to ED for evaluation. 61-year-old female with history of asthma, sleep apnea, environmental allergies, and hypertension presents emergency department complaining of shortness of breath and cough that started this morning and midsternal chest tightness rating at a 7/10. Sent home with prescriptions to manage cough, inhaler and steroid burst. 3.20.21 Office Visit: Patient states Wednesday 03/17/21 morning cough and mild fatigue started. Thursday 03/18/21 patient had shortness of breath with exertion x2 days. Yesterday 03/19/21 patient went down the stairs and was having severe shortness of breath. Patient felt like she couldn't get enough air in. Patient was seen in ED 03/19/21 and prescribed cough medicine. Patient states cough is constant with intermittent coughing fits. Patient was tested for COVID-19 while in ED and results were negative Shortness of breath is still present, but is better after ED visit. Patient states she feels 50% better today 03/20/21. Patient has been using inhaler and prednisone. Patient is needing to move slower to compensate for shortnbess of breath. Cough is present still. Cough is deep and dry. Yesterday 03/19/21 cough was productive. Today 03/20/21 patient is getting a small amount of phlegm out and it is white in color. Denies fever. No known exposure to COVID-19. History of asthma, not much relief currently with inhaler. When shortness of breath is present, it takes patient about 20-30 minutes to recover. Intermittent wheezing with mild wheezing present currently. Tightness in chest is present and coughing makes it worse. Patient had COVID-19 in April of 2020. Any treatment So Far: ED visit, Inhaler, prednisone, and prescribed cough medicines 3.22.21: Mon Mar 22, 2021 1722 This is a 60 year female presents for evaluation of shortness of breath. Some been going on for about a week now. She was just seen in the emergency department 3 days ago for same complaints. At that time she had a cardiac workup that was unremarkable. On initial evaluation here today she appears in no acute respiratory distress. She has normal room air oxygen saturations. Complete blood count shows a slight leukocytosis of 11.93 which may be elevated secondary to her current prednisone use. About 4 positive relative normal limits. Troponin was normal as was her proBNP. COVID PCR was not detected. CT angiogram thorax was negative for PE, pneumonia or other acute process. Patient is notified of these findings. She otherwise is discharged home with instructions follow up closely with primary care physician.

Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. Joint pain, Headache for 6 days.

Woke up around midnight with fever of 102.8 and chills. My normal temp is 97.4. Felt slightly dizzy when standing up. Took Tylenol and started feeling better after about 2-1/2 hours. The next morning, the 25th, felt like I had a mild case of the flu but, again, Tylenol seemed to help. No soreness in arm or other symptoms.

Received vaccine on Wednesday 3/17/21 @ 1250pm, pretty painful going in my R deltoid. Started feeling very tired on Thursday 3/18/21 around 7pm. Woke on Friday 3/19/21 with fatigue and diarrhea with body aches. Woke Saturday 3/20/21 with fever 101.7. (During this duration to include today I have taken Tylenol rotating with Motrin every 2 hours, this never broke my fevers). Fever continues on and off with body aches, nausea, the worst headache I have ever experienced and pain in the base back of my neck L side. These symptoms have continued since Saturday. It is now Friday, 3/26/21. I will say that during waking hours 8am - 10pm on Wednesday 3/24/21 and Thursday 3/25/21 I had no symptoms except absolute fatigue. The fever returned on those two nights at around midnight with it breaking about 4 am, waking up in a pile of sweat.

While she was in her 15 min wait period post injection she complained of palpitations. HR was 82 on Pulse ox and O2 sat was 97%. Listening to her heart with stethescope she was regular at 82. That night she stated she had hearing and visual disturbances. Saturday morning March 27 2021 she had a severe headache and took tylenol and went back to bed. Sunday still with same complaints.

teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog

Four days after vaccine, muscles at injection site started getting sore. No symptoms prior to day 4. Continues to worsen day 5. Day 5 very tired despite adequate sleep. Mild diarrhea. Symptoms not bad enough to keep me home from work, but I thought it odd symptoms didn't begin to appear until 4 days after vaccine.

On 03-25-2021, at 7pm, I started to feel flu like symptoms with body aches but no congestion. In the morning it seemed getting better but then my symptoms got worse. I took two Ibuprofen which helped. I still continued to feel tired. After my vaccine, I also got a weird taste in my mouth. I was very tired over the weekend. My armpit itched and so I scratched it and I felt raised bumps under my armpit, under the pit of my arms on both sides, right greater than left. My left arm was the one vaccinated. I also had bad diarrhea on 03-29-2021. Today I still continue with the rash under my armpits and still feel very tired and fatigued.

Had my COVID Janssen single shot on March 18, 2021. Became sick with chills, fever (100F), fatigue, headache, body ache after 9 days. Lasted 4 days before improvement. Decided to take a COVID test 3/29/2021. Result negative.

Eight hours after vac: Body aches, followed by low grade temp, headache, fatigue, resolved after 36 hours, then followed by moderate diarrhea.

Started feeling "woozy" Sunday night (vaccinated in the am), woke up in the middle of the night with a pounding headache, 101.4 temperature (taken orally), chills, body aches. Fever would break, sweats, then teeth chattering chills. This would cycle until Tuesday afternoon. The "woozy" feeling persists, although not as intense.

RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

The night of when I received my vaccine 03-25-2021, I experienced fever, chills. I took Tylenol for pain. I also developed soreness at the injection site and a red, rash on my left arm. I went to see my doctor, but saw a nurse practitioner who prescribed antibiotics and anti-inflammatory medication. My left arm is still sore at the moment and I have not completely healed.

very sore arm headache body aches chills low grade fever (100.3) All began approximately 12 hours after the vaccine was administered. As of this submission, it has only been approximately 16 hours since I received the vaccine. I am currently experiencing the listed symptoms. Given that, there is no information to provide for Item 21, below.

About 4 hours after the injection I developed terrible rigors. I had a fever up to 102 degrees, but I was also under blankets at the time. I continued to have a low grade fever for much of the next day and generally felt bad with headache and malaise. On the second day after my vaccination, 3/28/2021, I felt fine.

The first night I had severe chills and an intense headache but that went away the next morning. Then four days later I broke out in hives all over my body. Still have hives on day 6.

By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.

I was fine at first but after 11 hours, I began to get a bad headache within 30 minutes I also had nausea and severe pain all over my body to the point I did not want to move at all. Ibuprofen did not help. I was so tired, I could not move. It lasted through the night and would wake me up. I slept most of the next day until about 1:00pm. I finally began to feel better about 12 hours after it began and within 24 hours I was back to normal other that the sore shoulder.

FEVER; DIZZINESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included levofloxacin allergy, midazolam allergy, amoxicillin allergy, and aleve allergy, and concurrent conditions included myelodysplasia, recurrent bladder infection, and sulfa allergy. The patient was previously treated with levofloxacin, midazolam, amoxicillin, and naproxen sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 16:00 for prophylactic vaccination. Concomitant medications included aciclovir for myelodysplasia, and recurrent bladder infections, calcium carbonate for myelodysplasia, and recurrent bladder infections, colecalciferol for myelodysplasia, and recurrent bladder infections, docusate sodium for recurrent bladder infections, and myelodysplasia, fluconazole for recurrent bladder infections, and myelodysplasia, iron for recurrent bladder infections, and myelodysplasia, and nitrofurantoin for recurrent bladder infections, and myelodysplasia. On 18-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 18-MAR-2021, and fever on 25-MAR-2021. This report was non-serious.

Patient received the vaccine on 3/23/21 and developed symptoms of COVID on 4/5/21 (abdominal discomfort, heartburn, shortness of breath, and cough). On 4/8/21 she was admitted to hospital with COVID and is currently on supplemental oxygen.

Within 2 hours of the shot, I felt nauseous, somewhat dizzy, and very tired. I experienced this for over 24 hours. I still don't feel quite well. Also, my arm is still sore where the shot was administered, 3 days later.

Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.

The next morning, 09:00 am, I had mild flu symptoms which was full body aches and feeling feverish and unwell. I didn't register a fever on the thermometer. I was very tired; no appetite. I stayed resting all day. Slept a lot. It was easy for me to sleep - very unusual. By 9:00 pm that all lifted and I was feeling back to normal. The morning of March 28, I woke up with a very sore throat. And on 3/29, I had really continued sore throat on and off and Tuesday it got much worse. There was a really strange sensation of being extremely thirsty - I had never had experienced that before. Swollen gland on the right side of my throat - between the jaw and ear area. I had a little bit of an earache on the right side. I drove by the drive-in testing area. I am working in person each day so I get the drive by testing - I think Tuesday, the 30th. Called the dr and did the Telehealth visit - Wednesday - the 31st. I had in and out of laryngitis - raspy voice and headache. I looked in my throat with flashlight and could see a definitive red spot in back of throat and some white spots. They said it could be a blocked salivary gland and told me to eat something very sour to activate it. Over 6 to 8 hours it did clear the issue somewhat - thirst went away. I still had a sore throat. They told me that by the weekend, I could maybe start antibiotic. Saturday night I took first dose of Zpack - two tablets at first dose and then one tablet a day after that. By late evening Sunday (Easter) I felt some relief of symptoms. This week I still have a little bit of raspy voice and post nasal drip and clearing my throat at this point. I am recovering but not fully recovered.

Janssen COVID-19 Vaccine 6 hours after injection, my temperature was 101.4, my head was pounding and every inch of my body hurt and felt nauseated. Now that it has been just over 24 hours, temperature 99.2, I still have body aches (not as severe) and feel nauseated.

Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.

Chills started about 10 hours after vaccine but minimal. Extreme chills started about 11 hours after vaccine and lasted about 1 hour or so. Layered with clothes and blankets to get under control. I have had many vaccines over the years and never experienced any adverse affect. Next day a bit cloudy and headache but subsided after about 27 hours after vaccine

Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.

Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot

DIZZY; TEMPERATURE 99; LETHARGIC; DID NOT FEEL LIKE EATING; VACCINE WAS AMBER TO LIGHT BROWN IN COLOR; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced temperature 99. On 25-MAR-2021, the subject experienced did not feel like eating. On 25-MAR-2021, the subject experienced vaccine was amber to light brown in color. On 25-MAR-2021, the subject experienced lethargic. Laboratory data included: Body temperature (NR: not provided) 99 Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temperature 99, did not feel like eating and vaccine was amber to light brown in color was not reported. This report was non-serious. This report was associated with product quality complaint:90000175219.

VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious. Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.

CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.

began feeling tired and slightly light headed a few hours after the vaccine. Developed a headache by evening same day(Day 1). Arm very sore. Day 2- still tired with light head and headache, arm very sore. Day 3- tired, light headed, headache, arm very sore. Day 4- tired, light headed, headache, sore arm. Day 5- pounding, splitting, incapacitating headache that required 800mg Motrin to start and 400mg every 5-6 hours, fatigue, light headed, sore arm, felt horrible.. Day 6- Woke up back to normal.

At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra strength Tylenol which seemed to trigger cyclic vomiting every 15-20 minutes for approximately 4 hours. After this, I vomited once an hour for another 4 hours. I was finally able to sip water and sleep after this. I also took my first temperature once feeling better and it was 99.9F. My normal temp is in the 97s and I?m sure it was much higher during the vomiting. My fever broke approximately 12 hours after the first symptoms. Headache lasted approximately 36 hours and resolved the next day, although a milder one did come back off and on for a couple more days. I did not have much pain in the arm I received the injection in.

HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.

mild headache, dizziness, nausea, and lack of energy six days after shot... Let's hope this won't last long.

CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having symptoms though they are less severe

I received the J & J covid vaccine this morning at 8:30 a.m. At approximately 4:30 p.m a dull headache, nausea and aches in my joints began. About 1/2 hour later I had a brief bout of chills then a fever set in. At 6 p.m. the fever was 100.0.

Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle aches afterwards to 2AM 3/10/21 -fever broke. Fatigue, muscle aches continued for 3 days. (maybe not associated with vaccine... but hip/leg pain flared and continues as well as sudden fainting and flare of diverticulitis (ER-CTscan 3/28/21)

Day 3 - Chills, Thirsty, Tired Day 10 - Day 3 through 10 fatigue, with the worse being day 10. Slight headache, slight leg, thigh, shin pain after short walk. Still tired, with slight weakness 3 weeks after vaccine.

Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat down for a couple of hours and it went away. That night I could not sleep. I only had about 3 hours of on-and-off sleep through the night. One time I woke up with severe chills The following day (Saturday) I had a lack of energy and in the afternoon I was running a low grade fever (99.8). Went to bed around 8:30 Saturday night, slept all night and felt fine Sunday morning.

Chills, severe headache, fatigue, dizziness, lack of appetite, nausea, anxiety. On 4/9/2021, I started to feel a pulsating feeling on my upper head and felt anxiety. It felt like I could not reduce my stress by taking deep breaths and letting it out slowly which was unusual because this usually works.

Approx 5 Minutes post vaccination : Severe Headache lasting approx 10 minutes, slight throat tightening, acceleration of heart rate that lasted about 15 minutes but continued intermittently for the first day post vaccination. Leg pain (aching) that lasted for 4 days. I struggled to think...as though I was in a fog ...for example it took me along time to think of an answer to a question I was asked. This lasted for 2 days. Severe tiredness 6 hours post vaccination, I slept for 2 hours then insomnia the first evening. Nausea beginning 6 hours post vaccination then rolling nausea that continued 6 days .

Nausea, chest pain, diarrhea, headache, body aches, and fatigue. Symptoms start the next morning and lasted for 5 days. As of this writing, no symptoms persistent at this time.

Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain radiating down under left breast, alleviated with Aleve every 12 hrs, lasted for over 1 week @8-9 days, actual bruising underarm pit, and pain and bruising down to the wrist and fingers. Did not seek medical attention.

Shortness of breath, stomach issues, muscle aches and pain, headaches, rapid heart rate, nausea, vision problems.

Beginning approximately 10 PM (about 8 hours post-injection), I started to have chills (feet were freezing) and was exhausted. Went to bed, and slept most of the night, only waking once to urinate and to drink a small amount (approx 2 oz) of Coca Cola -- I was very nauseous and thought it would help settle my stomach. During the night I sweated profusely. At 8 AM, I woke again and went to urinate. At that time I felt very nauseous, dizzy, and light headed. When I walked about 2 -3 feet to my bedroom, I collapsed on the floor - unconscious. My partner called EMS, they arrived minutes later. By then I was conscious. They transported me to Medical Center Emergency Room, where I remained for several hours. They indicated that my SYNCOPE was a result of dehydration. TODAY, 4/13, news of BLOOD CLOTS has compelled me to report my adverse reaction.

Had flu-like symptoms night of shot. Fever and pain, plus arm pain. She thought shot was given rather high on shoulder.

Onset next day Chills. Fever, body aches, joint pain, abdominal pain, left breast swelled to double the size

FEVER, ACHES, VOMITING, DIARRHEA, STARTING THURSDAY AT 10 PM UNTIL WOKE UP MONDAY MORNING AT 6 AM AND ALL SYMPTOMS GONE

Began having chills about 7 hours after the injection. On the early afternoon of 4/8. Developed excruciating headache (very similar to when I had Covid previously in Sept. 2020), all over body aches, ringing in my ears and temp. 101. Unable to sleep during the night and excessively thirsty. Was essentially bedridden for 36 hours when headaches and body aches subsided on Saturday morning (4/10) Have only had a few brief headaches and some exhaustion since Sat. Morning. Of note, I have been donating convalescent plasma and platelets since my illness in September, 2020. On March 28 (approaching 7 months after my illness) I was still positive for Covid Antibodies prior to the vaccine.

Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.

Symptoms started as a dull headache , chills and myalgia that progressed to an ocular migraine the next morning and continued for the next 5 days. on the third day of the migraine I saw my PCP and was give Toradol IM and Zofran for the nausea. this dulled the HA but it returned the next day and remained for 2 more days before decreasing to a dull HA again. I have had a dull HA off and on since then, not a constant HA as initially.

Patient reporting numbness in both arms and legs which began 4 days ago (4/10/2021). Numbness comes and goes and increases in intensity throughout the day. Patient also reports extreme fatigue and headaches that have not resolved since vaccination date (4/5/2021).

4/12/21 12:30 pm began to feel fatigued, face felt flushed. No fever. Fatigue increased more in the evening. 4/13/21 2:30 am awoke and found entire face swollen and slight tingle in lips. Took Loratadine, Metoprolol and Triamterene/HCTZ and went back to bed. Awoke at 5 am, swelling better, but not gone. Still very puffy above and below eyes. Felt fatigue, no fever, went to work. Felt better by lunch time, swelling almost gone. 4/14/21 Slight sore throat, slight fatigue, no swelling.

She got the vaccine and immediately she had brain fever that came on immediately, her brain feels like it is swollen and nothing she does help it. She has an extreme splitting headache to where she feels her brain is going to go out of her head. She has also had numbness and tingling down the right side of her body and into her tongue. She cannot get to feeling better, she just keeps feeling worse. She has taken Tylenol/Ibuprofen, and dr. put her on prednisone and gave her a Z-PA to see if this will alleviate symptoms. Nothing she has taken has helped with it. She feels as though her brain is swollen and that she going down hill. She is a cancer survivor and cannot determine if having that has made her worse. The pressure has gone to her ears, feels like it is going to burn her ear drums up. She also has tinnitus with it as well. She also has tinnitus and the headache that will not go away. She has called her doctor many times and hasn't gotten any results back.

Swelling, tenderness at site. Headache within 5 hours. Muscle aches. Abdominal cramping and back pain all within 5 days (3/10-3/14 )of vaccine.Passed out on 4/10/21 while walking, noted fatigue on 4/8 until 4/13.

Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days Continued weakness left side of the body

Patient is describing right eye swelling 1-2 days after receiving vaccine. Some loss of vision as well as headaches. Patient states that she has never had these symptoms prior to vaccination.

Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.

Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, headache, tired. My arm never got sore or swollen. AFter 5pm till, the feverish feeling and hot cold got worse as time went by and I started shaking uncontrollably - pretty severe. I took Tylenol early hoping to stop the achy feverish and shaking but did not seem to help. THis went to till about 1am or 2am when I could finally lay down and try to sleep. The shaking had stopped. I did take more Tylenol and drank some herbal chamole type of hot tea. I could not sleep that night. Next day I was exhausted, body aches and still had some feverish feeling. By the way, took my temperature and it was normal. Then on Wednesday, I believe is when I had a huge episode of diarrhea (came on sudden). I kept calling and talking virtually to the doctor telling him all of what was going on. The next day I the feverish feeling and body aches and being tired kept happening - adding headache getting worse. I kept taking Tylenol. Seem to help some but did not take the pain away. EAch night , I could not sleep due to the headache. I started to feel better but then on the weekend, I had that headache and tired feeling. The headache was getting stronger and it circled my whole head and both shoulder and around my neck. It scared me because I felt at times that my throat was getting smaller. I could still swallow but it was so strange. I kept putting heat packs and ice packs and taking Tyelnol. I know that on Thursday or Friday the week, the doctor told me if I wanted to to go get tested for Covid and I did. I was tested negative on both the quick test and the other test that takes longer. I had that headache, sinus tension pressure for quite a few more days. Overall it took 7 days. I had to take off most of the week from my telework job because I could not function. I also did not eat much and drank lots of water during this time. It seem to go away and then about a week later, I got this painful diarrhea out of the blue and went to see an urgent care doctor. They tested me for blood, urine, and stool and they were negative. I was also having pain on my left side. Then it seem to go away after I was on the BRAT diet for a few more days. Then the diarrhea happened again the next week or so. This week, as of yesterday, I got a very strange throbbing pain in my left hand and not sure where that came from. It can be extreme at times. I tool Tyleonol but the pain is still there. Also, during this time and before the shot, I got a trigger finger issue on my right index finger. I don't think that has anything to do with the vaccine. Please note I have been told my doctors and I know this for a fact, my body is super sensitive to food, meds. I don't usually get the flu shot because of that. Today I am experiencing the left hand pain and now metal tasting in my mouth. I am about 5 weeks out from the vaccine. I wish I had never taken it. I pray nothing more will happen in my body If I have left anything off it is because I did not write this down when was happening. I really thought I was going to die one night because of the pressure I was having in my head, neck and shoulders. I have a little bit of a headache now and told my PT doctor that if I needed to know, I could get a brain or some kind of scan to see if I am hainvg any issues. I am going to bring this up to my virtual call today.

Severe headache, Chills, 100.2 fever, body aches, Headache lasting several hours High fever lasting 1 hour Chills lasting 2 hours body aches continue as well as right leg pain 5 days after shot, lasting 3 days. Called doctor, prescribed ibuprofen

101 fever for 12 hours. Chronic headache that has not resolved to date, ongoing chills since vaccination, unresolved insomnia, intestinal discomfort, and intermittent shortness of breath.

Chills, body aches, nausea, headache, tired beginning 7 hours after the vaccination and last 30 hours. I did not seek treatment. After 30 hours the symptoms had largely subsided other than a minor headache. Within 48 hours the headache was also gone.

Symptoms occurred 12 hours after shot - approx 2 am. Chills all over body - hands freezing, body aches- whole body, heart racing. After approx 6 hours - developed additional symptoms of a headache - location was back of head and severe teeth and jaw pain on right side of face. Unable to sleep all night. At noon - got up and read vaccine literature to see if I could take anything for the pain. Took Extra Strength Tylenol - 2 00 mg gel caps . Stayed awake for a 1/2 - pain in teeth, jaw and head got got better. Went back to bed for 4 hours. When work up later in the afternoon - felt okay.

Headache since shot with fluctuating intensity Extreme fatigue since 4/1/21 Cough since 4/5/21 (asthma) Dizziness since 4/11

patient was diagnosed with bilateral pulmonary emboli within 3 weeks of vaccine administration, developed dry cough within 1 week of vaccine that progressed to worsening shortness of breath.

My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches

vaccine reaction-passed out. c/o worsening headache and feels tire. states broke out sweat, stomach pain, HA, leg cramping and passed out (for about 30sec according to husband) on Mon. took Advil several days. last Advil 0600. J&J vaccine on 5 Apr. 61 yo f w/spouse c/o ongoing headache w/concerns for single episode of 'passing out' approx 48hrs pta approx 30-45 sec per spouse at bedside; Pt states nighttime episode w/preceding leg crampings, sweating, dizziness, sat on footstool and per spouse passed out but caught by spouse and avoided injury; spontaneous recovery w/o further issue from that episode, spouse denies any post-syncope seizure-like activity/urinary incontinence/tongue biting; Pt and spouse concerned. for cerebral venous thrombosis; Pt has sig hx of prior neurosurgery for posterior/occipital schwannoma around 2017, successfully removed, w/o further findings or complications on f/u (last DEC 2020) to include repeat imaging at that time Pt states has been taking advil OTC for ha but no sig relief at this time; Pt defers need for medications at time of provider evaluation; Pt denies any fevers/ns/chills, cp, sob, palpitations, dyspnea, abd pain/cramping, current nvd, prior syncope, fam hx of MI/SCD/dysrhythmias.

on March 28th I was diagnosed with covid19. The same day I went for the bam treatment at Hospital. On April 7th I was diagnosed with covid pneumonia

Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospital via ambulance c/o shortness of breath. Patient was diagnosed with pneumonia. Patient refused admission and returned home with prescriptions for inhalers, steroids, and antibiotics. Patient claims on 02 at home prior to event. Patient also c/o left leg pain (unspecified) but has not sought medical care. Patient treated at Hospital. Patient was advised to follow with her PCP for leg pain.

Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.

right after the vaccine in the pharmacy my throat felt like it was closing. and medicine taste going down my throat , pharmacist said no big deal. I went home 4 hours later i had fever and shakes and convulsions and my right finger were numb and my right leg and right low side hurt. My neighbor call the pharmacy and they said its normal to work thru. april6 pain in side was unbearable and i went to the doctor. had a ct scan and they put me on antibiotics.I had had headache for 15 days now. I don?t know how i am going to pay mymedica bill for a free covid vaccine.

ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, 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 zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.

CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, 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 patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness, weakness, muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.

Intense pain, hot from injection site, down entire arm immediately after given. Continued pain after two days into two weeks, shooting pains , crawling at injection site,and throbbing, even at elbow and wrist. Arm was also very weak, and still gets tired and throbs . Has been 4 weeks this week-end . Reported to nurse who tod me to see my Dr. which I did this week. No redness at injection site, just soreness, know something was off, according to side effects. Very tired feeling, still, and had some flushed color the first week in my face and like heat flashes for two weeks. Hope to get the normal feeling back in my arm. Not sure ? Maybe a nerve was nicked? But was not like a Bee Sting like tech described it would feel like that day. Had a ruff start.

WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate. On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.

Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21. Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine. Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm. No visible lower extremity swelling, redness and no pain. One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain. She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes. Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen. Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes. Patient has not had a physical exam with blood work since 11/9/17.

FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have any allergies. 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 feeling cold. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling cold, and dizziness, and had not recovered from body aches, tiredness, and headaches. This report was non-serious.

BODY ACHE; DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal pollen allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 19:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced dizziness. On 07-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, body ache, and dizziness. This report was non-serious.

Severe headache starting with 2 hours post injection lasting 6 days, severe nausea 6 days, diarrhea day 3 only. Red circular spot on hand, toes, shoulder area, day 2-4.

NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.

SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.

Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, passed out and taken to hospital by ambulance . Began at around 10am. Felt like I was dying. Placed on Stroke Unit. Scans and tests all negative for stroke and Drs. thought could be panic attack or TIA. Since then my lingering effects point to TIA, Seemed to clear up around 2pm with gradual improvement through the day. Still experiencing some side effects including tinnitus, memory and word retrieval issues, fatigue, anxiety. DO NOT HAVE PANIC ATTACKS. The only time I have had a panic attack was at 26 after the death of my mother.

My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.

Patient reports she feels like she can't get out of bed. The lethargy started the evening of the vaccine and has continued through the day of report (4/17/2021)

headache, light headedness, nausea, muscle aches, joint aches, lymph node swelling, fatigue, swelling at the injection site. All symptoms lasted about 48hrs. The swelling and bump at the injection sited lasted 1 week.

Starting around midnight, my joints were extremely achy. I went to bed, but tossed and turned, even though I was very tired, but so sore. I got chills and fever, but didn't take my temperature. The next morning, took my temperature and it was 101. Ate a piece of coffee cake with some tea. Was very tired, so went back to bed. Was also a bit queasy, and not hungry for lunch, and had a mild headache. Slept most of the day, had chills and fever off and on, and joints very sore. I did eat dinner. The next day I was much better, but still had some soreness in my joints, one or two episodes of mild chills, was somewhat tired and lethargic. The next day I was more or less back to normal. I did take Tylenol at some point, but I can't remember if it was the afternoon of the first day of fever, or not until the next afternoon. I know I did take it again the next morning. All in all, it felt like a full-blown case of the flu, but was of short duration.

COUGH; SHAKES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cough. On 08-MAR-2021, the subject experienced shakes. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, shakes, fever, cough, and headache. This report was non-serious.

Tinnitus. Woke up with loud ringing in both ears, which has yet to subside. This has never happened to me in 61 years, so I'm very sure this is related to the shot. Prior to that, I had run a fever, and had my whole upper arm swollen and hot , which have both just started to subside.

TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HANDS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling numb in the hands. On 05-APR-2021, the subject experienced tired in the body. On 08-APR-2021, the subject experienced tingling and burning sensation in feet. On 08-APR-2021, the subject experienced weak in the body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired in the body, and feeling numb in the hands, and had not recovered from tingling and burning sensation in feet, and weak in the body. This report was non-serious.

Not sure exactly when water retention began, but exactly 2 weeks after vaccine 03-27-2021 during middle of night, I woke to a bloody nose. Got it stopped. Next day felt a bit off but okay. At 9 pm 3-28-2021 had a huge bloody nose, just came out of nowhere. Looked inside was coming from not the nose walls but from way up inside sinus cavity? Tried to get it stopped, nothing worked, and 2 times it came out my mouth. Called our local Emergency room, went in. Blood pressure was at one time 220/110. They gave me 2 sprays of Affrin to reduce blood vessels, and tried to insert a nose plug (cotton gauze) to stop it, wouldn't fit, too small of nasal passage. Administered 2 pills, then drugs through IV then another pill form over 4 hours later blood pressure was still high some numbers while there were 204/94, 188/93 then when released and bleeding stopped 188/86. Next day 3-26-2021 immediately after taking my regular meds bleeding started again!!! So tried to get appointment with my doctor, they were full advised me to go /back to ER. Went about 1:00pm my BP was 181/73 Dr ran tests: EKG normal, Blood tests, good, and chest e-x-ray good. She also tried 2 diff types of meds, oral and iv, then I asked for losartan. and left.

Chills, severe body aches, coughing, spitting up phlegm, feeling cold, couldn?t get in my inhalers, couldn?t breathe good, call my doctor office ( lung & disease) was advise to go the hospital, lasting 2 weeks, took back to back nebulizer treatments, cough medication.

Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once while eating lunch. Left ring finger went numb, white and cold, with bruise appearing on the middle digit. Other finger tips turned pink. Skin turned red onhands with tingling sentation. Right hand blood vessels came to the surface and began to swell at intersections. Skin on rt. hand looked whiter and dry. The sudden onset sent me to the emergency room, the condition began to fade in 3 hours, not completely. The same reaction occured the next day at 12 noon. I took a hot shower and the condition improved followed by extreme tiredness. *At the time of vaccination, & on both of these events I had a stiff neck/red skin.

DRY MOUTH; TINGLING IN HANDS; HEADACHE; NAUSEA; INCREASED FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroidectomy, and concurrent conditions included breast carcinoma, and teeth problems. 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 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dry mouth. On 17-MAR-2021, the subject experienced tingling in hands. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced increased fatigue. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) normal (units unspecified), and electrocardiogram (NR: not provided) normal (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tingling in hands, increased fatigue, and dry mouth. This report was non-serious.

"Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a little pain. Headache and dizziness. Vaccine given in the right arm."

LIGHT HEADEDNESS (HER HEAD DOES NOT FEEL CONNECTED TO HER BODY); LIGHT SENSITIVITY; FLU-LIKE SYMPTOMS; CHILLS; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 106 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A-21A, 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 flu-like symptoms. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced light sensitivity. On 12-APR-2021, the subject experienced light headedness (her head does not feel connected to her body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, headache, and nausea on 11-APR-2021, and light sensitivity on 13-APR-2021, and was recovering from tiredness, and light headedness (her head does not feel connected to her body). This report was non-serious.

No immediate side effects except for a slightly sore arm. Extreme fatigue began 4 days from date of injection and lasted to day 16. Dizziness and nausea began about 10 days from date of injection but were intermittent. Nausea and dizziness finally resolved around day 16. No lasting side effects to-date.

LEFT GROIN PAIN RADIATING TO THE LEFT LEG/ HARD TO WALK; MUSCLE ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol hydrochloride. On 10-APR-2021, the subject experienced left groin pain radiating to the left leg/ hard to walk. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, nausea, and fatigue on 11-APR-2021, and had not recovered from left groin pain radiating to the left leg/ hard to walk. 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.

Horrible body aches, headache and chills for 12 hours. The following day I had horrible and painful shingles outbreak.

HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report received from a consumer concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 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 ringing in ears. On 08-APR-2021, the subject experienced shaking in arm. On 08-APR-2021, the subject experienced pain in both legs. On 08-APR-2021, the subject experienced tired. On 09-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 ringing in ears, headache, shaking in arm, and tired, and the outcome of pain in both legs was not reported. This report was non-serious.

I have severe dizziness when I am laying down/sleeping. Each time I wake up 1-2 times per night) my head is spinning. When I am awake and standing I don't have the spinning, but I do have a faint headache/fog and with that, nausea.

Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ended 4/11/2021 approx 1600; Nausea started 4/11/2021 approx 10:30 ended 4/11/2021 1600; Malaise started 4/11/2021 approx 10:30 ended 4/11/2021 ended 1600 sips of water throughout day and nibbled on saltines; photosensitivity (lights brighter than usual) started 4/11/2021 approx 10:30 ending 4/11/2021 1630; Bilateral eye pain started 4/11/2021 10:30 ending 4/11/2021 16:30 pain scale 7 (0 no pain, 10 extreme pain); Hot flashes started 4/11/2021 0800 ending 4/20/2021 0800

24 hours after vaccine - fever, chills, and aches. Currently (4/21/21) having chest pains. Doctor appointment this afternoon. He suggested I fill out the adverse reaction page.

DIARRHEA; VOMITING; BODY ACHES; CHILLS; TIREDNESS; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and non-smoker. 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 APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, tiredness, and headache on 10-APR-2021, was recovering from vomiting, and diarrhea, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424370.

BLURRED VISION FOR THREE DAYS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 193 pounds, and height was 64 inches. The patient's concurrent conditions included seizure disorder, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced blurred vision for three days. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision for three days on APR-2021, and headache, and tiredness on 12-APR-2021. This report was non-serious.

FLU-LIKE S/S THE NIGHT OF THE VACCINE FOLLOWED BY HA ON DAY 2 AND NOSE BLEED & CHEST DISCOMFORT ON DAY 3. THE PT REPORTS THAT THE CHEST DISCOMFORT LASTED X 1 DAY, BUT THE NOSE BLEED PERSISTED. 12 DAYS POST VACCINATION THE PT WAS SEEN AS PART OF HER ANNUAL HEALTH ASSESSMENT AND STILL C/O MILD HA FOR WHICH SHE REPORTS TAKING APAP.

DIZZINESS; HEADACHE ON LEFT SIDE OF FACE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced headache on left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and headache on left side of face. This report was non-serious.

HEADACHE; NOSE BLEEDS; This spontaneous report received from a patient concerned a 61 year old female. 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 had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine besilate/olmesartan medoxomil for high blood pressure, and hydralazine for high blood pressure. On 02-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nose bleeds and headache was not reported. This report was non-serious.

INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE NEXT TO IT; COULD HARDLY SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.

Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.

Cough began on 3/17/21 and lasted a month; chills and fever began 3/18 (102.5 on 3/23/21) and lasted 2 weeks. Took Ibuprofen from 3/18/21 thru 2nd week of April because feeling of chills/fever would occur when I stopped taking it.

After I left after waiting I felt find. I went to work and about hour or two I took a tylenol 800 in case my arm got sore. But I was so sleepy my eyes felt like sand was in it. I had to call my daughter so I could stay awake. I was extremely tire. The next day I was not as sleepy but I was very tire. It just started getting better. I not as tired no more. But I didn't know how to report it until I seen on news and my sister told me how to report it.

LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.

TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc, and concurrent conditions included osteoarthritis, non alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ceclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 19:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced achiness down left leg. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 12-MAR-2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achiness down left leg, nausea, and fever on 11-MAR-2021, and had not recovered from tinnitus, headache, and insomnia. 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.

LOSS OF APPETITE; MALAISE; CHILLS; TIRED; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, penicillin allergy, alcohol use, and nonsmoker, and other pre-existing medical conditions included patients was not pregnant at the time of reporting. patient had no history of illicit drug use or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNWON) dose was not reported, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included metoprolol for hypertension. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced loss of appetite. On 11-MAR-2021, the subject experienced malaise. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 16-MAR-2021, malaise, chills, nausea, fever, and headache on 12-MAR-2021, and tired on 15-MAR-2021. This report was non-serious.

CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have 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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.

CHEST PAIN IN THE MIDDLE OF CHEST; FELT TERRIBLE; ACHES ALL OVER; EXTREMELY TIRED; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 63 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt terrible. On 11-MAR-2021, the subject experienced aches all over. On 11-MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced terrible headache. On 12-MAR-2021, the subject experienced chest pain in the middle of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 12-MAR-2021, was recovering from extremely tired, and felt terrible, had not recovered from chest pain in the middle of chest, and the outcome of aches all over was not reported. This report was non-serious.

SWEATING; CHILLS; FEVER; HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sweating. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on MAR-2021, and had not recovered from headache, and soreness at injection site. This report was non-serious.

Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches. Felt like every bone in my body was broken (4 days)

My knee was swollen, body ache and fatigue for 3 day couldn't go to work. Since I heard the vaccination was stopped on 4/12 I was concerned. I went to doctor was advised to take Tylenol.

CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 150 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. 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 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced chest pain, right arm pain, headache and was hospitalized (date unspecified). She was en route to MRI and had to hang up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, chest pain, and headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210427406-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). 20210427406-covid-19 vaccine ad26.cov2.s-Right arm pain, headache. This event(s) is labeled per Agency and is therefore considered potentially related.

Fever and headache for several days. Day of vaccine I started with a funny taste in my mouth. I still have it almost 3 weeks later. I continue to taste it with whatever I eat.. This same taste/odor can be smelled when I have a bowel movement. The smell is so awful! That is why I am reporting this.

Pt called the call center. Reporting cold like symptoms"coughing, body aches, chills, both arms hurting, fatigue" after J&J covid vaccine 4/9/2021. Pt is taking ginger tea for symptoms but no medication. Pt denies emergency s/sx. Urgent Care appt made but pt no showed on4/21/21. New appt scheduled for 4/23/21. COVID test negative on 4/23/21.

J&J on 4/12/2021- other details unknown Fatigue, significant, prevents daily activity Headache, Arthralgia

1325- Patient received Janssen vaccine dose at drive through clinic. 1335- Patient?s son reports his mother is not feeling well. Patient able to respond appropriately to questions asked, however her responses were delayed. Patient presented with a blank stare and slow movements. BP 100/80, P 42, 99% RA, R16. EMS requested through 911. Patient denied CP, SOB, HA, N/V. Lungs CTA with respirations easy, unlabored. Radial pulses thready bilaterally. Water given to patient, air conditioning turned on in vehicle. 1339- BP 130/90, P 74, 96%, R18. Patient alert and oriented x3, responding appropriately. EMS arrived, patient verbalized she was feeling better and refused EMS assessment. Patient left in own car accompanied by her son who was driving the vehicle.

UNBEARABLE HEAD POUNDING; NAUSEA; VOMITING; LOW FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: unknown) dose was not reported, administered on 23-MAR-2021 14:37:00 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced low fever. 100 F. On 02-APR-2021, the patient woke up at 3am with unbearable head pounding for which the patient took 2 acetaminophen even after 15 min there was no relief so she took small amount of codeine around (1/3 of a 15mg tab) after 5-10 min the patient threw both meds and experienced nausea for which she took anti-nausea tab under her tongue but that did not released her nausea. The Patient could not take her medication due to nausea and vomiting. At 10:30 am one of her family member took her to Hospital in and performed CT (computerized tomography) scan and PET (positron emission tomography) scan which are normal The Patient was hospitalized for 5 hours and received IV of a steroid (unspecified), Benadryl, anti-nausea (unspecified) and (unspecified) pain medication as a treatment CT scan and PET scan was normal based on which Doctor concluded that the side effects are due to J and J vaccine. Treatment medications included: codeine, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable head pounding, nausea, and vomiting on 02-APR-2021, fatigue on 26-MAR-2021, and low fever on 27-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210452159-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related. 20210452159-COVID-19 VACCINE AD26.COV2.S-vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS

9 hours later began feeling a general "ick" like when coming down with something, then moderate headache and body aches, especially my back. This lasted less than 2 days. Other things, mostly starting 5 or 6 days later and some cropping up as late as 4/11. Random itchy red rashes on each shoulder and back of upper arm that would go away within an hour or 2. Itching and possibly bumps on buttocks and thighs. Intensely itching palms for a little while on 2 or 3 different days. Sudden appearance of a 4 x 4 inch patch of 15-20 bumps of various sizes in the crook of my left elbow (injection arm) with bright red skin. These looked similar to mosquito bites or blisters but didn't itch. It completely disappeared without a trace within an hour. Tingling tongue followed by tongue swelling on 4/6/21. I had eaten my bran flakes with some rice pudding a little bit before this, both of which I'd eaten every day for the past week or so and had had several times in the past. On the advice of my doctor's nurse, my husband drove me to an urgent care center. By the time we got there, probably 1.5 hours after this started, the swelling was some better. The nurse practitioner that I saw prescribed an antihistamine and 3 days of one 20 mg prednisone pill a day. I've never had a tingling or swelling tongue before in my life. I took only a half of one prednisone on 4/6, no Allegra. On 4/7 the random itchy red rashes mostly on arms/shoulders happened once or twice and disappeared fairly quickly, but my upper lip swelled. I could feel it happening as I sat in my recliner in the morning. I hadn't had anything to eat yet. The doctor advised I take my Allegra and prednisone I received at urgent care on 4/6, so I did. The lip swelling gradually went down over a few days, but it still feels irritated on the inside of the lip as of 4/11. Diarrhea beginning around 1:30 a.m. 4/8. Lasted about 3 days. I only very very rarely have diarrhea. Mild sore throat starting Friday 4/10. Better by Saturday. Sore throats are so rare for me that I can't remember the last one, possibly several years ago.

3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye. 03/19/21 -03/20/21, extreme fatigue, stayed in bed. 03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.

That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.

Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a bad headache. In the middle of the night my headache kept getting worse, my eyes started to hurt really bad and I also broke out in hives. About 6 hours later my headache felt like it wanted to explode. I saw a doctor through Tele-health by who prescribed a 6pk of steroids. Then on Day 6, my headaches came back along with the hives and I felt really tired and the hives broke out all over my body including my crotch and ear canal. He prescribed a 6pk of steroids and I started to feel and get better. On Day9, all of my symptoms were resolved except for the fatigue. To this day I still continue to have fatigue.

I have daily headaches since 04/12/2021. Wednesday evening 04/12 I was working and felt a vice like grip on my head. I had acute leg pains in my sleep that evening but not since then. Every day since then I have a headache. It feels like swelling in my brain (and heat) and I'm very upset and unhappy about it. I am a very healthy with no health problems. I don't go to doctor or even have a doctor (except a gyn). The headaches have not subsided and are causing me quite a bit of stress.

Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe chills fever nausea weakness and tiredness. Was unable to perform daily to asks the whole next day.

HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-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. This report was non-serious.

3/20/2021 @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fifteen minutes later I walked out, driving down road with friend and I said 'something is wrong'; really bad 'metal taste' in mouth, blurred vision, grabbed her arm and said I am going to throw up, I was so dizzy and I said I can't think. My face was drooping, I couldn't say my A,B,C's, and by the time I got to the ER they got me on an IV. I couldn't talk, think, and had the metal taste for a few hours. The dr. said we are going to give you fluids, my BP was elevated for 6 hours 198/130, no clots. BP went down to 178/98, taste started to go down, I was drinking fluids, I was able to talk a little bit. I felt like in a 'bubble', I couldn't think. When I was discharged I had no temp, my BP was normal. *my body reacted to the vaccination. *6 hours my body reacted *body had felt like I was recovering from the flu for 2 weeks *Never ran a temperature

That day when I woke up, I had a headache, my eyes felt hot, I was 99.3 temp, had diarrhea , lessoned Sunday and Monday and then on Tuesday , I had diarrhea and a headache again, I called my doctor and tele-med visit. Two weeks after that, the inside of my mouth felt irritated, faded away after four days and then it came back. I contacted my allergist, they ran test. She did not have an allergy to anything she has eaten. Then my tongue was raw.

PRESENCE IN LEFT LEG; BACK TENSION; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced fatigue. On 12-MAY-2021, the subject experienced back tension. On 18-MAY-2021, the subject experienced presence in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back tension, and fatigue, and had not recovered from presence in left leg. This report was non-serious.

Fever 102.2 lasting about 18 hours; Severe headache lasting about 24 hours; Nausea with vomiting lasting about 10 hours; Ringing in ears still occurring; Tiredness lasting 24 hours

Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breath and chest pain.

Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.

ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. 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).

SORE THROAT MORE ON THE LEFT SIDE OF THROAT; This spontaneous report received from a patient concerned a 61 year old female. 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, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced sore throat more on the left side of throat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from sore throat more on the left side of throat. This report was non-serious.

VERTIGO; RUNNY NOSE; FEELING SICK; This spontaneous report received from a patient concerned a 61 year old not Hispanic or Latino, African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, cholesterol, depression, and non smoker, and 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: 1805025, expiry: unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included blood pressure pill, cholesterol pill and anti-depressant. One week after vaccination, on 07-APR-2021, the patient was feeling sick and dizzy. She said that the ambulance picked her up that day she felt really dizzy and took her to the hospital. There they performed tests on her and kept her overnight. Doctor of Medicine (MD) diagnosed her with vertigo and told her to take some over the counter medications for it. She reported that her runny nose and sick feeling went away after about a day. One to two weeks after that emergency room (ER) visit, she again went to the ER. This occurred at around 1-2:30 AM she went to the ER and MD said she had vertigo but she just stayed until the morning. MD prescribed her medicine for the vertigo, but the vertigo had not gone away. The MD there, did tests for blood clots but did not find anything but told her to take Aspirin (acetylsalicylic acid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and feeling sick on 08-APR-2021, and had not recovered from vertigo. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210544583-covid-19 vaccine ad26.cov2-Vertigo, Runny nose. 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). V0:20210544583-covid-19 vaccine ad26.cov2-Feeling sick. This event(s) is labeled per RSI and is therefore considered potentially related.

With in 10 minutes of the injection my thoart closed, my lips swelled and I was having trouble breathing. Benaydyl was given and an Epipen was used, I was taken by ambulance to the local hospital ER where an IV was started, steroid was injected. I was kept several hours for observation and sent home. The following day I had attacks of itching and rashes as well as occasional numbness in my lips, by Thursday evening it was worse, returned to a different hospitals ER at 2am Friday morning, more steroid was given and I was observed, and sent home with an prescription for an epipen as well as steroids. Continued to take Benadryl often taking two with in a half hour, Monday May 24 went to my own docotor, as I had a new reaction of pressure in both ears with pressure in my cheeks and around the back of my head. She give me a prescription for additional steroids and is still monitoring me as I am still reacting.

Sore arm immediately. Headache, body aches and chills started within 3 hours. This lasted for 2 days. I had an off and on headache for a couple more days.

When I got home, I had a headache. I felt tired. I took a nap. When I woke up, I was sick. I was nauseated, my stomach and body hurt all over. The headache was three days long. I felt achy and sore the next day as well. I felt like I had a flu. There were huge blood clot looking blisters, and red dots on both my arms. My left arm was worse than my right arm. I called the doctor and she asked me to come in, but I had to take pictures first of my arms before coming in. Then when I was able to go to the office, I took blood tests and the MRI. Everything came back okay.

PLATELET COUNT INCREASED; EXCRUCIATING HEADACHE; INTRAOCULAR PRESSURE DECREASED; ANGIOGRAM NORMAL; ARTERIOGRAM CAROTID NORMAL; THROMBOCYTOPENIA; ARTERY BURST BEHIND HER EYE; OCULAR DISCOMFORT; PERIORBITAL SWELLING; EYE PAIN; ACHES AND PAINS; This spontaneous report received from a patient concerned a 61 year old female, ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included hypertension, hypothyroidism, and intermittent pancytopenia, and concurrent conditions included metronidazole allergy, hashimoto's disease, and microscopic colitis. The patient was previously treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, levothyroxine, losartan, rosuvastatin calcium, and ubidecarenone. On 09-Mar-2021, the patient got the vaccine and after few days she had aches and pains (very mild reaction) and went to bed early. The patient thought she was fine. On 18-Mar-2021, 04:00, she woke up with an excruciating headache above her left eye in her eyebrow. The patient wondered if it was an aneurysm and took 2 tablets of extra strength Tylenol and it helped. The patient stated that after every 5-6 hours, excruciating headache came back. The patient had the same headache for over a week. The patient got tested for Covid-19 and it was negative. The patient thought she had sinus problems but had no other symptoms. On 30-Mar-2021, the patient woke up with headache. Her eye was killing her, was sore and swollen, and felt like it was going to burst and her left eye was swollen shut in a couple of hours. The patient narrated it was excruciatingly painful. The patient's husband drove her to urgent care, where ophthalmology tested the pressure: right eye was normal (she thinks it was 18- normal) and the left eye was 51 (normal is 14-19), units unspecified (intraocular pressure decreased). The eye doctor started prednisone and the patient had a CT scan and lab work done. MRI was also ordered but they were unable to do it right away. On unspecified date in Dec/2020 the platelets were 349 in December and came down to 64, which was very low (low threshold was 150) (thrombocytopenia). The CT scan was performed, they thought she had a cavernous carotid fistula and she was scheduled for an angiogram for a further diagnosis on 01-Apr-2021. The angiogram determined she did not have fistula. The patient was admitted to the hospital after the angiogram and on 02-April-2021, MRI was done. All throughout the process, the ophthalmologist, radiologist and internist all thought it was related to the Janssen COVID-19 vaccine. The prednisone started working and the pressure started dropping in her eye. The patient states that doctors think an artery burst behind her eye. After discharge, the patient was taking prednisone which was helping. On the 13th, she was watching television and saw that the vaccine was being put on hold due to the women with clots whose progression matched hers exactly (severe headaches, low platelets, and required attention). She was on prednisone for a month. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative, CT scan (NR: not provided) Not reported, and Platelet count (NR: not provided) 64 (units unspecified). Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombocytopenia, intraocular pressure decreased, ocular discomfort, periorbital swelling, and eye pain, excruciating headache on 02-APR-2021, and aches and pains on 12-MAR-2021, and the outcome of artery burst behind her eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability or Permanent Damage). Additional information was received on 25-MAY-2021 following information was updated and incorporated into case narrative: Other identification number, patient contact details, events- Aches and pains, artery burst behind her eyes, excruciating headache, Tylenol drug was added, hospital details was added and narrative was updated accordingly.; Sender's Comments: V1: Additional information updated identification number,hospital details,events- Aches and pains, artery burst behind her eyes, excruciating headache,This updated information does not change the causality of previously reported events. 20210502268-COVID-19 VACCINE AD26.COV2.S-Artery burst behind her eye. Follow-up received regarding Clinical Details. 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 20210502268-COVID-19 VACCINE AD26.COV2.S-Excruciating headache. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related. 20210502268-covid-19 vaccine ad26.cov2.s-Thrombocytopenia, Intraocular pressure decreased, Ocular discomfort, Periorbital swelling, Platelet count increased, Eye pain, Angiogram normal, Arteriogram carotid normal. 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

Headache and dizziness started that day. Headaches got increasingly worse during the first week along with dizziness and loss of balance. Mid second week, headaches went from moderate to very severe. The nausea and back and forth between diarrhea and constipation began. Horrible headaches. PCP put me on zolfram 1 pill 1x a day. That did not help. I was then put on zolfram 2x a day. I was also put on pepcid AC 2x a day. I also stayed on tramadol for pain. It seemed to help. It delayed my nucala. At the end of week 3, I went in for my Nucala for my asthma. Within hours of receiving that shot, the side effects came back. With the medication, I was beginning to feel better but the Nucala shot brought them all rushing back. Week 4 was even more miserable. I was put on 10mg dextramethazone. My last dose was yesterday morning and today I woke up dizzy again with a massive headache and a sour stomach. I am still taking pepcid AC. My dr. office is working on a plan.

Patient presented to PCP on 05/18/2021 office from group home with C/O cough, runny nose, lethargic, fever, lungs rattling, uncontrollable shaking. Patient had a seizure the night before and had been having weak spells and coughing and fever since that time. Patient admitted to hospital on 05/18/2021 and chest Xray showed pneumonia. Patient tested for COVID-19 on 05/21/2021 after learning of potential exposure at group home and result was positive.

I started getting symptoms of UTI - I was treated with an antibiotic starting on 4/28/2021 - for five days. And then a few days later, it came back after I finished the antibiotic. I started on another antibiotic on May 8th. That took care of it. But after I finished with it, on May 19th, I had a fever that continued until May 24th. A urinalysis showed it wasn't UTI. No treatment.

5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.

I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills and the really bad nausea, that I had to sleep on the bathroom. The next day, I barely made it to the bed. I am very weak, still having a headache, body aches and feeling fatigue. The ringing in my ear has gotten worst than it was before.

Bleeding from belly button - extreme headache within an hour of the shot - very sore and tired - felt like an extreme hangover headache while still drunk - my balance was gone - could barely walk for two days.

Fever, cold, sinus infection, congestion, strep throat, tonsillitis ear infection and I haven?t been sick even a cold in10 years.

Janssen COVID-19 Vaccine 13 days after receiving her Covid vaccine, the patient stated ?I have been experiencing bad headaches that makes the right side of my face numb and/or painful to the touch. Although I have had headaches in the past, these feel different.? Patient stated that she started noticing these headaches late in the week that followed that administration of the vaccine (beginning on or around 6/4/21) Patient also stated that she began developing stomach aches approximately one week following the vaccine administration (beginning on or around 6/6/21)

Running nose and sore throat. Today is Monday June 14, 2021 still have runny nose and sore throat, no chills. Had chills in the beginning with runny nose and sore throat.

Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain, strong pain left leg left side of thigh. Felt like a bus hit my left side. Severe fatigue. Congestion.

Non-stop dry cough since day after vaccine, persistent headache since day after vaccine, vomiting 3 times on day after vaccine only.

Sore throat, tingling on left top of scalp (usual site). Presented as another flare-up of Shingles, but Zoster sine herpete (ZSH). Two days later, I visited my PA, and she immediately started me on Valtrex (1g/3x daily) and gabapentin.

BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.

the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and had slightly labored breathing. Patient also said she was diabetic and was given apple juice. Vitals- TIME: 4:37 HR: 116 RESP: 14 BP:168/100 SP02: 94%

When I first had the shot, I got very sick afterward with a fever and sore throat, although I was expecting that. However, it's possible that the vaccine has damaged my immune system because I suffered the effects of lactose intolerance yesterday (digestive problems), but, totally unlike other times that I had such response to lactose, I also had a fever and a bit of sore throat, which has nothing to do with lactose intolerance. Is the vaccine causing a reaction to lactose as though it is an invader? Please contact me right away. I am quite sick.

Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , muscle cramp at injection site resolved slowly over 3 weeks

Within an hour headache ,stomach ache, cough, exhaustion . After 10 days went in for Covid test per Dr.s orders. Came back neg. But had small bruise on arm below injection site that night. All symptoms resolved with in 2 weeks except bruising. Keep getting small bruises on arms and legs. Most are only about the size of a pea but now have one on forearm size of half dollar with 2 smaller ones just below it.

25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and fatigue, some confusion; migraine developed overnight. 26 June, 7 am: Out of bed, short walk, general myalgia, fatigue, migraine, had to lie down. 8:30 am: Slightly longer walk, felt slightly better, able to eat small amount after this. 9:30: Felt nauseated, migraine, fatigue, and myalgia worse. Noon: Brief walk outside, lay back down due to nausea, fatigue, myalgia. 2:30 pm: Nausea a bit better, ate apple, lay back down due to symptoms above. 5 pm: Migraine and nausea slightly better, fatigue and myalgia persist. 6:30 pm: Ate plain lettuce, extreme nausea, and tinnitus; vomited entire quantity; nausea improved. Remained prone rest of evening. 7:30 pm: Mild nausea persists, migraine improving, may be slight decrease in myalgia. 9 pm: To bed, slept well, definite improvement through night, some myalgia persists and occasional tinnitus. Able to drink water throughout.

Abdominal pain/cramping/diarrhea 2-3 days Some joint achiness off & on for several weeks. Severe right groin pain around May 12. Saw PCP. Xray showed chondrocalcinosis which I've never had before. Aleve, Volteran. Still achy but not severe. Muscle weakness, fatigue, double vision waxed & waned for several weeks & then just got worse. Saw neurologist May 21. (Doing so well I hadn't seen him for 3 years) Blood tests & brain MRI. Only abnormal was a seropositive AchR which I've always been seronegative. Doubled MTX & wants to do IVIg but insurance is denying at this time.

Woke up with a sore throat and cough. Lots of mucous and congestion. Fatigue as well. Sore throat was only for about three days. I still have the cough and the mucous. I went to ER a week ago today. I have been using my albuterol inhaler (I have not had to use that inhaler in months); and received steroids for cough - (Prednisone) and a Z Pac and Tussin Pearls for the cough. I am finally starting to feel a little better. I have a follow up doctor visit tomorrow.

Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of injection. Skin itched all over, but no rash, no other symptoms. Took usual aspirin & Tylenol before bed. Also began probiotics and elderberry/zinc/C supplements recommended in Covid handout. That night: Slept on other arm, when rolled over in early AM, hurt to press on shot arm. Day 2: Woke up hay feverish - sinuses completely blocked but could breathe through mouth, so airway OK. Moderate headache, all over muscle aches. Took usual aspirin & Tylenol. Skin still itches all over. Took a Zyrtec. Sinuses cleared, muscles and head aches went from moderate to mild, skin itch also from moderate to mild. Took usual aspirin & Tylenol before bed. Day 3: Woke up with sinuses partially blocked and sneezing. Mild headache and muscle aches. Took usual aspirin & Tylenol, and when sinuses wouldn't clear on sitting up and blowing and kept sneezing, took another Zyrtec. Day 4: Sinuses draining so I'm going to try to do without Zyrtec. Body still very achy so taking usual aspirin & Tylenol. Day 5 and beyond: Symptoms gradually subsided without further Zyrtec. Higher than normal tiredness persisted longer than aches and hay fever symptoms. Overall, much milder reaction than I had to a flu vaccine many years earlier, so I'm pleased, but felt VAERS should have complete information.

Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. I could taste the vaccine. Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen. By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021. My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021.. on 07/02/2021 I had chills until approximately 5:30 pm. I carry Epi-pens should I need to self administer.

At 1615 client informed EMT she "felt dizzy and her blood pressure was high". PHN arrived at 1618, client sitting upright in chair, alert and oriented x4. Per client has history of hypertension and pre-diabetes. Current medication Losartan and client stated she took medication this morning. Allergies to flu vaccine and cats. Vitals at 1818 by EMT: blood pressure 220/110, pulse 71, oxygen sat 99%. Client denies chest pain, shortness of breath, blurry vision, headache, or nausea. PHN retook blood pressure at 1824: 180/90. Per client feeling palpitations. Dizziness same, denies chest pain or shortness of breath. Vitals at 1826: blood pressure 180/90, pulse 71. Per client palpitations same. RN called 911 at 1830. At 1833 client stated new onset of "feeling sleepy" and "eye heaviness". PHN continued to speak with client, client alert and oriented x4. PHN advised to follow up with provider. Fire Dept and Paramedics arrived at 1839 and assumed care. Client transported to Hospital at 1845.

I went to bed feeling fine but experienced chills, achy joints and headache until the next afternoon. That was fine, expected that. On about the 4 or 5th day. I thought I had full blown Covid. Had all the symptoms. As this progressed my fatigue was overwhelming. I lost my appetite, had a bad headache, joints and muscles ached, etc. No fever at this time though and breathing was ok. Texted Dr. and was told it was my immune system overreacting and he prescribed oral steroid to calm it down. My fatigue lasted for a good 3 weeks. This was as sick as I have ever been.

On 15th of June I began throwing up, couldn't keep food down, major cramping in my stomach, wouldn't go away, chills that lasted until 6/24, I took peptol bispol, tums, ginger, but still cramped and threw up, couldn't eat, slept a lot because of pain. I did stop taking the metrondasel antibotic given for my swallon jawl, kept taking Pennicillin because I'm not allergic. I was very weak, on vacation when this started, couldn't be out in the side much at all, felt like I was going to pass out. Later in week begin having tingling in my feet like they were going to sleep and in my upper legs/hips. I do have stents in my legs that are doing well, so it kind of worried me that they were tingling. On 24th of June, went to my doctor, she gave me Hyoscyamine for pain/discomfort in my stomach and back, also PureGG 25B for probiotic. It's been working ok, but still having stomach episodes of pain and goes to my back like sharp object. Also I've never had heartburn until this sickness, have to have tums and something for pain every once in a while, should've been over all of this by now, but have called the new doctor because I'm not sure what's going on. I'm not a sickly person.

SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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).

Patient said that she is experiencing extreme fatigue and chronic pain in her hip back neck. she can hardly walk. She stated that she falls asleep any where. She has a strange feeling in her chest. She is experiencing breathing complications. She has a hard time drinking water without choking. She stated that she has a high tolerance for pain, but this pain is unboreable. She stated that she was taking walks and now she can barely walk to her car without loosing her breathe.

Immediate strong pain from injection that dissipated after 10-15 minutes; next morning low grade fever and moderate headache and moderate muscle/joint/body aches. Most symptoms dissipated after 3-4 hours after taking Advil.

I sat in a chair for 15 minutes after getting my vaccine. One minute after sitting down, I had a headache, and I never get headaches. The headache got worse and worse. I had lunch, and I still had the headache afterwards. I then went home, and the headache got even worse. At about 2 AM, I got out of bed and tapped my head in the hope that it would help the headache and it didn't. I then started to get a fever. The following morning, I had a full-blown fever, and I still had a horrific headache. I ended up having the headache for a whole week. With my fever, the temperature was 102; I didn't take anything, because I thought it would run its course and allow my body to get used to the vaccine. I eventually took two acetaminophen tablets, and it only reduced the temperature by one degree. I then took Advil, which also reduced it by one degree. The day after that, I had hives all over from the knees up, even in my crotch, eyes, and ears! I called a doctor, who prescribed me heavy-duty steroids. I was on steroids for 6 days . On the 4th day, I began to show signs of improvement. On the 9th day, the hives started to clear up, the headache began to subside, and the fever was gone. I had terrible fatigue for a while afterwards. Now, I'm trouble breathing. I always feel winded whenever I do any activity. Before the vaccine, I was very high-energy and had no trouble with fatigue or windedness.

Numbness in fingers and toes - tingling sensation - wrist - hand- finger- feet & toes. Weird headache especially when I sleep.

2 Straight Days Headaches 7/20/21-7/21/21 I Don?t Get Headaches 7/22/21 cramps in stomach light blood through 7/23/21 heavy dark blood with light clotting. 7/25/21-7/26/21 large blood clots until 7/28/21. 0n 7/28/21 called Primary Physician for a Consultation it?s scheduled for Friday. I have enormous swelling in my Right leg in rear upper thigh. I have decided to go to Emergency Room. I have a slight headache and after Blood completely stop I am now seeing very light blood. I?m 61 I had stop having periods at 58!started back when I first took John & Johnson shot. I reported here before.

8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night.

Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at least 12 hours

Minor chills 36 hours after shot with sever chills 6-8 pm evening of shot. Fatigue and joint aches 36 hours after shot. Slept much more then normal 12-36 hours after shot.

I couldn't sleep, I was very tired but I couldn't sleep. My head was throbbing , felt like it would burst. My blood pressure went up to 170/93. Ached all over rest of body.

Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.

Janssen COVID-19 Vaccine EUA - chills, extremely tired, low grade fever started about 12 hours after injection (only at night)- reporting this 42hrs later - Advil helped with fever and sleep helped with tiredness

8 hours after vaccination I got headache, fever (101), fatigue and body aches. Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired.

While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.

Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.

This was a Johnson & Johnson vaccine. No option was given on the website for this. Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95°. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated.

Headache, chills, nausea, body aches starting about 7 hours after the vaccination. The side effects lasted about 36 hours and improved with ibuprofen.

Mild Headache -15 mins. after injection Nausea- evening 3/9/21 Tummy ache- 3/10/21 @11 am Low grade fever-3/10/21 @ 5 pm Chills-3/10/21

Whole body pain; sweaty, feverish feeling but never registered a fever when checked. Extreme fatigue and brain fog, headache

Mild headache, mild muscle aches, light headedness. Regular aspirin taken about 11 hrs after onset were effective for the aches. Mild light headedness continued for about 12 more hrs.

First day had major chills, then fever and headache. After two days those symptoms subsided and 72 hours later feeling fatigued and tired.

The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so. I really thought I was going to pass out. A woman with a tag that said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better. The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home. They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore. Could the shot have hit a nerve? I?ve never felt such acute pain.

PT HAS BEEN ON DPXT FOR ABOUT 4 YEARS FOR ECZEMA & HAS CONTROLLED HER SX WELL. SHE RECEIVED J&J COVID VACCINE ON SATURDAY & HAD DOSE OF DPXT ON SUNDAY & IS HAVING BREAKTHRU IN ECZEMA SX NOW. PT STATES AFTER GETTING J&J VACCINE ON SATURDAY, SHE HAD NO FEVER, FELT LITTLE TIRED IN AFTERNOON, MAYBE SOME CHILLS (BUT WEATHER WAS COLD), & NOTHING ELSE TO NOTE OF. SUNDAY WAS HER DPXT DOSE. SHE TOOK IT IN THE AM & ABOUT 5 HOURS LATER SHE STARTED TO HAVE BREAKTHRU IN SX. HER MOST SEVERE TROUBLE SPOTS PRE-DPXT TX WAS AROUND HER EYES, CHEEKS, FACE AREA. SHE STARTED TO FEEL INFLAMMATION AROUND EYES & UPPER CHEEEKS ON SUNDAY. THIS MORNING THE SX FELT VERY STRONG BUT SEEM TO BE DIMINISHING SOMEWHAT THROUGHOUT THE DAY. SHE IS HOPING THAT IT WILL CONTINUE TO IMPROVE & RESOLVE TOMORROW. SHE CAN FEEL THE INFLAMMATION UNDER THE SKIN - NO VISUAL SX YET. SHE FEELS LIKE THE COVID VACCINE SOMEHOW BLOCKED THE EFFECTS OF HER DPXT. PT HAS NEVER HAD THESE SX DURING HER TX OF DPXT. THE DPXT HAS CONTROLLED ALL HER SX WELL THROUGH THE PAST FEW YEARS. SHE WANTED TO INFORM US SO THAT WE CAN COLLECT DATA. ADV PT THAT IF SX DO NOT RESOLVE OR IF THEY GET WORSE, CONTACT MD FOR ADV. PT AGREED.

Janssen Covid 19 Vaccine EAU - 3/14/21 -Headache, Fever (99.2) , joint aches, Took Ibuprofen X 400mg at 9AM. Had headache and felt tired and achy all day. At about 6:30PM took Ibuprofen 400mg, Awoke morning 3/15 with slight headache but nothing requiring medication. Feel that reaction is 99% resolved

Upper body achy ness & headache. Symptoms started around 5:00 PM & subsided overnight & by following morning headache diminished. Sore upper arm the following Thursday evening,

3p received infection. 8:15 severe chills, vomiting until 2am. From 2am through the next day fever ( 100c) with it breaking through the night. Mild flu the next day with general Malaise. The chills were so intense that I was constricted for much of the time with little relieve. I would call them violent chills with a tetany kind of full body involvement. Never have I experienced chills like I have described. I?ve never had a reaction to vaccines and tend have a high tolerance. I did not contact my physician but spoke to colleagues who suggested report the experience.

I started running a fever and aching very bad Saturday morning. By Saturday afternoon my fever was up to 103.5. I did not want to go to the hospital, but I came very close to calling. I decided to try ice packs on my forehead, neck and chest. I have never had a fever this high, or ached this bad. I don't know how long it took for my fever to come down, but finally came down to 102.5, where it stayed throughout the rest of the day and into Sunday. I continued to use the ice packs throughout Sunday. I drank a lot of water and took Tylenol for fever and pain. I had a fever for three days. Today, Tuesday, 3/17/2021, I am very light headed. I was diagnosed with covid-19 on Dec 29th 2020.

1st day: chills, pale skin, vomiting, loose stool, body aches,, fatigue; 2nd day fatigue, fever not exceeding 100.3, body aches. 3rd day: fatigue. 4th day felt 100% back to normal.

Body aches, fever 100.8, chills, loss of appetite, lasted about 24 hrs only. Nausea lasted about 1 hr Sore swollen arm at injection site sore for 6 days. They side affects put me to bed for the 24 hrs...slept through it.

My wife got the J&J shot last Wednesday and had the typical sore arm and a little fatigue. On the following Saturday she had a very severe episode of anger at the members of our household and wanted to leave our marriage, sell the house, and said she could not live like this anymore. She slammed doors, yelled and screamed, insulted everyone around her, and would not listen to reason. 3 days later she is calming down somewhat but still has a lot of anger. I have lived with the woman for over 30 years and have never seen anything like this before. She does have her moments and has had mood swings in the past but this episode was exceptional. I think she will be OK in a few more days but I wanted to report this to possibly prevent something similar from happening to others. It is possible this episode was unrelated to the vaccine. It is also possible this is related to her heavy use of Neurontin with Prozac. Let me know if you have questions.

Flu-like symptoms lasting 3+ days, including lethargy, body aches, light sensitivity/headache, nausea, chest pain

A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vitals were checked, I was given water and moved to a cooler area of the facility. HR was still elevated but I wasnt feeling as flushed. By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs. Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack. By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down. When in motion its elevated and when sitting its around 75.

6 hours after the shot I spiked a fever to 103.6. It stayed elevated for 12 an additional 8 hours. My normal temp is 97.6. 24 hours later it is at 99.5. I have had a crushing headache for 17 hours.

Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache, lower back pain.

first 2 days slight headache and body aches, third day through 10th day, nausea, vomiting on the days 9 and 10, stomach pain, hives. I went to the ER on March 19 for nausea and vomitting, was dehydrated and received IV fluids. I also had hives which I was prescribed Steroids for. The next day, March 20, I went to urgent care for severe hives and was given a steroid shot and epinephrine shot. I don't know if these symptoms are a result of the vaccine, but I did not have them prior to the vaccine so I thought they should be reported. Thanks

About 12 hours after receiving the vaccine I had a headache, fever (99-101 degrees), sore eyes, fatigue and some chills all day until I went to bed around 11 pm. I found relief with 500 mg of tylenol throughout the day. Upon waking up on March 11, all side effects had subsided and I felt just fine. No side effects since. (today is 13 days after receiving the vaccine)

Nausea then vomiting for 24 hours. Also had general aches, headaches, chills, fatigue. The nausea and vomiting required call to Dr or nausea medication prescription the next day.. Nausea and inability to eat much persisted for more than a week and required visit to CNP for additional nausea medication.

Headache started about 20 min after vaccine. As day progressed headache headaches on and off, fatigue. Following days headache persists intermittently and extreme fatigue with slight sore throat. PLEASE NOTE THE VACCINE IS COVID 19 PFIZER THE DROP BOX DID NOT HAVE A LISTING FOR PFIZER

Extreme tiredness starting at about 3 hours after the vaccination. Then about 8 hours after the vaccination got really cold, freezing, unlike another coldness I've felt. Feet and toes were especially cold to the touch. Shivering, heart palpitations too. Bloating and stomach ache and nausea. Tiredness continues the day after (today)

As soon as I was injected I felt a burning sensation that went from the site up into my neck. Day 2, 7am I woke with a temperature of 102 degrees, Throughout the day I had fever, chills and arm injection site to neck continued to be painful, arm swollen and warm to touch with a lump about the size of a walnut, and lethargic. Day 3-4 symptoms continued same as day 2 with temperature decreasing to 100 degrees. Day 5 fever gone. Day 5 through today the injection site continues to be somewhat painful with some heat in the arm and lump has decreased to dime size. Called and spoke with doctors office this morning. Advised to treat with wet warm compress and Ibuprofen for discomfort. Call is worsen.

I just started having problems breathing, I couldn't catch my breathe and heart rate went sky high. I ended up going to the ER, they have me some steroids and breathing treatments, monitored my heart rate for three hours. I stayed in the ER for 4 hours and discharged me. The next day I was feeling a little week but breathing better and heart rate was back down to normal. I have a cough that's lingering a dry cough.

Systemic: Headache-Medium, Additional Details: Patient called 3/24/2021 said she tested positive for Covid after found out Husband tested positive for covid on 3/20/2021- no taste or smell.\r\n

Extreme body ache night of injection, Tylenol remedied,. Fatigue and lethargy for approximately 24 hours after day of injection

Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something around 0900. Patient was given a granola bar and water. at 1405 BP 171/90, HR 83, SP02 98%, RR 16. Pt states heart is "fluttery", pulse regular. 1416 pt states headache is better. pt denies chest pain or SOB. After sitting up from laying position pt states she was dizzier, repeated BP at 1427, no improvement. Gave pt juice b/c she felt shaky and thinks it's because she hasn't eaten. Had pt rest for 10-20 mins more and then obtained orthostatic vitals, no concern for orthostatic HTN, pt states she no longer has headache or is dizzy. Per pt's visitor her color had returned to normal, pt still feels a little shaky. Pt rested another 5 mins, repeated vitals and pts BP was elevated. Discussed with pt and visitor that due to her hx of HTN and her already being on BP meds, pt should be seen in ER and EMS called. Explained that she should have an EKG done b/c of flutters and HTN along with headache. Educated pt on importance of being seen in ED. Gave pt and visitor time to discuss suggestion, when returning pt states, "Talked to niece who is EMT and said I should be fine if I just went home, rested, ate, and checked BP and took another BP pill (1/2) like suggested with doc before getting ahold of physician. All they'll do in ED is continue to check BP". Advised pt that ED would do more than that. Pt refused EMS and wished to go home. Pt visitor stated that they would watch patient and if anything changed take to ED. Patient left clinic in wheelchair and assisted to vehicle. Pt denies any symptoms that she initially presented with but states she just feeling weak.

Janssen COVID-19 Vaccine EUA -Chills with rigors for approximately 2 hours -Fever intermittently for approximately 24 hours -Headache for approximately 24 hours -Fatigue for approximately 48 hours

Fever 101 for 2 days Headache ongoing (currently day 5) Nausea ongoing Insomnia ongoing Fatigue ongoing

Day 1: Received vaccine @ 2pm and about 15 minutes later lymph nodes in neck started to swell with right greater than left swelling. Notified nurse and told to wait another 15 minutes and contact if difficulty breathing. Took 25 mg benadryl orally, Symptoms remained the same. At 2:30 left vaccine site. At 2:35 took another Benadryl due to tightness in throat. No change in breathing, Swelling in Lymph nodes increased. No change in breathing. Went to bed for a few hours. Upon waking felt achy all over. Day 2: The next day about 20 hours after the receiving the vaccine felt chilled, increased body aches, feverish, temp 102.4. Treating with Tylenol and Benadryl, warm showers to try and decrease chills and fluids. Day 3 increased body aches and now mild headache, temp continues 100.2 treating with Tylenol, additional fluids.

First noticed as driving away my tinnitus was triggered. More serious adverse events started about 6-7 hrs after injection about 10:30pm with achy body and nausea. Progressed to Chills, achy body, sore muscles, nausea. Took Tylenol but persisted. By 10:00am next day (12 hours after began) symptoms lessened, but still persisting nearly 24 hours after injection.

Patient received vaccine and immediately began to feel sweaty and light-headed. She did not faint or lose consciousness. Patient received an ice pack and some cold water and began to feel better. Her blood pressure was normal and after about 10 minutes she began to feel like herself again. There was no sign of anaphylaxis or further respiratory distress.

Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the time I came back home I went to bed with all my cloths on and 2 more blankets I had a fever of 103 and was very hot to touch the shakes would not go away. The next day I started feeling a little better still cold and had a very sore throat and runny nose body ached bad very bad friday I feel better but feel like I was hit by a truck

Confusion, anxiety, 4 to 5 days. Went back in time with things that happened years ago, brain fog. Abdominal gut pain , diarrhea. Exhaustion lasting 2 weeks.

INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

Chills; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 132 and height was 64 inches. The patient's concurrent conditions included penicillin allergy, sulfa drug allergy, alcohol use(3-4 glasses of wine), non smoker, and rash, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:13 on right (site unspecified) for prophylactic vaccination. Concomitant medications included atorvastatin calcium. On 10-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-MAR-2021. This report was non-serious. Additional information was received from physician on 30-MAR-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight), concurrent conditions (penicillin allergy, sulfa drug allergy, alcohol use, non smoker, and rash), covid-19 vaccine therapy details (batch number, therapy start date and vaccination site), concomitant medication (lipitor), reporter details was added.

8 pm- fatigue, beginning of headache. 11 pm chills and fever 1 pm body ached and crushing headache. did not sleep. fever went away after 3-4 hours, body aches dissipated over 2nd day, headache lasted until 3rd morning. woke up Sunday feeling tired but headache all but gone. now 3 days later, still have fatigue and a little fogginess. much like when I get over the flu- just weak and tired.

Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walking.

Janssen COVID-19 Vaccine EUA Started at 6:30 pm and Fever of 102 by 9:00 pm, Chills, Diarrhea, Ibuprofen brought down fever,

Injection site bruising, rash, with creeping red rash that continued to broaden each day. Swelling, itchiness. Minor wheezing (Day 2 or 3) Extreme fatigue (Day 1, 2, 3).

I started experiencing dizziness when my head turned in a specific position. This began about one week after the vaccination. At the next VSAFE check I reported that I was having some dizziness and tiredness. However, I saw a doctor on April 2 and he diagnosed me with Benign Paroxysmal Positional Vertigo and treated me in his office using the Epley Maneuver. The dizziness was cured and I am not experiencing it any longer. I do not believe it was associated with the vaccination but had not seen my doctor when I completed the report on VSAFE.

SORENESS AT INJECTION POINT (SHOULDER); NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection point (shoulder), nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection point (shoulder), nausea, and fatigue. This report was non-serious.

Chest palpitations vomiting fever breathlessness rash on neck and face thickening of tongue palate lips blood pressure 174/106 spike tiredness headaches aches since Friday I had called nine times to this number

Janssen COVID-19 Vaccine EUA Severe joint and muscle pain all over the body starting at 7:30 pm. Progressively worsening overnight. Overall weakness, cold shivers, severe palpitations with 136 heart rate in resting position. Initially decreased temperature and then increased temperature to 101. Tramadol for pain and diazepan for sleep taken at night. Felt better by the next day afternoon.

I got the vaccine at around 11am on 6th April. By 8pm the same day I was experiencing very severe chills - I have never felt so cold before in my life, and the evening was not cold.. The next day, 7th April, I woke up with bad aches in various, seemingly random areas of my body: both upper arms, outside parts of both thighs, center of back between shoulder blades. Interestingly all the aches were symmetrical. I had not done any serious exercise to cause these symptoms, just a stroll around the park after getting the vaccine. I also experienced crushing tiredness and had to go back to bed in the afternoon. Today, 8th April at 5:30 pm my left arm at the vaccine site still aches, but all the other symptoms had vanished by the morning. I'm 5' 4" and weigh 114lbs. My husband got the vaccine at the same time and had no symptoms. We are speculating that my smaller size may have contributed to my adverse reaction. He is 5' 6" and weighs 180lbs. In spite of this discomfort I'm so relieved and pleased that we were able to get the vaccine. Thank you!

Fever chills tired and aches for 2 days. Starting day 3 had lightheaded feeling with nausea and intestinal cramps. Had diarrhea for 2 days which resolved but lightheaded and nausea remained for 2 weeks. After 2 weeks had some relief but lightheaded feeling returns on occasion. Can remain functional but don?t feel right some days.

Fatigue that worsened over 3 week period, weakness in legs, arms that progressed over that time, dizzy foggy brain that progressed, chest tightness/heaviness that became more frequent over time, ending in inability to stay active for normal activities, fever on & off - thought MS exacerbation - symptoms completely subsided by 4/7/21

Began with muscles in legs aching, then a headache, body aches, feeling of being sick, chills. Started feeling better two days after shot, but still weak.

Patient reported feeling pain in the base of the head, difficulty swallowing, jaw pain, and dizziness Patient seen by medical team and ambulance was called Patient stated symptoms improved a little Patient refused medical transport because ?it?s too expensive? and signed AMA form Patient stated she will be driven by husband to ER

Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting with her head in her hands and alerted RN, then all responded at 1140. The client complained of shortness of breath and dizziness. Upon assessment, the client was pale, diaphoretic, and clammy, and her skin was cool and dry. The client stated that she is anxious about needles and vaccinations, and that her mask was making her feel "claustrophobic." The client was encouraged to practice deep breathing and her vital signs were obtained: blood pressure of 96/76, respiratory rate of 12. The client stated that she did eat breakfast that morning at 0930 and was offered some water to drink. . Per the client, she has a medical history of hypothyroidism and the only medication she takes is levothyroxine. The client also stated that she tends to have lower blood pressure and "110/60 is normal" for her. The client was alert and oriented. At 1145, the repeat vital blood pressure for the client was 97/63. She stated at this time that she felt like she was going to pass out, and was transferred to the reclining chair. At 1150, the repeat vital signs were as follows: blood pressure of 118/80, heart rate of 78, respiratory rate of 16, and pulse O2 reading of 95%. At 1155, repeat vital signs were as follows: blood pressure of 112/74, heart rate of 78, respiratory rate of 14, pulse oximeter reading of 96%. At this time, the client's color returned to normal and they were no longer clammy. At 1207, the client's blood pressure was 110/72, their heart rate was 73, their respiratory rate was 8, and their pulse oximeter reading was 97%. The client stated they "feel great" and left the facility at 1210, ambulating with a steady gait to their car, where they were driven home by an acquaintance.

Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bumps on the same side as the shot was given directly above my left breast that was severely itchy. This rash is just now starting to dissipate but still itches; I used OTC cortisone creme and Benedryl to address the itching. The other major effect involved my left arm. For a full week, the muscle in which the shot was given was extremely sore to the touch and the whole arm ached. I still cannot fully extend that arm above my head without it feeling like an aching weight. Lastly, I had a pain in the center of my back as a hard ache that one week later still has not fully dissipated. It appears to be going away, but has lingered longer than I would have expected.

Began to feel light headed around 11:45 pm followed shortly by achiness that was mild at first and within an hour became very significant. Then, headache started and was quickly very severe. Accompanied by fever and chills. Slept for 24 hours, woke up for five minutes and slept for another six hours. Though I felt better within 36 hours, I would not call the side effects mild. Still feel lightheaded and having difficulty sleeping.

4/1 at 10PM started aching. Took tylenol and went to bed. by midnight she was feeling worse. She had chills and achiness and shivering. By midnight she had chills and aching and shivering. By 4/2 0600 she took ibuprofen but had a fever, aching and chills that were getting worse. By 4/3 she had vomiting and diarrhea. She finally felt better 4/5 but remained very tired. She finally felt back to normal on 4/9/2021.

Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body shaking, a headache, SEVERE back and neck pain and elevated resting heart rate (96). I took 2.5mg of Ambian thinking that if I could just fall asleep, I would sleep it off. After an hour of non-stop symptoms, I fell asleep for about an hour only to wake up with the severe neck and back pain and headache still present. The body shaking had subsided. The next day, I was tired but fine.

Extreme headache for 2 days. Worse than any migraine I?ve ever had. Severe pain in neck, shoulders and spine. My heart heart. Extreme nausea, vomiting and diarrhea. Extreme fatigue. Couldn?t move or eat for 2 days. Didn?t think I was going to recover. 3rd day feeling light headed and tired but feeling better.

Fever 103.2 for 24 hours; Fever 102.1 for next 24 hours; chills for 6 hours; heart racing for 6 hours ; fatigue 1 week; diarrhea 3 days; headache on going; severe bruising to injection site about 1.5 weeks after the injection

Patient inadvertently received a 1.0 mL dose instead of the prescribed 0.5 mL dose. Patient was originally cleared to leave the office after having no symptoms or complaints for 15 minutes following inject. Once dose error was caught, patient was contacted by clinic physician. Patient notified of error, possible side effects reviewed and advised to go to ER if symptoms develop. Patient had no current symptoms or complaints at that time. Staff followed up with patient several times over the course of the next 24 hours. Was unable to reach patients until 04/09/21 approx. 1030 am. Patient doing OK, tired, but no other symptoms or complaints.

Four days after I received the vaccine (this week Tuesday), I suddenly felt very dizzy and faintish. I sat down until the dizzy spell passed. I felt very cold and clammy and nauseous. My hands were very shaky. I felt very weak and very tired so I slept the whole day. Today I woke up and felt the same dizziness, very cold hands and nauseous. Both times I had diarrhea. I have never had dizzy spells before so I know this has to be vaccine related.

Really bad headache, nausea, dizziness, fever, achy all over, arm swollen even in arm pit and really sore,diarrhea

Nausea, headache, stiff neck six hours later. Muscle pain, elevated blood pressure, severe ringing in ears occurred 15 hours (3am) after injection. Saw PCP on 3/25- prescribed blood pressure medication (never taken before) and referred to ENT. Saw ENT on 3/29 and 3/30. Prescribed high dose Prednisone for two weeks. Hearing test shows hearing loss in left ear. Received injection in left arm. Shrill high pitched ringing in both ears with no improvement. See Audiologist on 4/20 for hearing recheck to see if hearing has improved in left ear.

15 minutes after receiving the vaccine patient started to feel itchy in her throat but did not have tightening in the throat, hives or shortness of breath. Patient was taken to the emergency department where IV benadryl and solu-medrol were given.

03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.

At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy

Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs

A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects: headache, fever, muscle aches, tired and weakness. I also felt a little dizzie. I monitored my temperature thoughout the night; I recorded at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild. I do still feel a little dizzie and weak.

Numbness on left side of face lasting from 3pm to after midnight on 3/8/21. It subsided on 3/9/21 during the day, but again felt numbness on left side of face at 10:00pm on 3/9/21. Continue to feel nausea, no appetite, and extreme fatigue.

This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, 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: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. On 01-APR-2021, the subject experienced subject could not lift things (strength loss). On 01-APR-2021, the subject experienced pain in arm. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from muscle ache, pain in arm, patient could not lift things (strength loss), and tiredness. This report was non-serious.

A couple minutes after receiving the vaccine, patient started feeling dizzy and described it as her head feeling heavy, and some weakness. She was offered water and was brought in to the clinic for further monitoring. BP- 164/78. PR- 71. Symptoms did not worsen and it improved after 1 hour, but not totally resolved. BP recheck was 143/62. PR- 76. Patient said she felt better and volunteered to go home. Instructed to go to ER if her symptoms persist and worsen; patient verbalized understanding. Discharged to home after an hour of monitoring.

After the shot i had slight swelling in my neck glands, not too bothersome. Severe insomia up from 10 pm to 5 am , really bad headache, pain pressure in my ears, { Couldl feel my heart beating in my ears } Took acetamiphen and cold compress to the head and eyes, seemed to help. Awake at 10 with no further symtoms so far.

almost two weeks later my arm is still very sore at injection site. the next morning after the vaccine when i was at work i had to leave my classroom because i felt sick. i felt nauseated, sweaty, light headed, short of breath and my heart was pounding like i had been running a marathon. i thought i was gonna have a heart attack. i HAD to go outside for fresh cool air and sit down. i was also applying a cold compress, drinking cool water and taking very deep breaths i was able to return to work in about 15 minutes. i continued to feel nauseated for the rest of that day and the next.

8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the next morning.Took 1300 MG acetaminophen. Had no effect. Used ice bags, had no effect.

Swollen lymph nodes in groin (1 day)and underarms and under jaw (2 days), headache(2 days), loss of appetite (2 days), muscle aches(1 day), feeling very tired(1.5 days) Treated with acetaminophen and rest. Symptoms mostly resolved by end of 2nd day

Mild reaction the following day including fever, fatigue, pain in joints. No treatment and symptoms went away in a few hours. Tested positive for Covid 19 on March 19, 2021.

Day one: soreness at injection site, mild achiness and headache, brief episode of intense coughing/wheezing Day two: slight lightheadedness, episode of vertigo and nausea. All totally resolved by the end of day 2

Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.

WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-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 chills, warmth, headache, and achiness. This report was non-serious. This case, from the same reporter is linked to 20210413415.

Same night of the vaccine I had fevers & chills. They were gone after 12 hrs. On 3/18/2021 I stated having stomach problems. I had diarrhea & cramping this was going on & off. Around one week later I went to urgent care because of how much I was cramping. I followed up with my regular doctor & he did some la work. It kept going on & off but it started getting better & today on 4/12/2021 is the first day I started feeling like myself.

beginning the following morning: hot flash followed by chills followed by vomiting. Hot flashes, Chills, Nausea, Vomiting, Diarrhea continued for 48 hours

2 hours after I received the vaccination, I came down with severe chills. My entire body was shaking and I could not get warm. I got extremely fatigued to the point that I could not get out of bed. I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days). It seemed that every bone and muscle in my body began aching, from head to toes. My fever went up to almost 102. These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days). I alternated Tylenol, Advil and Alleve. They did not help hardly at all, unfortunately. 2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast. Today, these lymph nodes are still swollen and are painful to the touch. I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.

About two weeks ago, I started with a stuffy nose, SOB and I had a cough that was producing phlegm. I had to increase my oxgen to daily use.

Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. 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 drug allergies and no 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.

Temperature between 99 and 100 for four days, one episode vomiting 54 hours after vaccine, headache 3 days after vaccine, body aches just the day after, patient took Tylenol but temperature not getting below 99.

Chills, severe aches, pain in my left arm down to my hand , neck, back, chest, keytones due to type 1 diabetes.

I have mild headaches daily due to seasonal allergies, but I was told to report even if I wasn?t sure if it was a reaction. Early Monday, 4/12/21, I woke up with a severe sinus headache. I took some sinus medicine by 7 am but it remained fairly strong for 2-3 hours. It eased up some so I went to work and by 11 am took another dose of sinus medicine. I felt nauseated so I ate a couple of Tums through the afternoon. I assumed it was related to the sinus medicine. After work, I went home and was very tired. I went to bed earlier than normal but woke up this morning feeling normal. (With a mild - as usual - headache)

Vaccine given April 5, 2021. On April 5, 2021 around Midnight/April 6, 2021 12:01am, I became very chilled and a very uncomfortable headache started; I remained cold for about 1 hour; headache lasted for 7 hours - subsided after I took one 200 mg Advil softgel; aches and pains in head, both sides of jaw, knees, and ankles from Midnight to 4:00am; very tired and didn't feel like walking or moving around much from Midnight to Noon (April 6, 2021); felt nausea on and off from 1am to 7am; perspired from 2am to 4am (didn't get up to take my temperature so don't know if I had one but pretty sure I did since I sweated for so long).

Experienced strong all-day headache. A number of days later I experienced strong abdominal pain on at least two separate occasions. There is no history of pregnancy.

HORRIFFIC HEADACHE FOR 24 HRS. THE NEXT DAY FELT GREAT, THEN ON THE EVENING OF 4/10 HAD SEVERE STABBING ABDOMINAL PAINS THOUGHT THAT HAVING BOWEL MOVEMENR=T WOULD MAKE ME FEEL BETTER BUT UNABLE TO GO. A FEW HOURS LATER ABLE TO PASS SOLID STOOL THEN WENT TO MASSIVE UNFORMED STOOL IN LARGE AMOUNTS WITH VOMITING. CONTINUED STABBING PAIN BUT NOW FEELS LIKE MY INSIDES ARE BEING TWISTED., PAI HAS TRAVELED FROM LOWER ABDOMEN AND MOVED UP TO UPPER ABDOMEN. UNABLE TO EAT AND ONLY DRINKING WATER. . DAY 6 AND STILL HAVING PAIN

BAD Dizziness, Rash & Bruising at injection site, (hot to the touch & Burning sensation .) Headache, spots in left eye, I fell due to dizziness ..

I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Monday, April 12 at 9am. He sent me to the center where they did an Ultrasound which was positive . I was adviced to go to the Hospital for a CT scan of my lungs and brain. I went to medical center on Monday at 6pm. There I was given an Iodine CT scan. They noticed a small spot of pneumonia. They repeated the Ultrasound of my leg and took a swab for Covid-19. I was given a prescription for Xarelto and an antibiotic , Levaquin, 500mg.. I came home.

Fever, Aches, Chills, Fatigue have been ongoing since approximately 8 hours after the I had the vaccine. I had the corona virus in July 2020 and I feel like I did when I had the virus only worse! I am now going on day 3 and am still feeling these adverse affects and am wondering how long I can expect them to last. When I had the virus in July 2020, I was sick for 3 weeks. Will I be sick for 3 weeks with these vaccine side affects? I am taking tylenol and ibuprofen but they are not helping much. Taking Vitamin D and Zinc supplements and trying to drink lots of water. I haven't yet contacted my doctor thinking these side affects will go away soon but I am getting concerned.

Patient developed a severe headache on day 11 post vaccination 8/10, worst headache of patients life with body aches and chills.

Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J, March 20). Onset of sx approximately 15 days from J&J COVID vaccine. Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins. Tx: labs and imaging - see below.

Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21. It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.

received Jansen vaccine on 3/31/21 and the following day I had a headache,, achy and tired. I expected this, but a few days later I was still having what I describe as migraine type headaches and at one point I was sweating profusely, dizzy massive headache with not only nausea, but dry heaving so bad I could barely get to my medication and seriously thought it would never subside. I continued with headaches up until today April 14. This is the first day I have not had a headache. I contacted my vascular doctor as I had a blood clot several years ago and he has prescribed Eliquis twice a day for the next 2 weeks. Today marks 2 weeks and like I said, it's the first day I have not had a headache

She received the Johnson & Johnson COVID Vaccine 3/5/2021 9:30am. 3/6/2021 She reports that she was weak and exhausted and flu like symptoms. Symptoms began on 3/7/21, woke up horizontal binocular diplopia at 8:30am. Has been constant since it started. It is worst when looking to the left and best looking the right. Worse in the distance. No other associated symptoms 3/13/21: Around noon, was just sitting in the chair. She reports that she got a bad headache and then the entire left side of the body from head to toe was numb and burning in the left side face. This lasted all day, but completely resolved by night time. Had never had anything quite like that in the past. She had a headache that started soon before the numbness, that also lasted most of the day. 3/15/21: was seen in ED with reported normal MRI, CT, and EKG MRI brain with a small left pons lesion near the cranial nerve 6 nucleus She was seen by Neuro-ophthalmology Dr. (attending), Dr. (fellow) 3/17/2021 " MRI brain on 3/15/21 did not reveal a structural etiology for diplopia. Differential diagnosis includes microvascular ischemic left 6th nerve palsy versus possibly post-vaccination cranial nerve palsy (received COVID vaccine 2 days prior). Also on the differential diagnosis but less likely, includes myasthenia gravis (she did not have expected abduction saccade slowing of the left eye typical of an ischemic cranial nerve palsy). Thyroid eye disease also would be less likely. We will obtain antibody testing for myasthenia and thyroid eye disease. Today we applied a 10 prism diopter base out prism over her left glasses lens. I instructed her to remove this when appropriate, as I expect her diplopia to gradually improved." 4/7/2021 acetylcholine ab receptor negative, TSI negative, TSH receptor antibody negative, LH/FSH normal,

Onset of dull headache which worsened. Continued worsening into a massive migraine(cluster, light sensitive). After several hours I took a migraine relief OTC medication. The headache subsided with minor headache into the following day.

Upon waking 2 days after receiving vaccine, I suffered from excruciating headache that was incapacitating. It did not resolve with aspirin, which prompted me to check my blood pressure. My BP was extremely elevated at 145/85. I then took 1 dose of common "water pill" 25 mg hydrochlorothiazide. This did not bring down BP or resolve headache, 2 hours later I took 20 mg of Valsartan. This also did not resolve headache or lower BP, so I took another 20 mg of Valsartan, followed by another 25 mg of water pill. My BP stabilized later that evening and headache resolved by 8 p.m. This same event occurred 2 more times, the last day being 4/10/21. On that date I was completely incapacitated by excruciating headache. I took 40 mg of Valsartan but headache did not resolve until late that evening.

Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.

4/14/21 Per Patient, received Janssen vaccine on 3/5/2021, began experiencing headaches on side of face and intermittent sharp left leg pain 3/12/2021, does not usually get headaches and thought related to dental work, 4 tooth implants, evaluated by dentist who said headaches not related to dental work, had been more active, walking with nice weather and thought leg pain might be caused by tick bite, left knee "gave out", husband looked at back of leg and did not see any evidence of tick bite, noticed varicose veins had worsened (more prominent, not red or swollen) and thought should be checked, appointment at center 4/8/21 and is under the care of Dr, has follow up appointment 4/21/2021. Placed on blood thinner Xarelto 15 mg tablets, 2 tablets daily x 21 days, then reduced to 1 tablet daily x 22 days for blood clots. Headaches and leg pain improved after starting medication. Signed up for program 4/13/21 after suggested by daughter.

Some minutes after the injection I started feeling a burning sensation under my bra (around my chest), and it was hard to breath and then I started feeling it in my throat and then my lips started tingling, I also had a headache that started. I alerted the person at the vaccination site saying something was not right and then they called the paramedics who took my vitals and said my heart rate and blood pressure was extremely high. They gave me a shot of Benadryl and oxygen because I was feeling shortness of breath. They kept me until about 11:35 in observation when I felt myself again. The headache, nausea and body aches stayed for about 2 weeks but all other symptoms subsided.

I received the Janssen COVID-19 Vaccine EUA on Thursday morning. April 8, . Six hours later I had chills and a low grade fever for two hours. Then, thoughout the night, I experienced jaw pain making it difficult to sleep, but in the morning I applied ice and the pain went away. By Sunday, I felt 100% better.

Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chills, no big deal. Then began to get headache with slight fever and the headache got progressively worse, with nausea and rapid heart rate. The headache was so bad I could not sleep at all - the worst headache I have ever had. I took one extra-strength Tylenol at about 10 or 11 am the next day, March 12, which took the edge off the headache. The headache diminished till it was gone by about 8 or 9 pm. The rapid heart rate, along with tiredness, low energy, and feeling jittery continued for several days, then stopped. About 3 or 4 weeks later...there's more BUT FORM WON'T LET ME GO TO CONTINUATION PAGE

10 minutes after shot i started to feel tingling and numbness in my chest which traveled to my neck and into face. Began having a dry cough, went to nurse to as if normal, she said no, she started monitoring me. Still had cough, then became light headed and nausea. She gave me 25 mg of Benadryl, coughing continued, breathing became rapid, then I was given shot of epi, I became dizzy again and couldn?t complete a sentence. Words were slurred, heart beat racing. EMT?s were called. Received another shot of Benadryl. It did not counteract anything. Received another shot of epi. Had uncontrollable shakes and hard to breathe or speak. Was difficult to get BP reading due to shaking. Finally got reading of 196/99. EMT listened to heart and lungs. Said all was good. Taken to ER for monitoring of heart, Lungs and BP. Was there for approximately 2 hours u til shakes and BP were good.

Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.

Initial reaction was noted on 8:00 PM 3/17. Jitteriness and fatigue on 3/17. Around 9:00 felt neck pain and it was hard to move her neck. The neck pain was severe 10/10. Still has problems with the neck. Her neck pain has improved but the pain is worse than it was before she had the vaccine.

The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021

PT reports intermittent epigastric pain described as sharp x 04/09 after receiving JJ vaccine. reports nausea, denies vomiting and diarrhea.Patient is a 63 year old female who presents to ED with epigastric pain for 5 days, sharps, rated 9/10 associated with nausea. She denies any fever, no vomiting. She states the pain started one day after receiving the J&J vaccine. She has had some headache, denies any chest pain or shortness of breath. She was recently diagnosed with elevated cholesterol, has not had treatment for it yet. She had a colonoscopy with benign polyp removed, no other abdominal procedures.

severe headache from 2:30 am until 4:00 pm took tylenol nauseau took 1/2 dose of meclizine gone by early afternoon hive in mouth when woke up with headache gone by late afternoon I am 87 pounds

severe Headache started the next evening along with sore throat, cough, sweating, chills, pounding/throbbing in the ears, trouble breathing, elevated heart rate symptoms persist through today 4/15/21

Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen. 72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.

FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, 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 increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.

On Tuesday, April 6, 2021, about 11:45 am, I felt a sudden sharp pain in the right temple area just above eye level and about 2 inches posterior. I also felt some dizziness and wondered if I was having a stroke or some type of arterial inflammation. At the time I was treating a patient and wondered if I was going to have to leave to go home. I did get through the rest of my workday but had difficulty concentrating. I had recurring waves of pain in the same area several times that day and into the evening, was considering alerting my adult daughter that I might need to go to a hospital. Fortunately, resting and increased fluids seemed to resolve the pain and it was mostly gone by the next day.

FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent in heart, and stent in leg, and concurrent conditions included migraine, high blood pressure, gastroesophageal reflux disease, and irritable bowel, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gastroesophageal reflux disease, and irritable bowel, hydrochlorothiazide for high blood pressure, lisinopril for high blood pressure, metoprolol succinate for high blood pressure, pantoprazole for irritable bowel, and gastroesophageal reflux disease, butalbital/caffeine/paracetamol for migraine, acetylsalicylic acid for stent placed in heart, and clopidogrel bisulfate for stent placed in heart, and stent in leg. On 05-APR-2021, the subject experienced flu like symptoms. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, sweating, body ache, and migraine/headache on 09-APR-2021, and nausea on 07-APR-2021, and was recovering from fatigue. This report was non-serious.

DIVERTICULITIS ATTACKS; FLU- LIKE SYMPTOMS; FREQUENT URINATION; NOT SLEEPING WELL; DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 95.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Selexipag (form of admin and route of admin were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication; and Macitentan (tablet, route of admin not reported, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient had diarrhea, flu- like symptoms, body aches, nausea, fatigue, short of breath frequent urination and was not sleeping well. She was unsure if this was due to the vaccine or a combination of the Uptravi and the vaccine. The patient also had short of breath when she took her garbage out and that she had occasional diverticulitis attacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diverticulitis attacks, diarrhea, flu- like symptoms, frequent urination and not sleeping well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414881-Covid-19 vaccine ad26.cov2.s-Diverticulitis . This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-UPTRAVI-Diverticulitis. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-OPSUMIT-Diverticulitis. 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.

CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung transplant, and liver transplant, and concurrent conditions included hepatitis c. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and had not recovered from muscle aches, feeling tired, and feeling weak. This report was non-serious.

Vaccine administered on right arm on 4/8/2021. Approximately, 12 hours later she began experiencing severe abdominal stomach pain, fever and general malaise (fever and malaise have generally resolved), numbness in her left arm, and elevated blood pressure. She continues to have abdominal pain 7 days after immunization. Advised to go to emergency room out of an abundance of precaution.

colonic necrosis 62 yo woman history of prior L occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental status changes. Patient was noted to be in severe metabolic acidosis, renal failure and shock. Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2. She required intubation and mechanical ventilation. CT brain showed encephalomalacia and atrophy, no new changes. She was transferred on April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she was only treated with steroids, then antibiotics were added for fever and persistent hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April 8.

Patient began to experience upper thigh pain approximately 3/16/2021 - 3/18/2021. Can't remember which leg, reports the pain as a stabbing and aching pain. Leg was painful whether walking or not. Rates pain 4-5 on the pain scale with 10 being the worst pain ever experienced. Doesn't recall redness, swelling, or warmth to area of the leg. The pain lasted approximately 2-3 days . Patient did not contact her PCP. Also reports headache to back of the head which lasted around one day. Typically has sinus headaches. Recommended she contact PCP immediately so he/she can follow-up

Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body temperature(ongoing), severe fatigue (also ongoing), difficulty working, inappetince... Spoke with doctor. No help. No treatments.

Sudden onset extreme dizziness/vertigo. So severe and sudden I called 911 because I felt I might lose consciousness. Followed by nausea and violent vomiting. (EMT Vitals were all normal and they didn't think it was an allergic reaction this long after vaccine so I declined hospital ER visit.) After several hours of severe dizziness I developed violent chills with heavy breathing that lasted 20 minutes then stopped. Much improved after 24 hours but two days later I still have considerable dizziness. Headaches occurred Earlier in the week but none with onset of dizziness. Otherwise I experienced the typical fatique and flulike vaccine side effects with no pain at injection site about 2 days after vaccination that lasted several days.

NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.

I received the Janssen COVAX on Monday morning, 5 Apr 2021. A week later, on Monday evening, 12 Apr 2021, I experienced extremely painful leg cramps and broke out in a sweat. I felt extremely nauseous, and weak, this was followed by a sever pain in my head that was so extreme that I passed out. After coming to, the pain in my head finally began to subside, along with the leg cramps. My husband indicated that I was unconscious for just under a minute. For the next two days, I had bouts of nausea, headaches, sweats, and was extremely tired. On Wednesday, 14 Apr, after learning of the issues related to the Janssen vaccine, and the symptoms described being what I experienced, I contacted the advice (cont'd)..Additional information for Item 18: Line and was told to go to Emergency Room at the hospital, which I did. I do not feel that they addressed my concerns or the symptoms that I was experiencing, and at no time did they try to determine if it was due to the vaccine. The discharge papers did not even address the "event" and the "symptoms" that I described. They did not take any information down related to the vaccine, lot number, etc., that I had received. They seemed to go through a set routine: blood pressure, blood work, temperature, EKG, and CAT scan. 21. (continued)...Visited Emergency Room, however, was requested by ER to go to Primary Care as follow-up, however, as a Employee we cannot be seen by Primary Care on THIS site. Instead , we have to go on the local clinic to receive care. The issue is that this was a vaccine that I was scheduled by my leadership to receive, with no choice in choosing which vaccine I could receive, and without follow-up care for adverse reactions. The hospital did not indicate to me that I should report this incident, however, I am concerned as a result of the "event" that I experienced, that it should be reported. Furthermore,we should have a choice as to which vaccine we want to receive, just as everyone does. Your form does not allow for input addresses Also, your form does not allow for a phone number. I am out of the country.

HA, Itching all over, Rash (shingles like around neck), Itching ears, Swollen legs, Shortness of Breath

I was ill with diarrhea, sick to stomach, blood clots coming out of my rectum for 24 hrs., body aches.

CHILLS; FEVER; HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, non alcohol user, and non-smoker, 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, intramuscular, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 12:50 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.9 (unit not specified). On 10-MAR-2021 12:50, the subject experienced sore arm. On 10-MAR-2021 22:00, the subject experienced chills. On 10-MAR-2021 22:00, the subject experienced fever. On 10-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 10-MAR-2021 15:50, was recovering from chills, and fever, and had not recovered from headache. This report was non-serious.

2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled, had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic. This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep. On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine. My equilibrium is still affected from time to time.

MINOR HEART PALPITATIONS; HIGH FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at injection site. On 07-APR-2021, the subject experienced minor heart palpitations. On 07-APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor heart palpitations, and high fever on APR-2021, and was recovering from pain at injection site. This report was non-serious.

STABBING PAIN IN STOMACH; NAUSEA; INJECTION SITE SORENESS; FEVER; LOSS OF 5-6 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, and keflex, tylenol and asprin allergy. The patient experienced difficulty in breathing when treated with hydrocodone bitartrate/paracetamol, and hives when treated with naproxen sodium, erythromycin, and swelling of the face when treated with magnesium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of 5-6 pounds. On 01-APR-2021, the subject experienced stabbing pain in stomach. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and fever on 03-APR-2021, had not recovered from nausea, and stabbing pain in stomach, and the outcome of loss of 5-6 pounds was not reported. This report was non-serious.

SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.

LEFT CHEST PAIN; FELT VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt very tired. On 09-APR-2021 02:00, the subject experienced left chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left chest pain, and felt very tired. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

On the day of the vaccination and for the next 3 days I felt tired, fatigued and on Saturday the 10th I noticed my gland under my jaw on that evening that it was swollen. Then on the 15th or 16th I noticed that the roof of my mouth was hurting, was sore. So I asked my husband to check it for me because I could not see it very well and he said there was a sore on the roof of my mouth. Yesterday I asked him to check again and he said it was even worse. I am going to see a doctor today, appointment today at 12:30PM. I also saw another Dr. also at the same clinic on 04/14/2021.

Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.

Fever, body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes.

DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and 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: 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 diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.

4-9-21 vaccination Later that evening, I basically feeling 'outside of myself' like my 'spirit left my body'. Took me a week to feel like myself. I had the headaches, felt sluggish, lethargic for a week. I was unable to do normal daily activities. I went to see my PCM on 4-12-21. He did some medical tests / labs. Results were negative for clots. They said I have a cyst on the back of my leg. Waiting on results of my MRI. *HA are ongoing.

HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.

I developed fairly intense itching throughout my body, primarily arms , legs and torso. I did not develop a rash or bumps. This lasted from Wednesday April 7 to Thursday night April 8. By Friday this had resolved. Other than that I was very fatigued the night of the shot and somewhat achy the next day.

INCREASED HEART RATE; WEAKNESS; TIREDNESS AND EXHAUSTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-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 04-APR-2021, the subject experienced increased heart rate. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced tiredness and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness, tiredness and exhaustion, and increased heart rate. This report was non-serious.

HEADACHE/HEAD HURTING; FELT NAUSEA; FELT FATIGUE/TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low blood pressure. 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 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 08-APR-2021, the subject experienced headache/head hurting. On 08-APR-2021, the subject experienced felt nausea. On 08-APR-2021, the subject experienced felt fatigue/tired. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/62 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache/head hurting, felt nausea, and felt fatigue/tired. This report was non-serious.

TINGLING OF FINGER TIPS OF LEFT HAND; HEADACHE; TIRED; ARM PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cat allergy, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug usage and other pre-existing medical conditions included nothing significant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included minerals nos/vitamins nos. On 07-APR-2021, the subject experienced arm pain. Treatment medications included: Tylenol (paracetamol). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced tingling of finger tips of left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of finger tips of left hand on 09-APR-2021, arm pain on 08-APR-2021, headache on 10-APR-2021, and tired on 11-APR-2021. This report was non-serious.

FLU LIKE SYMPTOMS; STOMACH DISCOMFORT; BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,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 flu like symptoms. On 08-APR-2021, the subject experienced stomach discomfort. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 13-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, flu like symptoms, headache, chills, stomach discomfort, and body aches, and the outcome of tired was not reported. This report was non-serious.

HEADACHE; HOT FLASHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and arthritis. The patient was previously treated with tramadol 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: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol for drug used for unknown indication. On 09-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 10-APR-2021, and headache on 12-APR-2021. This report was non-serious.

BLOOD PRESSURE INCREASED; DEBILITATING HEADACHES; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included post-menopause hormone replacement therapy (HRT). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced blood pressure increased. On 29-MAR-2021, the subject experienced debilitating headaches. On 14-APR-2021 09:00, Laboratory data included: Blood pressure (NR: not provided) 150/85 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood pressure increased and headaches was not reported. This report was non-serious.

ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 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 kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye was not reported. This report was non-serious.

SORE THROAT; TERRIBLE COUGH; NO APPETITE; RUNNY NOSE; DARK GREEN MUCOUS; AFFECTING VOCAL CHORDS; FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient was previously treated with apixaban for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced no appetite. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced dark green mucous. On APR-2021, the subject experienced affecting vocal chords. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from sore throat, cough, no appetite, runny nose, dark green mucous, and affecting vocal chords. This report was non-serious.

DIZZINESS; HEADACHE; FEVER; TIREDNESS; SHAKING; GENERALISED ACHING; CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced generalised aching. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-APR-2021, and was recovering from generalised aching, chills, fever, shaking, tiredness, and dizziness. This report was non-serious.

MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and 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 pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.

RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. 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: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone. On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.

HAND EXTREMELY COLD; SEVERE CHILLS/TEETH CHATTERED; FREEZING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included leukopenia, hypothyroid, and epstein barr, and concurrent conditions included unspecified allergies, chronic medical condition, non alcohol, non smoker, arthirits, high cholesterol, gastroesophageal reflux disease, fibromyalgia, food allergy, animal allergy, nickel allergy, and degenerative disc disease, and other pre-existing medical conditions included the patient is on thyroid medication, no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner, calcium for general health, fish oil for general health, vitamins nos for general health, levothyroxine sodium for hypothyroid, and fluticasone for unspecified allergies. On 21-MAR-2021, the subject experienced hand extremely cold. On 21-MAR-2021, the subject experienced severe chills/teeth chattered. On 21-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand extremely cold, severe chills/teeth chattered, and freezing on 22-MAR-2021 04:00. This report was non-serious. This case, from the same reporter is linked to 20210342283. Additional information was received from (patient) on 13-apr-2021 .The following information was updated and incorporated into the case narrative; Events details ,disease, concomitant product

PT CALLED C/O NUMBNESS/TINGLING LEFT ARM FROM FINGERS TO SHOULDER 2 DAYS AFTER SHOT; HAD DIZZINESS FOR ABOUT 3 DAYS; FATIGUE; HAS HX OF HEART FLUTTERS BUT GREATLY INCREASED AND CONTINUES NOW; KNOT IN ARM JUST RESOLVED YESTERDAY

Patient called stating she began having severe nausea and pounding headaches 1 week post-vaccination. She said she went to urgent care due to nausea. They tested her BP and it was fine. Said she is still having the headaches now, 1 week after they started.

HEADACHE; SICK TO STOMACH; BODY HURT/COULD NOT MOVE/FELT LIKE A SEMI HIT 5 TIMES; START TO THROW UP; SICK FOR 2 DAYS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sick for 2 days. On 09-APR-2021, the subject experienced body hurt/could not move/felt like a semi hit 5 times. On 09-APR-2021, the subject experienced start to throw up. On 09-APR-2021, the subject experienced sick to stomach. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body hurt/could not move/felt like a semi hit 5 times, had not recovered from sick to stomach, and the outcome of headache, sick for 2 days and start to throw up was not reported. This report was non-serious.

SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 19/MAY/2021) dose was not reported, administered on 06-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced crawling sensation. On 06-MAR-2021, the subject experienced cold. On 06-MAR-2021, the subject experienced sore arm at site of injection. On 07-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation, and cold on 07-MAR-2021, slight headache on 08-MAR-2021, and sore arm at site of injection on MAR-2021. This report was non-serious.

FLUSHED; WATERING EYES; SUNBURN-LIKE RASH; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd from 911 exposure, asthma, chronic rhinitis, thyroiditis, lipidaemia, codeine allergy, and levaquin allergy. The patient experienced drug allergy when treated with betamethasone, ciprofloxacin, and bupivacaine hydrochloride/epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flushed. On 10-APR-2021, the subject experienced watering eyes. On 10-APR-2021, the subject experienced sunburn-like rash. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, and sunburn-like rash on 11-APR-2021, and watering eyes, chills, and low grade fever on 12-APR-2021. This report was non-serious.

COUGHING; SORE THROAT; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ 1805020, and batch number: JJ 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced coughing. On 12-MAR-2021, the subject experienced sore throat. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing and sore throat was not reported. This report was non-serious.

ALLERGIC REACTION; HEART BEAT ELEVATED; FATIGUE; GLASSY EYES; LETHARGIC; RUNNY NOSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included advanced multiple sclerosis, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced glassy eyes. On 14-MAR-2021, the subject experienced lethargic. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced heart beat elevated. On 17-MAR-2021, treatment medications included: loratadine. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, had not recovered from glassy eyes, runny nose, heart beat elevated, and allergic reaction, and the outcome of lethargic was not reported. This report was non-serious.

My wife has been sick for a few days with a slight fever, chills, weakness and cough. We figured she may have caught the Flu. Today she woke up and had no balance with the other symptoms listed. They went over her symptoms with her and gave her a rapid COVID test , according to their test she was found to be POSITIVE for COVID-19. Just can't understand this as she received her vaccination on the 7th.

1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/2021. Presented to ER on 04/25/2021 w/ a 2 day history of shortness of breath and some chest tightness worse with exertion, with worsening symptoms at time of ER visit. Admitted for observation with "Pulmonary embolism without acute cor pulmonale and Acute respiratory failure with hypoxia"

I had a headache and fever of 101.6 the night of the vaccine. I also had fatigue. All that was expected. I am surprised, however, that I am still feeling very fatigued 19 days later. This is not serious, but I thought that reporting the data could help. My guess is that I am very tired as my immune system is building its immunity, but that?s just a guess.

Day vaccine was administered to patient the only effective on that date was Tired and drowsiness were experienced. in the late afternoon this condition was only intensified . The next business day was difficult due to a Migraine that was in full force on that Friday. Patient was unable to perform any actions including Work from home. Patient slept for the next 20 hours. Other than sleep no other actions were committed. On that date 3/19/2021 it was noticed that her eyes were sensitive to Light and were also very puffy.. On the Sunday there was little and or no change still sensitive to light and the puffiness was still felt but the eyes were so swollen that it was almost impossible to open them. The Urgent care patient went to on the Sunday was the initial with Healthcare facility

FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. 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. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious

RIGHT GLAND BESIDE THROAT WAS SORE AND TENDER TO TOUCH BUT TOLERABLE; SLIGHT AND INTERMITTENT HEADACHE; FELT LIKE WHOLE MUSCLE EXPANDED AFTER THE INJECTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and sinus. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced felt like whole muscle expanded after the injection. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced right gland beside throat was sore and tender to touch but tolerable. On 22-MAR-2021, the subject experienced slight and intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like whole muscle expanded after the injection, and right gland beside throat was sore and tender to touch but tolerable on 24-MAR-2021, and had not recovered from slight and intermittent headache. 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.

SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.

MIND FOGGY; SHORTNESS OF BREATH; HEART RACING; UNABLE TO MOVE AROUND; CHILL; FATIGUE; FEVER; MUSCLE PAIN; VERY RED VEINS ON RIGHT LEG LOWER PART/RED VEINS ON LEFT ARM LOWER PART BETWEEN WRIST AND ELBOW; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, 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 very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. On 06-APR-2021, the subject experienced shortness of breath. On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced unable to move around. On 06-APR-2021, the subject experienced chill. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscle pain. Laboratory data included: Pulse rate (NR: not provided) 92 /min. On 16-APR-2021, the subject experienced mind foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, fatigue, fever, and muscle pain on 08-APR-2021, was recovering from shortness of breath, and unable to move around, and had not recovered from heart racing, mind foggy, and very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

Exhaustion, weak balance, foggy brain within 24 hrs. of vaccination. Neck pain (right side) within 1st week.

After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision and then my hearing....I called for help. They took me in a room to lay down and said my blood pressure had dropped vary low. After an out of doing better I just needed t get home. So another hour passes and I get home, go directly to bed and what seems like a bad flu begins. That night my temperature continues to climb, the aches and headache are horrible. I continue fevers for 3 nights. Feel a little better and then with 2 days it relapse and all starts again. I am in bed for 1 and 1/2 weeks, then stay home due to continued headache, dizziness. After 3 weeks the dizziness continues and I then start getting an aching pain in the back of my left leg. Seeing my doctor on May 11th and hope to discuss.

Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours. Lasted 20 hours or more. Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak. VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours. Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked) Fatigue unable to work until 5 days later.

Hives, rash, slight difficulty breathing, partial reduction in taste, fatigue, headache. 2 rounds of prednisone, benadryl, zyrtec

Broke out in hives over entire body except the face. Large splotches, intense itch, elevated skin temperation. Took Benadryl, contacted pharmacy. Benadryl treatment for four days, on the fifth day symptoms began to subside. Came down with Covid sick in bed Sunday, April 11 after 4 p.m.

VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. 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 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression. On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.

immediately my tasted buds were effected and I could not taste food. I could feel my taste buds go numb as soon as I got the injection or at least that is the best way I can describe it. I started getting fever around 6pm and felt like I had a cold. Runny nose and sore throat. My fever went up to 104.8 for about 3 hours then came down to 102.5 for the remainder of the first night. Felt better the next day on 5/11/21 but got a fever again that night. Today I feel a little better and my taste buds seem to be coming back a little.

Sudden rapid heart rate , sweat , nausea, light headed , almost passed out . Ems was called . vitals returned to normal while in ambulance . No further heart fluctuations. A month later tinnitus has begun . I?m currently being checked by an ENT to find out why . No previous tinnitus issues .

patient developed extreme fatigue, rash, fever , chills and swelling of lower extremities within few days of receiving vaccine. Also had red rash scattered on lower extremities extending from knees down to her feet.

First I had the itching and I came home and took a Benadryl and it subsided. The next day, I woke up stiff as a board. Everything hurt. Like I remember having the flu - feeling you get when joints etc. hurts all over. I took Tylenol - maybe took 1000 mg twice in that day. I have fibromyalgia and this was over and above that. The third day, the injection site on arm really hurt. The fourth or fifth day, the cough started - first a little irritation and then I started coughing and rattling and I have had the cough ever since. I have seen my doctor four times in the last month to get medications that work. I had to go to the walk in (Urgent Care at the clinic on Weekends) this Saturday (5/15/2021) and get this new medication that seems to be working - it's a steroid - it's Levaquin . Although, yesterday, I still had that overall body hurt (I was in bed all day) - could have been side affect of medication but today (after two doses) seems to be better and I'm not coughing as much.

LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 153 centimeters. The patient's past medical history included left ankle injury, and leg cramps, and concurrent conditions included seasonal allergy, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. history of taking birth control medication 40 years ago but she stopped it since then due to severe leg cramps. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. On 15-MAY-2021, the subject experienced leg cramps. On 15-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine a was not applicable. The patient recovered from leg cramps on 15-MAY-2021, and had not recovered from tiredness. This report was non-serious.

I experienced the next day, had chills and slight fever, lasting 6 hours. Then on April 8 2021, I developed shingles and I went to urgent care on 04-12-2021, started with rash on my face. No medical tests were done. Today I am still dealing with shingles.

Starting 3/21/2021 Pain, right knee, thumb swelled, terrible joint pain, muscle pain, tendon pains in legs and arms, knee is still swollen. Severe fatigue. In physical therapy

Approximately 5.5 hrs after vaccination - High fever with severe full body shakes lasting about 3 hours followed by a slight fever of 99.7 for about 16 hours, severe headache lasting about 24 hours, Full body aches lasting about 16 hours, tiredness lasting about 36 hours, moderate headache lasting about 3 days.

Immediate reaction = headache 4 hour reaction = increasing fatigue, headache 12 hour reaction = headache, joint aches, fatigue, fever 101.4 24 hour reaction = headache, fever gone, excessive fatigue and joint and muscle aches 24-72 hour reaction = headache, excessive fatigue, joint and muscle aches, bloating with intestinal discomfort Day 5 - 96 hour - symptoms improved, mild fatigue and joint aches, mild headache, able to do daily activities Day 5 - 10 pm = fatigue, headache, and joint aches increased Day 5- 11 = extreme excessive fatigue, joint and muscle aches, bloating and intestinal discomfort, mild headache - unable to work or perform daily activities Day 11- 17 symptoms improved slightly to allow some resumption of daily activities, intestinal symptoms include alternating diarrhea with constipation, joint and muscle aches prevent any return to walking and exercise, minimal work tasks completed Day 17-22 Symptoms the same as week before - becoming chronic - visit to MD on April 29th. Day 23-47 Treated with combination of Zyrtek, Pepcid, and Probiotic due to sensitivity to steroids. Symptoms gradually improved Day 48 (May 22nd) - first full day of ability to resume normal activities, including walking 2 miles (previous to vaccine was running 3-4 miles 3-4 times a week)

After week 4 I got bronchitis. I started feeling fatigued and I needed to be on antibiotics. I had to start another round of antibiotics after the first. I'm still not feeling well and I'm still feeling fatigued. I also have a cough and feel congested.

I have had a cold and cough ache and headache and vomiting from coughing, since 05/01/2021 it started with a scratchy throat then went into a bad cold and cough, it appeared like it was starting to go away and then it started all over again with the scratchy throat and quickly back into the cold symptoms cough and headache and coughing so hard I vomit again. As of today after taking antibiotics, prednisone robitussin dm , fluticasone propionate nasal spray and benzonate capusules. I am not getting any better.

fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine going through entire body tiredness hoarseness, heavy breathing 6 weeks after vaccine

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecified convulsions

It started with body aches, headache and sore arm at injection site. Left side -left leg started getting swollen - it started in middle on knee part - the swelling went down my leg to my ankle and up my leg; up my thigh . It was like there was fluid in my leg. There was no pain. It went like that for 1 1/2-2 months. Just had to let it run it's course. I was being treated for it and had tests run to test for blood clot. She prescribed 800 ibuprofen for it; that didn't work. That same day of the vaccine, I also broke out with a fever - 102. And fever blisters all over my mouth. I had those for about a week.

I had a very bad headache and soreness at the site of the injection for a couple of days after the shot. Since then, I have felt tired and out of breathe. I also felt some angina. I had a cardiology exam and no problems were found.

JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. 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 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.

62 YO female presents to the ED on 6/4 with complaints of non productive cough, chest congestion, post-nasal drip, nasal congestion, chills, SOB, sinus pressure, and sore throat. Denies fever. COVID rapid test results back negative the same day. Vitals were stable and pt was discharged with COVID-19 diagnosis. She is s/p J&J vaccination on 5/11.

6 days after vaccine after having no symptoms at all I suddenly felt nauseous about 9 p.m. Went to the bathroom and can't remember what happened next as I passed out. Fell hard and knocked shower out of track. Woke up throwing up massively. My husband ran in and helped me. I threw up a lot and had chills. After cleaning up, went to bed and piled on blankets. Woke up again sometime in the 11 to midnight range and threw up once more. Still chilled. About 3 a.m. I woke up and removed all the blankets as I felt okay again. I never found a place to report this in my daily reports as within 24 hours I felt normal again. I am 100% positive this was a reaction to the vaccine. I did not need to seek medical treatment as it passed within 6 hours or so.

MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT SIDE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced migraine on right front side. On 10-JUN-2021, the subject experienced feeling sleepy. On 10-JUN-2021, the subject experienced lack of energy. On 10-JUN-2021, the subject experienced headache on right front side. On 10-JUN-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 7. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on right front side, feeling sleepy, lack of energy, headache on right front side, and fatigue on 11-JUN-2021. This report was non-serious.

I had a lot of fatigue after my vaccine which is common for me after an influenza vaccine (which is why I no longer get them) and common for others with chronic fatigue syndrome for the fatigue to last longer than for other people. I have hypothyroidism and my antithyroglobulin and anti TPO antibodies have been tested two or three times over the past 3 years or so. They've always been either in range or very close to the bottom of the range. In February of 2019 TgAb was 6.4 IU/mL and TPO was 12 IU/mL . When I was recently (I used this for the vaccine reaction date) tested TgAb had jumped to 145 IU/mL and TPO was down to 1.0 IU/mL. I have no idea why one would jump and one would go down, but I mentioned it to a person following up with me from the CDC about my vaccine and they felt that I should report it to VAERS in case others had a similar experience or to help better understand how it might affect autoimmunity. I had a thyroid ultrasound yesterday to rule out any issues with a hot nodule although no nodules are palpable.

Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and had the following symptoms: headache, fatigue, nausea, body aches, loss of taste. She recovered after a few days and was doing well until 6/11/21. She began having the following symptoms: migraine headache, nausea, dizziness, loss of appetite, blurred vision, weakness, loss of taste, muscle weakness and joint pain. She went to ER on 6/13/21. They did a cat scan and ekg, both came back normal. They did not do a covid test. She then went to her regular Dr. on 6/15/21 and he gave her topiramate. He did not do a covid test. She was off work for a week and returned to work on 6/18/21. She is feeling better now and has worked for the last two days. She came to pharmacy and told me what was happening and she thinks that her symptoms are from the original J and J covid vaccine on 3/7/21 and she is worried that she may have recurring symptoms for the vaccine

Swelling, redness and soreness and a knot in vaccine site for a month. As of today I still have a knot under the injection site and soreness. Cannot sleep on that arm and some pain with active or not. Achy joints and fatigue.

Fever, Chills, Headache, Muscle pain, extreme fatigue for 8 days. Continued with chills and extremem fatigue for 8 more days

Chills. Headache. Nausea. After 6 hours of symptoms, I took Tylenol and felt normal 30 minutesl later.

Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, twitching, spasms, neuropathy in feet, low appetite, fatigue, weakness, tired eyes, blurry vision, heart palpitation when lying on either side at night, hypo thyroid

Wheezing; cough; similar symptoms to a cold but more attributed to asthma. Prednisone to treat - two week course - I had saw two different doctors and they gave me two different dosages. The first one was two pills a day for five days. The second was six pills for seven days and then tapered off. Codeine with cough syrup and Singulair, as well, to treat. It's been two weeks and I'm just now hearing my voice kind of get back to my normal tone. Still having symptoms but milder.

On April 2nd I woke up with chills, run down and achy. July 4th I began having a sore throat, bad headache, next day it was worse, runny nose, cough and congestion. I went City MD to see if I had the Delta Variant- was negative, but I was given a z-pack but I am not able to take that-I asked the dr if I can take the Amoxicillin I had at my house and they stated that would be fine

After receiving the vaccination I started experiencing a dry cough and problems breathing 3 months after. I visited the ER for the severe symptoms and was tested for COVID 19 to ensure I did not have another variant. I tested negative.

On June 14 I woke up with dry and sore throat the next day ears, eyes,head and body ache started. I waited 4 days and didn?t feel any better decided to visit my Dr. She didn?t find any infection she still gave antibiotics just Incase after two sets of antibiotics and pain medication I still feel the same I am hurting all over and am extremely tired all the time I have sharp pain shooting from back of my neck to the bottom of my scalp and my shoulders. My legs are heavy and tired. Over all I don?t feel good at all. It has been a month and not much improvement. I tested negative for covid about two weeks ago.

headache, left side of face was numb, tingling, weak right leg. this was all within a few days of receiving vaccine. I am now 3 months in, and continue with facial numbness on both sides of face, and weakness in right leg. These symptoms come and go, but I have them frequently. I might be a few days between the symptoms, but they always come back.

Patient presented with fatigue and SOB starting about a week after vaccination. Was admitted to hospital SOB. No evidence of TTS. Progressive ARDS and death in 2 weeks after admission. Microbiology negative. No aetiology identified.

Headache started at 4:oopm on Friday, July 23, 2021 and then light headed feeling. Started sweating at 6pm. Started vomiting around 6:15pm and have continued vomiting through Sunday. Patient took excedrin on Friday, for headache. Patient tried to take pepto bismol on Saturday and ant acids on Saturday, but she has had trouble keeping them down. She hasn't been able to keep food or drink down successfully until only a small amount of water on Monday, July 26, 2021. She has been in the bed and is still very light headed as of 1:oopm Monday, July 26, 2021.

Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue 03/07/2021

I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon.

Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.

Severe chills, body ,muscle, joint aches, fever and sweats. Some stomach cramping . These all lasted 7 hours. Next day still body aches, headache and fatigue.

Fever, chills, and vomiting the evening of the vaccine administration. Symptoms continued into the following evening. Fever broke early morning of 3/8/2021

After receiving the vaccine, the patient experienced tickling in the throat. Benadryl was given and patient soon felt fine

Day 1 - received injectionwithin a fe minutes of administration I noticed a slight lightheadness and feeling "off" within half hour slight nausea began and headache began within hour muscles aches began with joint pain. Above symptoms progressively worsened by midnight was in pain and could not sleep. no fever. took tylenol and only had moderate relief. Day 2 -entire day severe muscle and joint pain - worst headache of my life, severe nausea and chills - no fever. double vision and dizzy Day 3 - same as day 2 - in evening - around 7 pm headache lessened so that it was tolerable with tylenol - muscle aches jopint pain the same Day 4 - headache tolerable, was able to eat. muscle pain better but joint pain still sharp Day 5 - headache sporadic and better - fatigue and muscle pain would come and go, joint pain not as sharp, extreme fatigue Day 6 - extreme fatigue - other symptoms much better

My symptoms were muscle aches and pains, headache and nausea. it started about 10 hours after the injection and lasted about 36 hours. Thereafter I was just very tired for 24 hours. I took an Advil about 10 hours (around noon) after the headache set in, which lessened the headache.

The patient reported to the pharmacist that she was feeling sweaty and nauseous after receiving the vaccine today. She stated she got sweaty immediately after administration and experienced nausea during her 15 minute observation period. The pharmacist requested patient to stay for observation for another 15 minutes which she did. At the end of that period, the patient stated she felt fine and was ready to go home and sweating and nausea had gone away.

Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vaccine, i awoke with all-over body aches and a mild headache. I slept 3 more hours and woke up with all of the previous symptoms at once. I felt moderate malaise and these symptoms for 24 hours. I had a sore arm for 4 days.

The night I received the shot, I felt "achy" and took two Tylenol and went to bed. I woke up the next morning with a headache, chills, runny nose, fatigue, and nausea. I took an allergy medication and stayed in bed. This lasted all day. I woke up the next day feeling fine, except for the constant runny nose. Also, on that day, I started having "floaters" in my left eye that I never had before (probably unrelated but I want to let you know).

woke up not feeling well, little dizzy & chills, diarrhea. Got worse the next day with nausea & headache.

Body aches/quite severe, nausea, chills, headache beginning 4 hours post-injection and lasting 30 hours

6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired.

Starting at 0100 on 03/11/2021. Awoke with symptoms of fever with chills, headache, neck and back pain (moderate to severe), pain in what seemed the bones of the skull and mandible (moderate to severe), nausea and vomiting, unable to take fluids, unable to sleep besides 60 mins. 24 hrs post vaccine. Vomiting lasting 12 hours and nausea continued without ability to take fluids. Dr. prescribed Zolfan and after the first dosage, fluids were tolerated. Fever lasting less than 48 hours, muscle soreness was mild by 48 hrs and continues as mild at this point, 78 hrs hrs post vaccine.

About 5:30 PM, about eight hours after I received the shot, my temperature started to go up and got as high as 102.1. My usual body temperature is 96.7, not 98.6. I had chills. And about midnight my fever broke and started to go down. This morning it was back to being around 98 but now at about 2:30 PM it?s gone back up to 99.

Janssen COVID-19 Vaccine EUA Based on the paperwork I received at my vaccination, I am reporting my side effects for your records. I received the dose (1805029) on 3/12/2021 (Friday) at 4:30 in the afternoon. At around 10:30 p.m. I began to feel unwell with chills, shaking/tremors of my hands/arms, and overall aches. I had trouble sleeping through the night due to these symptoms in addition to night sweats (fever). These conditions persisted through the next day (Saturday) and evening (24 hours). I managed to sleep 8 hours and had only a headache the following morning (Sunday). I treated my symptoms by taking Tylenol which was helpful. Hope this helps with your research/records.

Headache over the left eye that caused caused stabbing pain in the left and eye was sensitive to touch like when you have a sinus headache. Took two ibuprofen and rested. Took two hous to gio away.

5-6 hours after vaccine-mild muscle aches, temperature elevated but above 100. About 8 hours after injection, muscle ached and so was chilled but felt ok otherwise. FitBit alerted me that I was earning points for being in my ?active zone? even though I was just watching tv - resting heart rate is 66 (actively exercising, heart rate is usually less than 120) but it was 136+. HR stayed elevated ( Verified HR with pulse oximeter) while I was not doing anything. Took temperature (forehead thermometer) and it was 103F. Took Tylenol. Heart rate slowly went down after Tylenol kicked in and fever came down to 101. Heart rate stayed a little higher than normal and fever lasted 24 hours. By 48 hours, all was well.

About 5 hours after the injection I started feeling funny. About 6 hours after the injection I had severe chills and shaking / spasms that were so severe I couldn't even hold or drink a glass of water. I believe I was running a high fever and was having trouble keeping the thermometer in my mouth because of the spasms but it did get up to 103.4. By morning, my temperature was down to 99.9 and I continued to run a temperature for 48 hours. My normal temperature is 97.2. I also had for fatigue for about 5-6 days but it was minor.

Janssen COVID-19 Vaccine EUA Severe pain developed about 6 hours following injection in central region of upper back, and at lowest ribs. Moderate pain developed in mid-abdomen. Duration of pain 8-12 hours. Unusual fatigue developed about 6 hours following injection, duration of fatigue about 5 days.

Received shot on 3/11/2021 felt okay, a little tired. 3/12 extremely tired - no energy, 3/13 felt a lot better but had a little sore throat, 3/14 extremely tired sore throat mucus drainage down throat, 3/15 tired no energy, sneezing, dry cough, 3/16 tired no energy sneezing dry cough. Today 3/17 finally feeling better but still a little tired.

Felt feverish and achy with chills and extreme fatigue beginning at 10:30 pm on 3/12 and lasting all day Saturday 3/13. Treated by alternating ibuprofen/aspirin every 3-4 hours. Fever was gone by Sunday morning, although extreme fatigue and head fog lasted the entire day. Felt completely fine by Monday morning - 3/15.

Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea; I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night. Felt very drained and tired with myalgia all of the next two days. Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head (and I have not had a cold since November 2019). I had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.

Fatigue, aches, nausea, cotton mouth, headache, wheezing, loosing voice, and arms and legs feel heavy. Called doctor the next day (the 16th) for medical advise, was told to drink coffee and take tylenol due to aspirin allergy.

Patient presented to clinic for Covid-19 vaccine. Patient started complaining of chest pain 5 minutes after vaccination. Patient denied shortness of breath, but states the pain worsened with deep breathing. Patient denies other complaints or symptoms. Vital signs stable and work of breathing normal. RN auscultated lung sounds, upper lobes clear bilaterally. Blood sugar 227. Patient states she has diabetes and hypertension. Patient kept closing her eyes, RN encouraged patient to keep her eyes open, but patient kept stating, "I'm tired." RN notified provider, provider in to assess patient. Per provider, patient to go to ED via EMS. Patient's husband notified and arrived to clinic to be with patient. RN contacted EMS and report given.

chills for approximately 12 hours, thru the night; back muscular pain for same amount of time. weak.

Janssen COVID-19 Vaccine EUA. extreme lethargy and headache began later in afternoon on day of vaccine. Headache became worse, and fever during the night. By morning dizziness, extreme fatigue, severe headache and stomach upset which continued throughout day and night of second day. By third day symptoms had subsided some but still incapacitating. By fourth day better but symptoms still there, kind of how a hangover feels. Each day since there has been a little more improvement. Received the shot Tues. morning. Now it is Sunday morning, and still some fatigue and dizziness, but headache is gone and stomach better. Only medication I used during severe symptoms was tylenol.

Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had fever of 101 and became very weak and tired. I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours. On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever. My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection. I felt weakness for approximately 3 days after the injection. I am currently recovered from all symptoms as of March 22, 2021.

Low grade fever the night of the vaccination. Redness, tenderness, and swelling just below the vaccination site began day following vaccination. The redness eased a bit but developed into a hard lump the side of a quails egg in the same location.

Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to my scalp. At bedtime, around 10:30 pm, I could not fall asleep, was freezing, achy, in and out of sleep. Took temperature at around 2:00 AM. My temp was 102 deg. F, my pulse was at 125 bpm. I could feel my heart rate beating rapidly. Was still dizzy. At around 6:30 AM, my temp was 101.9 deg. F. Stayed home from work. Got out of bed around 2:00 PM. As I went to the restroom during the morning, early afternoon, my temp gradually decreased, my heart rate gradually decreased. Still had headache. Was very fatigued. The next day, my temp was normal, had mild headache and was still fatigued.

3/14/2021 Goosebumps, shivering, fever (101.8), headache, nausea, achy. Took Tylenol and it helped for about 3 hours. 03/15/2021 Woke up with symptoms again around 2:30 am and took Tylenol. Woke up around 8 am with slight headache and VERY tired. Kept a nagging headache and "brain fog" all of the day and tired. Took Tylenol and it helped some. I felt a bit foggy all day even with Tylenol. 3/16/2021 Still felt tired with a bit of a headache on and off. Took Tylenol and it helped. I don't take meds often so I just took 500 mg Tylenol, 1 tablet. I am healthy with no underlying conditions and do not have reactions to the flu shot. I expected the same with this shot.

Started with chills, fever ,Nausea aches and pains for 2 days went into full sinue infection, weal and its been 5 days,

The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced feeling chilled all night long. It ended by morning. I had one bought of mild diahrea the next morning. Then all was fine.

I exp shaking and headache lasted few hours . I went to the doctor on 3/17 had a UTI(which is not normal for me).

Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which lasted 12 hours or so).

severe headache. both inner ears ached. trembling - could not get warm. entire body ached - even my fingers

Chills and fever 8:30 pm chills 9:30 pm fever 101 10:30 pm fever 102 11:30 pm fever 103 12:30 am fever 102.5 2:30 am fever 101 7 am headache, took aspirin. Temperature normal. Note that I usually have a low normal temperature, so this fever was very high for me.

I had my shot at 3:45 pm on friday, the 26th of March. at around 6:30 I started to feel nauseous and started to get body aches. Lot of congestion and a runny nose. I also got a stomach ache later in the evening. by the time I went to bed around 10 pm I hurt all over and was very sick to my stomach. I felt like if someone touched my skin my bones and muscles would all shattered. I did not sleep much that night and woke up on Saturday, the 27th with the same symptoms but not quite as bad. I still had nausea and a stomach ache and was very tired and drained. I did start to get diarrheic around 3:30, 4:00. I still hurt and have diarrheic and am very tired today, which is Tuesday, the 30th of March at 5:15 pm.

Pain injection site since day of vaccination, still have pain. Slight fever and chills, body aches, fatigue for 12 hours.

Saturday after shot: felt fine afterwards; no soreness in arm, no other effects. Sunday after shot: started feeling lightheaded/dizzy in the evening; headache Monday -- Friday: fatigue, muscle ache, lots of congestion (nose/lungs) and deep bronchial cough, intermittent headache, intermittent low grade fever -- unable to work. Saturday-today after shot: still fatigue but better; congestion better as well--still congested but cough is relieved (saline nasal rinse helped a lot); no headache; no fever

LOSS OF CONSCIOUSNESS, FAINTED; HEART WAS RACING; DIZZY; VOMITING; CANKER SORE UNDER TONGUE; HEADACHE; NAUSEA; FATIGUE; INFLAMMATION ON LEFT EYE; FALL ON BED; SMALL HIVES UNDER EYE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included seasonal allergies, and codeine allergy. 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 05-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, after vaccination, she felt fine all day and night. The next morning she woke up and felt sick. She had nausea, headache, hive under eye. She laid back down and tried to sleep. A few hours later, she woke up to use the bathroom. She was very nauseous and dizzy. She lost consciousness and fell trying to get to the bathroom. She fell on her bed and was uninjured. The paramedics took her to the hospital. She was given medication for nausea, headache, and IV fluids. She gave blood for lab tests and they came back normal. No COVID test was administered. When she felt better, she was released. A few days later, she discovered her tongue was sore and red. She called her primary care physician (PCP). PCP said the red and sore tongue was probably related to allergies. Two weeks later, her tongue was not sore, but still red. They advised her to get a second opinion with another HCP. She was going to visit her allergy specialist.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, fatigue, inflammation on left eye, and small hives under eye on MAR-2021, and vomiting on 07-MAR-2021, and had not recovered from canker sore under tongue, and the outcome of fall on bed was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from the patient on 23-Mar-2021. The following information was updated and incorporated into case narrative: Patient's medical history added as seasonal allergies and codeine allergy, Vaccination site as left arm added; Additional events as small hives under eye, fall on bed; lab test of blood work added; Event outcome of loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, and fatigue was updated to recovered/resolved.; Sender's Comments: v1: Follow up information received updates patient's medical history (seasonal allergies and codeine allergy), Vaccination site as left arm; Additional events (small hives under eye and fall on bed), laboratory test (Blood Work); Event outcome (loss of consciousness, fainted, heart was racing, dizzy, headache, nausea and fatigue was updated to recovered/resolved). This updated information does not alter prior causality assessment of reported events 20210323730-COVID-19 VACCINE AD26.COV2.S-headache, nausea and fatigue. These events are labeled and are therefore considered potentially related. 20210323730-COVID-19 VACCINE AD26.COV2.S-loss of consciousness, fainted, heart racing, dizzy, vomiting, canker sore under tongue. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are no information on any other factors potentially associated with the events.

Severe chills, fever, headache, neck pain, bad taste in mouth, severe nausea, dry retching and abdominal pain. The severe nausea and abdominal pain continued for 1 1/2 days. I still have some nausea and intermittent abdominal pain.

Backache (moderate), stiffness in legs (moderate), cold chills with shaking (moderate), Headache (mild) Side effects gone by morning of 4/2/21. Note: legs are most affected by MS, though mild. Still ambulatory. Thinking legs were affected due to existing weakness from MS.

At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hours. Kind of dizzy feeling. The next morning I was very tired. As time progressed, I felt like I HAD to be horizontal. No energy at all. No appetite at all. Took my temperature and was shocked to see it at 101.4º. Pharmacist suggested I take aspirin, which I took one, and then another one several hours later. It did help and reduced the fever to 99º. The following day the temperature remained at 99º but under 100º. (I never took any other aspirin other than the two that I mentioned). The third day I was good to go!

next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy, stomach was queasy, very low energy, croupy cough, nose runny, no stamina for long walks Was ok 2 days and then it started again off and on till 3/31. Sometimes stomach felt sick, couldn't eat much. Finally feeling better in stomach but still getting headaches. Still have little stamina and very low energy and headaches make it hard to think, runny nose, croupy cough comes and goes. Teleconference with Dr. on 3/23/2021 Saw family Dr. 4/2/2021. Saw no urgent needs, just noted side effects

Area around injection site firm, red and tender and remains that way as of 04/04/2021. Also had joint pain and fatigue.

Severe headache, chills and fever, muscles aches, muscle spasms. Headache, chills and fever lasted until about 5am 4/2/2021. Muscle spasms lasted until about noon on 4/2/2021 and muscle aches lasted until about 7am 4/3/2021. Took Tylenol which didn't affect symptoms until the second dose.