Johnson & Johnson

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.

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.

Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly. This happened about 30 minutes after the shot. I also was very nauseous the next morning.

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.

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.

Janssen COVID-19 Vaccine EUA Sudden, strong taste of old coppers pennies in my mouth. Taste lasted the rest of the evening.

patient started reporting tingling in the throat and tongue after receiving vaccine. patient was given 25 mg of Benadryl and was then assessed by a physician. After 1st Benadryl, pt reported that tongue tingling improved but lips felt itchy. On exam, pt had a perioral rash. Benadryl 25 mg x1 given. 10 minutes later, rash was still present. Kenalog 40 mg IM was given. 30 minutes later, rash improved and patient doing well. she was discharged on prednisone 20 mg daily x 3 days.

That night while watching television, right eye started tearing up, watery, glazed, eyeball felt sore. On Sunday morning had redness like hemorrhage, in the eye. She had no swelling or pain. The eye looks unsymmetrical.

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.

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.

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.

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 received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am on April 6th, I woke up hot and itching. I had a under the skin rash on my arms and legs with little pin prick spots my tongue was tingling. I took Benadryl. It was better in the morning but still visable and tongue was tingling. I took more Benadryl around lunch time.

On 3/22 started exp swelling on eyelashes left eye. I woke up on 3/23 entire left eye was red, swollen and pain. I called went into see Opthamologist said it was cellulitis referred me to ER. I went to ER had CT scan done ruled out cellulitis stated it was upper eyelid swelling sent home do hot compresses. On 3/24 seen, said it was stye and discharge apply heat, prescribe Tobramycin to eye rest of the week. I seen my Opthamologist on 3/29 said it was stye continue hot compresses wear no makeup. I called back on 3/30 symptoms worsened my eye appeared droopy. The work I do selling jewelry on live caused me to exp issues on the computer. I started seeing flashes causing me to get off computer. As of 4/7 still exp droopy on left eye and got darker tint added to my shades so people wouldn't notice.

-Within first day through 1 week: dry mouth, excessive thirst, thick mucus, skin sensitivity, dizziness, hyperactivity, hypervigilance, insomnia, irritability, -Persistent even 4 weeks after vaccine: confusion, increase in autism symptoms of sensitivity, "scrambled propioception sensory symptoms", "mismatch of emotions"

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

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.

Patient complained of feeling a dry mouth and blurry vision. She felt that this was a sign of an allergic reaction. EPI pen was administered and patient was brought to the emergency room.

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

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.

Pt reported feeling dizzy, blurry vision, chest pain directly after vaccine administration, while sitting in chair, 911 called, , ambulance arrived, pt refused ER transfer. Pt reported feeling better and went home with husband.

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

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.

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.

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.

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

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.

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.

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.

Patient reports that she had pain behind her eye. Went to hospital and was diagnosed with having a stroke. Patient states she lost sight in her left eye and is still blind in her left eye. Optometrist states patient will not regain her vision in her left eye.

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

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.

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.

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.

Developed visual loss to 20/800, double vision, oscillopsia, ataxia, dysarthria Symptoms started with difficulty with speech and loss of depth perception on 04/10/2021 (7 days after COVID vaccine shot) Trial treatment with Solu Medrol 1 gm 5 days and Gammaglobulin 0.4 mg /kg for 5 days. No significant improvement except vision went from 20/800 to 20/400

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

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.

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

Janssen COVID-19 Vaccine EUA Sloughing of skin of roof of mouth - has pealed off 3 times in 2.5 weeks white bumps on tongue - as if some taste buds have died Sensitivity of inner lips to acidic foods and mouthwash

Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: recieved shot at 3:10pm, patient reported severe arm pain, nausea, blurred vision. 1st bp: 96/66 pulse 64 at 3:34pm, 2nd bp:102/68 pulse 62 at 3:50pm, 3rd bp 122/76 pulse 68 at 4:04pm. advised pt not to drive and left pharmacy around 4:10pm, observed patient for over 30mins due to use of epipen for cipr allergy in past

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.

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

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.

Watery eyes, dripping like they were running, and they were dark red and teared up constantly had to have a Kleenex all the time. Had COVID in December 28, 2020

Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine

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.

Tingling around nose and mouth. Cold water given, reactions are starting to be relieved after drinking water.

Complete loss of taste and smell when I woke up on May 17 at 6 a.m. It is now June 14, and I still have complete loss

SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. 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 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.

EXTREMELY ITCHY EYES; BLURRED VISION; 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: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-JUN-2021, the subject experienced extremely itchy eyes. On 04-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely itchy eyes, and blurred vision. This report was non-serious.

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

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.

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).

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.

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.

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.

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.

PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.

EAR ACHE; LARYNGITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female. Initial information was processed along with the additional information received on 16-JUL-2021 and 19-JUL-2021. The patient's weight was 137 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user and non smoker and also the patient was healthy. The patient experienced drug allergy when treated with codeine 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: 1805018 and expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the patient underwent a covid-19 test and on 14-JUL-2021, the results came as positive (suspected clinical vaccination failure and suspected covid-19 infection). It was reported that the patient's covid-19 symptoms started with an ear ache, scratchy throat and laryngitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure, ear ache and laryngitis was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint -90000186156.; Sender's Comments: V0:20210733616-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

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

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.

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

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

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.

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

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.

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.

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.

covid-19 janssen shot given and seated in observation area. pt in observation area appeared faint and eyes rolled back. RPH, EMT, and store management all called to scene. Pt was monitored and clear to drive home.

The day following the vaccine I started feeling pressure in my ears. It increased as my head moved and interfered with my ability to hear anything. I'm used to plenty of tinnitus but this was much louder and I don't usually have the pressure.

Severe mouth ucers began to develop, resulting in taking prescription ofValacyclovir HCL 1 Gram tablet, 2 tabs every 12 hrs orally 1 day, beginning 3.14.2021. No relief. Mouth ulcers remained and lips swollen and cracked. 3.18.2021 via telemedicine visit, Dr prescribed Lidocaine 2% Viscous soln 15 mL as needed every 3 hrs mouth/throat 5 days. Also Famciclovir 500 MG tab. 3 tabs by mouth ever day for 2 days. (To be used if no improvement with Lidocaine solution) Did not use prescription Significant improvement, but still sore up until approximately 4/04/21

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.

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.

40 minutes after receiving shot, patient was home and felt swelling of the tongue, slight difficulty breathing. She called 911, EMS did full evaluation on her (vitals included) and said maybe she was just having an anxiety attack. EMS instructed her to take Benadryl. Patient did not want to. Patient called pharmacy and explained symptoms to me, the pharmacist who administered the shot. I told her it sounds like it was related to the vaccine and that I would report her reaction to VAERS. I told her it might be a good idea to take Benadryl.

10 minutes after the vaccine was administered she reported a bad taste in her mouth. The taste kept getting worse until her mouth was numb.

Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallowing, hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS, patient was responsive when sent in ambulance to ER.

Patient reported about an hour after the injection she developed a dry mouth, lip felt swollen, and she had a metallic taste in her mouth.

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

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.

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.

Blurred vision. Near vision suddenly and drastically became blurred and remains so. The degradation of my vision was so bad that I went from wearing readers that were only a magnification of only a 1.25 to suddenly, readers that are a 2.5 magnification just to be able to read standard font.

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

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

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.

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.

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.

severe eye pain left eye 9 days after the vaccine then periorbital swelling and increased intraocular eye pressures and thrombocytopenia platelets 63,000. Saw ophthalmologist who diagnosed idiopathic periorbital inflammation; no fistula or infection seen by mri/mra and carotid angiogram. Patient was treated with prednisone and platelets came up to 130,000 and improvement in pain and swelling and intraocular pressure dropped from 50 to 14.

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.

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.

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.

Change in vision.. right eye... pain and white lines.. peripheral.. heaviness over both eyes still present from shot although nothing in comparison to first three days after shot.

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.

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.

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.

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.

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

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.

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.

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.

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.

I am deaf in my right ear (pre-existing). Since vaccinated, I have so much noise in my deaf/right ear that I'm having trouble hearing with my left ear. It started the day after the vaccine, then let up for a couple days before returning and seems to get a bit louder each day.

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.

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 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.

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.

She received her vaccine, and on 4/9/21 she developed a severe ringing in her right ear really loud. It then just kept getting worse and worse and then went to the other ear. Then there was a buzzing at night inside her head. She started getting head tremors inside of her head, and it has not stopped as of 4/29/21. She called her doctor and talked to him and he gave her Zyrtec, however, she is very very sensitive to medications so she could not take a lot of it. It didn't help the right ear which is the worst one. The left ear just started to subside a little bit. It has now been on and off, but still pretty severe in the right ear. The head tremors feel like shaking inside of her head which are not apparent from the outside, and the buzzing. She had another phone APT again and she is scheduled to see a specialist an ENT on 5/3/21 as the condition is debilitating. She is not able to sleep, eat or function due to this condition.

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.

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.

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

A few minutes after the patient received dose 1 of the Janssen Covid-19 vaccine, the patient started having trouble breathing, her throat felt "swollen and thick", was shaky, had itchy hands, and her lip was swelling. Her blood pressure was 174/86 and her pulse was fluctuating in the mid-high 80s. I administered 1 tablet of diphenhydramine (25mg) and 1 dose of the 0.3mg epi-pen. After about 7-10 minutes, she said her symptoms started to level out and were no longer getting worse. Her lip swelling started going down by the time EMS arrived. I continuously checked her blood pressure, heart rate, and heart rhythm while waiting for EMS to arrive and take over her care. They took her to the closest emergency room for continued monitoring.

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

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.

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

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.

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

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.

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%

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.

04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to VERY carefully move around slowly for weeks after that (until mid June) I also had ringing in my ears for most of that time pretty severe at first & still present but better that when I was dizzy. I had not had this before & it is quite unnerving. I have been doing PT for the dizziness & it has pretty much subsided. I have also had pain (no rash or lymph discomfort or swelling) just muscular pain in my upper right arm. This started about a month after the vaccination. It is in the arm muscle NOT the bursa. It happens when I have not moved the arm for awhile & I reach for something, etc.. the pain is not severe but obvious (0 to 10 it is about a 4) & goes down to about a 1 after I move the arm around for 30 seconds or so. I have also had pain & a bit of weakness in my legs & a sharp pain in my left beast (not my chest - the upper left quadrant about 1" below my armpit & 3 inches in the breast tissue. It is a single sharp pain (0 to 10 = 7) and only stays for a few minutes.

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.

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.

My gums were inflamed they felt like they were pulling away from my teeth. My gums were discolored. I had cavities and it made the pain unbearable. All my teeth felt loose like they were going to fall out. I went to a dentist but no dentist could prescribe me any medication. It hurt from my ear all the way to center of the jaw. I got some antibiotics from my doctor but soon as I finished the pain would come right back. I did three rounds of antibiotics back-to-back. I went to an oral surgeon and he said the antibiotics were not working and he had to pull two of my teeth. The pain was has been unbearable, it feels like nerve pain. I did have some bloodwork sometime during this but I don't remember when.

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

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.

Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.

Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms. On 7th day, hives with raised red bumps and welts and intense burning itch appeared on lower legs. These gradually spread to upper legs and abdomen over several hours. After taking OTC antihistamine, itching subsided. Rash was gone the following day.

Pt began to have tingling in her tongue within minutes of receiving vaccine. Pt reports allergy to topical benadryl, so benadryl was not administered and two RN's observed patient with Epi on hand should it be needed. BP up to 212/90, HR 126 and 99% on RA. Pt observed by RN's approximately one hour until symptoms resolved and pt returned to baseline.

Patient went to the ER the morning after receiving the vaccine because she reports she was experiencing a severe migraine with ear and eye pain, nausea, vomiting, diarrhea, pain in hands and feet, and muscle spasms that last for 4 days.

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

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)

pruritus Narrative: 61 y/o female received COVID19 vaccine (Janssen) on 03/18/21 @0906. Has prior history to Shingrix vaccine on 02/2020 documented as causing diarrhea/facial numbness, but also had been exposed to Shingles prior to vaccination. Prior ADR was reviewed with RN and pharmD; was given the vaccine and observed for 30 minutes. @0930, was observed to be itching to back, legs, and left side of neck. @0935, diphenhydramine 50mg PO was given. @0944 itching continued and reports lips felt funny. @0947 patient reports feeling better and itching resolving, was observed until all symptoms resolved. Patient denied any shortness of breath. Patient stated symptoms of numbness/tingling in lips resolved. Patient left @1007. Instructed to seek emergency care if symptoms worsen or have any difficulty with breathing.

Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.

Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away

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

Anaphylactic reaction 10 mins after shot - drop in blood pressure, swelling of lips and upper palate and throat. Treated with epi-pen. Symptoms subsided with some residuals for about 90 minutes.

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.

The Pt presents with swelling of her lips 20 minutes following injection of 1 dose Janssen vaccine to the left deltoid. The Pt states that she has had anaphylaxis in the past to Macrobid, Sulfa, Amoxicillin. She has an Epipen at home but states that she has never had to use it because her symptoms develop slowly. In the past she has driven herself to the ER where she has received breathing treatments and observation. Pt denies swelling of the eyes, tongue, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. She also denies dizziness, lightheadedness, or vision changes. The Pt also has a Hx of meningioma and SVT s/p ablation. Suspicion for anaphylaxis high due to lip swelling, wheezing, and previous episodes of delayed onset anaphylaxis. Pt drove herself today so IM injection of diphenhydramine was delayed. Upon recheck Pt?s wheezing was unchanged and lip swelling had not progressed further. Due to past episodes of SVT and no progression of current symptoms, epinephrine was on stand by but not administered. Care was transferred to EMS. Care was transferred to EMS and Pt was transported to the hospital.

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

TINGLY ON THE RIGHT UPPER LIP; MILDEST ACHY JOINTS; NOT FEELING HUNGRY; 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 latent TB, and concurrent conditions included diabetes, obese, and skin eczema, and other pre-existing medical conditions included patient had allergies to MRI dye. The patient was previously treated with immunoglobulin g human; and experienced allergy when treated with metronidazole. 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 26-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling hungry. On 27-MAR-2021, the subject experienced mildest achy joints. On 28-MAR-2021, the subject experienced tingly on the right upper lip. Laboratory data (dates unspecified) included: Lab test (NR: not provided) negative, 7 times tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly on the right upper lip, and had not recovered from mildest achy joints, and not feeling hungry. This report was non-serious. T

C/O itching around mouth after receiving vaccine. No swelling, dysphagia, sob or other symptoms noted. No rash visualized. Gave Benadryl 25mg IM per RN, and patient improved shortly after. Continued monitoring and patient discharged home with husband as driver with precautions and close monitoring. Given epi-pen in case other symptoms develop at home.

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

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.

migraine Headache BP 235/110 was getting dizzy, tongue became numb she went to nurse 911 called. she was uncomfortable taking vaccination, For 30 minutes she was ok- tongue numb lips swollen still has migraine TMJ pains Did not get epinephrine. BP is on the "high normal side" 140/90, did not check pulse Oxygen level No rash

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.

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.

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.

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,

12-24 hours after the Covid -19 vaccine the patient had a seizure like event: eyes wide open, moaning, unresponsive for 2-3 mins. Patient had reported occurences of blacking out. These are new events. The patient does not have any history of seizures or seizure like symptoms. Patient was placed in isolation at the hospitial for 03/13/2021 thru 03/16/2021

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.

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.

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.

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.

After thee days of vaccination, experiencing severe tinnitus in both ears. Has not gone away as of today, 4/14/21. never had ringing in her ears in her life. We are very worried this will be permanent.

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

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.

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.

high level of pain and sensitivity and discomfort in gums, salivary glands and mouth and tongue. In evening, no breathing difficulties or airway obstruction. Took some aspirin and went to bed. ok next day.

Received the vaccine friday then monday has numbness to the tongue , near syncope, dizziness, ems called taken to ER and admitted to hospital for TIA. CT of neck, head, abd done, chest xray, full blood work, echo, results sent to primary care said all test ok

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.

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.

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.

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.

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.

HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; 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: 04DDZ1D 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 hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. 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.

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

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.

BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.

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.

Severe case of pink eye, in left eye, and a swollen lymph node in front of left ear. Started mildly on 04/15 and became much worse by 04/16. Both lids were swollen, itchy, discharge and RED. Started to get better by 04/23 and was almost gone by 04/25. Called the doctors office on 04/17 and they subscribed antibiotic eyedrops that I used for 7 days.

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

Per NP; "Patient is a 62 y/o female with hx of HTN, DM2, Asthma, severe obesity, being seen in the COVID vaccination clinic for their 1st COVID vaccination. After the vaccination they noted symptoms of tongue tingling and throat tightness approximately 20 minutes after vaccine administration. Denies facial, tongue or throat tightness, difficulty breathing or shortness of breath. Patient allergies: PCN and Sulfa Patient was moved to the aid station and evaluated. Vaccination provided today was Janssen Hx of reaction to vaccination in the past:denies Patient was given Zyrtec 10 mg PO Able to take PO water without difficulty Plan is to observe, will reevaluate Patient was advised to take diphenhydramine at home if continued or recurrent symptoms and to follow up with their primary MD. Strict return precautions to ED were discussed in detail. Diagnosis VACCINE ADVERSE REACTION, INIT (primary encounter diagnosis) Plan: CETIRIZINE 10 MG ORAL TAB Dispo Home Condition Good"

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.

Tinnitus First noticed toward end of 2 nd week following shot. Has persisted since. Intermittent, notice it a few times per day. Mild to mid range severity; a 4 on a scale of 1 - 10.

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 .

Sun I woke in middle of night with pain in thumb. There was nothing there. When I got up few hours later my thumb on left hand had enormous blood blister. Which immediately grew, was infected, and whole hand swelled up. Wednesday night I had same pain under right eye. Again nothing was there. Few hours later my eye was all swollen. I have another Dr appt tomorrow with Dr. I had the emergency room take care of my thumb. That Dr, Dr , a few days later sent me to Dr.

Rash and hives on entire face - took Benadryl, but that did not help Around 1:00 AM on 6/1/2021 - went to Emergency Room - lips were tingling and throat was closing up They gave me dexamethasone sodium phosphate injection 10 mg & famotidine 20 mg Rash cleared up on 6/3/2021 My known allergies are allopurinol and iodinated contrast media - IV dye

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.

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

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

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.

Pt reported 2 weeks of continuous yawning that resulted in a sore jaw. The symptoms self-resolved without treatment.

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

Intense metallic, burning sensation in mouth and on tongue within 1 minute after vaccine and lasting 3.5 hours. Mouth irritation is milder but still present the day following the vaccination (22 hours).

In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful.

approx. 15 minutes after vaccine, had left ear fullness, lip swelling and difficulty swallowing. Given EpiPen x1 IM right thigh with improvements in symptoms. 911 called and transferred to hospital.

Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15 of observation: "tingling around lips and left arm" Patient was treated/managed as follows: 1120: BP: 162/80 HR:65 RR: 18 O2: 99% 1130: BP: 160/90 HR: 69 RR:18 O2: 98% Pt reports tingling has completely stopped and feels fine. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to door by RN.

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).

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.

Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaws started aching, then they felt like they were swelling, along with my cheeks going down my neck, then I got a great deal of pressure, swelling, in my ear drums. I was speaking with a friend, who is a nurse, and she told me to take a Benedryl, so I ate a 12.5 milligrams children's chewable diphenhydramine. Twenty minutes later I felt normal again. Later that evening I noticed the palms of my hands were very hot. I did not have any fever. That passed the next evening.

March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues. 1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb. 3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.

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.

PT CALLED ON 3-27 TO REPORT A BLOOD CLOT IN HER EYE AFTER RECEIVING THE VACCINE ON 3-13, STILL PRESENT

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

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.

Shortly after the vaccine my tongue begin feeling really thick and furry. Moments later my lips began tingling causing me to seek medical attention. My body got really shaky and I got really anxious but after about 45 minutes my body returned back to its normal state. Later that day and up into that Saturday I was very fatigued, nauseous and the body aches were severe.

March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflammation/chills/fatigue/pressure in ears/pain in teeth (upper back molars), swollen glands - just plain "ill" Week of March 8 - See above, the same March 9 - Appointment at Primary Care Clinic due to March 5th symptoms and a 1-day bout of diarrhea Diagnosis ?cold, sinus issues? - try Mucinex/Tylenol / Covid Test = Negative Mid-March: fever blister appears for a few days and ringing in my ears (noise) increases. Fever blister lasts about 4 days. Week of March 15 - Same Symptoms as March 5 plus another 1-day bout of diarrhea Sunday, March 21 - stomach cramps / diarrhea - chills/overwhelming fatigue - same sinus issues as March 5 Week of March 22nd - equilibrium is off and starts to become an issue - 3 nights of vertigo but not severe during that week. Last vertigo attack was in 2018. March 28th - sinus situation the same, diarrhea again, start Pepto Bismol regime based on past microscopic colitis issues Mucus is thin and clear, just started to discharge. March 31st - Schedule another appt at Primary Care Clinic due to ?status quo? - this doctor thinks inflammation and prescribes prednisone (2) 20 mg for 5 days - Covid Test / Strep Test / Influenza Tests = Negative March 31 - April 4 / Prednisone: Visibly more stuffed up. Tooth/nerve pain increased from a 3 to a 7; didn't take the final days dose. After stopping my head felt numb. Vertigo stopped; equilibrium still off. Increased tinnitus and increased pressure/burning under my eyes and around my cheekbones. April 5 - 6 - New symptom appeared approximately a week ago; tightness in throat, difficulty swallowing. Still experiencing tooth nerve pain (sinus cavities). Woke up soaked the last 2 nights. Noticed increased difficulty concentrating "brain fog".

DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. 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 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. 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

Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respirations appeared normal. Also reported arm pain radiating up to left side of face and tight chest pressure. Was given 2 puffs of albuterol inhaler. Pt stated throat felt better at this time. Repeat BP 135/59, HR 64, O2sat 99%. Pt felt shaky and cold, possibly from albuterol. Pt stated chest tightness subsided but still continued to have weird sensation in her arm up to her jaw area and throat was still feeling funny. Repeat VS 123/61, HR 61, O2sat 100%. Was taken to ER via W/C. Pt c/o being dizzy and throat was tightening up again on the way to ER. Was given solumedrol in ER. Discharged home. Feels better but still has some left throat swelling, improved with steroids, antihistamine. Airway unaffected. Chest tightness/pressure resolved.

Patient's lips started to swell, itchy throat, back pain and stomachache, no fever, gave benadryl, called 911 after 30mins

woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.

Dizzy ,nausea ,complete loss of consciousness, catatonic, eyes rolled back , rigid total body ,extreme low blood pressure for over 1/2 hour Immediately at vaccine time ... 24 hours later chills , bad headache, nausea vomiting

very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shivers for 1 hour after 8 hours fever topped at 101.7 continueing nausia and fatigue the next day with low fever and low appetite continuing nausia and fatigue the third day tinitus the third night lingering fatigue and low appetite the forth day (today)

pt called today @ 10:09 on 04/12/2021 and stated that over the weekend, her lower lip swollen up. She contacted her dr. and was instructed to take benadryl. That's the only symptom she experienced.

BURNING SENSATION DURING URINATION; REALLY BAD TINNITUS; GENERAL MUSCLE ACHES; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced really bad tinnitus. On APR-2021, the subject experienced general muscle aches. On 07-APR-2021, the subject experienced burning sensation during urination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation during urination, and general muscle aches, and the outcome of really bad tinnitus was not reported. This report was non-serious.

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

Dizziness, weakness, digestive system issues, loose stools, active bowels actively with gas. 5 minutes after injection I noted pain below both of my ears and visual disturbances. Nausea with the taste of bile in my mouth

After the injection I started to sweat profusely. I could feel the vaccine traveling through my body. I started to get sick to my stomach. I had to regulate my breathing by slowing it down. When I opened my eyes the light was so bright I had to keep them closed. I thought I was going to faint. I finally decided to put my head between my legs and then I started too pullout of it. Very scary feeling. This lasted for 10min.

BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVING BLURRED VISION AND LITTLE HEADACHES

TASTE OF MEDAL IN MOUTH AT TIME OF VACCINE FELT FLUID OF SHOT ENTERING MY ARM CHILLS FOR 6 HOURS , NO FEVER NUERLOGICAL SENSAATION IN MY ARMS AND FINGER TIPS THAT CONTINUE SINCE THE VACCINE WAS GIVEN THAT COMES AND GOES. iTS AN ANORING SENSATION MORE THEN PAINFUL.

My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hours straight. I felt very fatigued and my eyes hurt so much and I could not keep them open. On 04-06-2021 I still was not feeling well. I started to have problems with my right side of my face, eyes and mouth which gradually got worse so I went to the hospital. At the hospital they checked me for stroke, performed lab work, did MRI and CT scans and the the doctors came back and said it was Bell's palsy. I again went to the hospital 04-11-2021 but this time due to GI issues with pain. On 04-14-2021 through 04-15-2021, I started to experience neck pain behind my right ear. At the hospital they had prescribed my prednisone 50mg, so I took half for my pain. I still have trouble sleeping and have lots of pain.

Woke up with black eye that began in corner of left eye and progressed down to middle of lower lid, later that day I had sudden onset of throbbing pain on left side of upper gum and cheek area. The pain in mouth would come and go and responded to heat pack and extra strength Tylenol. I also had a headache on the left side of my head. The black eye went away in about three days. The mouth pain went on off and on for about 7 days gradually subsiding in intensity over that time frame. The headache only lasted for a few days. I also felt some pressure behind my left eye.

Headaches, blurry vision right after she took the vaccine. She has history of migraines but these headaches and blurry vision are more frequently occuring.

Mild light sensitivity day of vaccine along with other reactions; Extreme headache morning after vaccination that was eased with Tylenol and sleep; since that day CONSTANT eye strain and low level headache that is not eased by medication, rest. Had CT of sinus -- clear; have seen eye doctor, nothing detected but slight prescription change; seen PCP who advised me to take aspirin, ordered CT scan, suggested seeing ENT but have not done so yet

Onset of Tinnitus/ a few days of injection. Right ear only . No history of ear issues ever . Hoping it?s just a temporary immune reaction to the vaccine. Hoping in due time symptom will resolve .

Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days. Finally feel somewhat normal on 9th day although tongue still heavily coated with white.

SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING; PRESSURE CHOKING; VERTIGO; Facial pain; SUSPECTED PRODUCT CONTAMINATION; FEVER BLISTER; Foggy feeling in head; DIARRHEA; SEVERE STOMACH CRAMPS; SINUS INFLAMMATION; Sensation of pressure in ear; Injection site lump; CHILLS; FELT ILL; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient. 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, 1 total administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, upon vaccination the patient woke up and experienced sinus inflammation, sensation of pressure in ear. On 05-MAR-2021, the patient experienced injection site lump. On 05-MAR-2021, the patient experienced chills, felt ill, injection site pain and fatigue. On 11-MAR-2021, the patient experienced severe stomach cramps and diarrhea. On 22-MAR-2021, the patient experienced foggy feeling in head. On 23-MAR-2021, the patient "believes the vaccine is contaminated", fever blister and facial pain. On 24-MAR-2021, the patient experienced vertigo. On 28-MAR-2021, the patient experienced pressure choking and difficulty swallowing. The patient visited 2 clinics and an ear, nose and throat (ENT) specialist but they were unable to diagnose and they felt there was some autoimmune effects (onset date unspecified). The patient suspected that the vaccine was contaminated based on the news report. On 02-APR-2021, the patient experienced stomach burning sensation. On 04-APR-2021, the patient experienced night sweats. On 05-APR-2021, the patient experienced tooth pain. The patient has been visited two clinic Treatment medications (dates unspecified) included: famotidine for 14 days for pressure choking and difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps, vertigo on 28-MAR-2021, night sweats on 06-APR-2021, stomach burning sensation on 05-APR-2021, and injection site lump, and injection site pain on 16-MAR-2021, had not recovered from felt ill, sinus inflammation, chills, fatigue, sensation of pressure in ear, tooth pain, foggy feeling in head, pressure choking, and difficulty swallowing, and the outcome of diarrhea, fever blister, facial pain, some autoimmune effects and suspected product contamination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a patient who experienced sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Approximately a week later, the patient experienced stomach cramps and diarrhea and 1.5 weeks later she had foggy feeling in head and "believes the vaccine is contaminated", had fever blister, facial pain and vertigo. Approximately 3.5 weeks after being vaccinated the patient experienced pressure choking and difficulty swallowing. A throat (ENT) specialist was unable to diagnose and they felt there was some autoimmune effects. A month after being vaccinated the patient experienced stomach burning sensation, night sweats and tooth pain. Given the close temporal relationship and the nature of the events, the events of sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue are considered related to the vaccination. The insufficient information precludes a meaningful medical assessment of the remaining events, including "autoimmune effects". The events will be assessed further when additional information is received.

PROFUSE SWEATING; SHORTNESS OF BREATH; EYES SENSITIVE TO BRIGHT LIGHT; FEELS AWFUL; PHOTOSENSITIVITY; SICK TO STOMACH/NAUSEA; This spontaneous report received from a patient concerned a 63 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, route of admin not reported, batch number: 1808978, expiry: not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced profuse sweating. On 29-MAR-2021, the subject experienced shortness of breath. On 29-MAR-2021, the subject experienced eyes sensitive to bright light. On 29-MAR-2021, the subject experienced feels awful. On 29-MAR-2021, the subject experienced photosensitivity. On 29-MAR-2021, the subject experienced sick to stomach/nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse sweating, shortness of breath, eyes sensitive to bright light, feels awful, photosensitivity, and sick to stomach/nausea on 29-MAR-2021. This report was non-serious.

On 4/20/2021 around 1 pm patient called the pharmacy and reported intermittent symptoms of severe headache, a feeling of tingling and pinching, and nausea. She stated the last symptom of HA 4 days before her call. She was instructed by the pharmacist to promptly call her primary care provider to report symptoms and receive instructions.

PAIN IN EYE; DRY EYE; HEADACHE; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in eye, dry eye, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in eye, headache and dry eye was not reported. This report was non-serious.

HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT 4 TIMES LAST WEEK AND LAST NIGHT; INCREASED SALIVA/MEDIUM AMOUNT OCCURS DURING NAUSEA EPISODE ONLY; SWEATINESS OCCURRED ONLY AT NIGHT, STATED THAT SHE WOKE UP WITH A WET T-SHIRT IN A COLD SWEAT; CHILLS OCCURRED ONLY AT NIGHT AT THE SAME TIME AS THE FEVER; RIGHT ARM SORENESS; FEVER/FELT HOT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg, and concurrent conditions included hypertension, and other 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam, and fluoxetine hydrochloride. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6/10. On 01-APR-2021, the subject experienced increased saliva/medium amount occurs during nausea episode only. On 01-APR-2021, the subject experienced sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat. On 01-APR-2021, the subject experienced chills occurred only at night at the same time as the fever. On 01-APR-2021, the subject experienced right arm soreness. On 01-APR-2021, the subject experienced fever/felt hot. On 01-APR-2021, the subject experienced mild nausea experienced it 4 times last week and last night. On 03-APR-2021, the subject experienced headaches/pain at the back of the head and base of the skull 3 episodes. Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat, chills occurred only at night at the same time as the fever, right arm soreness, and fever/felt hot on 03-APR-2021, had not recovered from mild nausea experienced it 4 times last week and last night, and increased saliva/medium amount occurs during nausea episode only, and the outcome of headaches/pain at the back of the head and base of the skull 3 episodes was not reported. This report was non-serious.

HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. 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.

Patient states she received the Johnson & Johnson COVID vaccine on April 3rd. Patient states on April 8th she went to her dentist for cleaning and do not expiring any gum bleeding at this time. Patient states 2 day ago (April 19th) her gums were bleeding so bad that she could not see her teeth and patient states she had a nose bleed as well. Patient also states she was experiencing headaches. Patient presented the the Emergency Department on April 21st . Patient was found to have thrombocytopenia (PLT = 2). Patient was admitted to Hospital on April 21st (as of April 23rd, patient is still admitted). Hematology was consulted for further management of thrombocytopenia. Patient received 2 platelet transfusions, IVIG x 2 doses, and is receiving corticosteroids.

After injection in automatic terrible taste in my mouth like I could taste the vaccine. Return For 20 days experienced severe diarrhea morning noon and night.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

15 minutes after vaccine - eyes were getting puffy; lip and tongue - tingly and numb. I took Benadryl and the symptoms went away. That night of the shot, I had a headache - (Like a bus hit me) at 07:00 PM. The headache never went away after that. 24 hours later, I had a full body itch - I took Benadryl for that and that helped the rash. Since that first headache - I have had headaches every day. I have had to manage it with Tylenol and Ibuprofen and I still do. I saw my doctor 2 weeks after vaccine. My vision was going blurry about two weeks after my vaccine is when I really noticed it. My doctor sent me to an Ophthalmologist - I was told I had cataracts. I had my regular Optometrist - in January 2020 and nothing was noticed with cataracts. The doctor told me to try to manage the headaches and if I have any extreme pain then to go straight to ER.

LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND FATIGUE; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.

I now have mini little eczema patches on my face - two or three of them; I use Fluticasone (steroid) on them which I was using for the original adverse event with red patches on/below my neck. I had a health report today primarily related to a different health issue but I asked her if I should use the Fluticasone cream on them. She cautioned me to use the steroid cream minimally on my face. The eczema I have on my hand - that is what I always there in dry, bad weather - seems worse than it normally gets. The rash on my neck is gone. Also, two weeks after the Vaccine, I have noticed that my eye sight is different. I am going to the eye doctor tomorrow because of this.

Visual disturbance in lateral visual field of right eye. Posterior vitreous detachment initially evaluated in the Emergency Room, on April 12, 2021 and subsequently diagnosed by Ophthalmology Department on April 13, 2021.

As soon as I got the shot, I immediately had a metallic taste in my mouth. I had a weird sensation in my nerves in my right arm and a little all over my body. I think the shot may have hit a nerve in my arm. Two weeks after the shot I was very pale, and my stomach was very upset. I had a headache and abdominal pain. I felt very ill so I didn't eat or drink much that day. The smell of food made me throw up and felt really bad for 24 hours. I did not eat much for three days and it helped my nausea and I recovered after four days I still had the unusual feeling all over my body. I got some IV therapy twice and it helped. It did start to fade over time and I finally started to feel normal after a month. I am fully recovered now.

Severely chapped lips, particularly at edges. Center of upper lip feels a bit swollen and numb. Staying hydrated, but skin on lips sheeting off at times. Also, using Chapstick. This is not normal for me and I can only connect it with having received the vaccine. I think the symptom is improving, but it very slow and minimal. This started shortly after receiving the vaccine a month ago and continues to this day. Other side effects were very temporary: Headache, fatigue. No arm soreness at all. Mild body aches within 24 hours, but diminished rapidly.

after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.

Less than 15 minutes after vaccine I experienced frontal sensations in my brain. I also felt very dizzy and have ringing in left ear. A day after I experienced a dull headache for almost a month.

The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.

5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Diagnosis: Bells Palsy

About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.

Ranging in the ears...I had thought and hoped it would go away by now and it hasn?t, so just felt I should report it. I have never experienced this prior to vaccine.

Headache, dizziness, chills, fever, eye movement, nausea, chest pain, muscle weakness and pain, falls.

LOUD TINNITUS IN BOTH EARS; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included tinnitus episodes, and concurrent conditions included penicillin allergy, and hear aid user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 2051A211A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced loud tinnitus in both ears. On 05-JUN-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loud tinnitus in both ears, and lightheadedness. This report was non-serious.

Neck pain left side of neck; ongoing tic upper left lip without pain. History of trigeminal neuralgia but rarely symptomatic for past 11 years.

I had a really severe sore throat; I lost my voice for awhile. Water on my ears and 101 degree temperature. Runny nose really bad. There was drainage down my throat from runny nose. Feeling really weak and tired. Really deep down in my lungs cough. I was sick for about five days and then went to Urgent Care; Cough medicine and Z-Pak Antibiotic that helped with all except the water in my ears. That hasn't gone away yet so my hearing is a little off. The cough lasted for about two and 1/2 weeks but is gone now. I cough every once in a while, but not bad. I may go back to the Urgent care for my ears.

Patient stated that that within 20 in 30 mins of receiving the vaccine her left eye started to itch and burn. She lost sight for about 3 or four hours. Mouth was dry and burning back was swelling and had a rash. Vaccine administrator had to call 911.

Probably immediately, I was lightheaded and woozy. As soon as she put it in my arm I could taste it and I felt like I was going to vomit. She kept me there for 45 minutes to keep an eye on me. As a disclaimer, I am a vegan and very earthy, I do not take any drugs or anything like that. When I was driving home the lightheadedness got so bad that I had to pull over and sat for 15-20 minutes. I called my brother and he told me to get something to eat. I just had some steamed vegetables. I came home, ate and drank a lot of water to try and get the wooziness to pass. I did not have an unusual amount, no more than I would usually drink. Then after the last bottle of water I had, I started getting more queasy and started to feel dizzy. I then vomited all over my self from head to toe. That lasted for two or three hours and then after that I was dry heaving. That happened on Friday, on Saturday I was too afraid to eat anything I only had toast and a smoothie. On Sunday I was just so woozy and lightheaded and exhausted. I didn't feel chills or anything though. My brother brought me soup on Sunday and I did have some broth. I also started drinking a little bit more water. The water didn't taste good though - it tasted like the vaccine so I did not want to have it. I did not workout at all for that week, I was just so tired. I felt like I could sleep for a month and just not get up. I normally workout five days a week. I got an IV with fluids for hydration and a glutathione push on 7/2/2021. On the following Saturday 7/3/2021, I was still lightheaded. Now, I still am extremely tired and there are days that focusing takes more energy than it typically does. My mouth feels like I have cotton balls in it, the nausea and the lightheadedness is still present, but the tiredness is the worst. I normally run everyday but I cannot even do that at all, walking is hard enough. I just had another IV today 7/14/2021. When this started happening, I did contact my DR but I am unable to get in yet, I need to schedule for a full blood panel and see the DR.

brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet

On 4/14/21, patient awoke with a severe headache and nausea and vomiting. She does not have a history of headaches. Some photophobia. Patient is treated with diphenhydramine, prochlorperazine and IV fluids.

I got all the symptoms I had when I had covid-19 back in Nov. I was just getting a little smell and taste when I got the J&J shot. After I got the shot, I got the headache, cough, loss of smell and taste, extreme fatigue, cold, aches, etc. I still do not have my smell and taste back.

at injection, arm was not opperable, too weak to pick up coat or purse. After about 15 minutes the full use of arm was back. The muscle is still affected and strained after 6 days. I waited a half hour at the site and got into my car at 3:45. On the drive home within 30 minutes my face started to itch and turn red, then my mouth inside started to itch, then my eyes started to itch. After that my throat started to feel gravely, so I took 75 mgs of gel cap benedryl. This is what I feel and take upon getting stung by a bee. I also took my albuterol inhaller two puffs which I also always have on me because of my asthma. I was sleepy but had dinner and went to be. I did not feel that I had to take more benedryl during the night.

64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little "woozy" Monday (3/8/2021).

Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tongue was swelling and her face was getting red and hot. Following the reaction protocol patient received 0.5mg of epinephrine IM at 15:26 and was moved to a stretcher. EMS was called, again per protocol. EMS recommended patient be transported to hospital but patient refused. Patient ambulated out of clinic independently and drove home.

My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy.

At 1003, RRT was activated at the end of client?s post-vaccine 15-minute monitoring period. 64 y/o F complaining of head ?heaviness? in the back of her head, dizziness, and mouth dryness. Head-to-toe assessment completed and WNL. BP: 118/60, HR: 68, breathing even and unlabored on RA. Client in no acute distress. Throughout response time, client?s condition improved. Recommendation to client to be monitored for an extra 15 minutes by post-vaccination nurses. At 1030, client felt much better and left facility ambulatory, in not acute distress, breathing even and unlabored.

Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided. Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.

Swelling in left lower eye and cheek within minutes of the injection. Has not resolved itself as of this reporting.

Approximately a week and a half after vaccine my senses of smell and taste changed. Most food smells and tastes a bit like acetone and slightly moldy. I also perceive that my breath and hands have this same smell. I had a mild case of Covid-19 in December 2020 and did not have these symptoms at that time. I had typical reactions to the vaccine for the 2 days after injection - fever, headache - but the impact on senses took some time to kick in. Those impacts have persisted, at least as of today.

Immediately after the shot, I felt dizzy and started to sweat throughout my body including my hands. I waited more than 40 minutes to see if improved but it was exactly the same. Didn't get better or worse. I did not report it immediately because it was not alarming and I did not feel bad. It was just my head that was spinning a little bit and sweating. After waiting more than 45 minutes I decided to drive home because the dizziness was not that strong. I would say it was like a 45% dizzyness if I have to calculate how I felt. The sweating passed after 4 hours and at soon as I arrived home I went to bed and relax. It is now 6:08 pm and the dizziness has improved considerably. I would calculate now about 10% of that vertigo feeling. It is getting better and better. I just wanted to point out that in no time I was feeling bad. Everything was just in my hearing labyrinth internal with balance. I also felt 20 minutes of echoing in my ears about 2 hours ago.

On the morning of March 15, I developed a red rash on throat, lower facial cheeks, and chin. Lips tingled a little bit. Rash did not itch. Took 2 Benadryl three times that day, contacted doctor via email. The rash was better the next day (March 16) but took 2 Benadryl again three times that day. Sent photo to doctor who had an allergist in the clinic look. He said it was a reaction to the vaccine. March 17 rash was completely gone and have had no other reactions since.

3/29/2021 metallic taste in mouth, 15 min after leaving the clinic. Tingling in lips and chin. 3/30/2021 hives, mouth sores on roof of mouth. went to ER received steroid and magic mouth wash. patient is at home recovering at this time.

day after vaccine was extremely tired and both hands were frozen cold, following day woke up with clogged right ear and I had vaccine shot in right arm. by end of day, I was feeling much better and ear was unclogged

tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to transport.

Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffness, tremor, and blurred vision

LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart defect. 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 in Left Arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced heaviness of head. On 08-APR-2021, the subject experienced cramps in legs. On 08-APR-2021, the subject experienced achey. On 08-APR-2021, the subject experienced feeling bad. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced nauseous. On 08-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 lethargic, nauseous, headache, heaviness of head, cramps in legs, achey, feeling bad, and dry mouth. This report was non-serious.

Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant other diagnosed with Stage 4 inoperable NSCLC ) and had been attributing the often present headache to that, but they were also accompanied by a butterfly pattern red flush across my nose. Acid reflux which I was attributing to stress or alendronate. Woke in the night 4/12 to severe acid reflux, nausea, headache, flush, thought maybe I was having a heart attack (I have no cardiac/BP issues); then last night, 4/14 about 6 PM, weird numbness tingling in right arm from center of my chest passed in about 5 minutes. Significant Other said I had the pattern flush on face at time of attack which faded as I began to feel better. I have not consistently felt at 100% since vaccination, but I have a lot going on and attributed it to that.

RUNNY NOSE; DIARRHEA; SORE THROAT; LOSS OF TASTE; VOMITING; UP ALL NIGHT; CHILLS; FEVER 101; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lactose intolerant, seasonal allergies, non-alcohol user, 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 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced runny nose. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced loss of taste. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced up all night. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever 101. On 08-APR-2021, the subject experienced headache. 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 diarrhea, vomiting, chills, and fever 101 on APR-2021, had not recovered from headache, sore throat, runny nose, and loss of taste, and the outcome of up all night was not reported. This report was non-serious.

Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later felt tightness in the chest, shortness of breath and a cough started. Feeling unwell. Continued and went to urgent care. Covid 19 test negative. continued to feel the worse and went back again to urgent care. Same symptoms with nausea and headache on and off. another covid test negative and chest xray. looked ok. Continued with the same symptoms and went to Primary Care Cough worse and pain in chest. Blood work done. Looked ok. Woke up with terrible headache at 3am. Went to the ER. IV ,Blood work ,ct scan, ekg. No real answersBP elevated. Still struggling but cough improving.

For the 1st 10 days it felt like my brain was swollen too big for my skull. Not like any headache I have ever had. I did take some acetaminophen but it didn?t seem to quell the pain. While still at vaccine site I got a weird taste in my mouth, dry mouth and my voice started going hoarse. I stayed a while longer to be watched as I also had itching. I did not go into hives. I had pain in my body from time of injection ? the ?typical? sore arm didn?t set in until day 3-4. I had hot spots all over my body ? but not fever or rash. On 4/11/21 I broke out into a rash on my forehead that lasted about 4 days. What I want to specifically report is I like these zinger/sharp traveling pain from my temples to posterior head. Still having this sensation but not as frequently. They don?t last long but are noticeable at the time they are happening. The only way I can explain the pain is that it felt like when you break a blood vessel in you finger and it really, really hurts for a short while and then pain subsides. I started having these pin prick sensations within the first few days all over my body (arms, legs, back) but the frequency has decreased. Days 2-6 I was just wiped out and rested. I am still feeling lack of energy still today.

Exactly a week after receiving the J&J vaccine, I was out on my morning walk when my head became very fuzzy and my vision was altered (seeing jagged zigzags-fuzzy ones with my left eye). The vision issue persisted when I closed my eyes. The fuzzy head issue continued during a very difficult walk home and when I arrived and things didn't clear, my husband ended up taking me to the emergency room. I got in quickly because the symptoms I described sounded to them like a stroke. But, I didn't have a stroke. They did a CT scan. It was fine. The vision thing they thought sounded like the effect of a migraine. But, I've never experienced migraines. (Note: this incident occurred the day before the news of the J&J blood clots became public). Anyway, after a couple of hours in the emergency room, I was fine and went home. So, I don't know what happened and it probably didn't have anything to do with the vaccine. I'm not prone to being alarmist and I would only consent to go to the emergency room if I thought I were in a serious situation. The blood work indicated my platelets were in the normal range. And, I'm too old to be in the category of the six women who experienced blood clots. However, I just thought I should report this in case anyone else experiences something similar.

CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. 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 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Patient stating day after vaccine was administered began experiencing nausea and vomiting and body aches. 4/4/2021 patient states began to experience loss of appetite, fatigue and weakness. Described all food and beverage having an acidic taste. As of today, 4/21/2021 patient states symptoms are still persistent but seem to be subsiding.

April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest

One hour after getting the vaccine,my face and neck swelled,but I had no breathing problems. Then 4 days after vaccine I experienced a strange buzzing feeling in my brain,and Tinitus ring in my ears,with sinus pressure. It lasted less than 10 minutes,and stopped. On the fifth day after vaccine,I noticed High Blood Pressure symptoms,and went to ER. On 8th day after vaccine,I I went to hospital for High Blood pressure again,and was put on medication!

PAIN IN RIGHT EYE COMING FROM BACK OF HEAD STOPS FOR A WHILE AND THEN REPEATS; EYE ITCHING; TIREDNESS; PAIN AT INJECTION SITE; STOMACH PAIN; This spontaneous report received from a patient concerned a 64 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 05-APR-2021 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 05-APR-2021, the subject experienced stomach pain. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced pain in right eye coming from back of head stops for a while and then repeats. On 15-APR-2021, the subject experienced eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and pain at injection site, and tiredness on 07-APR-2021, had not recovered from pain in right eye coming from back of head stops for a while and then repeats, and the outcome of eye itching was not reported. This report was non-serious.

Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. " Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.

Anaphylaxis in the form of swelling of the tongue after eating pineapple. Patient had never had an allergy to any food prior to this.

TINNITUS; UNABLE TO EAT; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 64 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: 042A01A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced unable to eat. On 08-APR-2021, the subject experienced unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, unable to eat, and unable to sleep. 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.

Patient was driving on 3/24 when her vision became blurry in her left eye. She saw her eye doctor on 4/21 and was sent to a specialist. On 4/23 she was diagnosed with a blood clot in her left eye. She is to begin eye injections for treatment.

Woke up out of a sound sleep with severe headache ,nausea and vomiting. Location of headache:Frontal, top of head, behind eyes. Severe pain. Different than her usual migraines. Had a brain bleed in 2013 so is familiar with how that felt and this felt very different per patient. Tylenol was taken and did help but not much . Constant thing. Had severe headache for 1 week. Dissipated and continues with it today. When had headache she was in bed . Only up to do her husbands medication. Was told to contact her PCP on 04/13/2021. Never had pain like this prior. She took BP 04/14/21 and was 119/65. Waiting for MD call back.

4-13-21 upon waking up, woke up migraines. took her migraine medication and migraine resolved. phlegm, fatigue, chills. 4-22-21 started numbness to lips and fingers with cold sensation. Reports no changes to color of skin so unlikely there is noticeable perfusion changes however advised to get seen at a HCF for this. spoke with pcp for the migraine.

FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 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 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.

Two weeks after the vaccine I noticed that I had a strange feeling in my eye. When I looked in the mirror I saw a little line of blood. I went to the ER and after examining my eye they could not find reason for the blood in my eye. I was told it was a Hyphema. The following day I felt pressure in my eye which lasted for one day. I went to the Optometrist a week later but the blood was no longer visible. The doctor could not find anything wrong.

Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue

I tested positive for Covid-19 with no severe symptoms in February of 2021. One week after the vaccine on 04/09/2021 I broke out in hives after eating a meal. The hives were mostly on the right side of my body but there were some on the left. I also had some numbness and tingling in my mouth. I used some anti itch cream, and the hives were mostly gone the next day. Twelve days after the vaccine I started to unusual vision symptoms which included wavy zig-zag lines in my vision. My doctor advised that they were Ocular Migraines. I had a headache at the same time, but I have never had Migraines before. I was also fatigued with a little dizzy and nauseous. The headache lasted for one day, but I still felt a little nauseous the next day. The feeling of fatigue and tired ness lasted for about six weeks. Two to three days after Ocular Migraines I started to notice a bright red rash on the right side of my back. It quickly spread around my side to the midline and then up my right side to my Bra line in front. I consulted my doctor on 04/19/2021 and he identified the rash as Shingles I was prescribed Acyclovir 800mg for 7 days and then an additional 5 days. I saw my Dermatologist on 05/06/2021 and he said that the Shingles were still active so I was Prescribed Valacyclovir. The Shingles lasted about six weeks total with some fatigue before I felt normal. I still have some visible signs of the rash on my back. Dr., PCP, 04/21/2021 Dr. Dermatology. 05/06/2021 for Shingles

She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't dizzy but wasn't herself, felt off. Then she got petechia in both legs and she took it easy, drank a lot of water. She took it easy, but ever since then her energy is not there, she is "zapped". She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue. She is now really concerned as it is lasting. She feels like she is mentally confused. She could not tell me her address without looking it up first. It has started to subside some the feeling of being off. She feels like that she has no blood in her. She feels like she's out of iron, and zapped of energy. She has not called her doctor.

I have had tinnitus since the day after vaccine. Never had it before. It is loud loud loud 24/7 and has been over 40 days and it is non stop.

35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fingers and toes. Went to nearest Emergency room, 8 minutes away. Treated with IV Solumedrol, Benedryl, and Pepsid. Stabilized and discharged after 2 hours. Minor symptoms for 2-3 more days. Back to normal now.

I have developed tinnitus and am experiencing hearing loss. It is sometimes very intense and sometimes mild but 2 months out still a problem.

Tinnitus, ongoing and no cure. Saw ear doctor on May 13. Will be going back as issue has not gone away. Was not aware this could be a Covid vaccine side effect so did not initially report.

Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.

J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.

DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, 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, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.

Janssen COVID-19 Vaccine EUA Per POD First Aid provider syncope episode, complaint of tingling to lips and difficulty breathing, patient experienced a syncopedic reaction when returning from bathroom, was unconscious for 1 minute, complained of dizziness, odd taste in her mouth and difficulty breathing. 12:15 PM B/P 150/82 Pulse 68 Respirations 16 Pulse ox 98% 12:20 PM B/P 122/72 Pulse 64 Pulse ox 100% Benadryl administered @ 12:20 PM, patient transported to A Medical Center for evaluation.

Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible. This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days. I took Advil and Tylenol without any relief. Called the nurse at physicians office who told me to increase the dosage and to use only Advil. If it got worse to go to urgent care to get Tordal and/or steroid injection. I didn?t want anymore side effects of medication so I just toughed it out. The injection site became the size of a half of a tennis ball, was red and hot to touch. It is now 18 days later and there is still a small knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night. I felt like I was in a dark hole for the first 3 days and was then in a fog for a week. I had blurry vision off and on for the first 3 days and then again on day 5.

Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.

started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.

VIRAL PINK EYE Monday 3/15 AM I received the vaccine. That night I had some mild achiness and headache which continued the next day. Nothing exceptional. The next morning, Wednesday, when I woke up I was surprised that my right eye was a bit crusty. It was rather red but not painful. I thought it would go away ignored it but that night I realized it was still red. I did some research about pink eye and realized I fit the description for viral pink eye. But when I saw that 90% of all viral pink eye is caused by the Adenovirus - the same that is used in the vaccine I realized I should report the coincidence. I made an appointment with my doctor to confirm before submitting this report.

Patient reported that she experienced blurry vision one day after receiving the Janssen COVID-19 vaccine, around 2:00 pm on 3/17/2021. She expressed concern that this might be related to the COVID-19 vaccine. She said it feels like there's something in her eye that's irritating it. I asked if she has seasonal allergies, and she said yes. She does not take anything for allergies. I advised her to try Visine eye drops. After consulting with Dr, I also advised her to take an over the counter antihistamine like Zyrtec, Allegra, or Claritin. Patient is diabetic, so we asked her to check her blood glucose as well. Patient reports that the Visine helped. Her blood sugar was 189. She reported chills and a mild fever. She took Tylenol and it brought her temperature down to of 99.6 F. I advised her to call me if any of her symptoms get worse or do not improve.

Patient reported feeling swelling lips at home. Patient called EMS on Friday morning to take her to the ER. Doctor's note from hospital said ambulance gave 50mg Benadryl and misc. steroids and that the patient was not a good historian when she arrived to the hospital so they admitted her.

Swelling and tingling of tongue. vaccine given around 11:55 Am.... time now is 3:48 and still have swelling and tingling

high fever, 102.1 in evening of short date received, took Tylenol. Tongue and lips tingling and loss of taste on Tuesday morning and fever of 101.9 took Tylenol Wednesday March 31, tongue and lips still continue to tingle and loss of taste. Thursday still running fever 99.9. Friday Morning fever gone however tongue and lips still tingle and loss of taste still present.

Patient received Janssen vaccine @ 11:44 am, while in the recovery area @ 12:01 pm, c/o numbness in the left neck area, blurry vision> VS 136/80, 63,20, Sats 99% on RA. 12:05, patient stated numbness was no longer present, VS @ that time: 140/92, 55, 24 Sats remained unchanged. Continued to monitor, final VS check @ 12:10 pm, 152/96, 54, 22 Sat's remain unchanged, no further c/o of discomfort of any kind. DC from recovery @ 12:25, all symptoms resolved, gait steady accompanied by Sister (who was present for vaccine as well).

On Sat. 3-13-2021 at 11:53am, Janssen covid shot was administered in left arm. Approximately 3 hours later, at about 3:10pm, I started seeing bright flashing arcs of light in my upper left vision. I wondered if these were precursors of a migraine coming, but mine normally are crackles of primary colors in the center of my vision. I remembered the vitreous detachment in my right eye 5 years ago. This seemed similar, but not very similar. Around 6pm I noticed a largish donut in my left eye vision, which I've never seen before. About 7:30pm I called the consulting nurse, who told me to go to Urgent Care. Got there about 8pm. The MD thought it was a vitreous detachment, but wanted to get an OD on the phone. Additional floaters appeared in my left eye vision while I waited. OD via phone thought it was a vitreous detachment and set up an appointment to see me on Mon. 3-15-2021. Flashing arcs/donut/floaters continued through the next day. Last flashing arcs were about noon on Mon. 3-15-2021. In total the flashing arcs lasted about 45 hours. 5 years ago, in the right eye, flashing lights lasted only 5-10 minutes. On Mon. 3-15-2021 had eye exam. OD said posterior vitreous detachment (PVD). Wanted second opinion about my retina. Second OD performed exam, agreed on PVD and that my retina looked okay. On Fri. 4-2-2021 had follow-up exam with same OD. Retina looked good. Floaters are diminishing. What terrible timing if this was a coincidence. It made everything post-covid-shot very confusing.

Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth, and headache. This lasted for 8 days and I'm still dealing with the fatigue and lack of energy. I took alternating doses of tylenol and motrin and drank lots of fluids. I had to miss 6 days of work because I was too sick to teach.

^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7 By 11:00pm my fever was 105.4. By midnight it was 105.9 I took Vicks NyQuil because it was the only pain med that had Tylenol in it. Fever reduced to 105.4 by 2:30 am fever was at 104.5 and I felt safe to try and sleep and not die. A nurse friend was telling me to go to the emergency room. I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out. also Icepack to neck. ate a popsicle. I hydrated emencely before the shot and All day with the shot. I kept moving my arm and it was fine after a few hours. THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL. My throat felt a "little" tightening. I swallowed every few minutes to make sure it did not progress. I had Benadryl on hand just in case. I slept from 3:00am until 9:30 am. My morning fever was between 103.7 and 104.5 It was 102.4 at 3:00pm it is 8:45 pm and my temp is 202.2 now. head ache is at 50% of yesterday.

Within 4 hours after receiving the vaccine, I developed a hissing sound in both ears. 26 hours later it is still prevalent. I?ve never had hissing before in my ears but have had some clicking occasionally. I also had a low grade fever, mild body aches and a headache, which lasted 24 hours.

Within minutes of the vaccine shot, began to sweat and was dizzy. Immediate attention by health care professionals at site. Blood pressure dropped severely. Laid on cot to recover. Left after approximately 50 minutes. Driving home, some tongue swelling, went directly to Hospital ER, where they proscribed fluids, Benedryl and observation. Arrived home around 2:30. 24 hours later, still having dizziness and some tongue swelling, headache and weakness.

No Sx immediately after. Joint and bone pain starting 12 hours later with increasing fatigue. Temp low -96.2° with chills (normal is 97°). Slight headache and ringing in ears started about 2pm. I felt like temp was going up, but I don't usually get a temp over 98.8° even when ill. Fever at 100° by 5pm Sat. No "CoVid symp" Eg cough, SOB, GI, loss of smell. Increase fluids. Allergies to PEG in Acetaminophen otc, and NSAIDs. Non critical event at this time.

Within minutes of getting the injection, became faint with a severe drop in blood pressure. Under observation at the site by Health professionals for 50 minutes. On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER. They suggested fluids and prescribed Benedryl and waiting nearby. When symptoms did not worsen, left and arrived at home around 2 p.m. Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.

I had the sensation/taste in my throat of a solvent/Chemical shortly after the injection, which lasted about an hour.

Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat and tongue. Took two benadryls and four ibuprofens.

When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow and About 2 AM on 4-7-21 I tarted feeling very very cold and trembling and delusional I could not recognize my home I had muscle spams on both legs and fever finally got up and took some Advil put on extra PJ's and socks and turn on the heater finally fell asleep about 4 AM about 8 AM on 4-7-21 woke up with a headache and very very tired lot of pain on my left arm so stayed home from work and rested on 4-8-21 came to work at 7 AM and was seeing everything blurry as the day progressed it got worse finally went home about 3 PM took more Advil and rested some more my left arm hurt me for 6 days and I felt very tired and a bit confused I did not call my doctor or any one at Health Department I just took care of myself

4days post injection she developed a full body rash, ears are "swollen", and throat has a funny sensations in it. Breathing normal. Treated on 2 successive days with a predinsone injection, but then was admitted for observation the next day. Treated as an inpatient for 24 hours with Solu-Medrol every 6 hours. Recovered and was released. Patient reported that she had been previously vaccinated against COVID-19 in January, but we have no record of that (all vaccinations in Louisiana are required to be in our State Immunization Registry).

Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.

april 7, extreme skin tingling all over, only lasted that one night april 12, noticed increased tinnitis, I already had it and it is now louder

I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.

About 4 and a half weeks after getting the J&J vaccine, I began to experience marked symptoms: dizziness and disorientation,, balance problems, bilateral numbness in hands, feet and tip of tongue, awareness of left side of brain, intermittent mild nausea (likely related to dizziness). These symptoms had a sudden onset. I am normally very healthy and active so these unusual symptoms without any illness were quite a departure from my normal health. They have, to date, persisted continually since onset over the past 3 weeks. They are very concerning. Last night I went to the ER to be seen since I could not get an appt. with a neurologist for several months and I am concerned about my sudden change in health status.

FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 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: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.

The day after the vaccine I experienced extreme fatigue, Some nausea, slight headache and some flu-like muscle aches. On day 13 I have a toothache that switches between my lower right jaw and my upper right jaw. It comes and goes throughout the day and I have since experienced the same pain daily. I have had no treatment for the pain. I take Tylenol.

On the way home I had neurological symptoms, tongue and lip tingling, nauseated. The smell of Lysol spray made me not be able to breath. Made me dizzy and nauseous. It was like an LSD trip. It like being on a roller coaster, It continued all the way home. I could see all the timbers and bright green colors. Neck was stiff and it crawled up my head to my temples. It was like someone was holding my head. About 3 days later after vaccine my throat started to close and we headed to ER. I took turmeric and ginger to the ER as well as Benadryl. The symptoms subsided before we reached ER so I didn't seek care. I took vitamin E and fish oil 2X everyday after vaccine for 10 days following vaccine.

Starting approx 5 days ago pt states that she has a constant ammonia smell that nobody else can smell. Does not smell if holds nose or breaths through mouth.

PATIENT FELT ODD AFTER APPROX 10 MINS. HER EYES GLAZED OVER AND IT SEEMED AS IF SHE PASSED OUT FOR A FEW MOMENTS. WE DETERMINED SHE WAS DIABETIC AND HAS HTN. WE ALSO DETERMINED SHE DID NOT TAKE HER MEDS IN THE MORNING PRIOR TO VACCINATION. EMTs WERE CALLED

Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.

1st 24 hours, the expected chills, fever, shakes, severe headache, muscle aches, N&V. After that, profound fatigue, disordered taste, nausea, for one week. After that, exhaustion continued, with any mild to moderate activity causing return of chills, nausea, and headache. This lasted over FOUR WEEKS and began to resolve only with naturopathic treatment.

Total Mouth Thrush includes swollen tongue, palate, gums..adverse event happened for 2 consecutive weeks ...stuffy nose, difficult breathing

MAIN COMPLAINTS ARE VISION IMPAIRMENT AND HIGH BLOOD PRESSURE SINCE VACCINATION. PATIENT STARTED EXPERIENCING DOUBLE-VISION THE EVENING OF VACCINATION. IT HAS NOT SUBSIDED AND CAUSES CLOSE UP VISION IMPAIRMENT. SHE HAS SINCE RECEIVED PRISM GLASSES TO HELP. SHE NOTES THAT HER BLOOD PRESSURE HAS BEEN ELEVATED AND HER FEET SWELL SINCE THE VACCINATION. CURRENT READINGS ~142/87 MMHG (NORMAL READING ~114/72 MMHG). HER PROVIDER, DR. (LAST SEEN 6/4/21), ADVISED PATIENT TO CHANGE DIET BEFORE BEGINNING MEDICATION REGIMEN.

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 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: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath. Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Had soreness in all muscles . Throat felt full 6/26/2021. 6/27/21 inside mouth/gums sore and slight fever... 6/28/21 gums still sore on upper left mostly hard to eat. did

DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache. On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.

I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to the hospital ER at 9:00PM. I had a PFO, which is something like Patent Forman Ovale, heart condition, hole in atrium of heart that causes the blood to go from heart to brain. Blood clots to the brain, venous blood gets into the arterial blood. The clots could have formed everywhere but they go straight up the brain. They went through an artery and put a mesh screen over my heart opening and eventually it will help that. It was done through an artery, 15 minute process. I left the hospital the following Saturday. This week (two days ago) I have really bad tinnitus starting in both ears. My hearing is quite disrupted. I don't know how serious it is right now. I am being treated with an anti-cholesterol drug (Lipitor) and aspirin. I still have a little bit of cognitive impairment and physical fatigue. My coordination is messed up. Physical therapy starts the 15th and Speech therapy on the 23rd. I had just gotten a job two weeks before the strokes.

increased irritability I have an exceptionally good memory, and post-vaccine began to struggle a bit with it (memoryissues) impaired appetite/food tastes different

Started w/ nauseau and diarhea, shaking and chills (even in hot climate), take ibuprofen and peptobismalevery three hours, dreams, weird fever dreams, left leg burning, lower teeth pain, joint pain in left hand (unusual). After two weeks burning dissapeared, everything else lasted only 4 days

Re-occurrence of Lyme symptoms that had been in remission - double vision, memory problems especially short-term memory, headache, back and neck pain, insomnia,

Patient is a 66-year-old female with a past medical history of diabetes mellitus, vertigo, hyperlipidemia, fall, syncope who presents to the hospital with right eye pain/infection that started about 3 days ago. Patient tested positive for COVID-19 upon admission on 7/17/21; but was asymptomatic. Please note: Patient received First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the second dose 22 days later, on 4/12/2021 (confirmed from health department)

Violent shaking and chills, 100.1 fever, muscle aches, headache, dry mouth, pain in arm, nausea but no vomiting

I have developed a metallic/salty taste in my mouth effecting the taste pf food and causing nausea at times.

Pt has PMH of anaphylaxis to PO sulfa drugs, red-syndrome to IV vancomycin and multiple food and environmental allergies. Physician and patient underwent shared decision making process in regards to getting vaccination. - 13:10, pt received shot. - 13:20, pt reports L orbital swelling and numbness/tingling in L upper lip. Given 50mg diphenhydramine. Lungs CTAB. Airway non-edematous. No visible abnormalities or facial edema. O2 sat 98%. HR 77. - 13:30, pt states that tingling has not subsided. Reports that symptoms are mild compared to historical allergic reactions. - 13:35 - pt discharged with instructions to take diphenhydramine Q 4-6 hours for 24 hours and to discuss reaction with PCP (pt already had appt scheduled on same day).

Began with tinnitus at both ears on the morning of March 31, 2021. On the morning of April 1, the left ear lost hearing and tinnitus appeared to better. In the afternoon around 12 noon felt nauseated, dizzy. At about 4:00p.m. vomited and felt the sky spinning with eyes open.

Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient's current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.

BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADACHE RADIATING TO SHOULDER AND NECK; TEMPERATURE 101.4 F; MUSCLE ACHES TO BILATERAL BUTTOCKS AND BILATERAL THIGHS; LEFT ARM PAIN ALL THE WAY TO THE BACK OF THE SHOULDER; VERY BAD HEADACHE; NOSE SWELLING; LIP SWELLING; LEFT EYE SWELLING; FEELS NASAL PASSAGE CLOSED; LEFT EYE NOT OPENING COMPLETELY; LEFT EYE TEARING; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 218 pounds, and height was 62 inches. The patient's past medical history included anaphylaxis (closed throat) to sulfa, and concurrent conditions included asthma, sulfa allergy, corn allergy, non-alcoholic, smoker, hypothyroidism, seasonal allergies, and allergy to pcn, and other pre-existing medical conditions included the patient have allergy to caines. the patient did not have any drug abuse/illicit drug use. The patient was previously treated with epinephrine for anaphylaxis (closed throat) to sulfa. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm pain all the way to the back of the shoulder. On 24-MAR-2021, the subject experienced very bad headache. On 24-MAR-2021, the subject experienced nose swelling. On 24-MAR-2021, the subject experienced lip swelling. On 24-MAR-2021, the subject experienced left eye swelling. On 24-MAR-2021, the subject experienced left eye not opening completely. On 24-MAR-2021, the subject experienced left eye tearing. On 24-MAR-2021, the subject experienced feels nasal passage closed. On 25-MAR-2021, the subject experienced both eyes were irritated. On 25-MAR-2021, the subject experienced both eyes were red. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced feeling very bad. On 25-MAR-2021, the subject experienced temperature 101.4 f. On 25-MAR-2021, the subject experienced muscle aches to bilateral buttocks and bilateral thighs. On 25-MAR-2021, the subject experienced fell against sink. On 25-MAR-2021, the subject experienced headache radiating to shoulder and neck. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, had not recovered from nose swelling, lip swelling, temperature 101.4 f, left arm pain all the way to the back of the shoulder, very bad headache, left eye swelling, both eyes were irritated, left eye tearing, muscle aches to bilateral buttocks and bilateral thighs, both eyes were red, and left eye not opening completely, and the outcome of feeling very bad, feels nasal passage closed, fell against sink and headache radiating to shoulder and neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Patient with mouth numbness that started a few hours after vaccine received and is still persistent 6 days later

Janssen COVID-19 Vaccine EUA Immediate dizziness, vertigo with nausea, dry mouth, shortness of breath, headache and increased blood pressure. Later at night I had a low grade fever with achiness and headache. The flu like symptoms resolved by morning but I continue to have vertigo and intermittent nausea and my BP was still high in the morning around 9 am but came down by 12:45 to my normal range. Paramedics at the site did a BP, pulse ox, blood sugar, ECG . Everything was normal except my BP which was 180/90. This morning it was 167/98 and 168/97. No treatment. Saw my doctor's partner at 1:00 today and BP was back to my normal range but I still have mild vertigo and intermittent nausea. Doc gave me some exercises to do for the vertigo and did not seem to think that it was related to the shot, but since the paramedics said they had seen a LOT of the same reaction yesterday to the J&J shot and two sites in other cities shut down for the same reactions, nobody will convince me that it was anything but the shot. I expected the flu like side effects but never dreamed it would cause my BP to spike and the vertigo.

Numbness & Tingling left corner of my lips/mouth, started 40 minutes after vaccine , lasting 3 hours. Bilateral numbness to skin on knees noted in the middle of night while sleeping & resolved upon waking today @ 6:00am.

COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 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 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.

About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. At the same time, my injection arm started burning. Also, I started experience a mild headache while on the way home which became VERY bad about an hour after the vaccination (at home). My head, neck and shoulders hurt so badly that I could not move and my vision was blurry; it was a searing type of pain. Then, I developed a fever which, at its highest temperature, was 101.6° along with overall achiness, malaise and severe fatigue,

Patient presented for Covid vaccination. She had multiple allergies with history of anaphylaxis including to other vaccines. Patient insisted her PCP wanted her to get J & J vaccine. Patient received vaccine at 12:20 AND AT 12:30 C/O of losing voice and feeling like she was reacting. EPI 0.5 given subq at 12:30. BP 138/80; HR 60 and regular. At 12:38 symptoms were getting worse with raspy voice and feeling SOB. Second dose of Epi 0.5 given subq. BP 130/84; HR 64. EMS called. Arrived at 1300 and patient was transported to hospital.

The patient is a 66 y.o. female with past history of diabetes, GERD and HTN who presents to the Emergency Department with visual changes of the right eye and associated pain to the face and neck. Per interpretor, patient woke up feeling at baseline yesterday morning, when she had her COVID-19 vaccine. Yesterday around dinner time, she began having issues with vision in her right eye, causing her visual field in that eye to appear dark to her entire right eye. She told her husband that she thought she might have a hair or eyelash in her right eye and that she had an irritating pain radiating from her right eye to the right side of her face. Even after washing her eye with cold water, the sensation did not subside. At approximately 3-4 AM this morning, she also began to experience pain to the back of her head and neck bilaterally. This morning, the visual impairment improved from the entire visual field to now only just the inferior aspect of the right eye. However, she denies weakness to any of her extremities. Patient also denies chest pain, numbness, abdominal pain or nausea. She was seen at ophthalmology, at which Dr. diagnosed her with a right retinal branch arterial occlusion and decided to send her to SHE to be evaluated for the possibility of a CVA. She denies being on blood thinners or taking Aspirin. She denies any previous diagnosis of a CVA or TIA.

Patient developed hives from upper thigh up to her neck bilaterally. These were more localized in the torso area, to the point they overlapped. These lasted for 3 days heavily but decreased in size and quantity over time. They continue but are now much smaller and less frequent. Claritan has helped to calm the hives. Patient also noticed minor swelling of lips two days after vaccine. No swelling of throat and no shortness of breath per patient. The lip swelling would come and go and has disappeared.

FATIGUE/SLIGHTLY TIRED; FEVER; CHILLS; HEADACHE; LEG CRAMPS; TWITCHY MUSCLES; BACK ACHES; ACHES; THIRSTY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and prolapsed mitral valve. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication, atenolol for high blood pressure, hydrochlorothiazide for high blood pressure, and acetylsalicylic acid. On APR-2021, Laboratory data included: Blood pressure (NR: not provided), and Fever (NR: not provided) 92.7 F. On 10-APR-2021, the subject experienced leg cramps. On 10-APR-2021, the subject experienced twitchy muscles. On 10-APR-2021, the subject experienced back aches. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced thirsty. On 10-APR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 103 F. On 10-APR-2021 17:00, the subject experienced chills. On 10-APR-2021 20:00, the subject experienced fever. On 10-APR-2021 23:00, the subject experienced fatigue/slightly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps, twitchy muscles, back aches, aches, thirsty, chills, fever, and headache on 11-APR-2021, and was recovering from fatigue/slightly tired. This report was non-serious.

SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol. 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 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported. On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. 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

HEADACHE; BODY ACHES; CHILLS; TIREDNESS; STRANGE TASTE IN MOUTH; This spontaneous report received from a patient concerned a 66 year old. The patient's height, and weight were not reported. The patient's past medical history included family history of cholesterol, and concurrent conditions included chemical allergies, and petroleum byproducts allergy. The patient experienced drug allergy when treated with cefotetan. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced strange taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, body aches, chills, and tiredness on 07-MAR-2021, and was recovering from strange taste in mouth. This report was non-serious.

Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenched in sweat: VIOLANT headache: SEVERE all-over body aches lasting 24hours. 9am: drenching sweats, nausea, hypersensitivity, hperacusis, overwhelming fatigue, mild nausea. 4/10 : seas, flushing , shaky, lightheaded. 4/11: body tremors, sweats, chills, nausea, diarrhea,. 7pm: tinnitus: severe body aches-diazepam. 4/12: Tinnitus resolved: flushing, profuse diarrhea,: Imodium. 4/313: diarrhea. Polyuria about every 2 hours the entire 6 days, even when taking little to no fluids. No fevers-i never run a fever. When body aches subsided, severe post-op spine and associated leg pain vanished, has not returned.

severe fatigue, sore throat, low grade temp off and on post-72 hours, ear pain, lymph nodes swollen under left jaw area, chest tightness and pain upon inspiration for the past 3 days. Reeived Janssen on 4/3/2021. Have white pus pocket on left tonsil for approximately five days

I had been sick since this past Friday; high fever, all over body pain, constant cough and frequent sneezing, migraines , eye pain and extreme fatigue. I tested positive for Covid April 21, 2021.

Developed burning in and around ear, ear ache, then rash after a couple of days , was out of town, so not diagnosed till the following week with Shingles. I still have it, it has not gotten any better after a month

I can't say for sure but 9 days after receiving the vaccine, my condition called Erythromelalgia flared up terribly, which involved uncomfortable to intense burning of the outer ears 24/7 with no relief. It calmed down for a couple of days and then came back with other symptoms, including the burning ears, and parts of my neck and face. In addition to that, my eyes were bloodshot and had drainage coming from them and in the morning, it appeared that they had like a lining of film over them. Skin is peeling due to all the burning in the areas described. Several different treatments were tried but none has slowed down the flare-up. After another trip back to the NP, she said that it was inflamation and gave me a steroid shot along with prednisone tablets. I also went to an optometrist who found some things wrong with my eyes and prescribed some steroid eye drops. Before the vaccine, we pretty much had the Erythromelalgia under control with meds but this time, it's been hard to get things under control and more tolerable.

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. 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.

03/17/2021 Night of the vaccination fatigue for the week and aching, fever of 102. developed the following week and lasted two weeks, taste was off, was able to control the fever with Tylenol but if she went too long with out Tylenol the fever returned. In person visit for blood, chest ex-ray to check for pneumonia, urine and stole test and while blood count enzyme's and liver enzymes was up, function up. Went in once a week for three weeks for three weeks for blood test. Was tested for bacteria infection in stomach.

I had a horrible migraine. After I described it to my Ophthalmologist, Dr. , he said he didn't believe it to be a typical migraine. I had vision disturbance in my right eye for about 2 weeks. After one week, I called my doctor. I'm not sure if it has cleared up or my brain has become used to it. I had a MRI and I followed up with a Neurosurgeon and he said I have a small brain tumor (meningioma), but it was not a part of the problem. I think that if the Janssen Vaccine hadn't been paused around the time I had my migraine, I wouldn't have been so alarmed and worried.

I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a little lightheaded which subsided but did not go away completely. The next day I was better, but I had soreness around the injection site. I also had diarrhea.

ON APRIL 16, 2021 I WOKE UP AND I COULDN'T SEE OUT OF MY LEFT EYE, I WAITED A WHILE TOO SEE IF MY SIGHT WILL COME BACK AND IT DIDN'T SO I CALLED MY EYE DOCTOR AND MADE APPOINTMENT AND THEY SCHEDULED ME FOR APRIL 23, 2021. A WEEK LATER I WENT BACK TO THE DOCTOR AND HE TOLD ME TOO GO TO HOSPITAL A.S.A.P. THEY TOOK A CAT SCAN AND SAW THE OPHTAQLMOLOGIST IN HOSPITAL THE DIAGNOSIS WAS A BLOOD CLOT IN MY LEFT EYE AND I TOOK A STROKE.

On May 27th, I had an episode of double vision and light headedness and my blood pressure was up. Not quite confusion but just strange. They thought it might be a mini stroke - so I had an MRI or MRA - showed vascular changes but showed no acute stroke and carotids were okay. Also did an EKG with some changes and a repeat EKG - and that one seemed like a normal EKG. I had an echocardiogram - on Tuesday; Coronary CT on Wednesday and radiologist called my primary care doctor and said there was a "broken glass" opaqueness (opacity) of left upper lobe. This Wednesday with the chest x-ray, I'm concerned - I have been short of breath and tired lately - just not feeling good. On May 28th, I started Lisinopril for blood pressure and also started aspirin. My blood pressure is still fluctuating. I'm waiting for a lung CT to be scheduled - Pulmonary function study to be schedule and that's a couple of weeks out. I haven't had another episode of double vision. Fatigue and short of breath and I have had some diarrhea. I had had some weird GI stuff all winter long but it restarted (diarrhea) 2 weeks ago. I hadn't had it for four months or so.

Instant headache and pain shooting down arm and side while being injected, sick feeling and light headed right as I was leaving the facility. Within 4 hours I was struggling to do anything. I was tired and felt and nauseated, light headed and felt like i was hit by a truck. The bottoms of my feet hurt and I had stabbing pains so bad in my knee joints I could barely walk without assistance. I felt very ill for about a week after the shot but the headaches continued constantly for over a month but aren't daily anymore even though I still have them, and the fatigue was getting worse and still is a problem to this day. Once I was feeling a bit better my right knee started to give out and my left knee was cracking. Since I got that vaccine on 3/6/21 I have had back to back problems. Below is a quick list of these things that have occurred by dates: 3/30/21 - Constant headaches since the vaccine and ear pain and throat issues. 4/16/21 - Right knee giving out on me that started shortly after vaccine and gotten worse. X-ray and physical therapy ordered. 4/22/21 - Shortness of breath, back pain, constant fatigue. Blood work that showed elevated D-dimer then chest x-ray and ct-scan ordered. 4/26/21 - Ultrasound for nodule found on ct-scan. 5/4/21 - Biopsy done of mediastinal mass. 5/11/21 - Physical done for surgery. 5/24/21 - Surgery to remove mediastinal mass, right side of thyroid, two parathyroids and lymph nodes. 6/1/21 - Follow-up for surgery. When I asked why this happened, the doctor said we may never know but the biopsy of the right thyroid nodule result showed thyroiditis, Autoimmune/Hashimoto's, and that my immune system attacked my thyroid. The doctor said she tested me for that in 9/20 and it was negative. 6/2/21 - Left knee pain. About 4 days after my surgery on 5/24 i turned towards the door and heard a loud pop in my left knee. It had been crackling since the vaccine but wasn't giving out like the right one. I couldn't walk on it at all and was using crutches. 6/9/21 - Mri on left knee showed medial and lateral meniscus tears. Referred to Ortho Dr. 6/28/21 - Test thyroid levels post op. TSH levels high. Referral to Endocrinologist. 6/30/21 - Left knee treatment, cortisone shot in knee for now to help with pain and inflammation so I can function and physical therapy. Since then my 4th toe on my right foot has been numb for almost two weeks. I am scheduled for numerous future physical therapy appointments and doctors appointments. Then to make matters worse I just heard 2 days ago that J&J is having more issues and mentioned autoimmune and wondered could that be what caused all of this? I regret getting that stupid J&J vaccine. I expected it to he the Pfizer because that is what was there 2 days before I got my shot. I told the person I didn't want it and she got someone in charge to talk me into it. I should have walked out of there and I am mad at myself for caving to this woman. If J&J says we need a booster I will refuse to take it. I don't know if the vaccine was what triggered all of this but I find it quite odd that all of this started almost immediately after I got that vaccine. Not only to me but also to my sister who got it at the same time. She fell within 30 minutes of getting that vaccine and 3 more times that day, and has had and is still having numerous problems that mimic mine, such as issues with her feet and legs. She struggles to walk and is having issues with her thyroid among other things that she wasn't having a problem with prior to the vaccine. This is just the short version of all I have been through. Any questions feel free to contact me.

Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home. 7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.

COULD NOT THINK; BRAIN FOG; CAN'T FOCUS; FORGETTING WORDS; AFFECTING BEHIND EYES; BRAIN FATIGUE; VERY TIRED AND PHYSICAL FATIGUE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no prior health issues and patient did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, 1 total administered in left arm on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the patient experienced brain fog, forgetting words, affecting behind eyes, brain fatigue, very tired and physical fatigue and patient couldn't focus. Patient was ok for few days. Symptoms started three days later of vaccination and it is progressing worse and worse. Patient stated that Friday was really bad and Saturday was horrible. On Saturday 17-JUL-2021 patient came home and slept for five hours because she could not think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, very tired and physical fatigue, can't focus, forgetting words, affecting behind eyes, and brain fatigue, and the outcome of could not think was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755714-Covid-19 vaccine ad26.cov2.s-Could not think . 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).

flu like symptoms; malaise in muscles throughout body; chills; headache; tiredness; loss of taste; pain in midsection

At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became dizzy, headache, About 2 hours after injection body aches, nausea, feeling very tired, teeth began to ache, all over joint pain About 9 hours after injection - low grade fever (~100* F.) and chills

Fever on the night of vaccination. Body aches that felt like every bone in my body hurt. Tylenol did not control the fever. Body aches lasted three weeks. Fever lasted about 4 days. No appetite, diarrhea. Sill lack of appetite and run down and nothing tastes good. The fatigue is lingering. The breathing and low oxygen levels are still causing problems since the first dose.

Pt remained in pharmacy 30 minutes after vaccination and then left. Returned within 5 minutes with left facial (upper/lower lip) swelling. Treated with ice pack and 25 mg of oral diphenhydramine (12.5 mg/5 mL oral solution). Swelling began to go down. Provided patient with famotidine 10 mg tablet to take home and take prn. Stated never had any tingling or trouble breathing. Advised to call us with any changes.

15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.

Right after I got it I had a metal taste in my mouth. About 45 minutes later I started seeing little light like Christmas lights, it lasted for about a half hour. The next morning I woke up, I felt like I got hit by a truck, I felt so bad, no chest and body hurt. I got up and did a breathing treatment. I went to the Dr. because it sacred me, she gave me antibiotics , cough medicine with codeine- I couldn't stop coughing. I asked her to change my nebulizer treatment because it wasn't working. The Dr. suspected that this would happen.

Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with blurred vision and eye pain, light sensitivity and swelling of face, the base of the neck and at the site of injection and behind shoulderblade, Numbness of lips and burning mouth, Ongoing nausea, and upset gastrointestinal issues. Low-grade fever and chills, tremors in both arms and hands, upset stomach Still have nausea and headache, body pains,, tremors, and strong fatigue. issues

Heart rate increased within 5 minutes of having the shot, went from 72 to 114. My heart rate stayed at 109 or more until 10 PM the next night when its slowly went down to a normal heart rate. At 3 am (12 hours after the shot) i had a blinding debilitating headache that lasted until 9pm the next night. It also affected my vision. The headache was so bad i could not concentrate on the simplest task. I was unsure of what i could take for the headache. So, I did not take anything. When i woke up i was very tired and this lasted until the following day. 6am i had a fever of 102.3 this went down to 100.4 at 9:15 pm that night. I also had chills for several hours. 9:20 AM the nausea started followed by vomiting and dizziness. This only lasted for a few hours. I experienced very vivid dreams the night of the shot. I only drank some coconut water all day and could not eat any food. The next day Saturday March 27 i felt better but the fatigue did not go away until late in the evening. Sleeping seemed to help but i could only sleep for 2- 3 hours at the most.

patient experienced tongue numbness during the first 15 minutes after the vaccine was administered. Patient received diphenhydramine and felt better shortly after taking the diphenhydramine

About an hour after having the shot, I was nauseous, dizzy and light headed, I thought I was going to pass out. I had to lay down. My eyes swelled and they started to tear up, I felt weak all day and into the evening. I never had a bad reaction to a vaccine before, so this was surprising. I contacted the health department as they came to my house and gave me the shot, but I could not get through to anyone. I had to leave a message. After I was contacted back, I was told that someone would contact me that very same day, but no one ever did that day or any other day. .Because of that, I thought it must not have been a big deal, but after reading today that people in a specific had some of the same reactions I did, I thought I should report it.

Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg

I went to bed and I felt OK I woke up about 1 o?clock and my head was exploring my body was aching and I was so thirsty I can?t explain it so I got up and I drank a bunch of water and seltzer I didn?t really want to take the Advil at that point because I had nothing in my stomach I just wanted to get back in bed. My legs kept cramping up because I was sweating so much I guess I was dehydrated this went on at three and then again at five. I finally got up at five and I took a piece of bread and two Advil drank some more water finally starting to feel better it was like having the virus all over again but much milder

Patient with racing heart, trembling within 15 minutes. Blood pressure checked and result was 131/61. Patient complained of dry mouth and Benadryl administered. Patient continued to be monitored and within 5 minutes following Benadryl, heart continues to race, chest heaviness, trembling hands, tongue numbness, tongue swelling, slowness of speech and thought. EpiPen administered to Left thigh. Within 30 seconds, tongue numbness and swelling resolved. 911 was called and responded to check patient. Vitals and EKG were monitored. BP somewhat elevated due to epinephrine. EKG WNL. Patient did not go to hospital.

About one week after my injection, I had severe cramping in left leg. On April 5th started with a couple of days with severe pain in tendons of right shoulder. The pain referred into the right neck and base of occiput. On April 7, 2021, I felt off then developed a severe, stabbing headache over my right eye referring back into the occiput. Was not steady on my feet. Did not eat dinner, went to bed. Felt tingling around my mouth, and my neck and shoulders were very tight. I debated about going to the hospital, but decided against it. Still have tightness on the right side of my neck into the occiput and right shoulder.

March 8th: After inj., floaters in eyes, slight dizziness, felt warm. Water given, observation by staff approx 30min. Nurse escorted me out of building for extra precautions. April 9th: Stomach cramping, headache left side. 400mg IBU taken. April 10th bi-lateral edema , lower legs, right sided headache. 400mg IBU taken and elevated legs. April 11th: slight stomach cramping returned, with excessive flatulence. April 12th: Tingling in lower legs, edema diminished.

Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Dizzyness, with vision looking 2D and flat by 15 minutes. Told Pharmacist, of spaciness who said stay as long as I wanted. Left at 30 minute point, still spacy and nauseous. Spaciness ended by an hour with nausea off and on. Chest pain - began around 7pm, continued to expand in area of chest, sharp stabbing pain later, pain from just above left elbow to hand and tingling of fingers, pain lower left leg and tingling of left foot. Irregular heart rate at different times. Checked into emergency room at 11:00. IV inserted, placed on continual heart and oxygen monitors, EKGs, chest X-rays (2), blood tests (3). Admitted to hospital sometime during the night. Given IV medications to counteract IV contrast allergy. These medications caused full body shakes, eyesight auras and extreme nausea with gagging. Heart CT taken with IV contrast. Discharged around 3:00 PM.

4/15/21 Pt called stating that she has had some of the symptoms that everyone is talking about with the vaccine. She stated that Friday after her shot on Monday she had severe tremors, so bad it shook the car, and she went to the ER. They ordered an MRI without contrast and she is scheduled for an MRI with contrast soon. She cannot remember the date, but she began having blurry vision in her left eye. She went to her eye doctor and he stated she had an "eye stroke". She had injections in her eye today. I asked her to please call her primary physician as well and she agreed. I told her I was going to report her symptoms.

Patient called pharmacy 4/17/21 and wanted pharmacist to report that she started experiencing tinnitus about 1 week after receiving vaccine which is still ongoing. She is aware of that side effect from Janssen clinical trials. Pharmacist encouraged patient to follow up with her primary care physician as well.

ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.

LOSS OF BALANCE; BLURRY CLOUDY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 67 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced blurry cloudy vision. On 15-APR-2021, the subject experienced loss of balance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blurry cloudy vision, dizziness and loss of balance was not reported. This report was non-serious.

PATIENT CALLED TODAY AND SPOKE WITH PHARMACIST AND TOLD THAT SHE HAVE RIGHT SIDE OF HEAD IS NUMB. PAIN IN CHEEKBONE. EYES ARE SWALLON. PHARMACIST TOLD HER TO SEE HER PRIMAMARY DOCTOR AND CHECK OUT THESE SYMPTOMS.

DISCOMFORT OF THE JAW; DISCOMFORT OF THE TEETH; ABDOMINAL PAIN; MODERATE HEADACHE; This spontaneous report received from a consumer concerned a 67 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 any medical history 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced moderate headache. On 31-MAR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced discomfort of the jaw. On 12-APR-2021, the subject experienced discomfort of the teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, was recovering from moderate headache, and the outcome of discomfort of the jaw and discomfort of the teeth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210445480.

SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache 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

was at work inside in air conditioning on 5/25/2021 when she noticed she had blurry vision and felt dizzy. called PHN who referred her to call her doctor or go to the emergency room as these could be signs of a blood clot. PHN spoke with on 5/26/2021 and informed PHN that she went home yesterday from work and declined to go to an emergency room or doctor's office, as she has not seen a doctor in the last 10 years. was offered rides from friends and coworkers to a hospital or clinic, but declined. She went home and drank a lot of water, ate some bananas and sat still. She felt better after and that and has not had any reoccurring symptoms. See CONTINUATION PAGE. PHN expressed continued concern for her and recommended considering going to an emergency room or contacting a doctor. PHN reiterated that if she has another episode like that she should go to the hospital or clinic to be checked out.

April 22, about 7 pm, vision was way off, blurry and even lost to the far left in my left eye. Woke up on the 23rd confused, I had a maintenance coming to the house and when they called, I had no idea who they were....thank the Lord they called 911. EMT's came and took me to the hospital where I stayed for 5-days. Diagnosis: Hypertension; Embolic stroke

SUSPECTED COVID-19 INFECTION; SNEEZING; HURTING OF TEETH; SINUS PAIN; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 67 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker and no alcohol 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 administration not reported, batch number: 205A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the patient started to have symptoms of coughing, fever, body aches, shortness of breath (subsumed under suspected covid-19 infection), sneezing, teeth hurt and sinus pain. She decided to take a covid-19 test and it came back positive (coded as suspected clinical vaccination failure and suspected covid-19 infection). She also stated that she lived healthy clean life. On an unspecified date, laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, hurting of teeth, sinus pain, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality compliant: 90000181578. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance on 03-JUN-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number, additional reporter as contact, and narrative was updated accordingly.; Sender's Comments: V0:20210604940-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.

I am not absolutely sure that my symptoms are related to my Covid vaccine but I clearly did not have any of them before my Covid vaccine. I began having peripheral binocular diplopia and cannot recall the exact date in May. I tried using lubricating eye drops to see if it would help and did this for several weeks. I am a retired nurse and hoped this would work. It did not and since then I have had 2 seizures - one focal motor in my right foot on 6/12/21 lasting for 40 seconds and one involving my right chin musculature on 6/15/21 lasting 60 seconds which I watched in a mirror which was frightful as it was something cannot be repeated voluntarily.

BLURRED VISION; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included blurred vision. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, 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 blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision. This report was non-serious.

On 6/7/2021- UTI, had to get antibiotics On 6/10/2021- CT scan, diverticulitis, antibiotics again On 6/26/2021-throat and ear infection, antibiotics

From the April 4, 5, 6 I felt very dizzy and out of it. When I got home on the 4th of April I had a metallic taste in my mouth and I started to feel pain in my chest. On my right side, center of my chest and the left side of my chest is where I felt pain. It was the worst pain I felt in my life, I took Tylenol. I called my doctor the next day 4/5/21 and she told me take off for 2 days per protocol for J&J vaccines. I did have a fever on 4/5/21On the 7th of April I had to stop working because my headaches were so bad. The doctor ordered new nebulizer kits for me, I was just using those. My doctor told me not take anything else except for Tylenol. I was having trouble breathing so I went to ER on the 20th of April, they ran tests (xray, blood). Since the ER visit, I have not been able to work full time. I have been feeling very unwell, breathing issues and a bad cough. I have been sick again since 6/2/21, I was given antibiotics and I have also been prescribed prednisone. The prednisone has made a huge difference, I was able to start working more. Once off the prednisone, I started to feel bad again. Since getting my COVID 19 vaccine, I have not been able to work a full work week.

SWOLLEN LIPS AND TONGUE; SLURRED SPEECH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included no abuse or illicit drug usage. The patient experienced anaphylactic reaction to morphine and drug allergy when treated with morphine, drug allergy when treated with codeine, lisinopril, hydrocodone bitartrate/paracetamol, and tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced slurred speech. On 12-JUL-2021, the subject experienced swollen lips and tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slurred speech on JUL-2021, and was recovering from swollen lips and tongue. This report was non-serious.

Within 2 minutes of receiving vaccine funny sensation in my mouth Very mild Only lasted few minutes never reported. Within 1 hour of receiving the vaccine numbness tip of my tongue. At around 0630 started with restlessness, sob, coughing which kept getting worse, stated losing my voice. Went to urgent care and given injection of solumedrol, and back to back doses of duo neb treatments Released. At 0400 next day started again with SOB, coughing, Resolved with duoneb treatment 4 to 5 hours later started again with SOB and coughing Resolved with duoneb treatment. No further episodes

15 minutes after injection, customer complained about metallic taste, tongue slightly swollen with small bubbles on each side of tongue. No difficulty in breathing. We asked to stay 15 minutes more for observation. Had tightness in the chest 5 minutes later. Called 911. Operator asks not to give water/benadryl/epipen. EMT arrived 5 minutes later and assessed. Watch 15-20 minutes later walked her out to car. We checked 6:45 pm still have metallic taste and just little swollen on tongue. Called 3/5/21 @ 2:30pm no more symptoms., only from the JNJ shot. tiredness

feeling very tired (within 25 min), headache (within 3 hrs) worsened over the next several hours, muscle aches (within 8 hrs) worsened in time, fever (@100 dgs) with chills (within 8hrs), runny nose, watery eyes and dry mouth (within 8hrs), sinus pain (dry) and loss of appetite Called advice line @ 7am on 3/7/21 to see if I could take Ibuprophen (yes) and that helped. All side effects subsided in @ 36 hours.

Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.

Jansen COVID-19 Vaccine EUA I received the vaccination on 3/12/2021, about 8:30AM, at Fairgrounds. I needed the J&J vaccine, one Moderna or Pfizer as I have a history of anaphylaxis. County Public Health received about 200 does of the J&J and 800 of Moderna and Pfizer. I waited at the vaccine site about 40 minutes after the vaccine. I went home, ate, read, and became unusually sleepy so took a nap. I woke up about 2:00PM and noticed my lips and tongue were swollen, and sore. I took 2 Benadryl. The Benadryl seems to have worked as expected. I will take 2 more when I go to bed, about 11:00. I'm unusually sleepy, and my joints ache. Overall, however, I think I am experiencing a very mild reaction and I'm thankful for the vaccine. I sent my doctor a message through the patient portal, telling him of the reaction. His office is closed so he will get the message on Monday.

16 days after 1st vaccine, woke up to fever and chills, muscle weakness, fatigue, raging headache, occasional sweats, which lasted off and on for 10 days. Did not lose taste or smell, but coffee tasted horrible.

Within 5 minutes of the shot, my skin began to itch all over (legs stomach, arms, neck) and my tongue went numb. I have had this reaction before with exposure to wet polyurethane. The doctor looked at my leg to see if if there was a rash (there was not) and she gave me a bendryl. The symptoms subsided. I stayed at the clinic for a total of 2 hours. Later that evening, the itching came back so I gave myself one benedryl and the itching subsided. The following morning the itching was gone and my tongue felt better.

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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).

Six hours after vaccine, experienced chills, headache, body aches the first day into the next day and gone by end of 2nd day Ringing in my ears which I've never had before started about 10 days after receiving vaccine and I am still experiencing

ITCHY SKIN ALL OVER THE BODY; NUMBNESS IN TONGUE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included hyperactive immune system, environmental allergy, food allergy, pharmaceutical allergy, alcohol user, non smoker, inflammation, hiatal hernia, seasonal allergies, and insulin resistance, and other pre-existing medical conditions included there is no history of drug abuse or illicit drug use. The patient experienced 2 anaphylactic events when treated with urethane. 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, 1 total, administered on 13-MAR-2021 13:00 for prophylactic vaccination. Concomitant medications included famotidine for hiatal hernia, metformin for insulin resistance, and levocetirizine dihydrochloride for seasonal allergies. On 13-MAR-2021, the subject experienced itchy skin all over the body. On 13-MAR-2021, the subject experienced numbness in tongue. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy skin all over the body, and numbness in tongue on 14-MAR-2021. This report was non-serious. Additional information was received from patient on 29-MAR-2021. Following information was updated and incorporated into the case narrative: other reference numbers, onset date for event numbness in tongue updated, Vaccination time updated. Upon review, following correction was performed in the case: Anaphylaxis to urethane coded as past event past drug format.

I'm not sure this is even a "reportable event"! I have had mild tinnitus for several years, generally not noticeable except in extremely quiet settings. But 2 days after receiving J&J vaccine - (the day on which I felt the most "fatigued" and experienced some muscle aches, which responded well to ibuprofen) - I awoke with several episodes of loud ringing in my ears. From that time until now, my continuous tinnitus is much louder than it had been. I keep hoping it will subside! It's more frustrating and annoying than anything else. No pain or discomfort. For this reason I have held off seeking medical treatment. It seems like more than a coincidence to me, so I felt I should probably at least try to report it.

Tinnitus developed suddenly. Very loud, very constant. No hearing loss noticed. No previous experience with tinnitus.

Approximately an hour after receiving the J&J vaccine, I noticed a loud constant ringing in my ears (tinnitus) which has continued. I still heard the ringing in my ears on April 8. The ringing was so loud on April 9, that it woke me up during my sleep. The morning of Saturday, April 10, I called insurance company Advice Nurse and was advised to go to an Urgent Care to discuss my symptoms. with a doctor who checked my ears and blood pressure--both look normal. He also recommended going to an ENT, for which I have set up a future appointment. Last night, I slept better, but still hear the ringing in my ears this morning. I am very concerned about this ongoing side-effect.

This may NOT even be related to the JJ shot I had, but I got Conjunctivitis (Pink-Eye) 4 days after the shot. Blurred vision and severe itchiness sent me to get relief from Urgent Care

4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth, tachycardia (110-120/min), Respiratory expiratory wheezes. Took Tylenol extended release 650mg po. Drank grape juice & 7up. Diarrhea twice during night (4/09/2021) 0100 - 0600. Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%, Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021. Didn't feel better til 4/11/2021.

Patient reported headache, hive on her face, tongue swelling. She reported that she took Benadryl for few days but it did help that much. She went to Urgent care and was referred to ER where she was prescribed Prednisone for 5 days. She reported feeling better after she started taking Prednisone.

Pt reported dry mouth 2 hours after getting the vaccine. Five days later she noticed that her current size (#16) didn't fit her anymore. She tried on size 16W, and didn't fit her either. She realized her current size is 18. Pt believes this is due to the vaccine she received on 04/11/2021. Pt stated she will change her PCP because she wanted to report this and they scheduled her an appt in August 2021. Pt is looking for a new PCP. Pt insists her pants are "unusually tight"

RUNNY NOSE; SORE THROAT; EAR PAIN; COUGHING UP WHITE PHLEGM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced runny nose. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced ear pain. On 14-APR-2021, the subject experienced coughing up white phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from coughing up white phlegm, and had not recovered from runny nose, sore throat, and ear pain. This report was non-serious.

STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE PAIN; PRESSURE IN THE CHEST; RIGHT BREAST (FROM CENTER OF CHEST) UNDER THE ARMPIT STILL FEEL DISCOMFORT; HEART BEATING FASTER; FELT LIKE HEART WAS JUMPING OUT OF THE CHEST; STOMACH PAIN/SHARP PAIN; FELT THE URGE TO GO TO THE BATHROOM; REDNESS OF THE FACE; PAIN IN THE JAWS (BOTH SIDE); FELT LIKE HAVING A HEART ATTACK; PAIN SHOT UP TO RIGHT SIDE OF NECK TO SHOULDER AREA, THEN ELEVATED TO THE EARS; HARD TO BREATHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included x-ray dye allergy, prednisone allergy, amoxicillin allergy, non alcoholic, non smoker, fibromyalgia, and lymphedema in the legs, and other pre-existing medical conditions included the patient had allergy to an unspecified pain medication. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pressure in the chest. On 10-APR-2021, the subject experienced right breast (from center of chest) under the armpit still feel discomfort. On 10-APR-2021, the subject experienced heart beating faster. On 10-APR-2021, the subject experienced felt like heart was jumping out of the chest. On 10-APR-2021, the subject experienced stomach pain/sharp pain. On 10-APR-2021, the subject experienced felt the urge to go to the bathroom. On 10-APR-2021, the subject experienced redness of the face. On 10-APR-2021, the subject experienced pain in the jaws (both side). On 10-APR-2021, the subject experienced felt like having a heart attack. On 10-APR-2021, the subject experienced pain shot up to right side of neck to shoulder area, then elevated to the ears. On 10-APR-2021, the subject experienced hard to breathe. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021 13:00:00, the subject experienced migraine-like headache. On 13-APR-2021, the subject experienced stuffy nose. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced faeces has really bad odour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating faster, and chills on APR-2021, redness of the face on 12-APR-2021, and pain in the jaws (both side) on 11-APR-2021, was recovering from migraine-like headache, pressure in the chest, and hard to breathe, had not recovered from stuffy nose, and diarrhea, and the outcome of stomach pain/sharp pain, injection site pain, felt like heart was jumping out of the chest, felt the urge to go to the bathroom, faeces has really bad odour, pain shot up to right side of neck to shoulder area, then elevated to the ears, felt like having a heart attack and right breast (from center of chest) under the armpit still feel discomfort was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

numbness in my right leg the night of the vaccine, a mineral or metallic taste in my mouth for a few hours after receiving the vaccine. Also severe diarrhea started around midnight the night of the vaccine and did not clear up until March13.

Patient's caregiver reported that the patient (wife) had swelling of the lips, and swelling of the ankles.

Pt said that on the day following the vaccine she felt very dizzy and kept blacking out. Her husband said that she was also mumbling nonsensical things, and started drooling. Today when she called, she had trouble with speaking and she is still drooling. Client suspects that she might have had a stroke or a blood clot, but she have not gone to the doctor because she does not have health insurance.

Severe headaches started March 12, 2021 and lasted for over a month and a half, every day. Affected eyesight of left eye, Swelling in both legs, ankles and feet fore a week. Now every once in a while the sharp headache reoccurs and lasts for a few minutes. Mainly up the back left side of my head, up to the top of the head. Swelling has not occurred again.

Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms . 03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches. 04/01/2021-8:30am Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am. Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on

About 1 hour after the vaccine I had tingling and numbness in the left side of my face. It lasted about 30 minutes and came back intermittently for several days. The morning after I received the vaccine I had a noticeable ringing in my ears when I woke. It lessened and went away after several hours but has been present most mornings since and has lessened and then stopped as the day progressed. Today (5/28) was not present when I woke but suddenly started again about 5:00 pm.

Headaches began Monday after vaccine. Burning on outside of brain 2 days. Headaches became severe head pain which moved around. Several times ice pick like feeling in stomach. Felt like brain was shaking or vibrating. That lasted almost two weeks. At the end of that time electrical shocks firing randomly throughout my brain. Severe fatigue daily. Had to fall into bed and sleep for three hours daily during the severe symptoms. Now headaches daily but pain much less. Mostly on left side of head and behind left eye. Lesser fatigue but still there. Has affected quality of life.

Smelling intense cigarette smoke when no-one is smoking for About week or so and continuing now as of June 13, 2021

LIP SWELLING; GENERALIZED ITCHING; This spontaneous report received from a patient concerned a 68 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced generalized itching. On 10-JUN-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and lip swelling. This report was non-serious.

TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.

WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.

Blurred vision, muscle & bone aches in most of the body, fogging brain, fatigue, & headache = 5/11/21 sick with very intense symptoms These same symptoms, much milder, continuing most days, all day long since 5/11/21 and still present today 6/19/21

Pt. states after receiving J&J started feeling dizzy, vision turned white. She sit down to avoid falling, lasting about 5mins at a time. Attempted to get to her feet but shortly after standing repeated vision blurring and dizziness. Decided to just lay down for awhile. Spoke with Physician regarding symptoms with no explanation, still continuing to experience symptoms. Fear of passing out while driving.

At the time of vaccination I had a feeling of numbness in my lips and tongue. Woke up at 4am with severe vomiting and diarreha. The ER stated to follow up with my PCP. Follow up visit my heart rate was 120. I was put on a heart monitor which results came back inconclusive. Been referred to see a cardiologist. Awaiting appointment for a future date.

Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future.

Janssen COVID-19 Vaccine EAU I had a terrible headache for 2 days, chills for 2 days but slight chills for 3 days, terribly achy body, dizzy, nauseous, a little trouble focusing my eyes, diarrhea for 2 days the 3rd and 4th days, slightly sore arm.

Patient states she received J&J COVID19 vaccine today at clinic site at 10:30am. States she noticed facial swelling starting at 11:30am. Patient went out to lunch and returned home and called COVID19 hotline to report symptoms. States when the swelling was at it's worst, it was difficult to see facial structure of cheek bones which she can usually see. States symptoms are improving facial swelling has 'mostly resolved' with mild swelling around eyes persisting. No OTC medications taken. Denies vomiting/itching/nausea/rash/SOB. Talking comfortably on the phone. Denies need to clear throat.

Described flushing on her face, took her own blood sugars = 62, then ate, came up to 300. Described eye swelling. Stayed for full 30 min after vaccine. All symptoms went away and counseled to f/u with PCP or go to ED if urgent symptoms returned.

Noticed a "full" feeling in head about a week after vaccine but nothing major. Not a headache sufferer, so felt like getting a cold or maybe sinus issue. Ears feel like a "roaring" at times, no ache or anything else, just noise (started days after head) Intermittent not being able to taste food (noticed last week) Smelling is noticeably off (noticed last week) Had just passed it off as generally thinking I was getting a cold, but today made French toast with cinnamon, and could not taste that it even had cinnamon in it. I usually have an acute sense of smell & taste

All dairy products, especially milk, have a carbonated almost sour taste. This has been present since the taking of the vaccine.

Patient is a 69-year-old female who reports a history of hayfever who is coming in today after recent Covid vaccination with concerns of facial swelling also complaining of the rash and itching to her chest. On exam the patient has obvious facial swelling. She has what appears to be an urticarial rash on her chest. While she does have swelling around her lips and face otherwise she does not appear to have any obvious signs of airway involvement with no swelling of her tongue or uvula, she has good phonation with normal respirations without difficulty. Does not appear to be having reactive airway disease exacerbation at this time. Does not appear to have impending respiratory distress. She otherwise does have some skin changes in her bilateral lower extremities that she reports is baseline with her history of eczema. Primary concern at this time is for possible allergic reaction. Patient appears to have angioedema. Does not appear to have anaphylaxis. Other abnormalities are considered. Patient will be connected to cardiac and respiratory monitors. IV access will be obtained. The patient will be given a 1 L IV fluid bolus. She will be given Benadryl, Solu-Medrol, and famotidine. Patient be monitored for response. Labs have been ordered to evaluate. EKG as well as chest x-ray will be obtained. We will file VARES report. Chest x-ray obtained. There is no acute cardiac no acute pulmonary pathology on my interpretation. Laboratory evaluation has returned. The patient's CBC is reassuring. CMP shows a glucose of 78, otherwise reassuring without significant abnormality. Troponin within normal limits. Covid, influenza, RSV testing is negative. On repeat evaluation the patient is resting comfortably. She reports that the itching has resolved. Her face feels less uncomfortable. She has had no progression of the swelling. On repeat examination she continues to have facial swelling as well as swelling around her lips however she has no tongue swelling, no swelling within her posterior oropharynx, and her phonation continues to be normal. She and her friend were informed of the initial findings. Plan at this time is to admit for further evaluation and treatment.

PRESSURE IN LEFT TEMPLE; NUMB LIPS; FEEL MORE TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included at the time of this report the patient was healthy, able bodied. The patient was not on prescriptions, had no fever and do not wear glasses. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered on 31-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pressure in left temple. On 31-MAR-2021, the subject experienced numb lips. On 31-MAR-2021, the subject experienced feel more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure in left temple, numb lips, and feel more tired. This report was non-serious.

Tinnitus starting approximately 10 days, two weeks after vaccine.This is very intrusive, and the lingering adverse affect I am reporting in this form. Initial adverse reaction starting +/- two days after vaccine; sore arm at injection site, lasting 10 days, still somewhat sore.. took Tylenol extreme tiredness. Low appetite. Feeling ?buzzed? ?high? , ( not lightheaded.) these reactions lasted for 10 days.

NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. 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, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.

I experienced two days later, nausea and fatigue and headaches in the frontal lobe and around and behind the eyes. On day 3-4; racing pulse ad felt breathless. I also felt fatigued, with shooting pain to my right arm. This pain comes and goes. I also have brain fog. My leg pain comes and goes. I have migraine headaches with fatigue, cough, nausea and sputum. I went to an acupuncturist which has helped a lot and will be going tomorrow for another session.

EYES WENT CROSSED; PERSPIREING; FELT LIKE SHE WAS GOING TO PASS OUT; VISION BECAME BLURRY/COULD NOT SEE; STOMACH WAS WOOZY; FELT A LITTLE OFF; This spontaneous report received from a patient concerned a 69 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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced vision became blurry/could not see. On APR-2021, the subject experienced stomach was woozy. On APR-2021, the subject experienced felt a little off. On APR-2021, the subject experienced felt like she was going to pass out. On 02-APR-2021, the subject experienced eyes went crossed. On 02-APR-2021, the subject experienced perspireing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from perspireing, and the outcome of eyes went crossed, vision became blurry/could not see, stomach was woozy, felt a little off and felt like she was going to pass out 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.

Night of vaccine, patient experienced weekness, dizziness, nausea/vomiting, felt "odd". prolonged symptoms, tinnitis, continues to get dizzy and fall. One fall resulted in hitting head leading to ER visit. continued vertigo to this day, new onset of headaches. has reported this to pcp.

Approximately 21 days after receiving vaccine I started to have symptoms of what was later diagnosed to be shingles. My skin was very sensitive to even wearing clothes and I thought I had bites on the back of my neck into my hairline because we had been on Nantucket. But I could not see it. I was feeling very fatigued and had pain from my left ear down my left arm and side. I did not think it could be shingles because I received the Shingrix vaccines in 2019. Finally I had my husband take a picture of it and sent it to me PCP ON 4/8/2021. She informed me it was shingles and put me on a prescription (not sure of name for 1 week). Because nerve pain in neck and ear still continues I was prescribed Gabapentin which I am still taking.

CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM; TINGLING IN LEFT FINGERS; SHARP HEADACHE; TWINGE OF PAIN IN LEFT SIDE OF TONGUE; LIGHT HEADEDNESS; BURNING SENSATION AT ADMINISTRATION SITE/ TENDERNESS AT INJECTION SITE; LEFT-SIDED NUMBNESS THAT SPREAD FROM HER JAW, FACE TO TOP OF HEAD; LEFT SIDED FACIAL NUMBNESS LASTED FOR AT LEAST 5 HOURS DESCRIBED IT AS WAS SIMILAR TO DENTAL ANESTHESIA, BUT MORE EXTENSIVE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and concurrent conditions included seasonal allergy, vision damaged, and sensitivity to alcohol, and other pre-existing medical conditions included azithromycin allergy (headache, rash, hives, swollen lips, tongue and throat , breathing problems, chest pains, raises blood pressure), sulfadiazine allergy (headache, rash, hives, swollen lips, tongue and throat), omnicef allergy (headache, rash, hives, upset stomach), cefdinir, clonidine allergy (headache, rash, hives, upset stomach), cipro allergy (headache, rash, hives, upset stomach), aspirin allergy (upset stomach), cortisone allergy (feels like shards of glass), lisinopril allergy (cough), amlodipine allergy (swelling of legs &feet), hydrochlorothiazide allergy (headache, upset stomach). The patient experienced drug allergy when treated with amlodipine, acetylsalicylic acid, azithromycin, cefdinir, ciprofloxacin, clonidine, cortisone, hydrochlorothiazide, lisinopril, cefotaxime sodium, and sulfadiazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:05 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On 06-MAR-2021, the subject experienced left-sided numbness that spread from her jaw, face to top of head. On 06-MAR-2021, the subject experienced left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive. On 06-MAR-2021, the subject experienced allergic reaction. On 06-MAR-2021 14:25, the subject experienced light headedness. On 06-MAR-2021 14:25, the subject experienced burning sensation at administration site/ tenderness at injection site. On 06-MAR-2021 15:05, the subject experienced twinge of pain in left side of tongue. On 06-MAR-2021 15:15, the subject experienced sharp headache. On 06-MAR-2021 16:00, the subject experienced constantly cleared the throat. On 06-MAR-2021 16:00, the subject experienced felt kind of swollen throat. On 06-MAR-2021 16:00, the subject experienced and had a lot of coughing. On 06-MAR-2021 16:00, the subject experienced numbness in left arm. On 06-MAR-2021 16:00, the subject experienced tingling in left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly cleared the throat on MAR-2021, and and had a lot of coughing, numbness in left arm, burning sensation at administration site/ tenderness at injection site, and sharp headache on 06-MAR-2021, had not recovered from light headedness, left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive, left-sided numbness that spread from her jaw, face to top of head, tingling in left fingers, and twinge of pain in left side of tongue, and the outcome of felt kind of swollen throat and allergic reaction was not reported. This report was non-serious.

Developed intense tinnitus on April 6th, partially debilitating accompanied with headaches, difficulty sleeping, aches in ear and occasional shooting pain. On April 7th I had a NEGATIVE Covid test to rule out the disease. Ear Nose and Throat exam ruled out causes other than vaccine induced ototoxic impact to the ear nerve. audiology exam for hearing loss scheduled. It is now a month with no improvement and no proven treatment available.

ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest 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.

First adverse reaction was a headache behind right ear. This was a throbbing pain. Had low energy and a feeling of unwell. On 5/10/2021 had bad headache behind right ear. On 5/12/2021 I began swelling on the right side of my face with numbness on my right side lip area. On 5/13/2021 my face was fully distorted. On 5/13/2021 my neurologist diagnosed me with Bell's Palsy (G51.0). Neurologist ordered me on Prednisone 20mg three times per day for one week and initiate Physical Therapy. Ordered a blood test for Lyme disease.

4 days after the vaccine I started my period. light spotting and cramps 6 weeks after the vaccine I woke up with a typical burst blood vessel in my right eye. I realized my actual eye color changed from hazel to blue. As silly as this sounds the color change is not the typical "I was wearing blue, so my eyes looked blue" It changed from hazel to blue overnight. The blood vessel healed, the eye color change has remained. Its pretty but a little strange. It is over 3 weeks.

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

Patient stated her throat started tingling and she thought it was feeling like it was ready to start closing and she usually takes Benadryl. Administered 25mg of liquid Benadryl. The patient waited 30 minutes and stated she felt fine.

Onset was 10 days after vaccination with a pressure-like headache and dizziness associated with constant loud tinnitus bilaterally. She noted these symptoms for over 5 weeks, plus some right ear ache with occasional throbbing, amplification of some sounds, and some shooting pains in the head, plus insomnia. Symptoms seemed to subside on about 5/21, perhaps helped by her avoidance of caffeine and alcohol. There was a brief flare up the week of 5/19 after a meal of spicy food. That same week she notice some shuffling of the left foot and apparent left leg weakness, without injury.

1 week after vaccine, my right eye lid began twitching--like it would do occasionally if I spent too many hours on the computer. But unlike previous twitching which would twitch off and on for maybe an hour, this one continues to this day, 3 months since it began and it's pretty frequent, up to 20 twitches per hour sometimes. It also twitches when my eyes are closed. Only thing different in my life/activities was that I had received the Covid vaccine.

2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-sickness, but I wasn't in a moving vehicle; It appeared that the center of the field of vision for my left eye had become blurred. Subsequently, I had a bad headache and body aches, which lasted most of that day and the next day. My vision is still blurred. A visit to my optician on 13 April 2021 confirmed an epi-retinal membrane, which was not present at my previous eye exam. 2) about two weeks after the shot, I experienced severe pain and raised blood vessels in different areas of both my fore arms, hands and fingers, and my lower left leg and left foot. These lasted a few minutes and then subsided. They were severe enough to wake me up multiple times every night. I finally went to my doctor's office on April 26, saw the nurse practitioner who actually watched one of these episodes. She consulted Dr., they were only concerned about my left leg being a potential blood clot; said the other areas were unlikely to cause significant problems, sent me for an ultrasound examination of my left leg on April 27th, which showed no blood clot. The intermittent raised veins and pain continued for another week or so then subsided.

NUMB TONGUE WITHIN 5 MINTUES OF VACCINE. GOT THE VACCINE ON WEDNESDAY AND THREW UP ONCE ON SUNDAY. SHE SAID LATER SHE HAD METALLIC TASTE IN HER MOUTH.

Within 1 week of receiving Covid Vaccine, patient developed extreme lethargy, severe shortness of breath, lightheadedness at times, oral sores and swollen gums, dysphagia. At 3 months out now, all symptoms have continued with no signs of improvement.

Metal taste in mouth Swollen face bright red. Later tinnitus rash on legs and arms a few racing heart beats. Itchy face. Headache Today (3/17) face swells and itches then better headache tinnitus but much better than last night.

Received Janssen vaccine 3/18/21 - on 4/1/21 (14 days later) woke up with numbness to left side of face (can't close L eye, can't raise L eyebrow, left mouth crooked with smiling, watery left eye), and possibly droopy R eye. No diplopia, no weakness limbs (gait ok), no pain - went urgent care - transported to ER due to concerns of TIA/CVA

EARACHE; SINUS BLOCKAGE; FACIAL PUFFINESS; ITCHY; RASH ON FACE; RED SPOTS ON FACE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included rosacea, and concurrent conditions included osteoporosis, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received COVID-19 VACCINE ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at 10:40 to right arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced earache. On 19-MAR-2021, the subject experienced sinus blockage. On 19-MAR-2021, the subject experienced facial puffiness. On 19-MAR-2021, the subject experienced itchy. On 19-MAR-2021, the subject experienced rash on face. On 19-MAR-2021, the subject experienced red spots on face. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from earache, sinus blockage, and nausea on 20-MAR-2021, had not recovered from rash on face, facial puffiness, and red spots on face, and the outcome of itchy was not reported. This report was non-serious.

BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

Patient complained of tingling mouth, throat and tongue. Administered 10 mg Cetirizine orally per Doctor at 1255. Patient stated feeling better 1305. Patient released at 1308 per doctor.

She got the vaccine, and where she got the shot it turned red, about the size of two silver dollars, very sore. Right above that a very big red spot popped up. She had itching and bumps on her feet and then over her whole body. she had red spots and a rash on her stomach, and a big rash on her back and all over her face. She had diarrhea, headache, flu symptoms with aches all over her body. The aches went away except in her feet and her toes, it hurt to walk due to the toe pain. She still has the bumps and the itching, but took the Benadryl, but cannot take that as it gives her restless leg syndrome, and is now takin Claritin. She now has itching in her lips, has allergies in her eyes, She has not call her doctor. She talked to the person who gave her the shot and also Wal-Mart pharmacist who told her to take the Claritin. These symptoms have continued.

About an hour after vaccine my eyes started hurting....got worse....felt like they were on fire; eyes were swollen and bloodshot within 1-1/2 hrs of vaccine; vision blurry. I applied cool/cold compresses rest of day and throughout night; took Tylenol . By next morning eyes were better but still a little bloodshot. And also had an ache behind the eyeball area. Took more Tylenol and eyes continue to improve that day.

Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body, feeling cold and feeling agitated.

METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breathing issues, milk allergy, sulfa drug allergy, and hoarseness of voice, and other pre-existing medical conditions included the patient is 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: clarithromycin ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) 500 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, sore arm, headache, and pain in shoulder. This report was non-serious.

On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness. Pt went to an urgent care where they found bleeding in brain so they sent her via ambulance to ER at another hospital. She had MRI, CT and blood work. She was admitted into the ICU where she was treated for 3 days and then transferred to telemetry. Pt was discharged to FU w/ Neurologist and Ophthalmologist.

Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.

Within 10 minutes of getting the vaccine I started having hay fever- like symptoms. Sinus drainage, itchy, burning eyes, runny nose, scratchy throat, hoarse voice. This lasted for several hours. It again worsened during the night and next day I had bouts of nausea and some head ache.

Submandibular lymphadenopathy, severe bilateral temporomandibular joint pain started 4/19/2021. Patient went to urgent care and received cephalexin without improvement. Patient saw me 4/27/2021 and we are trying pain control with naproxen and hydrocodone?acetaminophen as needed for pain. Labs below were drawn.

BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain 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.

Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramps, extremely loud and fast heartbeat for about seven hours followed by moderately loud but still very fast heartbeat for several more hours, urination approximately every half hour throughout the night resulting dehydration.

First night had chills, very slight nausea and low grade fever (99.3) the next two days. On the morning of April 7th I woke up with a swollen lip. Throughout the day the swelling continued on the left side of face, then on bottom of right foot and later on top of both feet. Went to emergency room and was treated for hives. Over the next five days, the hives kept moving around, the right side of face, and then to upper lip. I followed up with my Primary Care Doctor, who did extensive allergy testing. All came back negative. I felt that it was a result of my body reacting to the vaccine. In addition, I was feeling weak muscles and joints that kept moving around.

Patient got small blood clot show on skin 4 days after shot, it went away lighter red in 1.2 week, blood pressure went up and down suddently. Sunday was fine, Monday the 26 was fine, went to bed at 9:00 PM. Was not able to wake up, went to ER around 8:30 AM on 4/27 AM by daughter call 911. In ER for 28 hour and found out she got stroke. Pnewnewmia. ER gave antibootic around 3:00 PM, transfer to intensive care, MRI around 7:00 PM 4/27/2021 due to CT scan shown stroke. Lost Vision on right side and parcial on left side due to stroke.

A day after the vaccination, I experience loud ringing in my ears. I have not had this condition before. I could also hear a pulse in my ears. The tinnitus has still not resolved 10 weeks after the vaccine. Also, I was lightheaded and dizzy and that has only subsided somewhat. 3 days after the vaccine, I had very strong veryeffects when I took Snythroid, my thyroid medication which I have taken for many years. This issue has persisted even though we have lowered my dose. This was not an issue prior to the vaccine.

THE PATIENT WOKE UP A MONTH AFTER VACCINATION & COULDN'T SEE OUT OF LEFT EYE, SHE WAS SEEN BY OPHTHAMOLOGIST & WAS TOLD THAT SHE HAD A MILD STROKE THAT PROBABLY ORIGINATED FROM A THROMBUS IN THE CAROTID

TASTE HAS CHANGED; FEELING SICK; CHILLS; FEVER; NAUSEA; EXHAUSTION; This spontaneous report received from a patient concerned a 70-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other medical history reported. The patient experienced drug allergy when treated with codeine, and levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced taste has changed. On 18-MAY-2021, the subject experienced feeling sick. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced nausea. On 18-MAY-2021, the subject experienced exhaustion. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nausea on MAY-2021, was recovering from chills, and had not recovered from exhaustion, taste has changed, and feeling sick. This report was non-serious.

CONSTIPATION LASTING OVER A WEEK, STRONG HEADACHES FOR A WEEK, SINUS CONGESTION, RASH TYPE SKIN ERUPTIONS ON FACE, REMARKABLY SIZED AND A TYPICAL BOIL TYPE CANKER SORES INSIDE MOUTH.

Patient reported J&J COVID vaccine receipt on ?4/28. Symptoms of headache with visual disturbances and abdominal pain began less than 2 weeks later. She presented to the ED about 4 to 5 weeks after the vaccine with chest pain, abdominal pain, and hemoptysis. Work up identified right sided central and bilateral segmental pulmonary emboli, with splanchnic circulation thrombosis of the upper segment of the superior mesenteric vein, splenic vein, main portal vein, and intrahepatic portal veins, as well as dural sinus thrombosis. The patient was thrombocytopenic with elevated heparin pf4 antibody. She was initially started on heparin, but transitioned to argatroban and IVIG, with resultant increase in platelet counts over the course of her stay. She was also started on Diamox 250 BID for increased IOP. The patient was hypoxic on room air, requiring up to 4L of oxygen during her stay, but was down to 1L at the time of discharge. She was discharged on rivaroxaban for continued anticoagulation.

I GOT TIMED OUT WITH ALL THE DETAILS I GAVE ON MY FIRST ATTEMPT. THEREFORE, I WILL GET STRAIGHT TO THE POINT. PATIENT WAS FOUND AFTER 15 MINUTES OF ADMINISTERING THE VACCINE TO BE PALE , COLD SWEAT AND NOT DOING WELL. I GAVE HER SOME WATER AND AT THAT POINT SHE LOST CONSCIOUSNESS FOR APPROX 30 SECONDS. 911 WAS CALLED. SHE COMPLAINED OF HAVING BLURRY VISION AND FEELING MALASE. EMTS AND FIRE DEPT. ARRIVED. HOOKED HER UP TO SEVERAL MONITORS. THE ONLY ONE THAT WAS OF CONCERN WAS HER BLOOD PRESSURE OF ABOUT 84/43. IT WAS RECOMMEDED THAT SHE BE TRANSPORTED AS SHE LIVES ALONE. SHE HAD ONLY EATEN EGGS AND POTATOES AT 11AM AND WAS FOSTERING 3 KITTENS. RAN ERRANDS ON A HOT DAY AND SAID SHE WAS HYDRATED.

about two hours after injection, I experienced headache, then mild dizziness, then extreme dizziness, then sudden overwhelming fatigue, then swollen eyes and eyelids, then chills and elevated heart rate, with pounding. I had to cancel the class I was supposed to teach, because I would not have been safe to drive to campus. I slept from approximately 2:30 pm on March 8 until 8:30 am today, March 9, all symptoms continuing, with bathroom breaks, a couple of short reports to family members who were watching out for me, and one 2-hour window during which I ate a small meal, went back to bed, and read part of a book. During bathroom breaks I took more antronex, some milk thistle, and some glutathione, which seemed to at least temporarily reduce dizziness and eye/eyelid swelling. At one point I took some hawthorne tincture because I was concerned about the heart pounding. Today I woke up feeling symptom-free, but by 2 pm I was compelled by sudden fatigue to take a two-hour nap. After that I felt better, and I think I am now fine, at 7:45 pm on 3/9/21. I am happy to have gotten the Janssen vaccine, because it is one and done!

Pt initially felt palpitations, numbness around mouth and overall unwell. BP was elevated, EMS was called. Pt felt better after 30 minutes and went to an urgent care. Her blood pressure improved and now has follow up with her PCP.

I had a very strong metallic taste in my mouth immediately following getting the shot. It lasted for several minutes

1st day of symptoms. Hands started itching. Felt like I had placed my hands in scalding hot water. Slightly red blotchy look to palms of hands. 2nd day I have additional Symptoms, I woke up with strange feeling in my mouth. Feels like i drank scolding hot drink. Mouth is also Tingly feeling, I am definitely having some kind of allergic reaction i-week after the Covid vaccination.

TIREDNESS; BURNING SENSATION IN ROOF OF MOUTH AND ON TONGUE; ACID REFLUX; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included very rare instances of heart burn, but not acid reflux, osteoporosis, high blood pressure, lung cancer, sulfa drug allergy, no alcohol use, and non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on left arm on 30-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced acid reflux. On 30-MAR-2021 15:00, the subject experienced burning sensation in roof of mouth and on tongue. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acid reflux on 30-MAR-2021, and had not recovered from burning sensation in roof of mouth and on tongue, and tiredness. This report was non-serious.

side of mouth swelling, side of mouth numb. Evaluated by EMS- Transported to Emergency room/department or urgent care.

Pt complained of tinging, heaviness in tongue. No drooling. No CP has some shortness of breath. No wheezing. Pulse ox 96% on RA. HR-78/min Lungs were clear. Pt given Benaydryl 25mg 1 tab by mouth. Pt given solumedrol 40mg IM pt showed improvement in signs and symptoms. BP 120/80

Noon the day after the vaccine I was suddenly overcome with nausea, and dizziness that sent me stumbling to bed and vomiting into a bucket next to me. Vomiting lasted for one session, but dizziness and nausea stayed for about 3 hours, and then nausea, fatigue and general sick feeling kept me in bed until the next day. April 9 I woke up still feeling out of sorts, but not as bad. Note: 28 minutes after having the vaccine, once I started driving home, the vision in my left eye suddenly went blurry, and I nearly lost vision in that eye. I tried to find a safe place to pull over but couldn't. After 5-8 minutes the vision came back but stayed a bit blurry for a couple hours. Never had any such thing happen before.

Symptoms of covid began 4 days post-vaccine; congestion, cough, body and head aches, tired, chills, lost smell and taste Contacted my physician after positive covid test who prescribed 10 days azithromycin, vitamin C and D, zinc and pulse oximeter readings 3x/day

Taste in mouth. Could feel in lungs. Eyes watering. Teeth chattering. Could not walk at first. When could walk needed help of two person to sit in observation area. After about 40 minuets was able to walk. Felt like my heart was bouncing at times. Legs were very weak. Headache the next day and nausea. My legs and balance are still off but I?m much better. Notified md office on April 12, and 13th by phone and was told if not better by next Monday to call back then by the nurse that I did not need to be seen at this time.

As I was driving, I noticed that my vision was becoming blurred. I was ready to pull the car over to the side, when it cleared up. Total time of blurred vision was probably one to two minutes.

taste has changed, starting from 1st day of shot and ongoing. Salt is hard to detect and flavors of all foods have decreased. No other expected side effects, just a slight 30 second wave of nausea 20 minutes after shot, and again the next day with a feeling of being a bit "off" for a day or two. Only the taste decrease seems to be ongoing and unexpected.

Three days after the vaccine, I lost my voice and have yet to recover it and it has been over a month.

TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). 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 09-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 itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.

Moderate to severe tinnitus in combination with serious fatigue , not constant, comes in waves , will last for hours No treatment

About a week or 2 weeks later I had ringing in my left ear. It has not resolved I still have it. I went to my doctor they sent me to a ear specialist. They did a hearing test and they seen I had some lot of hearing on my left arm.

No events immediately following injection. Six days later I started to experience an allergic reaction for some unknown reason with red welts over body, swelling. and itching. On the 7th day, my tongue and throat started swelling and I went to Urgent Care. I was treated with prednisone and epinephrine on 4/18/21 and released. Prescription given for 5 days of prednisone. No further symptoms after 4/18/21. Physician recommended I file a report with VAERS.

PRONOUNCE THUMPING AND RINGING IN THE EAR; SQUEEZING IN THE RIGHT LOWER LEG; RIGHT EAR ACHE; This spontaneous report received from a patient via a representative concerned a 71 year old female. The patient's weight was 153 pounds, and height was 66.5 inches. The patient's concurrent conditions included mild case of high blood pressure, mild case of cholesterol, alcohol use 1 beer can a day, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced right ear ache. On 21-MAR-2021, the subject experienced squeezing in the right lower leg. On 30-MAR-2021, the subject experienced pronounce thumping and ringing in the ear. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from squeezing in the right lower leg, and had not recovered from pronounce thumping and ringing in the ear, and right ear ache. This report was non-serious.

Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, aches, pains, shooting pain in ears (first 9 days); uncontrollable shaking, erratic heart beat (April 17, 18); severe head and neck ache (lasted 2 days), resting pulse 100, head cold, diarrhea, cough, fatigue, weakness, chest tightness, pneumonia (X-ray on 04/30/2021), premature heart beat (EKG on 05/17/2021). As of 05/21/2021, still have heart beat irregularities, weakness, and fatigue.

I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,

I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real weak and watery mouth. Just didn't feel right, feverish, real thirsty almost like the flu and my body would ache, like going up and down the hill. For a while I was really totally upset and said I shouldn't have gotten the shot. All I wanted to do was lay down and I got so weak. I don't think I would take another shot again if they come out with a booster.

On my left leg - on my back of thigh - the night after - an itchy spot - a little rash; it was gone by the morning. A month afterwards, I did have a couple days of extreme tiredness. Left eye blurriness and I changed my contact lens; but noticed there was double vision in the left eye- Ocular migraine - the optometrist thought it was like that. It lasted about five hours. During that time I did have blood test for Thyroid.

Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.

Patient' husband stated patient started having severe itching, slight rash on arms and legs, shortness of breath approximately 45-60 minutes after receiving the vaccine. Patient told husband it was like she could taste the shot. Patient took Benadryl and used her Albuterol MDI at home but according to husband refused to go to a doctor. No symptoms presented during 15 minute waiting period after the patient received the vaccine.

Tinnitus (pulsatile) in my right ear started started in about two days. Loss of hearing in my right ear occurred gradually.

The following day, around 11:30 AM after receiving the J & J inoculation, I experienced ringing in my left ear. It has not subsided. Today is March 12, Friday and I am writing this at 9:52 AM

Within 10 minutes of receiving the vaccine, pt reported having tingling to left side of tongue and lips. BP 199/88 and continued to rise over the course of 15 minutes to 239/103. Pt denied shortness of breath, but tingling did not improve so Benadryl 50mg PO adminsitered but offered minimal relief. Pt then began to complain of blurry vision to left eye and headache. EMS called and manual BP was 258/100. Pt transported to local ED and treated. ED physician noted that he felt that this was a drug reaction related to the COVID vaccine.

Narrative: Pt did have hx of allergies and carried epi pen. We did consult provider, who ordered 50 mg diphenhydramine 15 min prior to vaccine administration. Approx 20 minutes post vaccine pt reported "itchy, swollen tongue" and significant swelling/redness was visualized. Pt taken to nurse exam room, 0.3 mg epinephrine administered, VS obtained, 02 NC applied, and 911 called for transport to hospital for further observation. Pt stable at time of transfer.

Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever and chills, cold sweats,, headache, brain fog, dyspnea on exertion, dry mouth. Medicated with Tylenol, bananas, oatmeal and herbal tea. Documented on pdf form, but unable to use "continuation page", so added sheet that unable to attach. Will try again to upload and send separately to this. NO forms given to me at pharmacy for reporting anything. I called several times and left messages, but no return call. Sent email, but response saying unable to help at this time. Very frustrating as I continued having severe symptoms and unable to get help. Finally feeling better enough today to send form.

Had a very intense right earache that lasted for about 30 minutes, with some neck pain. This disappeared after 30 minutes entirely.

HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. 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 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.

Received vaccine at approximately 1040. Patient then went to the self monitoring area where approximately 5 minutes later stated she felt "slight puffiness in lower lip and tingling on tongue". Patent was removed from the self monitoring area and brought to our First Aid room. Vitals remained stable BP 138/70 HR 80 and respiratory rate 16. After 5 minutes within the First Aid area patient stated " the tingling and puffiness of lower lip is extending to the back of my tongue and throat". EMS was called and patient was transported to SVMC ED.

No reaction until the 6th day, Sunday. Expected reactions on Day 6: temperature 100.4, tiredness behind eyes, slightly achy body. Massive headache by Monday and ringing in ears. Took Naproxin and Mucinex Monday morning before going to work. At the end of the day I took Naproxin and Mucinex in order to sleep. By Tuesday I had chest congestion which has gotten only worse along with needle-like pain in the chest upon coughing. I spit up yellow phlegm, tiredness behind eyes returned, sneezing, choking on phlegm, and constant runny nose and ringing in ears. This has made working difficult, but not impossible. Please ignore if these are normal reactions. I'm just not sure.

At unspecified date the patient's nephew noticed acute onset change in the patient's mental status. Upon arrival to unspecified hospital by EMS she was aphasic with right facial droop, right gaze preference, right sided weakness. CT and CTA showed Intraparenchymal hemorrhage with 3mm midline shift as well as superior sagittal dural sinus thrombus in the anterior 3rd. Repeat NCHCT showed bilateral parenchymal hemorrhages.

RINGING IN THE EAR; This spontaneous report received from a patient via a company representative concerned a 72 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: /MAY/2021) dose was not reported, administered on 09-MAR-2021 approximately 18:15 to 18:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 approximately at 11:30 AM, the subject experienced ringing in the ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear. This report was non-serious.

She received her vaccine, didn't really have any feelings. She went to get her glasses and when they checked her eyes they could not give her a prescription as she was bleeding behind her right eye. She is now going for injections in her eye, which was very painful and does not know if it is helping or not yet. She will be going back to see her doctor shortly.

I got the shot on 4/6/21 and on 4/10/21, I experienced brain fog, dizziness and a rash on my left side, right below my left breast. Now, as of 5/8/21, I have developed ringing in both ears, which I never had before.

LEFT EYE AND EYE BALL HURTS; LEFT EYE LID HURTS TO BLINK; EYE LID CRAMPS; HEADACHE ACCOMPANIED WITH DISCOMFORT WITH LIGHT (COULD NOT LOOK AT THE LIGHT); HEADACHE MIGRATES FROM ONE SIDE TO ANOTHER AND TO TOP OF HEAD; PAIN IN LEFT SHOULDER ON SITE OF THE VACCINE FOR WHOLE MONTH AND LONGER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included border line diabetic, breast cancer, and eye lid cramps. 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 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pain in left shoulder on site of the vaccine for whole month and longer. On 03-APR-2021, the subject experienced headache migrates from one side to another and to top of head. On 06-MAY-2021, the subject experienced left eye and eye ball hurts. On 06-MAY-2021, the subject experienced left eye lid hurts to blink. On 06-MAY-2021, the subject experienced eye lid cramps. On 06-MAY-2021, the subject experienced headache accompanied with discomfort with light (could not look at the light). Treatment medications (dates unspecified) included: paracetamol, menthol/methyl salicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in left shoulder on site of the vaccine for whole month and longer, and had not recovered from headache migrates from one side to another and to top of head, left eye and eye ball hurts, headache accompanied with discomfort with light (could not look at the light), eye lid cramps, and left eye lid hurts to blink. This report was non-serious.

By April 13, I had completely lost the hearing in my right ear. I was diagnosed with SHL, sudden sensorial hearing loss. No treatment. Permanent deafness. Use of hearing aid will not help.

Patient developed symptoms of sinus congestion around 07/13/2021. She has pressure that is in her cheeks, forehead, and into her ears and gums. Also has had a headache, vomiting, mild cough, loose stools.

lip swelling and tongue swelling 24 hours after vaccine was administered . patient was sent to the hospital

Constant and loud Tinnitus started in the middle of the night in both ears on the 2nd day of VAX and has remained constant and consistent currently, almost 2 weeks later. Also, slight nausea began within 5 minutes of injection and has not totally diminished, but the MAJOR issue is the tinnitus!!

5 hours after injection I was shivering with fever and body aches and head ache. Next day same symptoms, no taste and slept a lot. Second day after I still Ache, brain is not as foggy as first onset, and not as high a fever. I had covid in September and this was exactly the same minus the vomiting and diarrhea I had with the virus.

Existing mild tinnitus became severe five days after vaccination on March 31, 2021. 24 hours per day--Ears pulsing. Ears hurt. Headache. Can't sleep due to EXTREMELY loud ringing in both ears. Difficulty performing everyday tasks. I know of no other adverse event that occurred at this time other than vaccination. Visited primary care physician on April 8, 2021. She could not say for certain why I have these sudden ear symptoms. She wants me to monitor for 2-3 weeks.

All my teeth began to ache and progressively get worse to the point I wanted to pull the out. At the same time it felt like my head (in notch immediately forward of middle of ear to ear) was in a tightening vise. Then I got hot and cold but not severely. Same for dizziness, very mild. I was nasusseous and not able to eat. I had random muscles pains , none lasting more than a few minutes in any one place. Odd thing was that I felt no discomfort at sight of injection. Next day I felt just as bad but at 8:30pm I felt like throwing up (after having 2 teaspons of vegetarian vegetable soup). However, I only had dry heaves. I live by myself and started to get scared. I called my daughter and took a Tylenol at 9pm. Within 10 minutes the feeling of a vise and my aching teeth felt significantly better. but stil very fatigued. Next day, today, I feel much better but still a little foggy headed. I can eat. I can function normally, thank heavens. If I had to take another shot now, I wouldn't. Not even sure I'll take a booster when it comes out . It was very scarey.

Eye hemorrhage left eye 3-15-21 Eye hemorrhage right eye 3-27-21 Right eye much worst then left eye. Pressure on eye and itching. Still dealing with issue on right eye.

04/07 evening uncontrollably shaking tingling headache nausea Treated at ER released 3:00 am 04/08. Headaches tingling all day advised to take Tylenol. Advil 04/09. 12:00 am. Face burning mouth throat body tingling prickly heart pain trouble breathing. 2:00 went to ER. Admitted for observation. Given blood thinner copious medications Released 2:00 pm 04/09.

APRIL 2ND NUMBNESS IN TONGUE, FOLLOWED BY NUMBNESS IN LIP AND PART OF CHEEK, FOLLOWED BY NUMBNESS IN RIGHT HAND. TRIP TO EMERGENCY ROOM . A BLOOD TEST AND MRI WAS GIVEN AND A STROKE WAS CONFIRMED. I WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION IN EARLY MORNING OF APRIL 3RD. ECHO CARDIOGRAM WAS ADMINISTERED ON APRIL 3. I WAS DISMISSED FROM THE HOSPITAL ON APRIL 3. ON APRIL 5 I PICKED UP A HEART MONITOR TO WEAR FOR ONE MONTH. I HAVE A SCHEDULED APPOINTMENT WITH MY PRIMARY CARE DOCTOR ON FRIDAY, APRIL 16.

HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, tinnitus, nonsmoker, and penicillin 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 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced hyperacusis. On 07-MAR-2021, the subject experienced dizziness. On 07-MAR-2021, the subject experienced soreness in arm. 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 hyperacusis, and dizziness on 07-MAR-2021, soreness in arm on 08-MAR-2021 17:00, and tiredness on 08-MAR-2021. This report was non-serious.

I started feeling faintly, experienced headaches, flashing blackness in my eyes and head. I also had blurry vision , extreme fatigue, nausea and diarrhea. I sat down for 10 minutes to be monitored and then I went home. To this day I still have headaches that come and go and I have no energy whatso ever and still have nausea that comes and goes.

EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud's syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. 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, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.

After about 20 minutes of observation she started to dry heave/spit up white bubbles. She said her mouth felt "spicy" and her eyes felt "weird" Checked blood pressure it was over 180/90 on the first read, 153/109 on the second and 176/98 on the third. Pulse was normal, strong and steady. No classic symptoms of allergy. Called 911 to be taken in, no treatment given in facility.

Patient presented to the Emergency Room via EMS with lip, palette, and throat swelling and tingling, itching, and hives. The patient was treated with epinephrine x 2 doses and diphenhydramine. The patient began having symptoms soon after receiving the Johnson and Johnson COVID 19 vaccine.

I started having headaches everyday that increased in intensity throughout the day and felt really sick. It hurt all over, but mainly in the back. I waited to call the doctor because I have seasonal allergies. My head would feel really tingling on the outside, I started experiencing a high pitched screaming sound in my ears and I felt foggy/off, along with memory issues. So after a month, I decided to call my doctor and we had a video call. She ordered an MRI, which hasn't been done yet. I had a CBC count done in the middle of April and it was normal. The headaches are getting better and I'm getting them about once a week versus daily. However, I did have a really bad headache yesterday that I would say was over a 10 on the pain scale, but it's better today.

LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.

The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.

Pt entered the monitoring area of the high-risk anaphylaxis clinic at noon for her 30 minutes of monitoring. At 12:30pm when her 30 minutes had passed and the patient was ready to leave, patient reported to RN that her tongue felt itchy and mild tingling. Evaluation of her tongue revealed no redness or swelling. Pt states she is allergic to dogs, latex, codeine, and Augmentin (severe reaction). She does have a dog at home and reacts to his dander for which she take a Benadryl nightly. Pt was given diphenhydramine 25mg PO x 1. VS = 78, 148/85, 98% O2 sat. Pt reported resolution of tongue symptoms at 12:56pm. VS 71, 159/65, 98% O2 sat. Pt discharged home in no apparent distress at 1:05pm.

She got the vaccine, was feeling fine, went to church and did her normal things for the rest of the day, and approximately 24 hours after the vaccine around 12:30 to 1:00 and started getting chills. She wrapped up in a blanket and took a nap. Then approximately 1:30 PM she had blurry vision, couldn't see clear, and she felt very, very faint like she was going to faint and was sitting in a chair and continued to sit there for a few minutes. Then she was weak after that, and then a while later she was okay.

Patient contacted Public Health by phone call on 04/12/2021 to report the following information. Patient states approximately 15-20 minutes after leaving vaccination clinic her "tongue felt swollen, dizzy and staggering around, felt out of it, nausea, face was pale, felt drained". Patient also stated she still feels "out of it, tongue feels weird, doesn't feel 100%, trouble sleeping". Patient denies taking any medication such as an antihistamine and denies contacting her healthcare provider. Public Health advised patient to contact her healthcare provider now and seek emergency care if symptoms worsen, any shortness of breath, difficulty swallowing.

Tinnitus - ringing in the ear. Began approximately one week after shot, got continually worse 12 days after. Went to doctor 15 dayts after. Prescribed amoxicillin and Fluticasone Propionate. After a week, had hearing check by audiologist and saw Physician Assisstant. Left hear showed dangerous signs of not hearing...more than right ear. Received Prednisone and continued with Fluticasone propionate.Doctor was concerned with Meniere's disease. Went back 2 weeks later, left ear more in tune with right ear, which was good. Doctor said nothing more could be done and would have to get used to the ringing. Brain would start to ignore in 4-6 months.

She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.

Immediately felt dizziness and dry mouth. Then within 2 hours felt extremely nauseated and fatigued. For two days I felt shortness of breath and fatigue for 4-5 days. The nausea lasted for over a week and then by the 4th day, diarrhea set in, which is now finally resolving after two weeks in.

SWOLLEN LIPS; SICK; NAUSEA; FATIGUE; This spontaneous report received from a patient by a Business partner on 15-APR-2021 was received on 15-APR-2021 and concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included waldenstrom's macroglobulinemia, and sulfa antibiotics allergy, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included alprazolam, ascorbic acid, bifidobacterium lactis, chlordiazepoxide hydrochloride/clidinium bromide, denosumab, fluoxetine hydrochloride, ibuprofen, nebivolol hydrochloride, and vitamin d nos. On an unspecified date, the subject experienced swollen lips, sick, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fatigue, swollen lips and sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20201245161.

NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO THE FINGERS AND TOES; BLURRED VISION; INTERMITTENT HEADACHE; PAIN INSIDE THE RIGHT THIGH; FATIGUE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, hypothyroidism, milk allergy, tomato allergy, wheat allergy, allergic to weeds, allergic to cat and dog dander, sulfonamide allergy, and tetracycline allergy. The patient experienced drug allergy when treated with epinephrine, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore right arm. On 06-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced tingling to the hands, feet and throughout the whole body. On 12-APR-2021, the subject experienced numbness to the fingers and toes. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced leg cramps. On 12-APR-2021, the subject experienced pain inside the right thigh. On 12-APR-2021, the subject experienced intermittent headache. On 14-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore right arm, and fatigue on 09-APR-2021, and had not recovered from tingling to the hands, feet and throughout the whole body, numbness to the fingers and toes, intermittent headache, blurred vision, diarrhea, nausea, leg cramps, and pain inside the right thigh. This report was non-serious.

LIP SWELLING; VOMITING; LOW GRADE FEVER; CHILLS; NAUSEA; BODY ACHES TO UPPER THIGHS; This spontaneous report received from a patient via a company representative concerned a 74 year old female. The patient's weight was 116 pounds, and height was 155.44 centimeters. The patient's past medical history included hives, and concurrent conditions included anxiety, waldenstrom, alcohol use, non smoker, sulfa allergy, dog allergy, and cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use, no 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included ibrutinib. On 09-MAR-2021, the subject experienced body aches to upper thighs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced lip swelling. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip swelling, and vomiting on 10-MAR-2021, and had not recovered from chills, nausea, low grade fever, and body aches to upper thighs. This report was non-serious.

Headaches in eyes and head, extreme sensitivity to light non-stop!!! since April 12, PM until today May 8th. Just starting to diminish a little bit.

Sore arm right away and then went to a sore muscle like normal the next day and was sore for three days. What happened next, I had gone to ENT for my ear (5th) and he put me on heavy dose of Prednisone (6th). Following Tuesday, I was on Prednisone for ear. I was already really achy by then. On the third day after the Prednisone I fatigue, headaches and neck pain but I didn't have any other pain. I still couldn't hear though. I was on this for almost 4 weeks and from them I started like I was having a hot flash and then I would get cold; sore throat; headaches heavy bones and achy muscles; earaches; fatigue; dizziness like you wouldn't believe. They were cyclical - I'd have them for a couple days and then for about a half a day I'd be a bit better and then it would start up again. The fatigues and dizziness didn't change when the other symptoms seemed to be a bit better. My hearing didn't start to clear until I went to see the 2nd ENT which was a couple of weeks down the road. I do not have the stamina I had before the vaccine - I'm not sleeping well at night and I'm always short of breath at any exertion. It is improving but it's slow. Again, the symptoms I experienced during cyclical times: Cold symptoms, runny nose, sore mouth, ringing in my ears was horrible; dizziness and short of breath - cyclical for three weeks. The Prednisone took away all my cramps and pain in my joints that I had before the vaccine. Currently: My heart feels like it's going 100 miles an hour at night in bed - chest discomfort at night. Legs blue in the shower. The week of the 28th, I was done with the Prednisone and then all the pain came back and more. I can't take an inflammatory - the pain is still there and my usual cramps came back.

After getting the vaccine I came home and I fell asleep for a couple hours and I woke up very sick to my stomach and vertigo really bad. I was coughing a lot and I could not breathe and it was terrible. I was also tired and my muscles were sore. I made a doctor's appointment and I was waiting on the car and I tried eating some chips and I could not taste them. Then they let me in the hospital and I had a Covid test done and it was positive. That happened in 04/09/2021. They gave me a medicine for vertigo and an inhaler, Ibuterol and a medicine to control wheezing in my lungs

Patient was a COVID-19 vaccine breakthrough case who was hospitalized. Patient reported the following COVID-19 symptoms: headache, sweats, chills, fatigue, boy aches, runny nose, cough, loss of taste, nasal congestion., and fever. Patient was hospitalized on 4/17/2021 and discharged on 4/19/2021.

Severe ringing in the ears, ongoing, off and on; muscle aches, bad cramping in calves, feet and toes turned "beet red," very painful. Still sore feet.

After months one day my eyes were bleeding and I had to go the doctor and they didn't give me any medicine or anything.

Awoke 7:30 am day after vaccination (16 hrs later) unable to hear R ear. Unable to access medical care because it was Sunday. Contacted primary physician who said he would try to get me ENT appointment ASAP, but suggested I get audiology evaluation ASAP, which I did, on Monday afternoon, 3/22/2021. Eval confirmed hearing loss with problem in R middle ear. Developed mild flu-like symptoms on Monday evening that persisted for about 30 hours...mild nausea, headache, malaise. Appointment with Dr, ENT scheduled for 3/25/2021. He said I was about the 5th vaccine related hearing loss he had seen, and has prescribed a course of Prednisone, in hopes hearing will return.

Friday morning after the shot, I noticed I had a sore on the roof of my mouth and on my lip. As the day went on, I had more sore in my mouth. Saturday morning, I had more blisters. On Tuesday, I went to my PCP, he felt like I was turning the corner and thanked me for coming in. Tuesday night, it was bad. I called the pharmacy and they advised calling my doctor. I called the doctor and talked to the nurse but my doctor was out of town. Late Wednesday night, I picked up a script to rinse my mouth with. On Friday, I went to the ED and was diagnosed with Shingles and went to a different doctor for treament and was given medicine. I had pain even when using the ear drops. I stopped the ear drops as directed. I developed paralysis on the right side of my face. I went to an UC you was diagnosed with Ramsey Hunt Syndrome.

Patient developed chills and fatigue Saturday and Sunday (April 3rd and April 4th) . Patient developed diarrhea and lack of appetite Monday, April 5th. Patient was reported to be bedridden Wednesday, April 7th. Patients husband stated hat patients eyes were halfway closed, experiencing shallow breathing, and had a soft pulse. Husband call 911 while instructed to do chest compressions until EMTs arrived on site. First responder were reported to perform resuscitation efforts on the patient for 35 minutes until transporting the patient to the hospital.

Got shot on the 1st of april; felt nothing for a few days then felt like in a tunnel....ears plugged and wouldn't pop...got apt with wahpeton clinic on 15th and made apt in fargo for the 23rd...got audiology test and saw ear dr. hearing in left ear was zero. Dr gave shot of prednizone in left ear and 2 week regime of prednizone. I can faintly hear but still have sound in left ear. See dr on tuesday the 4th of May.

o Patient with several complaints that started after receiving her Johnson&Johnson COVID vaccine 3 weeks ago. She has swelling in her medial malleolar area with negative calf tenderness or Homans' sign. Due to recent findings with Johnson&Johnson vaccine, will send patient for doppler testing to look for the presence of a clot. Her swelling could be due to mild injury while working in her garden or varicose veins. o Will obtain CBC to evaluate platelets due to patient's concerns for recent vaccine. o Other complaints that may be related to the vaccine (visual change and fluid area on shin) have now resolved. Discussed with patient that based on the vaccines being new, difficult to know what side effects may be seen, but she should continue to watch for changes and encouraged her to see an eye specialist for an eye check. o Last vitamin D was normal and advised that no check necessary at this time and that she can take Vitamin D 1000-2000 units daily.

TROUBLE SEEING (COULD ONLY SEE THE WALL); LOTS OF BLOOD IN NOSE; OPEN MOUTH; This spontaneous report received from a consumer concerned a 75 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: 206A12A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced trouble seeing (could only see the wall). On 01-MAY-2021, the subject experienced lots of blood in nose. On 01-MAY-2021, the subject experienced open mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lots of blood in nose, open mouth, and trouble seeing (could only see the wall). 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.

No Immediate effect. Not sure if events are related ! On March 24th 2021, patient received the one Janssen # 1805022 Covid vaccine, at home, from a at Home doctor. 1) On May 12th 2021, patient, at home on the vent, began getting tired, she threw up, could barely walk and eventually became totally lethargic. Her oxygen was low and the on hand nurse used the Ambu bag to get her oxygen up to 100, while I called the ENT?s. The ENT?s checked her vitals, and did an EKG. We spoke to the doctor, and although by that time she was acting somewhat ?normal?, the decision was made to take her to hospital. Her oxygen was stabilized and her CO2 at the hospital was 80. She remained in the hospital for four days. 2) On Sunday, July 4th, patient was at home on the ventilator. Approximately 1:30 pm she seemed to become somewhat tired and she dropped her coffee cup.A little later, while eating, she threw up, spilling food and drink on her top. She seemed more tired and needed help changing her top. She sat in her recliner for a while and then she had to go to the bathroom. I took her there in a wheelchair. By the time she was ready to leave the bathroom, she was comatose and I had to lift her, she was dead weight, and place her in the wheelchair. I rolled her to the recliner and lifted her into it. She was then completely unconscious, with a continuously running nose and bubbles and fluid coming from her mouth ! Note: This was exactly same experience we had with her on May 12th 2021, when she was taken to hospital. I increased her breath rate on the Vent from 16 to 20, hoping that would expel CO2. I also increased the oxygen setting on the floor concentrator to 9, her pulse oxy was stable at 90. With the help of my daughter in law and grandson, we repositioned her on the recliner to a more comfortable and accessible position, connected the AMBU bag to the oxygen and slowly applied oxygen through her trach connection. We had also called the emergency, requesting assistance. By slowly squeezing the AMBU bag, I got her oxygen up to 100 ! Note: This Is exactly what we did on May 12 th. The ENT?s arrived shortly and within a few minutes after they arrived, patient started to come out of her comatose condition. The ENT?s checked her vitals,(somewhat normal) did an EKG, and checked her CO2 (45).We spoke to the doctor, and by that time she was acting ?normal? ! The decision was made to keep her at home instead of going to the hospital and an at-home X-ray was ordered in case she aspirated and conducted the following day. This x-ray Did Not show any aspiration !

DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.