Johnson & Johnson

Cardiovascular symptom reports

Female, 16 - 25 years

Age Reported Symptoms Notes
16 2021-05-16 chest pain Headache and chest pains
18 2021-03-11 loss of consciousness about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, los... Read more
about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, loss of consciousness, vomiting and of her left hand getting cold.
18 2021-03-15 fainting, pallor, heart rate increased PATIENT WAS DESCRIBED AS HAVING SYNCOPE WITH PALE SKIN RAPID HEARTBEAT AND BP OF 147/103
18 2021-03-16 chest pain Extreme difficulty breathing and severe chest pain.
18 2021-03-16 pulmonary embolism, fibrin d dimer increased On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain wh... Read more
On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain while taking a deep breath. Mother called on 3/16/21 and patient was seen in primary clinic for issue. She had labs and xray done. Xray showed possible mild opacity in left lower lobe and to do ct scan. Ct pe study done same day showing bilateral lower lung pulmonary emboli and lower lung patchy infiltrates. Patients pain progressively got worsened and was seen in the er to be transferred to outgoing facility for care.
18 2021-03-28 pallor At 1428, patient mother alerted medical staff, stating her daughter had a seizure. Upon arrival, dau... Read more
At 1428, patient mother alerted medical staff, stating her daughter had a seizure. Upon arrival, daughter was sitting upright in passenger seat, mother holding her, eyes open, appearing pale. No convulsions , incontinence, or other seizure activity noted. EMS notified and arrived within a minute and evaluated patient. No medications or additional treatment given. Patient ambulated to EMS stretcher with one person assistance. Awake and talking. Patient transported via ambulance at 1437.
18 2021-03-31 heart rate increased Increased heart rate and throat tightness per patient
18 2021-04-01 loss of consciousness Patient received Janssen Vaccine around 11:30 am. Patient was told to wait around 15 minutes to mak... Read more
Patient received Janssen Vaccine around 11:30 am. Patient was told to wait around 15 minutes to make sure everything was ok. Patient got my attention a few minutes later saying she felt dizzy. As i was guiding her back to the chair she passed out and i guided her to the floor. In a few minutes she was able to sit upright in the chair. EMS was called and she later went to hospital for further evaluation.
18 2021-04-05 loss of consciousness pt was shopping in store for 15 min wait time, got light headed and blacked out and fell 10 min into... Read more
pt was shopping in store for 15 min wait time, got light headed and blacked out and fell 10 min into vaccination, did not hit her head. She had not eaten yet and was under stress for not finding keys. Pt had not had water either for today. Pt has no history of reactions to vaccines, or any other factors.
18 2021-04-05 fainting, pallor Within 5-10 minutes after receiving vaccine, patient began to become very pale. Her symptoms includ... Read more
Within 5-10 minutes after receiving vaccine, patient began to become very pale. Her symptoms included dizziness, syncope, stomach ache, foaming at the mouth, vision disturbances. 911 was called and paramedics arrived.. Her vital signs were all normal. Patient did not wish to go to hospital, and her mother took her home. Other pertinent information is that patient has a history of seizures and had been off of her seizure medication for 4 weeks. I believe that I understood her mother to say that her neurologist knew she was getting the vaccine today. Patient reported no allergies to any other vaccine, medication, or other.
18 2021-04-05 fainting 8pm 3/31/2021 Fever, nausea, fatigue 4/1/2021 Extreme nausea, fever, fatigue, body aches, Heightene... Read more
8pm 3/31/2021 Fever, nausea, fatigue 4/1/2021 Extreme nausea, fever, fatigue, body aches, Heightened symptoms of neurocardiogenic syncope, easily bruising on legs 4/6/2021 Continued agitation of neurocardiogenic syncope symptoms- fainting and nausea
18 2021-04-05 fainting Syncope about 5 minutes after shot. Fell out of chair, immediately awake. Sweating, no trouble breat... Read more
Syncope about 5 minutes after shot. Fell out of chair, immediately awake. Sweating, no trouble breathing. Paramedics checked her out, said she was ok. Mom picked her up.
18 2021-04-05 fast heart rate Patient had seizure-like activity about 10 minutes after receiving the Johnson & Johnson Covid Vacci... Read more
Patient had seizure-like activity about 10 minutes after receiving the Johnson & Johnson Covid Vaccine. Nurse saw her eyes rolling back and struggling to breath. She was placed on her side until wheelchair was brought to her side and then transferred to wheelchair and taken to the ER. While in transit she regained consciousness and was lethargic but was responding appropriately to questions. Patient was checked by Dr. and his review was tachycardic and mild dyspnea. Skin was pink and warm. She was taken to the ER for further evaluation.
18 2021-04-06 loss of consciousness Pt passed out after getting vaccinated. Her BP and pulse were normal. Pt stated that she did not eat... Read more
Pt passed out after getting vaccinated. Her BP and pulse were normal. Pt stated that she did not eat anything since morning breakfast around 9am. Paramedics were called to verify that Pt was doing ok. Gave pt both orange juice as well and some food ( chicken nuggets). After 30 minutes pt was calm and stated that she was feeling well. Called pt on 4/7/21 at 9:05am to verify that she was doing all right. She stated that other than sore arm she was doing fine and did not go to the hospital.
18 2021-04-06 pallor Local injection site pain and soreness immediately after. Starting about 6 hours later, started feel... Read more
Local injection site pain and soreness immediately after. Starting about 6 hours later, started feeling nausea, shivers, whole body aches. About half an hour after that, had a bout of vomiting, loss of vision for about 10 seconds after standing up from bed (possibly associated with undiagnosed iron deficiency), and paleness of skin and mucous membranes.
18 2021-04-06 fainting Patient received the vaccination and was waiting 15 minutes while we monitored her. she began to fai... Read more
Patient received the vaccination and was waiting 15 minutes while we monitored her. she began to faint after 10 minutes. shortlyafter she regained concsciousness. paramedics were called and patient was taken to the hospital .
18 2021-04-07 palpitations Patient approached this RN stating that she felt lightheaded and nausous. Assisted patient to floor,... Read more
Patient approached this RN stating that she felt lightheaded and nausous. Assisted patient to floor, lying flat with feet elevated. Pt began complaining of "dark vision," swelling sensation and tingling in tongue, numbness and tingling in bilateral upper extremities and heart racing. Alerted physician. EMS notified for transport. Vitals obtained 1212- BP 90/48; HR 139; o2 98%; RR 22. Epipen 0.3mg LOT 0FM400 EXP 12/31/21 administered to R thigh at 1215 per physician order. 20g IV inserted into R-AC. 125mg Solumedrol LOT DA6800 EXP 6/2022 (administered 1217) and 25mg Diphenhydramine LOT 049343 EXP 4/2021 (administered 1220) administered IV push per order. Vitals obtained 1220- BP 122/50; HR 123; o2 99%. EMS arrived at 1225 to transport patient to ED.
18 2021-04-07 fainting Immediate ringing and loss of hearing in ears, blurred/starry vision, excessive sweating, nausea, an... Read more
Immediate ringing and loss of hearing in ears, blurred/starry vision, excessive sweating, nausea, and faintness.
18 2021-04-07 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was administered vaccine per protocol. Prior to injection patient was complaining of being nervous, and permission was sought to proceed with the shot. Patient fainted about 10 seconds after the completion of the injection and was stabilized in the chair. When the patient came to she was complaining of nausea and proceeded to vomit several times. Mother of the patient was present at the time and said that she had a crippling fear of needles.
18 2021-04-07 fainting Patient fainted 5 minutes after receiving the vaccine
18 2021-04-08 chest pain Patient received vaccine at 14:22, waited the 30 minute observation period. Patient returned to clin... Read more
Patient received vaccine at 14:22, waited the 30 minute observation period. Patient returned to clinic at 15:35 with reports of chest pain and c/o throat closing. She did not use her epi pen, but had it during the observation period after her injection. Nurse met patient in waiting room and escorted directly to ED. Patient was seen by ED physician and was given albuterol, solumedrol and benadryl. Was discharged home in good and improved condition at 17:33.
18 2021-04-08 nosebleed My nose is very dry and has been bleeding
18 2021-04-08 loss of consciousness, fainting Patient fainted within minutes after receiving vaccine. Fell out of chair and blacked out. She wok... Read more
Patient fainted within minutes after receiving vaccine. Fell out of chair and blacked out. She woke up immediately but felt very confused and shakey. 911 was called and vitals were taken by EMTs. Patient was picked up by her parents.
18 2021-04-08 loss of consciousness RIGHT AFTER THE SHOT, THE PATIENT SAID THAT SHE FELT LIGHT HEADED AND TIRED. SHE STARTED TO SHAKE AN... Read more
RIGHT AFTER THE SHOT, THE PATIENT SAID THAT SHE FELT LIGHT HEADED AND TIRED. SHE STARTED TO SHAKE AND SLUMPED OVER AGAINST HER FATHER THAT WAS NEXT TO HER. SHE STARTED TO SNORE, WOKE UP AND THEN PASSED OUT AGAIN. HER FATHER SAID THAT SHE REACTS TO SHOTS THIS WAY. SHE DID NOT RECEIVE ANY TREATMENT. SHE WAS IN THE PHARMACY FOR A TOTAL OF 25 MINUTES.
18 2021-04-08 fainting The patient fainted a few minutes after receiving the vaccine. She came to shortly thereafter and ch... Read more
The patient fainted a few minutes after receiving the vaccine. She came to shortly thereafter and checked out thoroughly by paramedics. All vitals were normal and she was picked up by another party.
18 2021-04-09 excessive bleeding, lightheadedness Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff held... Read more
Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff held her and guided her to floor to lie down put feet up. MD assessed summized vagal vasal response. No LOC, No SOB. pt did not hit her head. Applied ice to back of neck, gave water for hydration. VS146/84, HR 60 reg, resp 12, SpO2 97% Pt's . Left Deltoid site benign - reddness - swelling -bleeding. Mother was at her side. stated "she has a problem with needles this happens to her". Provided reassurance. Monitored 30 minutes. kept reassessing condition. Pt stated she felt better. Ok'd to exit with family after 30 minutes. 4/10/21 next day tried to contact x 2 to check on condition , no answer left message, no return call back
18 2021-04-09 hypotension, very slow heart rate Transient hypotension and bradycardia.
18 2021-04-09 lightheadedness, hypotension Vagal, Tremors, hypotension, seizures,
18 2021-04-10 very slow heart rate, hypotension Transient hypotension and bradycardia
18 2021-04-10 chest discomfort I got the vaccine at 3:45 arm was sore but I wasn?t worried Later that night around 6 I started feel... Read more
I got the vaccine at 3:45 arm was sore but I wasn?t worried Later that night around 6 I started feeling disgusting from vaccine so I took an Advil. Around 8-10pm my body started getting chills, I started shaking, I had a headache my muscles were sore, and I started getting a fever. Around 12am all of the previous symptoms got worse my fever was at about 101 and rising and I was extremely tired. At 1am I felt the worst I have ever felt in my entire life. I could barely walk because my muscles and joints hurt and my fever was over 102.5 and I felt like my veins were on fire. At 2 am I moved to my bathroom because the floor was cold and I didn?t want my roommate seeing me cry from how much pain I was in. I have a high pain tolerance but this was the worst pain I?ve ever been in. In the bathroom I was at the peak of the pain of the vaccine. My fever was over 103 all of my previous side effects were worse than ever I felt weak and a little dizzy. I also was having a hard time breathing, my breathing was weak and I felt like I wasn?t getting enough air. I tried looking up on my phone if I should go to the hospital but I could barely pick up my phone to type or look. I dropped my phone and fell asleep in the floor for 20 minutes before I woke up. I walked slowly over to my bed and took a Tylenol and then had a sip of water and felt like I was going to puke. I tried to use my inhaler and I couldn?t hold my breath to use it. I crawled into bed and slept until 11 the next day and was too sore to walk to class all of my joints still hurt and I had a fever of 101 and a headache . I took a Tylenol and around 6pm my fever broke and I was feeling better. The next day I was still too sore to walk to class and had a headache. Today I am still sore but better my lungs still feel a little tight, I feel unfocused , and I still feel dizzy occasionally. I have no appetite and I feel nauseous when I eat so I?ve been eating in smaller portions . Every single day since the shot I?ve felt very tired. I hope these symptoms get better and Looking back on the night of vaccine I should have gone to the hospital.
18 2021-04-10 chest pain Heartburn and a burning pain in my chest that?s making me drink more fluids.
18 2021-04-10 heart rate increased, increased heart rate, palpitations Heart palpitations that turned into sinus tachycardia lasting for around 6 hours until intervention.... Read more
Heart palpitations that turned into sinus tachycardia lasting for around 6 hours until intervention. Heart rate peaked around 180. Rapid heart rate was likely a response to a high fever of 103 degrees F.
18 2021-04-10 pallor While at recovery after 3 minutes pt complained of dizziness, became pale diaphoretic. put pt on cot... Read more
While at recovery after 3 minutes pt complained of dizziness, became pale diaphoretic. put pt on cot to lie down feet elevated with ice pack to back of neck. no LOC no SOB no NV VS taken 116/78, HR 68 reg strong, resp 12 reg non labored. pt stated she is afraid of needles. Also stated she didn't eat anything all day. Monitored for 30 min. pallor, diaphoresis and dizziness subsided. Provided reassurance sat for 30 minutes. stated I feel fine now. OKd to exit
18 2021-04-11 heart rate increased Around 5:00 PM the day I got the shot I started to get a slight headache. Shortly after the headache... Read more
Around 5:00 PM the day I got the shot I started to get a slight headache. Shortly after the headache appeared I started to get the chills, I was wrapped up in multiple blankets and started shaking uncontrollably. I then checked my temperature and at this time it was 100.3. I then ate dinner and decided to try and fall asleep. When I lied down my heart began to beat very fast. I tracked my heart rate via a watch and my resting heart rate was around 140 bpm. My fever had also increased to 102. My head ache continued to get worse and I began to have bad neck and lower back pains. I was also having muscle spasm in my calfs. The entire night I could barely sleep because of my high heart rate, body aches, shakes, and the constant change from freezing cold to hot and sweating.
18 2021-04-11 heart rate increased High Fever, 103.8 -16 hours, chills, headache, dizziness, high heart rate (above 120)
18 2021-04-11 loss of consciousness, pallor Patient collapsed 2-3 minutes after vaccination. The whole body was pale and irresponsive. She was... Read more
Patient collapsed 2-3 minutes after vaccination. The whole body was pale and irresponsive. She was laid down on the floor. 911 was called. Within a minute, her skin color became pinkish, and breathing was detected. She became aware of her environment. While we waited for the paramedics, her breathing and skin came back to normal. She reported of no breakfast or lunch before getting the vaccine. We gave her some chocolate and water. Her family later reported that she passed out after a flu shot a few years back. Her family refused to take her to hospital after the paramedic's advice.
18 2021-04-11 loss of consciousness passed out after vaccine was given moved to EMS room BP: 108/61 HR:77 O2 98%
18 2021-04-11 pallor She felt totally fine after the shot and many hours after. She felt fine to go to a horseback ride ... Read more
She felt totally fine after the shot and many hours after. She felt fine to go to a horseback ride lesson at 4. Half way through the lesson she acutely felt like she was going to faint/nauseous (she had a ton to eat that day, had a bottle of water just before lesson, etc. so she knew it wasnt those kinds of things) and then had a crushing headache with a lot of "pressure behind her eyes", dizziness, and a really "strange" feeling like out of body, bawling crying, and started FREEZING. I got there 15 minutes later and she was under lots of blankets, white as a sheet, freezing, said her spine was sore from the top to bottom... just tons of symptoms. When I got her, she moved to my car and had seat heater on high and I had to put all the clothes from a suitcase I had in my car on top of her bc she was so cold and her skin was burning up. I gave her 3 200 advil and a bottle of water. ½ hour later i had a thermometer and even after that she still had 102.3 fever. She was rambling some nonsense and seemed very disoriented for a while. She went straight to shower and laid on the floor of the shower for ½ hour, took cold medicine, and evnetually went to sleep. In the night she was freezing again and the fever had spiked and she took more advil. The next day she felt much better in the morning and fine by lunchtime. She was VERY sick/uncomfortable with basically every symptom under the sun.
18 2021-04-11 palpitations Headache, body pain, fever, nausea, dizziness, short of breath, racing heart, hives
18 2021-04-11 fainting, loss of consciousness Approx 5 minutes after receiving the vaccine, the patient experienced syncope and slid out of her c... Read more
Approx 5 minutes after receiving the vaccine, the patient experienced syncope and slid out of her chair. She was unconscious for approx 10 seconds. After lying down for approx 10 minutes and using a cold compress on her forehead, she felt better and was able to walk unassisted. Her mother is taking her to Care to be checked.
18 2021-04-11 fainting At 2:00 pm, the patient had fainted 2-3 minutes after receiving the Janssen covid 19 vaccination. ... Read more
At 2:00 pm, the patient had fainted 2-3 minutes after receiving the Janssen covid 19 vaccination. She regained consciousness about 1 minute later. The patient was sitting down, and collapsed over and hit her head on the table. The patient had answered "no" on the VARs consent form that she didn't have a history of dizziness or fainting after vaccinations. She also verbally answered "no" as well when she was asked if she had a history of dizziness/fainting. It was only AFTER the patient had received the vaccination and fainted that her mother mentioned that her daughter "often faints or gets lightheaded" after receiving vaccinations.
18 2021-04-11 fainting Patient fainted upon receiving the Janssen COVID-19 vaccine. They were in a chair in the waiting are... Read more
Patient fainted upon receiving the Janssen COVID-19 vaccine. They were in a chair in the waiting area and did not fall or injure themselves. We gave her no food or drink, took her blood pressure and stayed with her. She then fainted again at which point we called for a paramedic. They evaluated her and took her blood pressure again and her blood sugar. She then recovered and walked out of the store unassisted. She did not go to the ER but chose to go to an urgent care center I believe.
18 2021-04-11 fainting dizziness and fainted, shivers/chills, 4 x episodes of break through seizures
18 2021-04-12 pallor, fainting, blood pressure decreased Patient arrived to clinic to receive Janssen COVID-19 vaccine. Patient was accompanied by father. Af... Read more
Patient arrived to clinic to receive Janssen COVID-19 vaccine. Patient was accompanied by father. After consenting to receive vaccine, vaccine was given to left deltoid muscle. After about eight minutes, patient started to express feeling strange, reporting that she felt like she was going to pass out. Patient became clammy and pale. Clinic MD was called for assistance. After a few minutes, patient started yawn, with head nodding back. Patient was slow to respond for approximately 30 seconds during syncope. There was no loss of pulse or no s/s of trouble breathing. In clinic emergency response called, along with 911. Paramedics arrived to clinic, received report from MD and nurse about situation. Patient was assessed by paramedics, EKG done and was NSR, blood glucose done, and VS several times throughout incident. Patient was initially hypotensive with BP 80s/60s, with BP returning to 116/62 within a few minutes. Patient was taken home by parents following incident, electing not to go to hospital with paramedics. Patient was in good condition when leaving clinic with directions from clinic staff and paramedics to seek emergent care if needed.
18 2021-04-12 fainting, chest discomfort Fainted and hit head, ,fever, threw up, bad headache, nausea, body aches so bad that it hurt her to ... Read more
Fainted and hit head, ,fever, threw up, bad headache, nausea, body aches so bad that it hurt her to touch her anywhere, chest heavy, mouth felt like something in it Lasted for about 36 hours and then weak for another 12 hours Took Tylenol and Motrin after calling Doctor
18 2021-04-12 fainting I experienced 4 syncopes in a span of 5 minutes. I was taken to the E.R. and given fluids before the... Read more
I experienced 4 syncopes in a span of 5 minutes. I was taken to the E.R. and given fluids before they sent me home.
18 2021-04-12 blood clot Flu-like symptoms. Muscle cramping in the left leg. Continuos period with heavy blood clotting.
18 2021-04-13 nosebleed, blood clot multiple large blood clots from her nares on Monday 4/12
18 2021-04-13 loss of consciousness Mild seizure, passed out
18 2021-04-13 fainting Fainting, Syncope for less than a minute
18 2021-04-14 fainting 12 days after COVID vaccine, patient had episode of syncope, preceded by dizziness and confusion.
18 2021-04-15 palpitations, heart rate increased, chest pain She got her J & J vaccine around 4:30 on April 7th ,2021. She was feeling fine up until around 10:0... Read more
She got her J & J vaccine around 4:30 on April 7th ,2021. She was feeling fine up until around 10:00 that night when she began to have some of the regular side effects in addition to some unusual ones that were more concerning. She had chills was feverish and nauseous with flu like symptoms of her body aching. However, at around 10:30 that night she reported having difficulty breathing and having chest pains with pain when she would take breaths. She noticeably was taking very small but frequent breaths due to the pain. She described a pressure on her chest as if there was a bowling ball sitting on top of her chest. She was crying from the pain and her difficulty breathing. She also reported that her throat felt like it was smaller/ constricted. At that time, she was given Acetaminophen and later around 12:00 she was given Benadryl. When she went to bed that night, she was in pain but she also reported that her heart was racing and her resting pulse at the time was 110 bpm. She had the flu like symptoms into Thursday evening but by Friday she looked a lot better except for her difficulty breathing with complaints of chest pain when she breaths with continued pressure on her chest. She rested in bed for most of Friday and on Saturday she got dressed in the afternoon and took a walk around half a mile at which time she was exhausted and felt out of breath. When she walked back from her destination about a half mile, she needed to rest in bed to recuperate. The pain while breathing lasted into Sunday. Monday morning, she attempted to run and became winded from running a short distance of ¼ of the block and could not catch her breath having difficulty breathing and throwing up with a lot of subsequent chest pain that day. She was taken to the doctor by 10:00 that morning to run lab tests and get an examination. She is slowly getting better and taking it easy but Tuesday she still had some pain and by Thursday she is reporting that while the chest pain is still there it is more of a discomfort that she feels when breathing as compared to pain. She continues to report the discomfort when breathing till today 4/16/21 and is still limiting her physical activity but going about her daily routine.
18 2021-04-15 fainting 10 pm 3/6 fever chills body aches nausea headache 7 am 3/7 nausea headache and syncope x 2 mins low... Read more
10 pm 3/6 fever chills body aches nausea headache 7 am 3/7 nausea headache and syncope x 2 mins low blood pressure 90/60 x 48 hours thereafter
18 2021-04-19 nosebleed HEAVY NOSE BLEEDING; This spontaneous report received from a parent concerned an 18 year old female.... Read more
HEAVY NOSE BLEEDING; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced heavy nose bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy nose bleeding on 20-MAR-2021. This report was non-serious.
18 2021-04-20 loss of consciousness Patient was nervous and shortly after injection reported that she had vision changes and got diaphor... Read more
Patient was nervous and shortly after injection reported that she had vision changes and got diaphoretic. While assisting the pt into a reclining position she briefly lost consciousness; total duration 3-5 seconds. She regained consciousness immediately once she was flat and her feet were elevated. I monitored her blood several times and it was normal. Over the course of 30-40 minutes she recovered and left the pharmacy.
18 2021-04-21 platelet count decreased Significant ecchymosis posterior legs and buttocks without trauma along with hematuria. Slightly low... Read more
Significant ecchymosis posterior legs and buttocks without trauma along with hematuria. Slightly low platelet count. Spontaneous resolution.
18 2021-04-22 palpitations After getting the vaccine patient didnt feel well which was expected, but shortly after she begin to... Read more
After getting the vaccine patient didnt feel well which was expected, but shortly after she begin to complain about feeling dizzy, fatigue. and heart palpitations
18 2021-04-24 heart rate increased Janssen COVID-19 Vaccine immediately caused injection site pain which lasted for about a week after ... Read more
Janssen COVID-19 Vaccine immediately caused injection site pain which lasted for about a week after gradually getting better. About eight hours after injection, a fever and fast heartbeat accompanied by chills began and persisted for about twelve hours. A few mild and extremely brief feelings of nausea were present as well. After taking Tylenol six hours in, the symptoms started improving and were gone after seven hours. Feelings of tiredness were present for about two days after the first symptoms showed up.
18 2021-04-25 pallor During obs, member became pale, felt faint, appeared to be hyperventilating and was obviously very a... Read more
During obs, member became pale, felt faint, appeared to be hyperventilating and was obviously very anxious. Adult emergency called. Moved to holding room. BP 80s/40s O2 sats 60%, patient hyperventilating, c/o numbness in her hands and fingers. Alert and oriented, talking the whole time and very anxious. Member improved with O2 sats 100% BP 120/56. Observed x1 hr.
18 2021-04-28 chest pain, chest discomfort, heart rate increased April 7th Adverse reactions to vaccine 5 hours after taking it including, feeling like a bowling bal... Read more
April 7th Adverse reactions to vaccine 5 hours after taking it including, feeling like a bowling ball was sitting on my chest, throat felt like it was closing, racing heart, resting pulse at 110, headache, chills, nausea April 8th flue like symptoms with chest pains April 9th chest pains, headache and fatigue was in bed entire day April 10th rested at home on Saturday but was very fatigued when I took a slow paced walk April 11th rested at home on Sunday continued chest pain April 12th Was part of a game where there was running involved after a ¼ of a block of running I threw up and felt like I could not breath, the rest of the day I had chest pain and went to
18 2021-04-28 loss of consciousness Felt dizzy, brief loss of consciousness, nausea and vomiting. Recovered after about 5 minutes.
18 2021-04-28 fainting patient fainted about 5 min. after receiving the shot. Hit her head on the floor, was immediately aw... Read more
patient fainted about 5 min. after receiving the shot. Hit her head on the floor, was immediately awake, alert. Paramedics checked her out and said she was fine.
18 2021-04-30 fainting, pallor, skin turning blue Adminstered vaccine at 12 noon. At roughly 12:03pm the patient started experiencing signs of syncope... Read more
Adminstered vaccine at 12 noon. At roughly 12:03pm the patient started experiencing signs of syncope. She had pale blue lips, ringing in ears, changes in vision/blurry vision, she felt dizzy/light headed. The symptoms began improving at roughly 12:10 and had almost completely resolved by 12:15. I kept the patient for an additional 15 minutes for monitoring. I counseled patient on what to do if they felt as though they were going to pass out. I provided a cold compress for the back of the patient's neck, and had ammonia inhalant on standby but didn't have to use to help keep patient conscious. By 12:30 the patient was feeling completely normal again. Her mom/stepmom was with her and was able to drive her home. I asked them to reach out in case of any other symptoms developed.
18 2021-05-02 pulmonary embolism Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20... Read more
Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20/2021 Doctors Diagnosed with Pulmonary Embolism
18 2021-05-03 loss of consciousness Patient was given vaccine and about 5 minutes after felt faint. Patient passed out for a few seconds... Read more
Patient was given vaccine and about 5 minutes after felt faint. Patient passed out for a few seconds. Patient peed herself. Patient left pharmacy after 45 minutes and was fine
18 2021-05-04 loss of consciousness Patient was waiting the 15 minutes after her vaccination and lost consciousness. She began to shake... Read more
Patient was waiting the 15 minutes after her vaccination and lost consciousness. She began to shake slightly which concerned me and we called 911. She came to within a minute and was aware of her surroundings. She stated she felt ok but her head hurt from hitting the floor. We gave her an ice pack for her head. After about 5 minutes she got back in the chair and was here until EMS arrived. While they were there questioning her she lost consciousness again two separate times and displayed potential seizure activity again. They put her on the stretcher and took her to the hospital. She reported she has not had seizures in the past but has fainted from a vaccination in the past but was younger and received 3 immunizations.
18 2021-05-05 heart rate increased PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report re... Read more
PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. 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 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.
18 2021-05-07 loss of consciousness, blood pressure decreased Within 5 minutes of receiving vaccine, patient was hot and covered in a full body sweat, seeing spot... Read more
Within 5 minutes of receiving vaccine, patient was hot and covered in a full body sweat, seeing spots, kept losing consciousness, nauseous. I couldn't get a reading on the BP monitor at that time as it was too low to read and she couldn't move her limbs. While waiting for EMS she could breathe fine, I could feel a faint pulse, but I had to keep taping her leg and talking to her to keep her awake. She was able to tell us her name and how many fingers I was holding up. I kept trying to get her to squeeze my hand, but I could only feel the tips of her fingers twitching and the whole time she was unable to move her feet/toes. I was able to look at her HR on her watch right before EMS arrived and it was at 62 and by that time her body temp seemed to be back to normal as her Mom said she felt cool and clammy. The BP reading by EMS was 100/60 and they tried to get her to stand but she couldn't and she still kept wanting to roll her head back and sleep.
18 2021-05-07 pallor Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: within ~ 5 minutes of dose administration, patient's mother got our attention that the patient was having a reaction. Patient was pale and lightheaded/dizzy and complained of blurred vision severe enough that she could not see my hand in front of her face. Patient remained concious. Pt was instructed to place their head within their lap and remain in the chair and was given a cold water to sip. within ~ 10min the vision changes returned to normal, & the lightheadedness subsided after 15 min.
18 2021-05-09 heart rate increased HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING U... Read more
HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 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 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.
18 2021-05-09 hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
18 2021-05-09 loss of consciousness Pt passed out for few minutes, had seizures like symptoms
18 2021-05-09 pallor On 4/20 at 5-6 AM mother found patient in bed moaning with a decreased level of consciousness/ alter... Read more
On 4/20 at 5-6 AM mother found patient in bed moaning with a decreased level of consciousness/ altered mental status. She was not handling her own secretions. She could not talk. Mother tried to scoop secretions out of her mouth and stimulated her. She appeared very pale and could not hold her own head up. She called 911. She was taken to a local ED. The appropriate amount of carbamazepine pills were found in her pill bottle. She denies overdosing. Mother noted no mood issues or findings that make her think she would overdose. ??Potential interaction between antiepileptic and covid 19 vaccine immune response?? Reduced expression of cytochrome P450 enzymes??
18 2021-05-10 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: REC... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: RECOVERED ABOUT 5 MINUTES AFTER FAINTING. 911 WAS CALLED. PT RECOVERED IN 5 MINS
18 2021-05-10 fainting Vasovagal syncope
18 2021-05-11 superficial blood clot, deep vein blood clot Deep venous thrombosis involving the common femoral vein and central portions of both superficial a... Read more
Deep venous thrombosis involving the common femoral vein and central portions of both superficial and deep femoral veins. Thrombus is also present within the saphenous vein. symptoms- leg swelling and pain since 5/2/21
18 2021-05-14 fainting syncope
18 2021-05-16 hypotension, fainting, loss of consciousness Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresp... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for a few mins, she came to it after a few mins. Paramedics was called in and the pt was checked out. pt stated that she did not eat allday, her blood presssure was low. she was fine after a few mins.
18 2021-05-16 pallor, lightheadedness Patient felt dizzy less than 5 minutes after vaccine, patient became light headed and pale, had dif... Read more
Patient felt dizzy less than 5 minutes after vaccine, patient became light headed and pale, had difficulty opening eyes. She remained sitting, but was on the verge of passing out. Our technician then called 911 and they advised not to give patient any water. Paramedics arrived and took her to the hospital for observation. Appears to be a vasovagal response to the vaccine.
18 2021-05-16 fainting, loss of consciousness The night of the vaccine: body aches, intense chills, fever, night sweats, headache, insomnia The mo... Read more
The night of the vaccine: body aches, intense chills, fever, night sweats, headache, insomnia The morning after: Passing out/fainting (loss of consciousness for a couple seconds), body aches, chills, headache. *Symptoms improved with sleep throughout the afternoon of the the day after. Body aches and weakness continued for about 4 days.
18 2021-05-16 fainting Patient received the Janssen COVID vaccine on 5/17/2021 around 1513. Prior to vaccine administratio... Read more
Patient received the Janssen COVID vaccine on 5/17/2021 around 1513. Prior to vaccine administration during prescreening questions, the client reported "I have a history of passing out after vaccines because I have to have monthly vaccines in my leg for headaches and I hate them" Client was taken to another room with a reclining seat to lay down during vaccine administration. She remained in the supine position for several minutes afterwards and after reporting she felt fine was changed to the sitting position for several minutes and again reported feeling fine. Patient was then changed to standing, reported she felt fine and ambulated to the waiting area, escorted by an RN assistant to be observed for 15 minutes by the EMS provider on site. Soon after, patient appeared to be having a syncopal episode. EMS provider on site called 911 to transport patient to the nearest hospital.
18 2021-05-21 loss of consciousness Patient's friend reported to pharmacy patient passed out as they walked out the store about 15 minut... Read more
Patient's friend reported to pharmacy patient passed out as they walked out the store about 15 minutes after the shot, and someone already called 911. Pharmacist walked out to check on patient, paramedics were already there checking on her. Paramedics said patient is ok, and they will release her. Patient came back to the pharmacy about 10-15min later to tell us she is ok.
18 2021-05-21 fainting Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had trouble walking 5 minutes ... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had trouble walking 5 minutes after vaccine injection. Sat patient down. She fainted and was unresponsive for over 1 minute. 911 called and emergency team came to check vitals. NP on duty also assisted checking vitals. Patient became conscious 1 minute after fainting. Her and her mom stayed in the store for an extra 30 minutes and decided to leave. Patient feeling normal.
18 2021-05-21 fainting DIZZINESS, SYNCOPE FOR A FEW SECONDS, THEN REGAINED CONSCIOUNESS. PARAMEDICS CAME, SX RESOLVED, NO T... Read more
DIZZINESS, SYNCOPE FOR A FEW SECONDS, THEN REGAINED CONSCIOUNESS. PARAMEDICS CAME, SX RESOLVED, NO TRANSPORT.
18 2021-05-22 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has vasovagal and experiences syncope somewhat regularly. 911 was called when she did not immediately regain consciousness, however she came to within 1-2 minutes. After 45 minutes of rest, reporting she felt normal again and being evaluated by EMTs she was cleared to leave on her own.
18 2021-05-23 loss of consciousness Patient passed out about 5 minutes after getting the covid vaccine. Pharmacist was called right awa... Read more
Patient passed out about 5 minutes after getting the covid vaccine. Pharmacist was called right away and the patient was found lain on the floor, coherent and talking to the mother. She rested there for a few minutes, drank some water. She looked ok and refused further EMS help when EMS arrived.
18 2021-05-25 loss of consciousness Patient walked away with dad to walk around store for 15 minute observation period. She started feel... Read more
Patient walked away with dad to walk around store for 15 minute observation period. She started feeling lightheaded within 90 seconds fell on the floor and hit her head on the ground about 10 feet from the pharmacy. Pharmacy called 911 immediately and they arrived within 5 minutes. Patient became more conscious after a few minutes, but started to lose consciousness again so they transported her to the hospital.
18 2021-05-26 loss of consciousness I started having chills and a fever and went to bed. I woke up the next morning brushed my teeth and... Read more
I started having chills and a fever and went to bed. I woke up the next morning brushed my teeth and i passed out and hit my head and was dehydrated. I stayed in the ER for about 5 hours.
18 2021-05-26 pallor, loss of consciousness Patient passed out a couple minutes post vaccination and recovered quickly. Patient's face was pale,... Read more
Patient passed out a couple minutes post vaccination and recovered quickly. Patient's face was pale, feeling nauseous, no EPIpen was given as this doesn't manifest allergic reaction. Patient was given alcohol pad to smell on to reduce nauseous feeling and bottle of ice water. Patient recovered quickly after 10 minutes and was observed for additional 10 minutes, she was alert and was walking around the store.
18 2021-05-27 loss of consciousness Patient passed out a couple minutes after vaccine was administered. She was disoriented when she cam... Read more
Patient passed out a couple minutes after vaccine was administered. She was disoriented when she came to. I give her some Gatorade and she seemed ok for a couple minutes then she passed out again for 30 or 40 seconds. She was disoriented and confused when she came to. She laid on floor for 15 minutes with her elevated and then sat in waiting area with her dad for 20 minutes. She said she felt fine and color returned to her face.
18 2021-05-29 loss of consciousness Pt started complaining of blacking out about 10 minutes into her observation period after she took t... Read more
Pt started complaining of blacking out about 10 minutes into her observation period after she took the COVID vaccine shot. She complained of Blacking out and she requested to use the bathroom. When she returned from the rest room, I had her lie flat on her back with her feet elevated. I observed her for 3 minutes ,and she was breathing normally and remained conscious and she said she was feeling better. I took her blood pressure and pulse at intervals of 5 minutes. Her readings were 95/68,pulse 68;91/67,pulse 64;99/68,pulse,66;99/73,pulse 57. Her mom came about 30 minutes later. I advised mom to keep an eye on her and to give Pedialyte and continue to monitor her BP and pulse. I suggested Benadyl 25mg pill to her. I advised her that if her situation deteriorates she should take her to the ER. I also advised her to contact her primary care doctor. The mother then took her home
18 2021-05-31 loss of consciousness After receiving a Jansen vaccine, pt got up to leave and started to complain that she was dizzy. The... Read more
After receiving a Jansen vaccine, pt got up to leave and started to complain that she was dizzy. Then, she slowly lost consciousness in this RN?s arms. Pt was lowered to the floor with her feet elevated in a chair. Pt regained her consciousness quickly and sat up for a while to make sure that pt was not dizzy any longer. After 15 minutes, pt went home with her mother.
18 2021-06-02 loss of consciousness Patient passed out immediately after receiving vaccination
18 2021-06-02 pallor Patient received J&J vaccine and walked to sit down for her post injection wait time. Patient had p... Read more
Patient received J&J vaccine and walked to sit down for her post injection wait time. Patient had previously fainted after a vaccine so she was suppose to sit for 30 minutes anyway. Patient immediately after sitting down got extremely light headed, pale, and dizzy. We immediately moved her to the floor and put her feet up. After approximately 3 minutes, patient regained color and was feeling a lot better. EMS was called but father who was with her called to cancel and refuse after patient felt better so quickly. Patient had history of anxiety with shots and it seemed to be truly an anxiety issue.
18 2021-06-05 pallor, fainting syncope: Immediately after receiving the vaccine, patient complained of being dizzy, weak, 'turning ... Read more
syncope: Immediately after receiving the vaccine, patient complained of being dizzy, weak, 'turning black' and pale. Her mother said that she had a similar reaction to her HPV vaccine. It looks like this was primarily due to anxiety to vaccine. Patient was instructed to lie down on supine with feet elevated. Patient never lost consciousness. After 2-3 min of lying down, patient was able to get up by herself and was instructed to take a seat in waiting area for 15-20 more min. AFter 15 min, the family left and patient was feeling normal.
18 2021-06-06 ischemic chest pain, inflammation of the pericardium I started having heart pain about two weeks after getting the vaccine, it escalated very quickly. I ... Read more
I started having heart pain about two weeks after getting the vaccine, it escalated very quickly. I was soon having severe heart pain every 20 minutes, and I pushed through this for a few days before I became concerned and couldn't do my day to day actions with constant stabbing heart pain. I had no prior illnesses or health issues. I went in to my local PMC who gave me an EKG and got me a ultrasound on the area, they then said they say some fluid around my heart, I was diagnosed with pericarditis. They said this was very weird for a healthy 18 year old, and usually I would be seriously ill before this happened. A few months have passed, the treatment has not worked and now I'm going through more medication and testing.
18 2021-06-07 fainting Fainted after vaccine for couple seconds
18 2021-06-08 loss of consciousness, pallor Patient received vaccination seemed okay went to get a drink of water. Sat down in waiting room and... Read more
Patient received vaccination seemed okay went to get a drink of water. Sat down in waiting room and said she was going to pass out. I ran out she passed out for 30 seconds. She was completely out I shook her arm called her name several times. She came to and was very clammy and sweating. Her skin went pale. She vomited. I laid her down on the floor.
18 2021-06-09 loss of consciousness, pallor, fainting Patient fainted and loss consciousness for approximately 1 minute about 5 minutes after being vaccin... Read more
Patient fainted and loss consciousness for approximately 1 minute about 5 minutes after being vaccinated. Patient was pale, and had shallow breathing.
18 2021-06-09 pallor Patient was very anxious prior to being vaccinated. About 10 minutes after vaccination, patient beg... Read more
Patient was very anxious prior to being vaccinated. About 10 minutes after vaccination, patient began to feel faint and was very pale. EMT evaluated. Patient was not transported to hospital.
18 2021-06-09 fainting Vasovagal syncope, Pt resolved quickly, given a cold water and watched for an additional 30 minutes
18 2021-06-12 pallor, fainting Alert and talkative prior and during vaccine. Appeared warm, pink and well perfused. After sittin... Read more
Alert and talkative prior and during vaccine. Appeared warm, pink and well perfused. After sitting for 3-4 minutes in recovery area had episode of syncope and fell off chair onto hard floor. Fall was observed by another patient in recovery as well as pharmacy staff. Continued 1:1 observation from pharmacy staff for and additional 45 minutes. Food and fluids were offered. Patient was alert and talkative as pharmacy staff approached her on floor. Mild pallor and sweating were noted. Continued to observe patient the full 45 minutes after event. At time of discharge had eaten, taken fluids, was alert, talkative and pink.
18 2021-06-13 loss of consciousness, fainting WITHIN 3 MINUTES OF ADMINISTERING VACCINE, PATIENT ALERTED ME THAT SHE FELT DIZZY; SAT HER BACK DOWN... Read more
WITHIN 3 MINUTES OF ADMINISTERING VACCINE, PATIENT ALERTED ME THAT SHE FELT DIZZY; SAT HER BACK DOWN IN IMZ BOOTH; WITHIN SECONDS SHE FAINTED; CALLED EMS; LOWERED HER TO THE FLOOR; POSSIBLE SEIZURE (NOT CONFIRMED) BUT LOOKED AS THOUGH HER ARM STIFFENED; PT HAD NO HX OF EPILEPSY; MADE GURGLING NOISES B4 SHE REGAINIED CONSCIOUSNESS; ROLLED HER ONTO HER SIDE SO SHE WOULDN'T ASPIRATE; SHE STATED THAT SHE WAS IN A DREAM STATE WHEN SHE WAS SITTING IN THE POST VACCINATION SEATING; BODY FELT NUMB& THROAT FELT TIGHT BUT BOTH RESOLVED WITH NO NEED FOR EPIPEN; FELT QUEEZY FOR CONTINUING OBSERVATIONS; EMS ROLLED HER OUT ON THE STRETCHER TO CONTINUE OBSERVING HER IN THE TRUCK & THEN RELEASED HER INTO HER FATHER'S CARE;
18 2021-06-19 skin turning blue, pallor, loss of consciousness Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine sh... Read more
Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine shot. The next morning at the breakfast table she began crying and shouting that she had lost her vision and everything went dark. Within minutes she stopped breathing and her eyes rolled back in her head. Her body went rigid and her mother caught her as she was falling backward in her chair. Her skin was white and her lips blue. I administered CPR and after approximately 4 mouth to mouth breathes she began breathing again. When she regained conciousness she said she could not hear. The paramedics arrived and tended to her.
18 2021-06-21 excessive bleeding, loss of consciousness PATIENT RECEIVED JANSSEN VACCINE AND FELT FINE BUT WHILE WAITING FOR THE 15 MINUTE TIME PERIOD AFTER... Read more
PATIENT RECEIVED JANSSEN VACCINE AND FELT FINE BUT WHILE WAITING FOR THE 15 MINUTE TIME PERIOD AFTER SHE PASSED OUT AT 11:57 AM AND FELL FROM THE CHAIR TO THE FLOOR AND HIT HER HEAD CAUSING A WOUND ABOVE HER LEFT EYEBROW WITH SIGNIFICANT BLEEDING. 911 WAS CALLED AS WELL AS THE PATIENTS MOTHER WHO WAS STILL IN THE STORE. HER MOTHER CAME OVER IMMEDIATELY AND EMS ARRIVED AT 12:15 PM AND TOOK HER TO THE HOSPITAL FOR EVALUATION. WHILE WAITING FOR EMS WE GAVE THE PATIENT MOIST AND DRY PAPER TOWELS UPON REQUEST AS WELL AS SEVERAL SMALL CONE CUPS OF WATER AND THEN A WATER BOTTLE. EMS LEFT WITH THE PATIENT AT 12:24 PM.
18 2021-06-21 fainting, loss of consciousness PATIENT HAD SYNCOPE IMMEDIATELY UPON RECEIVING THE INJECTION IN HER LEFT ARM. PATIENT REPORTED HISTO... Read more
PATIENT HAD SYNCOPE IMMEDIATELY UPON RECEIVING THE INJECTION IN HER LEFT ARM. PATIENT REPORTED HISTORY OF FEAR OF NEEDLES AND WAS NERVOUS PRIOR TO RECEIVING THE VACCINE. PATIENT DID NOT FALL OR HIT THEIR HEAD. PATIENT REGAINED CONSCIOUSNESS WITHIN SECONDS. BLOOD PRESSURE WAS CHECKED AND OK.
18 2021-06-24 chest pain TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS ... Read more
TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.
18 2021-06-26 inflammation of the pericardium Pericarditis, treated OTC
18 2021-06-29 fainting Patient passed out momentarily. She was sitting and fell back in chair and had convulsions. Eyes rem... Read more
Patient passed out momentarily. She was sitting and fell back in chair and had convulsions. Eyes remained slightly open, breathing not affected in any way. Patient was awake, alert and responsive within a minute. 911 called and patient taken to hospital.
18 2021-07-05 loss of consciousness Passed out (twice) within 5 minutes of receiving shot. 1st time she was standing and fell to the gr... Read more
Passed out (twice) within 5 minutes of receiving shot. 1st time she was standing and fell to the ground. 2nd time she passed out while still laying on ground.
18 2021-07-07 lightheadedness Patient developed dizziness, had a vasovagal reaction where heart rate dropped to 50s and improved t... Read more
Patient developed dizziness, had a vasovagal reaction where heart rate dropped to 50s and improved to 70-80s after patient had a chance to rest. She was given 25 mg of benadryl, observed for 30 minutes and recovered without incident and was discharged homed.
18 2021-07-08 cerebrovascular accident Seizure secondary to 5 cortical strokes that happened within 1 month of the vaccine
18 2021-07-08 pallor, hypotension After patient got the Janssen vaccine, patient was told to sit and wait for 15 minutes. While waitin... Read more
After patient got the Janssen vaccine, patient was told to sit and wait for 15 minutes. While waiting patient was walking around and felt fine. After about 10 minutes, patient said she felt dizzy and fell. She got back up right away. She looked pale. Told her to sit down and gave her water and power bar. Patient didn't eat anything beforehand. After sitting and drinking water patient felt better. Out of precaution we called 911 and when EMT came to check her vital signs. Her blood sugar and blood pressure were low. She also said she was feeling dizzy again. EMT took her to hospital for further monitoring.
18 2021-07-08 pallor After vaccinations and during the observations period, patient turned pale with white lips and vomit... Read more
After vaccinations and during the observations period, patient turned pale with white lips and vomited. Her BP was 99/52 then later 99/62 after 1/2 hour of observation she was joking and feeling better. Both of her parents were with her when she left the store.
18 2021-07-13 chest discomfort, heart rate increased, pallor SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLIN... Read more
SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLING IN FEET/SKIN FEELS STRANGE; SORE THROAT; BUBBLED EARS/RINGING IN EARS; PALE HANDS AND LEGS; RESTING HEART RATE WAS 99-110; SHOULDER PAIN; RIGHT LEG PAIN; HEAVINESS IN LEGS; CHILLS; PAIN AT INJECTION SITE (DURING ADMINISTRATION OF VACCINE); FEVER; HEADACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 153 pounds, and height was 65 inches. The patient's concurrent conditions included positive for lupus anticoagulant factor (anti-phospholipid factor), non smoker, non-alcohol user, latex allergy, rubber allergy, allergic to silicone, and resting heart rate runs high. 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 05-JUL-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Heart rate (NR: not provided) 99-110, and Oxygen saturation (NR: not provided) 96-99%. On 05-JUL-2021, the subject experienced shortness of breath. On 05-JUL-2021, the subject experienced chest pressure. On 05-JUL-2021, the subject experienced stomach pain. On 05-JUL-2021, the subject experienced back pain. On 05-JUL-2021, the subject experienced neck pain. On 05-JUL-2021, the subject experienced numbness in calves. On 05-JUL-2021, the subject experienced tingling in feet/skin feels strange. On 05-JUL-2021, the subject experienced sore throat. On 05-JUL-2021, the subject experienced bubbled ears/ringing in ears. On 05-JUL-2021, the subject experienced pale hands and legs. On 05-JUL-2021, the subject experienced resting heart rate was 99-110. On 05-JUL-2021, the subject experienced shoulder pain. On 05-JUL-2021, the subject experienced right leg pain. On 05-JUL-2021, the subject experienced heaviness in legs. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced pain at injection site (during administration of vaccine). On 05-JUL-2021, the subject experienced fever. On 05-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 06-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F, Heart rate (NR: not provided) 117, and Oxygen saturation (NR: not provided) 97 %. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high, and Lupus anticoagulant (NR: not provided) positive, slightly high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pale hands and legs, had not recovered from neck pain, and the outcome of fever, pain at injection site (during administration of vaccine), headache, sore throat, chills, heaviness in legs, tingling in feet/skin feels strange, shortness of breath, bubbled ears/ringing in ears, stomach pain, back pain, numbness in calves, chest pressure, right leg pain, shoulder pain and resting heart rate was 99-110 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.
18 2021-07-17 pallor, loss of consciousness Pt received Janssen Covid-19 vaccine this morning at 10:40am. About 10-15 seconds after immunizatio... Read more
Pt received Janssen Covid-19 vaccine this morning at 10:40am. About 10-15 seconds after immunization, pt turned pale white and slumped sideways in armchair. Also in the IMZ room were patient's mom and sister. I had CPht call code White and 911. After about 10 seconds, patient came back conscious and coherent to questions correctly of name, time, date and place. The pt's mom and I continued to talk with her and monitor her. Emergency personnel arrived within 10 minutes, talked with her, took vital signs (BP - 119/73, Pulse 85, Oxygen 100%). Patient remained stable and chose not to go to hospital. She stayed at pharmacy for another 30 minutes before leaving.
18 2021-07-18 loss of consciousness Right after administering the vaccination, patient became very lightheaded and dizzy. She said she ... Read more
Right after administering the vaccination, patient became very lightheaded and dizzy. She said she could not see and everything went black. We called paramedics and they monitored her HR and BP.
18 2021-07-19 loss of consciousness, excessive bleeding, heart rate increased, hypotension I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed m... Read more
I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed my fingers had turned yellow and lost all circulation. I went downstairs to ask my dad what to do, and immediately felt like I was going to faint. Sat down on a chair and put my head between my legs, but passed out as I was doing so, and fell on the floor. According to onlookers (brother and sister, who is an EMT) I was convulsing and stopped breathing for about thirty seconds, and my eyes were glassy and rolling. I woke up to my sister telling me to breathe. There was blood on the floor (I had hit my face on the way down) and I was trembling uncontrollably and had wet myself. I was awake and aware of my surroundings, and remembered everything up to and including sitting sitting on the chair before I passed out. My brother had called 911 while I was out and an ambulance came within five minutes. The paramedics put me in the ambulance and took me to the hospital (they would have taken me to local except there was risk that it was a seizure, which I guess local isn't equipped to handle). They measured my vital signs, made IV ports in my arms and drew some blood. My blood pressure was super low and my heart rate was super high, and I had a temperature of 102. When I got to the hospital they put two liters of saline drip into me to rehydrate me, did a CAT scan, and some bloodwork. They discharged me around 3:30 AM on Monday morning, told me to stay hydrated and get a lot of rest. I slept all day yesterday (Monday) and was feverish and weak. By today (Tuesday) I think I have mostly recovered.
18 2021-07-19 pallor, loss of consciousness Patient walked to waiting area and sat down and then appeared to lose consciousness, and slump over ... Read more
Patient walked to waiting area and sat down and then appeared to lose consciousness, and slump over on the table beside her. Patient appeared pale and was perspiring from her face. After about a minute she regained consciousness and was responding vocally.
18 2021-07-21 loss of consciousness, fainting Patient had syncope within 5-15 minutes after shot. After LOC, fell and hit head.
18 2021-07-22 fainting, loss of consciousness patient passed out shook a couple times and slid down in the chair then a few seconds later woke up ... Read more
patient passed out shook a couple times and slid down in the chair then a few seconds later woke up scared and unaware of where she was. She was warm and clammy plus felt like she was going to vomit. All complete symptoms of syncope. I stayed with patient and placed ice pack on her back neck area and offered her a drink of water. after about ten minutes she was completely back to norm and i continued to watch her for 30 minutes. she states that she faints every time she receives a flu vaccine as well. she went home with mother after the waiting period.
18 2021-07-23 fainting PATIENT FAINTED 5 TO 10 MINUTES POST ADMINISTRATION. SHE WAS NOT UNCONSCIOUS FOR ANY MEASURABLE AMOU... Read more
PATIENT FAINTED 5 TO 10 MINUTES POST ADMINISTRATION. SHE WAS NOT UNCONSCIOUS FOR ANY MEASURABLE AMOUNT OF TIME. SHE DID REMAIN DIZZY AND LIGHT HEADED FOR APPROXIMATELY 15-20 MINUTES BUT RECOVERED AFTER DRINKING SOME WATER AND ORANGE JUICE.
18 2021-07-26 fainting Approximately 2min after injection patient slumped down in chair and fainted. She came too briefly t... Read more
Approximately 2min after injection patient slumped down in chair and fainted. She came too briefly then fainted again with snoring resperations. I immediately placed her on the floor and opened airway. I got more help and elevated her feet. Patient came too. Her face was flushed but no other rash on body. No signs of difficulty breathing or cramping. Vitals were b/p of 92/60 with pulse of 88. I placed an ice pack behind her neck and gave her something to drink I monitored her for about an hour. She was able to sit in a seat with no dizziness or difficulty and b/p came up to 96/72. Patient ended up walking out with dad feeling better.
18 2021-07-27 heart rate increased TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOL... Read more
TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOLLAR WHEN IT FIRST STARTED IT SPREAD DOWN TO CALF TO STOMACH AND TORSO AND UP TO CHEST; NAUSEA; HEADACHE; FEVER SPIKED TO 102 F; BODY ACHES; HEART RATE WENT UP; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known drug allergies and patient had no underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced heart rate went up. On 02-MAY-2021, the subject experienced a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest. On 02-MAY-2021, the subject experienced nausea. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever spiked to 102 f. Laboratory data included: Heart rate (NR: not provided) from 115, 120 to125. On 03-MAY-2021, the subject experienced trouble breathing. Laboratory data included: Body temperature (NR: not provided) 102 F, Below 100 F, and Laboratory test (NR: not provided) unknown. On 04-MAY-2021, treatment medications included: salbutamol. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Unknown, and Laboratory test (NR: not provided) Unknown. Additional 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 a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest, and fever spiked to 102 f on JUL-2021, and the outcome of nausea, heart rate went up, trouble breathing, headache and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755447.
19 2021-03-07 loss of consciousness Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash... Read more
Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash can. She immediately passed out and fell forward. She hit her head on the wall and received a cut. We called the paramedics and she was transported to the emergency room at the local hospital.
19 2021-03-10 fainting, loss of consciousness after administering vaccine patient fainted and was found on the floor of observation area. She was ... Read more
after administering vaccine patient fainted and was found on the floor of observation area. She was conscious when i ran to her.She said she usually feels nausea after vaccines and feels like this was just her normal reaction. She refused an ambulance and felt like she was ok. We gave her ice water and and ice pack as she bruised her head when she fainted. We continued to monitor her and she kept refusing medical assistance. She had a friend come to drive her home.
19 2021-03-10 fainting patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitch... Read more
patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitching occurred before waking up. Paramedics were called, once arrived, patient was evaluated and denied transport.
19 2021-03-11 nosebleed Nose bleed started day after vaccination along with nausea which makes it hard to eat. Had flu like ... Read more
Nose bleed started day after vaccination along with nausea which makes it hard to eat. Had flu like symptoms day of vaccination with head ache and body aches persisting.
19 2021-03-11 heart rate increased Rapid heart rate. 3/12/21
19 2021-03-12 heart rate increased Body Aches, extreme fatigue, increased heart rate, fever (101°F) starting at 7:15 pm 03/13/2021. Ta... Read more
Body Aches, extreme fatigue, increased heart rate, fever (101°F) starting at 7:15 pm 03/13/2021. Taken 1000mg acetaminophen 10:00 pm - fever increased from 99 to 101
19 2021-03-16 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: she f... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: she fainted shortly after administration. when i went back to her..she was conscience and breathing ok. She felt like it was typical to what she experiences with vaccines and did not blame the vaccine at all. She was responsive and did not seek additional help. she refused an ambulance. she had a friend pick her up so she didnt have to drive home.
19 2021-03-18 fast heart rate Soon after vaccination, pt developed generalized muscle aches and SOB along with low grade fevers. ... Read more
Soon after vaccination, pt developed generalized muscle aches and SOB along with low grade fevers. Pt was admitted to hospital on 3/13/2021 for fever, diffuse myalgia, arthritis, rash, tachycardia, and dsyphagia and got diagnosed with likely serum sickness like reaction after COVID-19 vaccination after all the work up for autoimmune etiology such as vasculitis or SLE came back negative. she's currently getting IV solumedrol 50mg BID since 3/17 (switched from prednisone 40mg daily) with a good response.
19 2021-03-30 loss of consciousness Patient felt like she was going to pass out, did not want to lie on the ground as instructed. Patien... Read more
Patient felt like she was going to pass out, did not want to lie on the ground as instructed. Patient passed out in her chair, provider was next to patient and lowered patient to the ground. Patient was unconscious and not alert for a few seconds. When patient came to, she was alert and oriented, answered questions appropriately. Patient's BP was 118/82, HR 80, BG 63 (after a large lunch 2 hours prior). EMS was called, patient felt fine. Decided not to go to the hospital. Patient waited at vaccine clinic, BG 110 after an apple juice.
19 2021-03-30 fainting The patient reported that beginning around 6 pm on the day of the vaccination (3/30/21) she began to... Read more
The patient reported that beginning around 6 pm on the day of the vaccination (3/30/21) she began to feel achey, with body aches and headache that was a 4 on a 1-10 scale with chills, fever, and a temperature of 99.1. She stated that at 8 pm her symptoms worsened and she took Ibuprofen 600 mg without effect. She was able to sleep, however. This morning (3/31/21) @ approximately 8:30 AM she was standing in the bathroom and became lightheaded and thought she was going to pass out, sat down for a few minutes, felt better, began to walk into her bedroom holding onto the walls and then collapsed against the wall and "passed out". She recoved later on her own and sought help. She denied any head injury or tenderness of the scalp. Upon arrival at the clinic her vital signs: BP 80/46, P 88, R 16, O2sat 98%, T97.5 (she had just come in from outside where it was cold). Her vitals signs after 10 min: BP 80/50, P 104, R 16, O2sat 98%, T 99.1 She remained lightheaded for the remainder of her visit. She was instructed she would need to be evaluated in the local ED where she was then sent.
19 2021-03-31 fainting fainting following day, muscle aches, headaches, nausea (no vomiting), tiredness, weakness
19 2021-03-31 fast heart rate, fainting Syncope, fever, tachycardia
19 2021-04-01 fainting Patient sustained a vasovagal syncope event about 3 to 4 minutes subsequent to vaccine administratio... Read more
Patient sustained a vasovagal syncope event about 3 to 4 minutes subsequent to vaccine administration. Struck back of head on chair with fall to ground. Evaluated by medical staff and referred to medical center via ER non-emergent transport. Subsequent to ER staff evaluation for syncope and head injury, she was treated and released from the ER without need for further work-up or imaging.
19 2021-04-01 fainting 3 min after vaccine given patient felt light headed and got vertigo, became green, fainted and was s... Read more
3 min after vaccine given patient felt light headed and got vertigo, became green, fainted and was sweating.
19 2021-04-02 loss of consciousness Patient had the Janssen vaccination for covid. In the observation period she sat on the floor and as... Read more
Patient had the Janssen vaccination for covid. In the observation period she sat on the floor and asked for a trashcan in case she vomited. She then vomited and lost consciousness for about 10 seconds
19 2021-04-02 pallor At 0830, RRT was called for a 19 y/o F with c/o dizziness, lightheadedness, pain in neck area, and d... Read more
At 0830, RRT was called for a 19 y/o F with c/o dizziness, lightheadedness, pain in neck area, and difficulty with vision. At initial meeting, client was pale and stated she had difficulty breathing and had blurry vision, per client, like in ?hyperspace?. Head-to-toe assessment completed. Client was diaphoretic and cool and clammy. Pulse was thready. AA0x4 and tachypneic but has clear breath sounds. PERRLA. Vitals: BP: 100/60, HR: 55, 02: 95% on RA. Mother and father present during this time. No PMH, NKA. Did not take any medications today, only ate a small breakfast. Not pregnant. Client states she had a similar reaction like this with the HPV vaccine 1 year ago. During monitoring/observation time, client?s status improved. Client insisted for EMT/ambulance assistance. 911 called. EMT arrived at 0845. During EMT evaluation, client vomited about 70 ml of clearish/yellow emesis. After paramedic explained options of going home or transportation to the hospital, client opted to be transported to the hospital. Client left facility with paramedics (AMR 332), accompanied by mother and father. Patient transported to Hospital via ambulance.
19 2021-04-03 heart rate increased I began to have a high heart rate about hours after getting the shot then a fever came along and I h... Read more
I began to have a high heart rate about hours after getting the shot then a fever came along and I had chills, and my lips were dry and I also had a headache. My heart rate would barely stay below 100 BPM, even when laying down in bed. I developed a 102 F fever last night and took motrin, which helped lower it but I?ve also been having lingering throbbing headaches. My heart rate went to about 100-105 when while I took a nap but as soon as I got up and moved it jumped to 117, in the morning I went to use the bathroom and did nothing else and just that made it jump to 160. I have no trouble breathing. I was sitting in bed eating and my heart rate was around 123-130
19 2021-04-04 heart rate increased Fever, chills, headache, nausea, increased heart rate, body stiffness
19 2021-04-04 loss of consciousness, pallor Patient became dizzy and lightheaded shortly following vaccination. Other symptoms included paleness... Read more
Patient became dizzy and lightheaded shortly following vaccination. Other symptoms included paleness, partial loss of consciousness, momentary loss of vision, diaphoresis and slurred speech. Patient was given a cold compress for the back of her neck, some peanut butter crackers to eat and water to drink. She had not eaten anything today with the exception of candy and coffee. Feet and legs were elevated and patient began to regain some color in her face and started feeling better after a few minutes.
19 2021-04-04 pallor Within 10-15 minutes after receiving the vaccine, the patient complained of nausea and was very whit... Read more
Within 10-15 minutes after receiving the vaccine, the patient complained of nausea and was very white and clammy. When observing her, she appeared like she was going to fall over so I had her mom help me put her on her back. 911 was called and I took her blood pressure and it was 80/49 mmHg. She remained conscious and EMS took her to ED for observation. She was given liquids, discharged and told to come back if she had any other symptoms. Per her mother, she had not ate or drank anything prior to receiving the shot.
19 2021-04-04 fainting Approximately 15 minutes after receiving her vaccine, patient reported feeling "light headed". When... Read more
Approximately 15 minutes after receiving her vaccine, patient reported feeling "light headed". When I was called to help her, she had fainted. She was able to slowly respond to us and was breathing. We placed her on the floor laying on her side. A cold compress was placed on the back of her neck and a pillow was placed under her head. 9-1-1 was called. When EMS responded, she had normal blood pressure and blood sugar, but was still feeling "out of it". She was place on a stretcher and taken to the ambulance, but did not get transported. She had a family member pick her up from the clinic. She was able to walk from the ambulance to the car on her own.
19 2021-04-05 excessive bleeding Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure ... Read more
Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure if hit head, head atraumatic without abrasions, lacerations, bleeding. Pt was assisted to a recumbent position with BLEs elevated. VS as follows: BP 122/70, HR 78, sats 97% on RA. Pt was given water and snack bar and recovered within 15 mins. She ambulated out of clinic in NAD and was driven home by roommate.
19 2021-04-06 blood glucose increased, chest discomfort 11:16 am Shortly after receiving vaccine, complained of pressure in chest, dizziness, body shaking, ... Read more
11:16 am Shortly after receiving vaccine, complained of pressure in chest, dizziness, body shaking, lightneaded. Offered water and granola bar and ate the bar. Blood sugar checked by EMT on site at 115 at 11:20 am. BP=98/60, 99 O2 sat, 60 pulse and regular. After about 10 minutes, recovered fully and was able to leave the clinic. Roser is from Spain and limited English, so Spanish interpreter was used to communicate.
19 2021-04-06 chest discomfort She had no history of anaphylaxis from any cause, she had no history of reactions to vaccines or com... Read more
She had no history of anaphylaxis from any cause, she had no history of reactions to vaccines or components. After about 5 minutes I checked on her and she said she was feeling very dizzy. I called management for assistance and got her ice packs for neck and forehead. I took her blood pressure and it was 150/90, HR 73. We laid her down and elevated her legs. She said that she felt some pressure in her chest but she had pulled a muscle there the day before and wasn't sure if it was related. She said the room was spinning as she continued to lay on the ground and it was not improving. Her blood pressure was taken about 5 minutes later and it was 143/85 HR 73. She said it is usually low. She had no signs of local reaction, hives, or swelling. She complained of nausea. After a few more minutes she said she was not feeling any better and was having pain in her throat and difficulty breathing. I asked her to try to take a deep breath and she was gasping for air, unable to breathe deeply. I administered epinephrine (one dose) and called 911. I rechecked blood pressure while waiting for paramedics and it was 125/80. She was taken to hospital when they arrived. Her mom arrived shortly before the ambulance and went with her. Pt never lost consciousness. Management followed up with patient this evening and patient is home and well, but the ER did classify the event as an allergic reaction.
19 2021-04-06 fainting, heart rate increased I had an incredibly fast heart rate, even while laying down for a long time. I fainted after walking... Read more
I had an incredibly fast heart rate, even while laying down for a long time. I fainted after walking less than a half mile to get food
19 2021-04-06 fainting SYNCOPAL EPISODE ~2 MINUTES POST INJECTION, TEMPORARY LOSS OF VISION, HEARING VITALS: SP02: 97% PUL... Read more
SYNCOPAL EPISODE ~2 MINUTES POST INJECTION, TEMPORARY LOSS OF VISION, HEARING VITALS: SP02: 97% PULSE: 90 BP: 122/58 GCS: 15
19 2021-04-06 fainting Patient fainted after receiving the vaccine. She was seated at the time and immediately the chair w... Read more
Patient fainted after receiving the vaccine. She was seated at the time and immediately the chair was reclined. She did NOT hit her head and regained consciousness within a minute. Felt nauseated and dizzy. She remained laying down for ~15 minutes until feeling better. She left later feeling fine.
19 2021-04-06 fast heart rate HEART RATE OF 120; FEVER; This spontaneous report received from a patient concerned a 19 year old fe... Read more
HEART RATE OF 120; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 26-MAR-2021 08:40 at right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced heart rate of 120. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2, and Heart rate (NR: not provided) 120. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and heart rate of 120. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
19 2021-04-07 fainting, loss of consciousness Patient fainted within 15 seconds of receiving vaccine. Patient came too approximately 15 seconds a... Read more
Patient fainted within 15 seconds of receiving vaccine. Patient came too approximately 15 seconds after passing out. Patient was nauseated and dizzy for another 10 to 15 minutes. Pharmacy called local emergency squad to evaluate patient. Patient refused to be transported to local hospital. pharmacy made your patient had someone take her home. Contacted patient the next day and patient said she was feeling better. Patient believed it was "needle anxiety" and does not believe it was caused by the vaccine itself.
19 2021-04-07 fainting I fainted about 2 minutes after receiving the vaccine.
19 2021-04-08 chest discomfort Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then w... Read more
Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.
19 2021-04-08 chest pain, chest discomfort Symptoms started around 9:15pm on 4/8 ??Mild Arm Soreness initially ??Fever of 100.0 at 10pm. 101.4 ... Read more
Symptoms started around 9:15pm on 4/8 ??Mild Arm Soreness initially ??Fever of 100.0 at 10pm. 101.4 at 11:30pm, 99.6 at 4am ??Chills/Tremors: Stop and Start after a couple minutes. Did not stop until 2am ??Hot Breath; Felt like fire after cold water ??Extra Discomfort on lower back/sides ??Jaw Pain after chills stopped around 11:50pm. Took Advil to help Symptoms for 4/9 ??Sharp pain in chest when breathe in too hard at 4:50pm ??Fatigue all day. Only got out of bed to pick up mail and use the bathroom ??Diarrhea at 6pm. Couldn't keep anything solid down except oranges and bone broth ??Chest Pain after 8:30pm: Put ice pack on chest and it relieved pressure. It feels like something is stuck down my esophagus, even though I have not been able to eat anything solid.
19 2021-04-08 skin turning blue My school, hosted a clinic and pressured students to receive the vaccine, threatening them with an e... Read more
My school, hosted a clinic and pressured students to receive the vaccine, threatening them with an email saying we may not be able to return to school the next semester if we did not receive the vaccine in the next day and a half. I felt extremely dizzy after recieving the vaccine, and I've never felt like that after any shot before, sho I was concerned. Within five hours, I started feeling really weak, and I developed a fever. In an hour, my fever rose to 104, my hands and feet were blue, and I felt so cold my fingers and feet were numb. I couldn't breathe, and I started coughing every time I took a deep breath. My entire body ached and I had stabbing pains in my abdomen. This was the worst pain I had ever felt in my life.
19 2021-04-08 loss of consciousness Patient received the vaccine and approximately 5 minutes later, patient passed out and fell out of h... Read more
Patient received the vaccine and approximately 5 minutes later, patient passed out and fell out of her chair onto the floor. 911 was called. Patient was unresponsive for approximately 30 seconds. She came to and was very disoriented and her pupils were extremely dilated. The paramedics came and did blood pressure checks and several other evaluations. They advised her to go with them by ambulance to the ER to be evaluated due to falling directly on her face/head. Patient went outside and was evaluated further in the ambulance but was not willing to go to the ER.
19 2021-04-08 loss of consciousness About 3-4 minutes after I vaccinated the patient, while she was in the 15 min observation seat, she ... Read more
About 3-4 minutes after I vaccinated the patient, while she was in the 15 min observation seat, she lost consciousness, her fiance caught her from falling out of her chair. I ran over, and as soon as I got there she started to convulse, therefore appeared to be having a seizure. I help her fiance get her onto the ground safely and placed her on her side, then called for my tech to call 911. The seizure/convulsions only seemed to last 10-15 seconds. She then came to, and was disoriented. Then she felt nausous, and threw up a small amount. The paramedics arrived, checked her out. She said she was felt fine, and refused to go with them to the hospital.
19 2021-04-08 loss of consciousness passed out 2 minutes after moving from vaccine seat to observation area 20 ft away, very brief mild... Read more
passed out 2 minutes after moving from vaccine seat to observation area 20 ft away, very brief mild, seizure less than 30 seconds. regained complete alert and consciousness
19 2021-04-08 lightheadedness, fainting, fainting, fainting Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt r... Read more
Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.
19 2021-04-08 fainting Syncope immediately following vaccine Rapid recovwry
19 2021-04-08 fainting Systemic: Fainting / Unresponsive-Medium
19 2021-04-09 chest discomfort, chest pain vaccination with the one dose Covid-19 vaccin Johnson & Johnson at 11:40am. Around 6pm patient began... Read more
vaccination with the one dose Covid-19 vaccin Johnson & Johnson at 11:40am. Around 6pm patient began having headaches and a bit of fever. By 9pm patient had high fever, body aches, nausea, head spinning, bad headaches, and very fatigued. Mother gave her some pain and fever medicine. By 10pm she began complaining her chest felt like being squeezed. Mother applied some camphor essential oil on her chest. Seemed to bring a bit of comfort. Mother prepared her few bottles to drink throughout the night. Next morning 6am, patient still had a high fever throughout the day and evening, nausea, headaches, body pains but no more chest squeezing! Friday morning: patient's fever is gone. Yet she still has head aches and tired.New symptoms are sore throat and a blue toenail! Saturday morning: still some headache, sore throat, a bit of pain in the chest between the breasts, her arm where the injection took place is swollen as big as a grapefruit and painful to the touch as well as warm. You can clearly see the spot where the neddle was inserted.
19 2021-04-09 heart rate increased Fast heartbeat within 3 minutes of injection, slight swelling of face and mouth, weakness, numbness... Read more
Fast heartbeat within 3 minutes of injection, slight swelling of face and mouth, weakness, numbness and pain of injection site, red rash on arms and legs, difficulty breathing, losing breath walking short distances, 10 hours later I developed muscle pain all over my body, chills, 102° fever, extreme shaking, difficulty sleeping due to muscle pain/aches, and fatigue.
19 2021-04-09 hypotension Transient hypotension that resolved.
19 2021-04-09 fainting After vaccine, patient fainted and registered nurse and CNA assisted to floor with no incidents. EMT... Read more
After vaccine, patient fainted and registered nurse and CNA assisted to floor with no incidents. EMT and Doctor at side. Vitals 123/75, HR 86, 97%. Food and water was given. Dr. cleared patient to sit at the thirty minutes tent for closer observation.
19 2021-04-09 fainting Patient fainted immediately after vaccination.
19 2021-04-10 loss of consciousness You came to the ER today because of a passing out episode after you got your first covid vaccine. Yo... Read more
You came to the ER today because of a passing out episode after you got your first covid vaccine. Your exam was reassuring. Your labs and EKG are unremarkable. The cardiologist recommends continuing outpatient testing. Please call your doctors today to set up follow-up appointments. Please return to the ER if your symptoms change or worsen.,
19 2021-04-10 palpitations i started to have severe muscle pain in my thighs/legs , shooting pain throughout my legs and lower ... Read more
i started to have severe muscle pain in my thighs/legs , shooting pain throughout my legs and lower back. My heart was racing majority of the night , upwards of 100 at all times.
19 2021-04-10 fainting, loss of consciousness Female pt felt lightheaded and dizzy after receiving vaccine. Did not alert staff and had a syncopa... Read more
Female pt felt lightheaded and dizzy after receiving vaccine. Did not alert staff and had a syncopal episode, falling out of her chair. EMRs at pts side, pt regained consciousness. She did have a small hematoma on her head measuring approx. 1 inch. Pts vitals were HR 68, BP 116/70, RR12 , sats 100%. Pt sts all symptoms have resolved. She denies all further treatment and/or transport.
19 2021-04-10 fainting SYNCOPAL EPISODE POST VACCINATION
19 2021-04-10 fainting SYNCOPAL EPISODE POSE COVID VACCINATION WITH JANSSEN COVID 19
19 2021-04-11 chest pain A few days after getting the vaccine, I was dizzy, light-headed, nauseated, short of breath, and had... Read more
A few days after getting the vaccine, I was dizzy, light-headed, nauseated, short of breath, and had bad chest pains. It has been three weeks and my symptoms have not gotten any better.
19 2021-04-11 chest pain Patient has felt Blurred vision, extreme nausea. Numbness in hands and legs. sweaty and most imp. Fe... Read more
Patient has felt Blurred vision, extreme nausea. Numbness in hands and legs. sweaty and most imp. Felt CHEAST PAIN from it.
19 2021-04-11 heart rate increased That night, around 9 pm - from the time I got the shot until then I was fine. At 9 pm, I came to my ... Read more
That night, around 9 pm - from the time I got the shot until then I was fine. At 9 pm, I came to my dorm and I got hot and woozy. My friend told me that my forehead was puffy (swollen). I laid down and I realized I was really really cold but skin was hot to touch. I think I had a fever. I was shaky and shivery and trembling. I tried to take a nap. Fell asleep for an hour - don't remember that time at all - but my friend told me I went to sleep. My smart watch was telling me my heart rate was 120s and 130s while I was sleeping. I debated whether I should go to the Dr. and I called the school police and they took me to the ER - at 03:00 am on the 8th - and they told me to rest for day and wait it out. I still feel like I have a lot of adrenaline - my watch says that my heart rate is way to high for what I'm doing. It's usually in 70's and 80's but it's in the 120's and 130's every day and I am really shaky with adrenaline. I have had a headache since Wednesday night and it hasn't gone away. If it goes past Wednesday, I will go to my primary care doctor but otherwise no treatment at this time.
19 2021-04-11 loss of consciousness Patient passed out/syncopal episode with head injury approximately 16 hours after getting vaccine p... Read more
Patient passed out/syncopal episode with head injury approximately 16 hours after getting vaccine per patient. Patient states she had a headache, fever, body aches, chills approximately 7 hours the vaccine. Patient sustained a head injury/possible concussion with nausea, head pain, irritability after syncopal episode.
19 2021-04-11 pallor Patient received her vaccine and was being observed in the observation area upon becoming diaphoreti... Read more
Patient received her vaccine and was being observed in the observation area upon becoming diaphoretic, pale, clammy and not looking well. RN approached asked if she was having difficulty breathing and pt reported yes. initially unable to obtain pulse or 02 reading. BP 58/38 and Epi injection was administered to the right outer thigh. Patient color and vitals started to improve and breathing was better. patient also was placed on cot in supine position initially. Last set of vitals prior to EMS arriving was BP 84/72, p-71, 02-99% and respirations are 22.
19 2021-04-11 fainting, pallor Syncope 1 minute witnessed by clinic staff in monitoring area approximately 10 minutes after vaccine... Read more
Syncope 1 minute witnessed by clinic staff in monitoring area approximately 10 minutes after vaccine administered. Patient denied chest pain, shortness of breath, abdominal pain and dizziness. Patient's skin assessment: pale, cool, diaphoretic. Vital signs obtained: BP 110/60, HR 84, Pulse Ox: 99%, RR 18. Patient remained in medical monitoring area for 30 minutes with no further reaction. Patient given fruit snacks and juice. Patient's skin color returned to normal, stated she felt better after lying down and eating.
19 2021-04-11 fainting Vasovagal syncope within 10 minutes following administration of vaccine
19 2021-04-12 cerebrovascular accident Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakne... Read more
Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakness. Brain CTA showed a M1 branch occlusion. Patient was given TPA and transferred to Medical Center for further management and mechanical thrombectomy. Successful thrombectomy done. Etiology of stroke cryptogenic but suspect emoblic event. Questionable moyamoya disease - notes state "if moyamoya suspect, patietn will get neurosurgery survice on board/appreciate neuro recommendations"
19 2021-04-12 chest discomfort Nausea onset the evening vaccine was received - 03/08/2021. Severe headache the following day 03/0... Read more
Nausea onset the evening vaccine was received - 03/08/2021. Severe headache the following day 03/09/2021. Symptoms persisted and continued to progress/worsen. Patient presented with neck stiffness, chest tightness, difficulty breathing, severe migraine. Admitted to hospital where she was tested for viral meningitis and had lumbar puncture and CT Scan. Treated with steroids.
19 2021-04-12 chest discomfort Janssen COVID-19 Vaccine EUA Numbness on left side of body, numbness in fingers, chest feels heavy,... Read more
Janssen COVID-19 Vaccine EUA Numbness on left side of body, numbness in fingers, chest feels heavy, no shortness of breath
19 2021-04-12 chest pain Patient developed complaint of headache and dizziness , "whoozy", post vaccination nearly immediatel... Read more
Patient developed complaint of headache and dizziness , "whoozy", post vaccination nearly immediately after injection. Stated prone to dizziness when gets shots. Not SOB no rash. Monitored over 30 minutes, given juice, blood sugar 89 BP 129/78, EMS on scene and assessing along with NP. Pt felt better and discharged from vaccination clinic but about an hour later patient called to report dizziness and persistent headache and returned to vaccination clinic for re-evaluation. EMS on scene administered 2L o2 via NC for comfort as pt highly anxious and tearful reporting feeling dizzy and frontal HA. Is not with Shortness of breath or chest pain. Advised transport to ED for further evaluation and management
19 2021-04-12 heart rate decreased Nearly fainted after the injection. I was very close to passing out, though I soon regained consciou... Read more
Nearly fainted after the injection. I was very close to passing out, though I soon regained consciousness. My heart rate dropped to 40bpm with the blood pressure being 71/40. After 10 minutes of laying down in front of the pharmacy I felt better with my feet elevated, though I was tired for the rest of the day with an acute headache.
19 2021-04-12 loss of consciousness Weakness/Fatigue starting the evening of the injection and persisting for about 48 hours. Chills/fev... Read more
Weakness/Fatigue starting the evening of the injection and persisting for about 48 hours. Chills/fever, nausea, and lightheadedness starting the next morning. Loss of consciousness (Uncertain if it was vasovagal syncope or seizure) 10:30 pm the next day.
19 2021-04-12 fainting, chest pain 4/11/21 fatigue weakness slept 5 hours 4/12/21 chefs pain, clammy dizzy, fainted Headache 4/13/21 tr... Read more
4/11/21 fatigue weakness slept 5 hours 4/12/21 chefs pain, clammy dizzy, fainted Headache 4/13/21 trouble tracking, time. Clammy, dizzy, fainted, headache, vomit, body aches, fatigue, tingling, shaking, cheats pain
19 2021-04-12 fainting About 4 hours after the injection I began to feel extremely tired and took a nap for a couple of hou... Read more
About 4 hours after the injection I began to feel extremely tired and took a nap for a couple of hours. When I woke up at 5 pm I noticed body aches and chills, and a migraine that would get substantially worse and became throbbing when I would sit up or stand. After taking some Tylenol (300 mg) I thought I was able to walk for small periods or time (aka walk to the bathroom) but I fainted on the way back
19 2021-04-12 fainting Patient was in observation area and syncopized and vomitted. VS 118/68, HR 76, 98%
19 2021-04-13 cerebrovascular accident Had a stroke, left side affected. Received TPA upon hospital arrival
19 2021-04-13 loss of consciousness Dizziness, nausea, passed out, hit head, had seziure
19 2021-04-13 lightheadedness pt experienced weakness, nausea, and near syncopal episodes within 10 minutes of receiving vaccine. ... Read more
pt experienced weakness, nausea, and near syncopal episodes within 10 minutes of receiving vaccine. Symptoms resolved within minutes, pt was monitored in clinic for an additional 30 minutes with stable vitals and no further episodes. Pt left clinic in good condition, brother drover her home.
19 2021-04-13 fainting Pt with syncope about 3 minutes after her injection. Pt placed in recumbent position, returned to fu... Read more
Pt with syncope about 3 minutes after her injection. Pt placed in recumbent position, returned to full consciousness after about 20-30 seconds. Vitals monitored x 20 mins, offered cool water and ice packs, pt discharged after observation period feeling well.
19 2021-04-13 blood clot On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next ... Read more
On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next few days easy, and laid in bed for the majority of the weekend. On 4/10/2021 I left my residence to get dinner and noticed I was short of breath just walking from the building to my car. The shortness of breath worsened over the next few days. On 4/13/2021 I called a clinic and told them I had been short of breath and they directed me to the ER. I arrived to the ER around 2:30 in the afternoon. They ordered a chest x-ray and ran a test to determine if I could have a blood clot. The test came back with results indicating I could have a blood clot, so they did a chest CT and an MRI. The chest CT showed a blood clot in my left pulmonary artery. They prescribed a blood thinner, told me to stop taking oral birth control, and discharged me.
19 2021-04-14 pallor Extreme fatigue lasting over a week, inability to workout without abnormal extreme soreness, poor di... Read more
Extreme fatigue lasting over a week, inability to workout without abnormal extreme soreness, poor digestion and nausea for over a week, looking pale and gaunt to the degree of notice by others, overall feeling bad consistently over a week.
19 2021-04-14 pallor Patient described feeling light-headed and blurred vision immediately following vaccine administrati... Read more
Patient described feeling light-headed and blurred vision immediately following vaccine administration. POD nurse stated patient appeared pale. Patient was assisted to supine position on floor, did not fall or lose consciousness. Patient was observed by EMS, who continued to monitor vital signs over 35-40min. Patient improved and was released from clinic after 35-40min observation with no treatment warranted.
19 2021-04-15 loss of consciousness Patient claims she felt dizzy after vaccination and lost consciousness near checkout lane approximat... Read more
Patient claims she felt dizzy after vaccination and lost consciousness near checkout lane approximately 10 minutes after vaccination. She was assisted by asset protection staff and pharmacy staff. She left the store under her own power. She reported that she has had headaches and dizziness after the vaccination and was seen at an urgent care that did not provider her with a diagnosis, but felt her symptoms may have been caused by a concussion. She was advised by clinical team to contact her primary care doctor to follow-up, especially with recent reports of thrombosis linked with the J&J vaccine.
19 2021-04-15 fast heart rate, chest discomfort Started a mild headache a few hours after the shot, then progressed to a moderate headache that even... Read more
Started a mild headache a few hours after the shot, then progressed to a moderate headache that evening with body aches. Friday morning, woke up with chest tightness. By Friday afternoon, headache was blinding, and can't breathe well. Go to ER around 430pm. Had fever of 100, tachicardia. Given IM Tordol to help with the fever, body pains, and migraine. Sent home withSteroid inhalants through nebulizer prescribed and picked up at 6pm and started at 7pm that evening. Sunday morning at 4am, back at ER for severe can't breathe, migraine back. Tachicardic again. IV Benedryl, Reglan, and Tordol given. Sent home. Body aches remained, headache stayed moderate from Sunday to Thursday at 2am, when headache became blinding again, chest was tight again. Back to ER. Given muscle relaxer and sent home.
19 2021-04-17 chest discomfort CHEST PRESSURE; FEVER; MUSCLE ACHES; HEADACHE; CHILLS; This spontaneous report received from a paren... Read more
CHEST PRESSURE; FEVER; MUSCLE ACHES; HEADACHE; CHILLS; This spontaneous report received from a parent concerned a 19 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: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99-100.5 F. On 08-MAR-2021, the subject experienced chest pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, and muscle aches, had not recovered from chest pressure, and the outcome of headache was not reported. This report was non-serious.
19 2021-04-18 loss of consciousness At 9:30 am per vaccinator , patient lost consciousness for less than 2 seconds with no injury. Pati... Read more
At 9:30 am per vaccinator , patient lost consciousness for less than 2 seconds with no injury. Patient was assessed and was coherent. VS obtained. BP 90/60. Pulse 63. Respirations 14. O2 sat 99%. Denied shortness of breath, throat swelling, nausea or headache. Was able to change position from lying to sitting. Patient was transferred to second floor clinic via wheelchair for further evaluation. 10:40am Care handed over to nurse.
19 2021-04-22 pallor, loss of consciousness She has a history of Bipolar II, dx about 2 years ago. She has been in counseling for the past 5 yea... Read more
She has a history of Bipolar II, dx about 2 years ago. She has been in counseling for the past 5 years. She just changed from effexor to lexapro about 1 month ago. She has been on abilify 10mg for the past ~6months. On 4/8/21 she went to bed around 11pm and awoke on 4/9 around 8:30am. She had her JJ covid vaccine on 4/9/21. She had 2 handfuls of goldfish crackers on the way to her vaccine appointment around 11am. She had ~6-8oz of water when she awoke. She arrived at the Clinic on campus. She sat down for ~5 minutes and then the staff came to get her. She had the shot administered in left deltoid. When she first felt the pain her vision started to go black and she felt like she was going to pass out. She denies feeling hot or dizzy prior to event. Her vision went completely black, then when she "came to" she was bent over in her chair with arms drawn up to body and fists clenched. Immediately her body relaxed and she felt very confused. She was told she just had a seizure - bend forward and had whole body shaking for ~30 seconds. She felt extremely nauseated and had some dry heaving. Someone helped her to the floor and put up her legs. She was told she looked very pale. She felt much better within 5 minutes. Vitals were checked and were stable. She was given granola bar to eat and drank ~12oz of water. No one sided weakness, no incontinence, no tongue bite. She stayed there for ~45 minutes for monitoring. Someone walked her to her car, asked her if she was ok, and then she drove herself home. Of note, the room she was in was warm and they were going to open doors to get some air. She was not ill or tired at the time. After the event she drove for 5 minutes to her home. Once in her room she felt extremely tired and then slept until 7pm (~6-7 hours). She then called Mom. Mom reports that patient sounded different on the phone. Speech was slow and she seemed "off." Mom drove to her and was at her room by around 7:40pm. At that time, patient looked very pale to Mom. Mom took her home, gave her chicken soup. She did not have an appetite. She just wanted to go to sleep. Mom tried to have her stay up until around 10pm. She had ~8oz of water and then went to bed. She slept through the night. She awoke the next morning and reports that her brain felt like it hurt to work. She had chills, body pain, shakiness during the day on 4/10/21. This was easily managed by tylenol q4. Of note, she did have covid19 in 8/2020. She was ill for ~1 week with lack of smell/taste, febrile, shakiness, headache. She had an odd event on 4/19/21 while giving a presentation at school. She had sudden onset of left pinky numbness/tingling with radiated up the side of her forearm. This lasted ~1-2 minutes. However, her left arm hurt for a few hours afterward. She denies any fatigue after event. She has a Mirena IUD. She smokes nicotine via vape numerous times per day. She smoke weed up to 3X/day but not every day. She drinks beer a few days per week.
19 2021-04-23 blood clot Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to... Read more
Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to check her leg, they discovered a blood clot per patient. She is now doing well per her.
19 2021-04-27 heart rate increased Started with shortness of breath (still have it) and high heart rate with little exertion. Extreme m... Read more
Started with shortness of breath (still have it) and high heart rate with little exertion. Extreme migranes lasting uo to a week.
19 2021-04-27 heart rate increased Hives, tingling in fingers, toes and on my tongue, fast heart rate, severe fatigue, headache
19 2021-04-28 chest discomfort Patient has been feeling ill with persisting nausea, headaches, malaise, generalized abdominal pain.... Read more
Patient has been feeling ill with persisting nausea, headaches, malaise, generalized abdominal pain. She has intermittent shortness of breath with chest discomfort. She is not sure if this related to panic attacks. For the last 3 days she has had left posterior neck pain with radiation of pain to her head and left upper and lower arm. Her left arm feels numb and limp at times. She received the vaccine in her left arm.
19 2021-04-29 pallor, loss of consciousness, fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine pt felt lightheaded and blurred vision. then passed out. patient advised to sit down then passed out again and started to shake head (seizure like symptoms) for a few seconds. patient was pale, confused and started sweating, fingers were cold to touch. Then her fingers started to get numb and tingly. she was having a hard time seeing colors and she started having ringing in ears. Ambulance was called and they took over.
19 2021-04-30 loss of consciousness, pallor Pt was leaving vaccination area when she passed out. She described it like she was listening to musi... Read more
Pt was leaving vaccination area when she passed out. She described it like she was listening to music and woke up with her mom over top of her. Patient has a history of fainting when seing needle. Ate water and crackers; color improved - released with mom
19 2021-05-02 lightheadedness Vasovagal episode without syncope. Patient with dizziness and vomiting.
19 2021-05-04 chest pain CHEST PAIN; This spontaneous report received from a patient concerned a 19 year old female. The pati... Read more
CHEST PAIN; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, shellfish allergy, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 12:50 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 03-MAY-2021 22:00, the subject experienced chest pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest pain. This report was non-serious.
19 2021-05-05 skin turning blue, loss of consciousness PATIENT IMMEDIATELY FELT DIZZY AND PASSED OUT A FEW SECONDS LATER. THE VACCINATOR WAS NOT ABLE TO CA... Read more
PATIENT IMMEDIATELY FELT DIZZY AND PASSED OUT A FEW SECONDS LATER. THE VACCINATOR WAS NOT ABLE TO CATCH HER FALL AND SHE FELL OUT OF THE CHAIR AND HIT HER FOREHEAD. PT WAS IN AND OUT OF CONSCIOUNESS Q5 MIN, UNRESPONSIVE TO PAINFUL STIMULI, AND MUCOUS MEMBRANES WERE BLUE FOR 30 SECONDS BEFORE JERKING AWAKE AND COLOR RETURNED TO NORMAL. SHE DENIES NECK PAIN, HEADACHE, AND SPINE INTACT. SHE REPORTED DIZZINESS, BLURRED VISION, AND RINGING IN THE EARS FOR Q15 MINUTES UNTIL RESIDED. PT PRESENTED WITH DIAPHORESIS UNTIL HER REPORTED SYMPTOMS RESIDED. VITALS, CLEAR LUNG SOUNDS, AND GLUCOMETER WERE DONE. MEDICS GAVE ORAL GLUCOSE. VITALS MONITORED UNTIL STABLE. PATIENT STAYED WITH FIRE Q1H AND SIGNED AMA WITH FIRE TO GO HOME. SCHOOL SECURITY WALKED HER HOME.
19 2021-05-05 loss of consciousness, hypotension, heart rate decreased After about 6 minutes post-injection, she started feeling really dizzy and briefly passed out. Afte... Read more
After about 6 minutes post-injection, she started feeling really dizzy and briefly passed out. After a couple minutes she was responsive, but still really weak and tired and said she had blurry vision. We called 911 and they came in and monitored blood pressure and heart rate, which was really low when they started, but did come back up into normal range and patient was feeling much better after about 15 minutes, but still tired.
19 2021-05-06 lightheadedness, very slow heart rate Patient had a vasovagal episode immediately after receiving Vaccine- Janssen Lot # 1808609 injection... Read more
Patient had a vasovagal episode immediately after receiving Vaccine- Janssen Lot # 1808609 injection on the Left deltoid. Vitals were taken every 15 mins 116/61, 89/48, 100/57. 12 Lead EKG taken, patient found in Sinus Brady Cardia. Patient was isolated from other patient. Focus head to toes assessment completed by doctor and EMT. 911 contacted. Paramedic and Fire Dept. Arrived on site. Patient offered to be taken to the hospital. Patient refused.
19 2021-05-08 fainting, loss of consciousness The patient fainted about 20 seconds after I gave her the vaccine. I lowered her to the floor and ... Read more
The patient fainted about 20 seconds after I gave her the vaccine. I lowered her to the floor and was going to lay her on her side when she regained consciousness. She then felt nauseous and stayed on the floor for about 15 minutes. She never vomited. She started drinking her beverage and felt better in about 25 minutes. She communicated that she did not need further medical attention and I agreed.
19 2021-05-12 heart rate increased About 10 minutes after my throat and mouth was extremely dry. I went to the EMT and noticed my heart... Read more
About 10 minutes after my throat and mouth was extremely dry. I went to the EMT and noticed my heart rate was beating fast. They told me to go to ER and I was having a bizarre reaction and also had an anxiety attack, which took a little while for my heart to go down. I was extremely nauseas the following one week and a half. I am no longer having these symptoms today.
19 2021-05-12 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: fainted upon standing but was responsive-Sever... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: fainted upon standing but was responsive-Severe, Additional Details: patient got up to go to bathroom and fainted but was responsive. mother came picked her up, patient was drinking gatorade
19 2021-05-14 pallor Patient said she had ringing in ear, and was nauseous immediately after immunization. Patient appear... Read more
Patient said she had ringing in ear, and was nauseous immediately after immunization. Patient appeared pale, sweaty, and shaky. I told the patient to put her head between her knees. She regained color within minutes. She felt better but we called 911 just to be safe. The patient and the EMT decided the she would be driven home bu her mother to rest.
19 2021-05-17 blood pressure decreased patient started bleeding at the site of injection. During her wait time initial felt hot and was see... Read more
patient started bleeding at the site of injection. During her wait time initial felt hot and was seeing spots. The patient also was sweating and didn't feel well. Patients blood pressure did drop. We gave the patient an ice pack and water. Patient refused 911 and refused Benadryl. We took the patients blood pressure and had the patient wait for 30 /40 minutes after the vaccine. the patient felt better
19 2021-05-24 heart rate increased I have heard, and saw recently that a small group of primarily male adolescents and young adults hav... Read more
I have heard, and saw recently that a small group of primarily male adolescents and young adults have developed difficulties with their hearts after taking the vaccine. I am also having this problem. I am an athlete with a resting heart rate of around 55-65. Now my resting is 75-90. When I went on a light jog; it reached 210. I received the COVID vaccine. I don?t know exactly who to contact for this, or if you guys need to know this. I just knew they were looking into/ researching people with this rare affect. Have a nice day!
19 2021-05-25 heart rate increased, blood pressure decreased Sudden drop in blood pressure (systolic dropped to 80s, unsure of exact number), vertigo and lighthe... Read more
Sudden drop in blood pressure (systolic dropped to 80s, unsure of exact number), vertigo and lightheaded-ness, increased heart rate, fading vision and changes to hearing, tingling in extremities. Nurses started checking bp, apple juice to increase blood sugar, symptoms started to abate after 5-10 minutes. Free to go 30 minutes after vaccination.
19 2021-05-26 loss of consciousness After administration the patient stated that "it felt weird". She moved her arm around a little and... Read more
After administration the patient stated that "it felt weird". She moved her arm around a little and said she was afraid to move it too much. A minute later she said she felt like she was going to pass out. She leaned against the wall and her eyes started to close. I noticed that she was starting to break out into a sweat. I asked it she was having trouble breathing, if her throat felt like it was swelling or if she felt nauseous. She said no, just dizzy and really thirsty and asked for some water. I asked again if she was having trouble breathing or was nauseous and she said no, then passed out. I took her blood pressure, which was normal. After a couple of minutes she started to wake up, although not fully, and asked what happened. I told her I had given her a COVID vaccine and asked if she remembered that. She said yes then seemed to pass out again. I then decided to call 911. A minute later the patient woke up. I asked how she was feeling and she said better. After a minute she asked if she could sit up and I said yes, as long as she felt she could. I took her blood pressure a second time. By the time EMS arrived the patient was fully alert, we were having a conversation and she said she felt fine. EMS checked her over but she refused to go to the hospital. I had her sit a few more minutes while I filled out her immunization card. When she left she said she felt completely fine.
19 2021-05-30 loss of consciousness Patient recieved vaccine and in appoximately 5 minutes stated she didn't feel right. Momentary loss... Read more
Patient recieved vaccine and in appoximately 5 minutes stated she didn't feel right. Momentary loss of conciousness then "I feel sick going to throw up" proceeded to vomit. Staff called 911. She was shaking and upset. EMTs arrived and checked pulse and other vitals. After observation for approximately 30 minutes from time EMTs arrived, patient , her father, EMTs and pharmacist agreed she did not need to go to the ER.
19 2021-05-31 chest pain, palpitations Racing heart that continued on and off for over a week; longest it lasted was several hours; feeling... Read more
Racing heart that continued on and off for over a week; longest it lasted was several hours; feeling of shortness of breath with racing heart; sporadic chest pain that has been on going since vaccination
19 2021-06-01 chest discomfort tightness in chest
19 2021-06-02 cardiac arrest, loss of consciousness Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home... Read more
Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home, sitting on floor. alert, speaking. Patient with sob, saying she can not breath , states it came on suddenly about a half hour ago and pt has not been feeling ill prior to this. No trauma, no pains or other complaints. pt went unconscious then into pea cardiac arrest, witnessed. Laid pt down and check for heart beat and breathing, became pulseless and apneic Initial treatment CPR, IV, BVM. Family states no medical history other than anemia. no drug use, no respiratory or cardiac issues. Pt was given J and J covid 19 vaccine recently. Pt also just returned from a trip and noted to not have gone diving. 2 epinephrine IV given on scene with no change to heart rhythm. Pt loaded into the ambulance and cpr continued while transporting. pt with copious amounts of vomit, suction enroute to ed. Pt w/o shockable rhythm throughout transport. Continue cpr and bvm via king airway , cap at 9. unable to get capnography higher. no change in heart rhythm. while enroute to er. At ED pt did get pulses back however it was reported that pt loss pulses and was pronounced
19 2021-06-07 chest pain The night of vaccination I had fever, aches and body chills that lasted for 4 days. On the 6th day a... Read more
The night of vaccination I had fever, aches and body chills that lasted for 4 days. On the 6th day after the vaccine the chest pains started. I've been seen in the ER three times now. A stabbing pain under my left breast that is continuous.
19 2021-06-07 pallor With in 5 minutes of receiveing the vaccine, the patient developed shock-like symptoms. Patient pres... Read more
With in 5 minutes of receiveing the vaccine, the patient developed shock-like symptoms. Patient presented with pale, cold, clammy skin. Then her vision became blurry and her arms shook when she moved them. After 15 minutes she began to feel better and the symptoms completely resolved after 30 minutes.
19 2021-06-07 fainting lightheadedness with syncope 5 hours after vaccination, 3-4 episodes of lightheadedness over 2 days ... Read more
lightheadedness with syncope 5 hours after vaccination, 3-4 episodes of lightheadedness over 2 days 2 months after vaccination. Pt states the later symptoms feel identical to the initial one.
19 2021-06-08 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
19 2021-06-09 heart rate increased, chest pain High heart rate, shortness of breath, chest pains, and swollen hands. Could possibly have heart infl... Read more
High heart rate, shortness of breath, chest pains, and swollen hands. Could possibly have heart inflammation; waiting to hear back from doctor.
19 2021-06-11 fainting Patient experienced vasovagal syncope about 4 to 5 minutes after vaccine. Patient was unresponsive ... Read more
Patient experienced vasovagal syncope about 4 to 5 minutes after vaccine. Patient was unresponsive for about 50 seconds and then came back for a minute then was unresponsive for 10 seconds and then came back for good. the paramedics we called and patient was checked out. they gave her the ok to leave.
19 2021-06-13 hypotension, loss of consciousness, pallor, fainting Patient was given the Janssen vaccine then sat in the pharmacy to wait for the 15 minutes observatio... Read more
Patient was given the Janssen vaccine then sat in the pharmacy to wait for the 15 minutes observation period. About 5 minutes of sitting down the patient fainted with loss of consciousness and looked pale. The patient almost fell out of the chair she was sitting in but was caught by her mother. Pharmacist rushed over to check on patient and emergency services were contacted. Patient regained consciousness within about 30 to 60 seconds of fainting. Paramedics then arrived and took the patients blood pressure. They found it was low but it regulated back to normal at later readings. The patient had multiple risk factors for fainting including, not eating that day, having anxiety about the vaccine, having worked a lot the day before, and she recently lost a significant amount of weigh. After the paramedics assessed her the patient was feeling much better and the paramedics told her she was ok to go home with her mother and she did not require further medical examination. Patient left with her mother, pharmacist followed up with the patient and she is feeling much better the next day.
19 2021-06-15 fainting At 1259 client aged 19yo, was vaccinated in her left arm with the Janssen vaccine lot#205A21A. At 1... Read more
At 1259 client aged 19yo, was vaccinated in her left arm with the Janssen vaccine lot#205A21A. At 1306 client requested a bottle of water as she reported feeling dizzy. Vaccine monitor brought a bottle of water to vaccination room and immediately observed client's eyes begin to lose focus, so client was supported as she fainted, and placed safely on the floor with her legs elevated her legs on a chair and within seconds she regained consciousness. RN conducted a neuro-check on client and confirmed client was AxO x4. The zero gravity chair was retrieved and EMT summoned, and at 1310 client was assisted to her feet by Co-Lead RN and RN and transferred to this chair. At 1311 water was offered to client and she took a few sips and admitted she felt a lot better. At 1312 EMT took client's first set of vitals which were: BP 110/70, HR 60, RR18, and O2 98%. Co-lead confirmed with Vaccinator that client had been appropriately screened, that client had denied past syncopal episodes and had ate food today at 1000. At 1314, Co-Lead RN asked client again if she had ever experienced syncope, and she admitted that she had once when visiting her uncle in the hospital. Co-Lead then educated client that it is not uncommon to faint due to anxiety related to medical procedures and encouraged her to report this to her physician and to any medical personnel in the future during medical procedures so proper safety precautions can be engaged. Co-Lead then applied a cold pack to the back of client's neck, and EMT took a second set of vitals: BP 120/70, HR 63, O2 100%. Client remained in the vaccination room 1328 when she felt well enough to walk to the observation room escorted by EMT to complete a 30 minute observation period. At 1339 when EMT approached client to take her vitals again, client stated she was dizzy again, so EMT requested she remain for another 15 minutes and have a snack. At 1400, client stated she felt better, her vitals were taken for the last time by the EMT: BP 110/60, HR 56, O2 98%, and EMT then escorted client downstairs where her mother was waiting with the car. EMT and Co-Lead RN educated client to take it easy for the rest of the day and seek additional care with her PCP or Urgent Care if symptoms worsened. EMT observed client ambulating independently with a steady, even gait.
19 2021-06-16 loss of consciousness, pallor Patient received Janssen vaccine and passed out/threw up after receiving vaccine. She told us ahead ... Read more
Patient received Janssen vaccine and passed out/threw up after receiving vaccine. She told us ahead of time that she occasionally passes out with blood draws, but never had any issue after a vaccine. About 3-5 minutes after the vaccine, the patient turned very pale and passed out in her chair. She did not fall on the floor but slumped to the side as we held her in place. After she came to she threw up. We had called 911 because it took her a while to wake up. EMS arrived and she was already feeling much better. They took her blood pressure and cleared her. Patient waited another 30 minutes after they left to make sure she was still feeling okay.
19 2021-06-18 fainting, hypotension The patient fainted upon exiting the vaccine room and sitting back in her observation chair approxim... Read more
The patient fainted upon exiting the vaccine room and sitting back in her observation chair approximately two minutes after the vaccine was given. She was in and out of consciousness for about 10 minutes total, was sweating heavily, and eyes dilated and unable to track. We applied a cold compress and ice packs, and then laid patient down flat. Upon laying her down she quickly came back to consciousness and then the paramedics arrived. Paramedics recommended patient go to the hospital for fluids, but patient felt like she was okay. She went out to the ambulance for further observation and testing.
19 2021-06-19 fainting, loss of consciousness, pallor 19 yo female reported to her father she was not feeling well after receiving Janssen vaccine at 15:0... Read more
19 yo female reported to her father she was not feeling well after receiving Janssen vaccine at 15:00. Father flagged observation nurse over as patient displayed a syncopal episode. Client reported her vision went black but did not recall if she lost consciousness. Client became alert without assist. BP 72/50; client appeared pale client given gatorade and reported feeling better BP 100/50 client finished observation and was ambulatory upon leave with father
19 2021-06-22 fainting, loss of consciousness Syncope-- about 10 sec after administration, patient became tonic that lasted approximately 5 seco... Read more
Syncope-- about 10 sec after administration, patient became tonic that lasted approximately 5 seconds, then passed out for approximately 20-30 seconds Immediately, EMS was alerted and responded in approximately 8 minutes. Patient's blood pressure was monitored and then patient declined to be transported to the hospital
19 2021-06-22 fainting Fever, loss of sight and hearing, fainting
19 2021-06-29 chest pain About 7- hours after injected, woke up in the middle of the night hyperventilating and unable to mov... Read more
About 7- hours after injected, woke up in the middle of the night hyperventilating and unable to move. Sweating and sensitive skin all on the body. Headaches that have been constant for the past week and a half and chest pain
19 2021-07-04 fainting Patient fainted
19 2021-07-15 chest pain, loss of consciousness Passed out 2+ times for at least 30 sec and more over the course of about an hour. Signs were feelin... Read more
Passed out 2+ times for at least 30 sec and more over the course of about an hour. Signs were feeling light headed, dizzy, nauseous, chest pains, and clammy.
19 2021-07-18 fainting was sitting in a chair in the waiting area and within 5 minutes of receiving her vaccination she exp... Read more
was sitting in a chair in the waiting area and within 5 minutes of receiving her vaccination she experienced an episode of syncope and her head and upper body slumped over to the side. A customer in line noticed and rushed over, then the pharmacy technician running the register noticed and pharmacy staff ran out to assist. The syncope only lasted for a couple of seconds before she jerked herself awake. I brought her into the consultation room and she declined to lie down but requested to sit. She drank water but refused any other food or drink. She said she felt better but was visibly shaken up from the incident and was crying. She refused any medical treatment and declined when I offered to call EMS. She called her dad and asked him to pick her up. Then she sat in the consultation room for a few more minutes and left.
19 2021-07-19 blood clot Blood clot in left leg
19 2021-07-23 loss of consciousness After the vaccination, patient reacted in a couple of minutes. She had stressed breathing, body star... Read more
After the vaccination, patient reacted in a couple of minutes. She had stressed breathing, body started to drop and she started to sweat. Patient seemed to have loss consciousness for about a minute so we helped her lie down on the floor.
19 2021-07-26 loss of consciousness After patient received the vaccine she sat in the waiting room. She began to pass out in the chair ... Read more
After patient received the vaccine she sat in the waiting room. She began to pass out in the chair she was sitting it. She came to immediately and was OK.
20 2021-03-07 fainting Adverse event: Vasovagal syncope , nausea 2 minutes after injection , treatment - supine leg elevati... Read more
Adverse event: Vasovagal syncope , nausea 2 minutes after injection , treatment - supine leg elevation -- ice - water , outcome : patient felt better after 15 minutes , left pharmacy observation after 30 minutes after injection
20 2021-03-09 pallor Patient received her vaccine with 2 family members in the room who also got the vaccine. Moments aft... Read more
Patient received her vaccine with 2 family members in the room who also got the vaccine. Moments after (less than 2 minutes) giving her the vaccine, I was giving another family member the injection and patient asked if she could take her mask off. I turned around and she was very pale. She took her mask off and started slumping in her seat. She was taking deep breaths and reported no difficulties breathing. She then became ill and began gagging, at which point I gave her the trash receptacle to vomit in. I had a technician grab the patient a water and packet of crackers. After half an hour of resting in the chair, monitoring her breathing, blood pressure, heart rate, and getting some food and water into her system, she appeared and reported to feel back to normal. Patient's family member mentioned she had a similar reaction a few weeks ago when getting blood drawn at her doctor's office.
20 2021-03-10 fast heart rate Difficulty breathing Fast heartbeat Headache Weakness Chills Fever Eye heaviness
20 2021-03-11 fainting Patient was flushed, could not hear, was feeling nausea, and fainted for few seconds. I administered... Read more
Patient was flushed, could not hear, was feeling nausea, and fainted for few seconds. I administered Epi 0.3mg and called 911. Paramedics arrived and patient was taken to the hospital.
20 2021-03-12 heart rate increased felt fine until about 6 hours after (approx 12 am 03/13/2021) and then i got severe chills, felt fev... Read more
felt fine until about 6 hours after (approx 12 am 03/13/2021) and then i got severe chills, felt feverish, had severe muscle and joint aches, a moderate headache. woke up at 4 am with nausea but no vomiting, still had muscle and joint aches. felt like i had the flu. it's about 13 hours since i got the shot, now having headache, muscle and joint pain, and increased heart rate
20 2021-03-12 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
20 2021-03-15 nosebleed Around 10PM on the day of the vaccine I had full body chills and the worst headache ever. I woke up ... Read more
Around 10PM on the day of the vaccine I had full body chills and the worst headache ever. I woke up at 3AM with a fever and then I took Tylenol. I went to the walk in clinic at CVS on Saturday because I was still feeling fatigue, headache, nose bleeds (I was having them before the vaccine about a week before) and sinus congestion, they antibiotics and I was able to get started on them on the same day. I still feel the fatigue, congestion and the sinus pressure/headache. The fever and chills are gone.
20 2021-03-30 fainting Around 9pm I got very short of breath and got very sick. I was very nauseous and the next day I fain... Read more
Around 9pm I got very short of breath and got very sick. I was very nauseous and the next day I fainted.
20 2021-03-31 heart rate increased Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): e... Read more
Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit
20 2021-03-31 loss of consciousness Patient passed out shortly after vaccination, nursing staff attended patient, used an alcohol swap, ... Read more
Patient passed out shortly after vaccination, nursing staff attended patient, used an alcohol swap, patient came to, pulse rate taken (86), patient was in chair during the duration of this. Patient was given juice, water, snack and was laid at an examination table. Was assessed by a nurse and after the patient was cleared she was walked /escorted to her vehicle out of the vaccination site by a security guard.
20 2021-04-01 palpitations At 4:00pm I got lightheaded, dizzy, and achy. The lightheadedness was such that my heart was poundin... Read more
At 4:00pm I got lightheaded, dizzy, and achy. The lightheadedness was such that my heart was pounding, vision was lost for a second (similar to the effect when you stand up too fast), and the sound went out for a second. Around 7:00 I got chills, a 101 degree F fever, and headache. The chills, fever, and headache lasted throughout the night, but they were gone in the morning. The entire day after getting the vaccine, 4/1/2021, I had a metallic taste in my mouth. By the morning of 4/2/2021 the metallic taste was gone.
20 2021-04-02 chest discomfort Intense confusion Panic attacks/ anxiety Tight chest Muscle and joint pain Fever
20 2021-04-02 chest pain Patient experienced swelling of the face, eyes, and lips, and a burning sensation in her throat and ... Read more
Patient experienced swelling of the face, eyes, and lips, and a burning sensation in her throat and chest. We called 9-1-1 to check vitals and they recommended going to her doctor or the hospital in case of additional swelling. We called the doctor and they told us to try Benadryl. This worked a little bit, but she is still in a lot of discomfort today (Saturday after Thursday shot).
20 2021-04-02 loss of consciousness Patient was given the injection and then she started feeling dizzy right after administration. She ... Read more
Patient was given the injection and then she started feeling dizzy right after administration. She sat with her head against the wall and dropped her phone and passed out for just a moment. She had a slight tremor/shake for a few seconds. (I did not witness, unsure exactly what happened or how long) She came too fairly quickly after being yelled at, are you ok? When she regained consciousness she complained of being hot all over for a bit. We gave her ice packs to cool down. She felt hot for maybe 10-15 minutes, but felt relief with the ice packs. She also drank some sips of cool water which seemed to help her cool down.
20 2021-04-02 fast heart rate It started with my teeth chattering and chills, but no fever yet. All of the muscles in my body had ... Read more
It started with my teeth chattering and chills, but no fever yet. All of the muscles in my body had a severe tremor, and I had trouble with simple tasks like filling my nasal rinse bottle, because the tremor was so bad. My jaw was smacking the entire time, so hard that the headboard smacked against the blinds. Then I checked my temperature and it had gone from 97.5 to about 99.5. The symptoms got worse, and added in excessive thirst, pain at the base of my head where it meets my neck, pressure under and behind the eyes, severe lower back pain, muscle pain escalating on the right side of my body only, nausea, pain across the top of my forehead, and a weird heat sensation under my fingernails? Maybe and hour or so passed, and my fever rose to above 101, and I tried to go back to sleep. By this point the tremors were over, but slight chills and every other symptoms remained. I took my temp later and it was 102.7, and I again had all symptoms except the initial tremors. I also had tachycardia (super rapid heartbeat) and got dizzy for a second and have a little trouble focusing my vision when I sat up in bed.
20 2021-04-05 loss of consciousness Patient fell off chair and was convulsing and unresponsive. Has not eaten since breakfast.
20 2021-04-05 fainting Patient fainted after injection. Mom was with her and stated she has done this in the past with vacc... Read more
Patient fainted after injection. Mom was with her and stated she has done this in the past with vaccines or giving blood. Becomes very anxious and has needle phobia. Mom put cool pack on back of neck and wet cloth on forehead. Also gave water as she was waking up. She was fine and ready to go in about 20 minutes.
20 2021-04-06 chest discomfort CHEST TIGHTNESS; FEVER OF 101.1 F; This spontaneous report received from a consumer concerned a 20 y... Read more
CHEST TIGHTNESS; FEVER OF 101.1 F; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 3580333, and expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 28-MAR-2021, the subject experienced chest tightness. On 28-MAR-2021, the subject experienced fever of 101.1 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever of 101.1 f and chest tightness 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.
20 2021-04-06 loss of consciousness After receiving her vaccine, she sat with her friend that she came with and told her that she felt l... Read more
After receiving her vaccine, she sat with her friend that she came with and told her that she felt lightheaded. She placed head between her knees initially, then sat up and leaned over to her left where she landed prone unresponsive. PCPH staff attended and turned her supine and noted that she was having a seizure like movements, not breathing for 10 sec., incontinent of urine, gurgling at one point. While assessing for need for CPR and with stimulation of sternum, regained consciousness and took deep gasp, asking "did I pass out?" "I usually get dizzy and sometimes faint with shots." VSS initially 98/60-71 hr-16-99% ox reading. EMTs summoned by Director of PCPH on site encouraged her to call her parents as s
20 2021-04-06 pallor Patient became light headed and pale approximately 5 minutes after injection. Did not pass out. Pati... Read more
Patient became light headed and pale approximately 5 minutes after injection. Did not pass out. Patient sitting and given water. 10 minutes later patient feeling better and left 30 minutes after injection.
20 2021-04-07 blood pressure increased, fast heart rate Nausea Fever Chills Body Aches Elevated Blood Pressure Rapid Heart rate Severe Headaches
20 2021-04-07 heart rate increased Elevated heart rate. Fever. Body aches and pain at injection site. Chills, hot cold flashes. Weaknes... Read more
Elevated heart rate. Fever. Body aches and pain at injection site. Chills, hot cold flashes. Weakness and fatigue
20 2021-04-07 loss of consciousness Patient received vaccine at clinic but unsure as to the time. She left the clinic feeling fine, but... Read more
Patient received vaccine at clinic but unsure as to the time. She left the clinic feeling fine, but shortly after started to develop a rash. EMS was called to assess and felt it did not warrant ED visit, however, she went to softball practice and began to have lightheadedness, trouble speaking, in and out of consciousness, trouble breathing, clammy. A rescue squad was summoned and taking patient. Awaiting further word on her condition
20 2021-04-07 pallor uncontrollable laughing and crying, nausea and vomiting especially when standing, feeling of going t... Read more
uncontrollable laughing and crying, nausea and vomiting especially when standing, feeling of going to pass out and lightheadedness, very red, swollen, and flushed face and ears, eyes were droopy, barely had feeling in face and had a hard time moving jaw. Extreme back pain and facial pain, feeling of shakiness, face turned white like was going to vomit or pass out. Very cold feeling all over but was drenched in sweat. Very tired.
20 2021-04-07 palpitations Racing heart for about 3 hours post vaccination. Heart stopped racing, but turned into a severe hea... Read more
Racing heart for about 3 hours post vaccination. Heart stopped racing, but turned into a severe headache, fever, vomitting, nausea, full body aches and dizziness. This has been going on for 24 hours.
20 2021-04-07 fainting, loss of consciousness Syncopal episode appearing as a vasovagal response from receiving the vaccine. Patient fainted and f... Read more
Syncopal episode appearing as a vasovagal response from receiving the vaccine. Patient fainted and fell back onto her head. Unconscious. When patient woke up she was very confused and alarmed. EMS was called and brought her to the hospital. BP, O2, resp normal
20 2021-04-07 fainting, pallor Patient began to feel dizzy and appeared pale to the technician. She was asked how she was doing, an... Read more
Patient began to feel dizzy and appeared pale to the technician. She was asked how she was doing, and just before responding she collapsed. Patient regained consciousness almost immediately and refused the ambulance. She reported feeling hot and thirsty, water was given and patient's blood pressure was taken. It read 98/67. It was checked again in 20 minutes and increased to 114/82
20 2021-04-08 hypotension The Patient was in observation and felt faint and weak. She advised the Medic and an assessment was ... Read more
The Patient was in observation and felt faint and weak. She advised the Medic and an assessment was started. The patient was noted with a low BP. She was laid down and a response from the local ems system was started. The patient felt better, refused RX and TX, and signed out AMA.
20 2021-04-08 lightheadedness I began feeling a migraine at 3pm. I took a nap and woke up at 6pm feeling extremely ill. My tempera... Read more
I began feeling a migraine at 3pm. I took a nap and woke up at 6pm feeling extremely ill. My temperature was 101.5F and my entire body was in pain. I took two Tylenol as suggested. Over the course of the entire evening, I was vomiting profusely; I vomited approximately 10 times. By around 10pm my extremities became numb and I could not walk without assistance. I could not think or speak straight. I nearly fainted every time I tried to sit up. I tried to take ondansetron for vomiting but proceeded to vomit the medication as well. I wanted to go in to the ER because I felt like I was dying, but I do not feel financially comfortable doing so. All symptoms remained consistent until about 3am when I was able to sleep until 7am. I woke up with several bouts of diarrhea, intense nausea, and head to toe muscle and joint pains, as well as numbness and tingling in my arms and legs still. It is now 5pm the next day and I still can't eat or stand for too long without feeling faint. I still have diarrhea and strong migraine.
20 2021-04-08 fainting, pallor Patient stated that she has a previous history of fainting when receiving vaccination, and was nervo... Read more
Patient stated that she has a previous history of fainting when receiving vaccination, and was nervous to be vaccinated. Patient was seated but became pale, sweaty, and fainted for approximately 5 seconds after receiving the vaccination. Conversation was maintained with the patient through out the entire transaction. Pt was evaluated by emergency personnel, refused treatment, and went home to rest.
20 2021-04-08 fainting On 3/21, 10 hours after shot 101 fever. 11 hours after shot fainted Fever for 24 hours 36 hours afte... Read more
On 3/21, 10 hours after shot 101 fever. 11 hours after shot fainted Fever for 24 hours 36 hours after shot developed swollen lymph nodes in neck that lasted 4 days
20 2021-04-08 fainting pt stated that 4 hours after vaccine on 4/8/21 she fainted while at home and hit her arm. She state... Read more
pt stated that 4 hours after vaccine on 4/8/21 she fainted while at home and hit her arm. She stated that she believes she did not eat enough. She said that after eating and drinking electrolytes she felt better. AS of 4/9/21 she states she has a headache and feels icky. pt stated she did not receive any medical attention
20 2021-04-09 hypotension, fainting While the vaccine was going in my arm it was stinging and burning. I fainted about 30 seconds after ... Read more
While the vaccine was going in my arm it was stinging and burning. I fainted about 30 seconds after the injection. I waited at my vaccination site for about 30 minutes after that. My vision was blurring and turning black and white and my hearing went out. I felt lightheaded and fainted for a few seconds. Afterwards, I was lightheaded for quite some time and my blood pressure was a bit low.
20 2021-04-09 pallor Client reported feeling "hot and light headed" approx 2 minutes after receiving vaccine. She was led... Read more
Client reported feeling "hot and light headed" approx 2 minutes after receiving vaccine. She was led by EMT to zero gravity chair. 12:31 V/S: HR 67, O2 99, BP 98/60. V/S @ 12:46 BP 118/80, HR 82, O2 99, AOx3 EMT observed client's to have pallor color. V/S @ 12:56 BP 92/58, HR 72, O2 100, RR 20 and client report of "feeling much better." Client reported having hx of syncope with nose piercing. At 1312, client left site unassisted and with a steady gait.
20 2021-04-09 fainting Syncopal episode. Evaluated by EMS-Cleared
20 2021-04-09 fainting Patient fainted a few minutes after vaccination. The patient told her father she was feeling lighthe... Read more
Patient fainted a few minutes after vaccination. The patient told her father she was feeling lightheaded and then her legs became weak. Her father grabbed her to make sure she didn't fall and hit her head. We had the patient sit on the ground. Pulse and color for patient was good. We gave the patient water and had her sit for about 30 more minutes before releasing her. We checked in with her every few minutes and patient had noi issues.
20 2021-04-09 fainting Fainted but responded when I talked to her. Had her lie on floor. Gave cold compress and cold water... Read more
Fainted but responded when I talked to her. Had her lie on floor. Gave cold compress and cold water to drink. She stayed awake from then on. We sat her up and had her wait until she felt better. Waited here 30 minutes after vaccine and felt ok when she left.
20 2021-04-09 fainting Patient fainted 1 minute post vaccination. Patient said experienced arm pain and felt off immediate... Read more
Patient fainted 1 minute post vaccination. Patient said experienced arm pain and felt off immediately after vaccine. Patient came to within one minute of fainting. Blood pressure was checked and was in range at 119/90. Patient was slowly given water and started feeling better. Patient was also given orange juice and crackers. Blood pressure was taken again at 122/82. Patient experienced feeling cold and some yellowing of hands as well. Patient has a history of fainting when giving blood and is afraid of needles. After 50 minutes patient felt much better and left pharmacy. Followed up with patient after 2 hours and patient stated felt fine.
20 2021-04-10 pallor, lightheadedness, blood pressure decreased At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to re... Read more
At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet elevated. Ice pack to back of neck. VS taken 98/60, HR 66 reg strong, rest 16 reg non labored, SpO2 99% no LOC, no SOB, no N/V. Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine. after 15 min pallor, dizziness, diaphoresis and nausea subsided. 2nd set of VS taken 110/72, HR 68 reg strong, resps 16 reg nonlabored. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel better" Ok'd to exit after 30 min.
20 2021-04-10 lightheadedness, pallor (prior report filed incorrect description of event disregard report 427860) At recovery table pt bec... Read more
(prior report filed incorrect description of event disregard report 427860) At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet elevated. Ice pack to back of neck. VS taken 122/80, HR 67reg strong, rest 12 reg non labored, SpO2 97% no LOC, no SOB, no V. Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine. after 10 min pallor, dizziness, diaphoresis and nausea subsided. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel much better" Ok'd to exit after 30 min.
20 2021-04-10 fainting, loss of consciousness Pt stated that she has vasovagal syncope when she has needles and stresses. Pt received vaccine lyi... Read more
Pt stated that she has vasovagal syncope when she has needles and stresses. Pt received vaccine lying down on recovery cot. Friend was at her side providing support. Ice to back of neck, feet elevated. status post receiving vaccine approx 30 sec while talking to pt she had syncope unable to recover with verbal nurse provide sternal rub pt came to alert and oriented smiling and laughing. She stated this happens and is normal for her to pass out due to vasovagal syncope condition that it happens all the time. refused to go to hospital. She has had all kinds of tests (cardiac, neurological, ENT per pt it has been dx as vit def, NA def, nutritional def ) While talking to her she had a 2nd syncopal episode used ammonia salts to recover pt awakened immediately. VS 110/72, HR 84 reg strong, resps 12 reg nonlabored, SpO2 98%. Provided water for hydration. Friend stayed a side the whole time. after 20 min sat pt up, no LOC again, no SOB no N/V. Sat in recovery 30 minutes. Pt stated I feel fine . OK'd to exit
20 2021-04-11 fainting Patient fainted and had seizure like symptoms with eyes rolling back in head, clamminess, sweating, ... Read more
Patient fainted and had seizure like symptoms with eyes rolling back in head, clamminess, sweating, severe stomach cramps, blurred vision, and temporary loss of hearing
20 2021-04-12 heart rate increased Fever, fatigue, chills, body aches, headache, nausea, elevated resting pulse rate. Fever has lasted ... Read more
Fever, fatigue, chills, body aches, headache, nausea, elevated resting pulse rate. Fever has lasted for 3 days to date as well as the elevated heart rate.
20 2021-04-12 heart rate irregular SHORTNESS OF BREATH, IRREGULAR HEART BEAT, FEVER, MUSCLE ACHES, WHOLE BODY SWOLLEN, NAUSEA, FATIGUE,... Read more
SHORTNESS OF BREATH, IRREGULAR HEART BEAT, FEVER, MUSCLE ACHES, WHOLE BODY SWOLLEN, NAUSEA, FATIGUE, NECK AND BACK STIFFNESS
20 2021-04-12 hypotension ABOUT 10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT WAS SITTING WITH HER MOTHER AND BECAME LIGHT H... Read more
ABOUT 10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT WAS SITTING WITH HER MOTHER AND BECAME LIGHT HEADED AND BEGAN SWEATING. SHE NEVER LOST CONSCIOUSNESS AND WAS ABLE TO FOLLOW DIRECTIONS DURING THAT TIME. EMS WAS ALREADY ON SITE ATTENDING TO A PREVIOUS PATIENT WHO HAD FAINTED. THEY RENDERED AID TO PATIENT BY CHECKING HER VITAL SIGNS. SHE WAS HYPOTENSIVE ON A MONITOR. THEY DID NOT CHECK BLOOD SUGAR. UPON GETTING HER HISTORY, IT WAS DISCOVERED SHE HAD DRIVEN 3 HOURS FROM HER HOME TO FIND A LOCATION WITH THE VACCINE AND HAD ONLY EATEN LITTLE DURING THE DAY. AND PRIOR TO HER VACCINE, ANOTHER PATIENT FAINTED.
20 2021-04-12 loss of consciousness At 10PM (8 hours after getting the JnJ vaccine) pt developed chills and pulsate headache. Pt was a... Read more
At 10PM (8 hours after getting the JnJ vaccine) pt developed chills and pulsate headache. Pt was able to sleep. Next day in the morning by 7:40AM she went downstairs and got dizzy and fall gradually on the floor. Pt got help, but when she was trying to get up she got lightheaded/passed out again bumping her head on the wall. Pt reacted, fluids were given. Pt slept all morning. At 2PM she got up from bed. No pulsate headache, just "mild headache." Today, 48 hours later, pt reported light headache. Denies abdominal pain or pain in extremities. Pt and parents of pt were encouraged to report to patient's PCP.
20 2021-04-12 loss of consciousness At 5:30 PM she was feeling nauseous and weak. She passed out, had a headache, chills, and intermitt... Read more
At 5:30 PM she was feeling nauseous and weak. She passed out, had a headache, chills, and intermittently experienced profuse sweating. She had a fever at 12:30 AM that evening (next day). She was a little nauseous and took it easy the next day and was fine after a day passed.
20 2021-04-12 fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: Regained consciousness quickly (less t... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Regained consciousness quickly (less than 30 seconds)
20 2021-04-12 fainting I was in the passenger seat while my mom was driving me home after vaccination, and I began to feel ... Read more
I was in the passenger seat while my mom was driving me home after vaccination, and I began to feel nauseous a few minutes into the drive. About ten to fifteen minutes after we left (in total, about 25-30 minutes post-vaccination) I felt so sick (nausea, sweating, chills) that I couldn't keep my head up. I briefly fainted, but I woke up about two minutes later. My mom finished driving me home, and my condition improved with rest over the following hours.
20 2021-04-13 chest discomfort, chest pain Full body aches and pains, fever, chills, sweats, severe headache, nausea, chest pain/pressure, fati... Read more
Full body aches and pains, fever, chills, sweats, severe headache, nausea, chest pain/pressure, fatigue but not being able to sleep due to intense pain.
20 2021-04-13 chest discomfort Started with B leg achiness and pain the day after vaccination. She was having difficulty walking. t... Read more
Started with B leg achiness and pain the day after vaccination. She was having difficulty walking. the second day began having arm pain L>R to the point she could not lift her left arm. Also has severe headache unable to be treated by otc medicine, chest tightness and some difficulty breathing.
20 2021-04-13 chest discomfort About 10 hours after receiving my vaccine- I became extremely ill. I had migraines, fever of 101, ch... Read more
About 10 hours after receiving my vaccine- I became extremely ill. I had migraines, fever of 101, chills, nausea, tightness of chest, abdominal pain, difficulty with my stool / bowl movements, and body aches. I could not move, and most effects subsided after laying in bed for two/three days straight. However, continuing up to today (three weeks later) I have still had tightness of chest/throat, bowl difficulties, and abdominal pain. I also noticed that for the past 2/3 weeks I have also had blood spotting with clots alongside my abdominal pain. It has not yet subsided.
20 2021-04-13 chest pain, heart rate increased Started out with a headache and dizziness within a few minutes of the vaccine, along with nausea. I ... Read more
Started out with a headache and dizziness within a few minutes of the vaccine, along with nausea. I stayed put laying down with a lollipop and water bottle along with ice packs on me for about an hour until I was well enough they thought for me to drive back to my dorm. Once I started driving the headache was back but I was driving so I couldn?t do much. Almost pulled over because I was getting over whelmed but ended up making it back to my dorm. Once I got back I changed and laid down in bed hoping to fell better. Things started getting worse from there. Throughout the rest of the day my head ache and dizziness got worse to the point where I was pretty unsteady on my feet. Chills and body aches also started and progressed rapidly despite no fever. My nausea was present in waves but eventually dissipated around 8 PM. I tried to go to bed around 11 hoping to sleep off the symptoms. I began tossing and turning. My chills were really bad and it got to the point where my skin was so sensitive that the clothes I was wearing touching and rubbing against my skin were hurting me. I was so dizzy and light headed to the point where it didn?t matter if I was laying down or sitting up, I felt the same, extremely dizzy and lightheaded as if cotton were in my brain or as if it were working too slow. It was like trying to process thoughts through molasses. Then around 1:30 I couldn?t take it anymore and thought maybe a quick shower would help me to at least feel better so I could sleep. When I got in the shower I immediately knew things were worse. My vision started going black at the edges and black spots in the middle to the point where at certain moments I couldn?t see. I was fighting to stay on my feet and conscious and it was hurting to breathe. I knew I needed to get help so I stumbled to my dorm and collapsed when I got in the doorway to my room. My vision was spotty, my chest was hurting and I could barely breathe. My hands and feet went numb as well, I was shivering, and my body temperature was a little down to about 98.1 degrees Fahrenheit. I was transported to a hospital via ambulance my vitals were normal except elevated heart rate and O2 and was admitted at 2:40 in the morning. I received a chest x ray and my heart rate was better. The dizziness was under control by then. I was discharged at 4:50 in the morning.
20 2021-04-13 pallor LOOKS PALE; FEELING SICK; HEADACHE; TEMPERATURE 102.4C; DIZZINESS AND WHEN TRIED TO SLEEP DIZZY; BOD... Read more
LOOKS PALE; FEELING SICK; HEADACHE; TEMPERATURE 102.4C; DIZZINESS AND WHEN TRIED TO SLEEP DIZZY; BODY ACHES; FEELING COLD; SWEATY; PRESSURE IN HEAD; PRESSURE IN EARS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included dehydration, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:40 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 C. On 08-APR-2021, the subject experienced dizziness and when tried to sleep dizzy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced sweaty. On 08-APR-2021, the subject experienced pressure in head. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced temperature 102.4c. On 09-APR-2021, the subject experienced looks pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness and when tried to sleep dizzy, feeling sick, body aches, headache, feeling cold, sweaty, pressure in head, temperature 102.4c, looks pale, and pressure in ears. This report was non-serious.
20 2021-04-13 increased heart rate, chest pain I had Janssen vaccine on 3/10. I had some fatigue after, and was doing well until several hours late... Read more
I had Janssen vaccine on 3/10. I had some fatigue after, and was doing well until several hours later, when I developed severe chest pain, shortness of breath, headache, and back pain. I went to ER, fever to 102.2F. EKG w sinus tachycardia, heart rate 153bpm, treated with IV fluids, tylenol and IV ativan with significant symptomatic improvement. Labs and CXR were normal. Since then, I have not had any more symptoms.
20 2021-04-13 fainting patient recieved J& J vaaccine on saturday at 2 pm following am patient woke up walked to bathroom... Read more
patient recieved J& J vaaccine on saturday at 2 pm following am patient woke up walked to bathroom told mom she wasnt feeling well, mom noticed she was going to pass out and assisted patient to ground, syncope lasted < 30 sec. Patient drank water/ginger ale, patient returned to sleep and woke up and reported feeling normal Patient took an adderrall 15 mg saturday night around 6 pm after vaccine to do school work Patient ate and drank normally saturday night patient has period currently- normal bleeding normal cramping patient on tri lo marzia BC and on spirnolactone for acne Of note patient does report hx of syncope in the am 1 year ago- never seeked treatment it was non recurrant Patient also states that a couple times a week she wakes up feeling dizzy- last about < 1 min and goes away.
20 2021-04-14 chest pain sharp Left-sided CP x 2 days with HA after receiving J&J vaccine yesterday; denies any radiation; re... Read more
sharp Left-sided CP x 2 days with HA after receiving J&J vaccine yesterday; denies any radiation; reports nothing makes worse or better; continuous
20 2021-04-14 loss of consciousness Nurse administered vaccine, within 1-2 mins the patient became drowsy, drooping head forward, closin... Read more
Nurse administered vaccine, within 1-2 mins the patient became drowsy, drooping head forward, closing eyes, and slurring speech. Patient lost consciousness and slumped into chair, EMS on site, administered IV fluids and transported to hospital.
20 2021-04-15 chest discomfort, chest pain Janssen Covid 19 Vaccine clinic held at(Onsite Employer Services)Lot # 1808980 exp. 6/20/2021 As re... Read more
Janssen Covid 19 Vaccine clinic held at(Onsite Employer Services)Lot # 1808980 exp. 6/20/2021 As reported on Episode Note: Client returned to vaccination area c/o lightheadedness, dizzy, warm, chest discomfort. BP 114/74, HR 80 C/o centralized chest pain, pain level 5/10, sharp stabbing pain. "Feels like I swallowed water and it's stuck." Pain began when she walked down from the observation area. 1154- approximate time EMS called d/t continuing chest pain. 1156 BP 122/68, HR 84. continued dizziness, increasing fatigue. Applied ice pace to nape of neck. After ice pack applied, client c/o numbness/tingling of Right arm. Ice pack removed. 1158 Patient requested RN call father. Father notified of client status per client request. 1207 Reports feeling chilled, continued chest pain and fatigue. EMS arrived. Vital and 12 lead EKG completed by EMS. Patient denied transportation to hospital. 1215 EMS left. Patient requested RN to notify father to pick her up from employers. HR met with client to complete incident report. 1219 Father contacted to pick up patient. Client voluntarily walked to main entrance of building with HR contact.
20 2021-04-15 chest discomfort Johnson and johnson covid-19 vaccine eau March 20th - allergic reaction to covid vaccine Johnson & ... Read more
Johnson and johnson covid-19 vaccine eau March 20th - allergic reaction to covid vaccine Johnson & Johnson. Allergic reaction started approximately 2 minutes after receiving shot. It started with itching and redness on my arms and upper chest. After approximately 10 minutes, I knew something was wrong and I signaled an attendant. They immediately brought me over to the EMTs on site, where they looks me over and started drawing up IV Benadryl. In the time it took for them to draw up IV Benadryl and insert the IV, the hives on my chest started to turn into burning and ice sensations intermittently. As soon as they administered the IV Benadryl, the itching redness and hives on my arms went away within a couple minutes, and I was left with only redness on my upper chest. They felt comfortable with me getting a ride to the ER from my dad and not getting emergency transport. At the ER, they gave me pepcid and prednisone. About an hour and a half later, I started developing chest tightness and hives and redness on the side of my face. They decided to administer more Benadryl and start epinephrine. I was discharged a couple hours later. March 22nd - I went back to the hospital, with complaints of severe stomach pain. The stomach pain lasted approximately 24 hours. March 20th to march 26th - I experienced extreme fatigue. I was exhausted to the point where on Wednesday I took a ten minute shower and by the end of it I had to lay down again because I was shaking from exhaustion. Symptoms improved slightly until April 5th where it started taking a turn for the worse. April 5th - I started noticing black spots in my vision that wouldn't go away. They didn't move and they stayed in one spot for hours until I fell asleep and then they'd be gone the next morning. They usually started around 8:00 or 9:00 at night. Sometimes a couple hours earlier. They came every day until Friday April 9th when they did not come. April 5th to present - I also started noticing light-headedness, motion sickness when I stood still or sat in a chair, nausea, neck pain, and periods of muscle weakness in the neck. These symptoms have not stopped. Friday April 9th around 6:45 p.m. I started having a bad migraine, I noticed in the bathroom at work my eyes were dilating over and over and over again rapidly. The pain was very high. I ended up leaving work early and going to the emergency room. While at the emergency room they treated my migraine with a cocktail of Benadryl, toradol, and compazine. It reduced the pain at the time, however it did not take away the migraine. Friday April 9th to present - My migraine has continued from April 9th and is still happening. I have been having severe light sensitivity, sound sensitivity, and trouble reading. The rapid dilation of my eyes stopped April 10th, however my eyes stayed dilated until April 12th. In addition to all of my other symptoms, there are others that I am not as positive are relevant. I have asthma and it has been worse over the past couple of weeks, it it is not usually worse this time of year. I've been also been having quite a bit more light bruising than normal over the past two weeks and over the past one and a half weeks I have noticed red spots all over my skin. I was not sure if these red spots were normal or not because I do have them on occasion however these are darker than normal.
20 2021-04-15 chest pain Symptoms began evening after receiving vaccine. Patient reports headache which progressed into the n... Read more
Symptoms began evening after receiving vaccine. Patient reports headache which progressed into the next day to fever, fatigue, intense chills, chest pain. Patient had these symptoms over 2-3 days and had began to experience arm tingling in arm where vaccine was administered, which then spread to both arms. Patient reports arm tingling will come and go. Patient reports taking OTC medication (ibuprofen). Patient called a nursing line and was told to go to the ER. Patient went to ER on 4/14 and was admitted for observation. Chest X-ray was done with no remarkable findings. According to patient, additional testing was done. Patient was discharged on 4/15 and was told to return if arm tingling returns and does not go away.
20 2021-04-18 chest pain Nausea, vomiting, severe headaches, chest pain, SOB (only occuring at night), slight leg pain, and u... Read more
Nausea, vomiting, severe headaches, chest pain, SOB (only occuring at night), slight leg pain, and upper back pain
20 2021-04-18 lightheadedness At 11:20am the nurse, was called into vaccination room for near syncope. Patient was lying down with... Read more
At 11:20am the nurse, was called into vaccination room for near syncope. Patient was lying down with the assitance of two vaccinators. She was alert and oriented x3. She reported feeling lightheaded and was moved to a chair, then a wheelchair. She was transferred to the observation room on the second floor of the clinic. VS were obtained and the care was handed over to another nurse. Patient was given gatorade, applesauce and resting comfortably for observation. At 11:30am denies injury or loss of consiousness. Stated she had nothing to eat or drink prior to vaccine appointment. She denies history of syncope.
20 2021-04-20 chest pain HISTORY OF PRESENT ILLNESS: 21 yo F p/w midsternal chest burning since 2200 last night. Acute, sharp... Read more
HISTORY OF PRESENT ILLNESS: 21 yo F p/w midsternal chest burning since 2200 last night. Acute, sharp/burning, constant, mild. No similar prior pain. Reports associated subjective dyspnea. Denies fever, chills, nausea, vomiting, syncope, palpitations, back pain, abdominal pain, weakness/numbness. Patient states she received the J&J COVID vaccine 3 days ago, and had chills, fatigue and body aches that resolved the following day. She has since been asymptomatic.
20 2021-04-20 platelet count decreased, chest pain myalgias, sharp left sided chest pain, shortness of breath. Chest pain is worse with deep breathing... Read more
myalgias, sharp left sided chest pain, shortness of breath. Chest pain is worse with deep breathing. Patient is treated with normal saline fluids.
20 2021-04-21 pallor, heart rate increased Pt was anxious prior to the vaccine administration; became dizzy, pale ,clammy, weakness. Evaluated ... Read more
Pt was anxious prior to the vaccine administration; became dizzy, pale ,clammy, weakness. Evaluated by paramedic, HR increased to 134, no shortness of breath or tingling/numbness noted. Paramedic called, patient declined, called brother to take her to her apartment, agreed to keep an eye on her.
20 2021-04-21 increased heart rate, heart rate increased Patient called to report her reaction today to the county vaccination effort and ask for a copy of h... Read more
Patient called to report her reaction today to the county vaccination effort and ask for a copy of her consent. Patient stated that 4 hours after vaccine administration, she experienced headache, fever, chills, rapid heart rate, and shortness of breath. After 30 minutes of symptom onset, she presented at local emergency room and was admitted with sinus tachycardia. Patient was discharged the following morning. She states she followed up yesterday with her PCP, states she has some lingering hip and back pain, but original symptoms have resolved.
20 2021-04-25 chest pain severe fatigue, headache, chills, body aches. low grade fever, hot flashes, sweating, chest pains, s... Read more
severe fatigue, headache, chills, body aches. low grade fever, hot flashes, sweating, chest pains, shortness of breath, sore throat, stomach pains, congestion
20 2021-04-28 fainting patient was administered vaccine as per EUA/standin order. Approx 30 seconds after the vaccine was ... Read more
patient was administered vaccine as per EUA/standin order. Approx 30 seconds after the vaccine was injected, the patient who was seated,stated she didnt feel well, fainted and slumped forward in chair. RPH who administered shot was able to catch her, keep her from further injury. Approx 10 seconds later, she came to and was disoriented. RPH explained where she wasand what had occured. She complained of nausea, feeling hot and sweaty and numbness in fingers. 911 was called, and while waiting for EMTs to arrive she stated that she had had some similar reaction during a previous blood draw. EMT arrived and transported her to local ER
20 2021-04-29 fainting Patient became very dizzy and fainted.
20 2021-04-29 fainting Patient fainted less than 30 seconds after administration.
20 2021-04-29 fast heart rate, hypotension, hypertension Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Additional Details: Loss of hearing for a few minutes. EMTs came to store monitored pt and BP for additional 15-20 mins. BP increased to over 100. PT had water, crackers and chocolate. Pt felt fine and refused to be taken by ambulance but had a friend pick her up. I explained situation to friend and pt was told to take it easy for the rest of the day.
20 2021-04-30 chest pain Persistent headaches, shortness of breathe, body aches, fatigue, sharp chest pain
20 2021-05-02 chest pain Chest pain immediately after receiving the vaccine described as a 6/10 on pain scale. (10 being the ... Read more
Chest pain immediately after receiving the vaccine described as a 6/10 on pain scale. (10 being the highest) Patient also reported her arm feeling numb after receiving the dose.
20 2021-05-04 loss of consciousness Patient stated that approximately 6 hours after receiving vaccination she became dizzy, developed a ... Read more
Patient stated that approximately 6 hours after receiving vaccination she became dizzy, developed a high fever, and was sweating. She then proceeded to pass out.
20 2021-05-04 fainting Dizziness and quickened breath after injection and then fainted about a minute or so after injection
20 2021-05-05 pallor Patient complaints of dizziness. Per pt, last meal was 6 am ( over 9 hours ago) Patient noted to be ... Read more
Patient complaints of dizziness. Per pt, last meal was 6 am ( over 9 hours ago) Patient noted to be pale and diaphoretic. Legs elevated. EMS evaluated. Vital signs obtained. HR noted to be in 40-50s. Patient provided powerade. Patient drank powerade. After drinking powerade, patient stated that she is feeling better. Vitals signs within normal limits.
20 2021-05-06 hypertension, heart rate increased Patient felt faint, headache, arm/throat/tongue became numb, blurry vision, felt cold, feel tired a... Read more
Patient felt faint, headache, arm/throat/tongue became numb, blurry vision, felt cold, feel tired and nausea. Patient BP and HR was initially high, lied patient on ground with legs elevated and cold pack and patient eventually felt better and BP and HR eventually normalized. Patient had already eaten prior to coming in.
20 2021-05-09 loss of consciousness Patient passed out and body started to shake. within less than a minute patient regain consciousness... Read more
Patient passed out and body started to shake. within less than a minute patient regain consciousness.
20 2021-05-12 hypotension, loss of consciousness, fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: immunization given on 5/12/2021 at pharmacy at approximately 5:25p. about 3 minutes later patienst complained of lightheadedness and black spots covereing her vision. in an attempt to help her lie down, when patienst was reposistioning, she went limp and passed out for a few seconds. vitals were checked by rph. 911 was called. patienst was cleared and went home on her own record. patienst has driver friend
20 2021-05-13 chest discomfort Chills, Fever, Dizzy, Chest Tightness
20 2021-05-14 loss of consciousness patient described feeling unwell about 30 seconds after administration while reviewing recommendatio... Read more
patient described feeling unwell about 30 seconds after administration while reviewing recommendation to stay near the pharmacy for 15 minutes. She lost consciousness and fell out of chair. I caught her and lowered her to the ground, contacted store management and helped monitor her for about 30-45 minutes. The patient felt well, confirmed she felt safe walking, and called a family member to drive her home.
20 2021-05-16 pallor After patient received Vaccine she started immediately to look very pale and stated she was not fee... Read more
After patient received Vaccine she started immediately to look very pale and stated she was not feeling well. Patient reported feeling numbness in her right arm and radiating to her left arm . Patient given oxygen via nasal canula , vital sign taken and offered orange juice to drink. patient stated has no breathing concerns or chest tighten. She continued to complain of numbness to both arms and now radiating to her face. patient also displayed cramping of both her hands. Ambulance notified and patient transported to local hospital. Patient was orientate, responsive and alert .
20 2021-05-16 fainting patient fainted. smelling salts used, cold pack to neck area and pt put in lying position with feet ... Read more
patient fainted. smelling salts used, cold pack to neck area and pt put in lying position with feet up
20 2021-05-17 fainting Patient fainted after getting the vaccine; she woke up and stated she was fine. Called EMS and they ... Read more
Patient fainted after getting the vaccine; she woke up and stated she was fine. Called EMS and they spoke to her but she did not want them to come . Followed up with patient next day and she stated she was fine as well
20 2021-05-19 fainting, lightheadedness, loss of consciousness Patient had a vasovagal response and fainted a few minutes after her injection. She was unconscious... Read more
Patient had a vasovagal response and fainted a few minutes after her injection. She was unconscious, not breathing for a few seconds as her head fell to her chest, but resumed breathing when we opened her airways. Her body seized upon taking in air and 911 was called. She regained consciousness before the paramedics arrived and her vitals were within normal limits when they checked her. Pt went home on her own with mom.
20 2021-05-23 fainting Patient did not disclose she is prone to fainting after getting shots/blood drawn. 3-5 minutes afte... Read more
Patient did not disclose she is prone to fainting after getting shots/blood drawn. 3-5 minutes after getting Janssen vaccine patient fainted in one of our aisles. We had her sit down. We gave her some water, kiwi strawberry, and a tootsie lollipop. We monitored her for 15-20 minutes, then her mother took her out to parking lot. We asked if they needed anything else while at our store, and just re-iterated that she is okay and is prone to fainting after any kind of shots/blood drawn.
20 2021-05-23 fainting PATIENT GOT THE SHOT & COMPLAINED OF FEELING DIZZY. HER MOM WAS WITH HER. SHE WAS PROVIDED WITH WAT... Read more
PATIENT GOT THE SHOT & COMPLAINED OF FEELING DIZZY. HER MOM WAS WITH HER. SHE WAS PROVIDED WITH WATER & FELT OK. SHE SAID SHE GAVE HER EXAM AND CAME TO GET SHOT, DID NOT EAT OR DRINK. THEN SHE FAINTED FOR SECONDS. WE CALLED 911 & AMBULANCE. SHE WAS CONSCIOUS AGAIN, SAID SHE IS FEELING BETTER. THEN AFTER 2 MIN FAINTED AGAIN. WAS BREATHING OK. AMBULANCE ARRIVED AND SHE WAS CONSCIOUS AGAIN. SHE FELT BETTER AS SHE DRANK WATER. SHE WAS OFFERED TO GO TO HOSPITAL IN AMBULANCE BUT PREFERRED TO GO TO HOSPITAL WITH HER MOM IN CAR. SHE SAID SHE WAS FEELING MUCH BETTER WHEN SHE LEFT. RECOMMENDED TO KEEP HER HYDRATED AND GIVE ELECTROLYTES AND WATER
20 2021-05-23 fainting Brief syncopal episode occurred after vaccine. Vomited x 1.
20 2021-05-24 loss of consciousness patient felt lightheaded and then passed out. She also felt a little naseuous. Patient was laid down... Read more
patient felt lightheaded and then passed out. She also felt a little naseuous. Patient was laid down in supine position with feet elevated and given ice packs. Patient threw up and after 30 minutes felt better and left
20 2021-05-24 fainting Syncopal episode within 10 days of receiving vaccine with residual sharp headache. Followed by devel... Read more
Syncopal episode within 10 days of receiving vaccine with residual sharp headache. Followed by development of abdominal pain.
20 2021-05-25 loss of consciousness, fainting She had a syncopal episode 10 minutes into vaccine administration. Reported history of syncopal epis... Read more
She had a syncopal episode 10 minutes into vaccine administration. Reported history of syncopal episodes with injections. Vital signs checked and stable. She was passed out for approximately 2 minutes, woke up and was not post-ictal. 911 was called and medics came in to check on patient. She was stable. Refused and signed AMA form for hospital transport. We observed her for approximately 30 minutes and made full recovery. Left in stable condition, asymptomatic.
20 2021-05-25 fainting Patient received Janssen covid19 vaccine, she was sitting in post-vaccination waiting area, when she... Read more
Patient received Janssen covid19 vaccine, she was sitting in post-vaccination waiting area, when she became little headed. Patient closed her eyes and slumped over in chair and fainted. We brought patient to the floor and she came to. Patient stated this commonly happens after vaccines or giving blood as she has anxiety of both. She also stated she did not eat anything all day. Patient was given ice pack and remained in post vaccination waiting area for 30 minutes. Patient stated she felt fine shortly after laying down on the floor.
20 2021-05-27 loss of consciousness At 15 minutes past vaccination patient is crying. When asked if she is ok, she doesn't speak just ke... Read more
At 15 minutes past vaccination patient is crying. When asked if she is ok, she doesn't speak just keeps crying. Then her eyes roll back in her head and she proceeds to pass out. She comes in and out repeating this process for 5-10 minutes. Patient is non verbal during event. Once Patient came to, she knew her name, year, and president but did not know what day it was.
20 2021-05-31 loss of consciousness, pallor, skin turning blue approximately two minutes after administration of vaccination patient had sat down in waiting area a... Read more
approximately two minutes after administration of vaccination patient had sat down in waiting area and became lethargic/dizzy/blurred vision. She had passed out with face pale and lips turning blue, minimally responsive. Called 911 and while awaiting for ambulance patient had recovered from all symptoms with the exception of "spotted visions." Observed patient for over an hour while a family member came and upon the time of departure there was resolution of all adverse events.
20 2021-06-05 loss of consciousness Immediately after the vaccine was administered, the patient stated that she felt sick and light head... Read more
Immediately after the vaccine was administered, the patient stated that she felt sick and light headed. I instructed her to remove her mask, place her head between her legs and take some deep breaths. Before she had completely bent over she lost consciousness and began seizing. She remained in the chair for the duration of the event and until the paramedics took her out of the pharmacy. I made sure she did not injure herself or fall out of the chair and when the event was over I called ED. I continued to monitor the patient until she was taken by paramedics.
20 2021-06-06 pallor, loss of consciousness patient was seated when received vaccine. she was led to main waiting area to wait for observation.... Read more
patient was seated when received vaccine. she was led to main waiting area to wait for observation. about 5 to 10 min after the shot patient was seated and began to pass out. she came to after a few min and put into lying down position with feet up. appearance was and clammy skin. 911 was called. her blood pressure was normal. heart rate normal. 911 call- based on my answers to their questions they decided to come to the pharmacy. patient stated that she did not have much to eat and that she has passed out from a nose piercing in the past. her color came back by the time she left. ems checked her out. she signed a form stating that she did not want taken to hospital.
20 2021-06-06 fainting patient experienced syncope, fainted 5 minutes after recieving vaccinefor 1 minute then came back co... Read more
patient experienced syncope, fainted 5 minutes after recieving vaccinefor 1 minute then came back conscious
20 2021-06-07 heart rate increased FAST HEART RATE; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 20 ... Read more
FAST HEART RATE; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 20 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 02-JUN-2021 09:15 am for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced fast heart rate. On 02-JUN-2021, the subject experienced shortness of breath. Laboratory data included: Heart rate (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heart rate, and shortness of breath. This report was non-serious.
20 2021-06-08 chest pain Anaphylaxis as a result of COVID-19 vaccination. Chest pain, chest burning, swollen tongue, nausea, ... Read more
Anaphylaxis as a result of COVID-19 vaccination. Chest pain, chest burning, swollen tongue, nausea, dizziness, lightheadedness.
20 2021-06-17 cerebral haemorrhage, brain sinus blood clot 6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for... Read more
6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for migraine headache and nausea. She was giving medication for pain and vomiting. Slept until the next day. Felt somewhat better the next day and continued meds. She went to work on 6/3 and towards the end of her shift she told her boss about the severe headache and sat in her car outside and then became unresponsive. The paramedics were called and she was transferred to the hospital and diagnosed with a brain blood clot and brain bleeding. She was flow by air car to another hospital and admitted to ICU. She was in Neurology ICU until 6/6, and then transferred to a normal neurology bed and released on 6/11. Diagnosis of left venous sinus thrombosis and hemorrhage in the left temporal lobe.
20 2021-06-19 fainting AFTER GETTING SHOT , PATIENT WAS WAITING FOR 15 MINUTES. PATIENT FAINTED AND FELL ON FACE . CALLED 9... Read more
AFTER GETTING SHOT , PATIENT WAS WAITING FOR 15 MINUTES. PATIENT FAINTED AND FELL ON FACE . CALLED 911 AND AMBULNACE CAME OVER, SHE WAS AWAKE AND RESPONDING. NEXT DAY ON DUTY RPH CALLED BOYFRIEND ( HE WAS WITH HER ON 06/19/20 VACCINATION TIME) AND FOUND OUT THAT SHE HAD ANXIETY FROM VACCINE
20 2021-06-20 pallor PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patien... Read more
PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 16-JUN-2021, the subject experienced pale. On 16-JUN-2021, the subject experienced sweats. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced pounding headache. On 16-JUN-2021, the subject experienced sick stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pale, fever, sweats, pounding headache and sick stomach was not reported. This report was non-serious.
20 2021-07-11 heart rate increased RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerne... Read more
RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
20 2021-07-15 chest pain Chest pain in left upper chest described as sharp, shortness of breath, myalgias.
20 2021-07-15 pallor, loss of consciousness Patient felt dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for ... Read more
Patient felt dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for about 30 seconds in the vaccination chair. Vitals were taken. BP was 90/55. EMS was called
20 2021-07-16 loss of consciousness PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF T... Read more
PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF THE NECK UP TO THE SKULL; WHOLE BODY BURNING; LEFT ARM NUMB; LEFT ARM PAIN; PAIN ON THE LEFT SHOULDER BLADE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient reported that the patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 14-MAY-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient experienced left arm completely numb and painful where she got the shot, pain on the left shoulder blade, her whole body was burning. The patient also experienced surges of heat throughout the whole body, the heat started attacking the heart of the patient. Then the patient started experiencing pain in the back of the neck up to the skull. On the same day, the patient passed out and went to the hospital however, they could not find anything and advised that it was basically from the shot. The patient was discharged from the hospital after five hours. All of those symptoms lasted for three weeks and then everything resolved. As of 14-Jul-2021, the patient still had random pain and numbness in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, surges of heat throughout the whole body/heat attacking the heart, pain in the back of the neck up to the skull, and whole body burning on JUN-2021, and had not recovered from left arm pain, pain on the left shoulder blade, and left arm numb. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730970 - covid-19 vaccine ad26.cov2.s -Passed out- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
20 2021-07-20 chest pain MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent con... Read more
MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A 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 pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.
20 2021-07-22 palpitations, chest pain, hypotension Heart rate 160+ beats per minute, chest pain, heart palpitations, low blood pressure, dizziness, sh... Read more
Heart rate 160+ beats per minute, chest pain, heart palpitations, low blood pressure, dizziness, shortness of breath, dehydration, migraines, hallucinations, COVID-like symptoms, chills, muscle spasms, fever of over 103 degrees Fahrenheit, vomiting, diarrhea, POTS. I have gone to the ER 5 times since the date I received the vaccine on April 6, 2021. Symptoms are ongoing. I have been referred to and seen by a cardiologist, gastroenterologist, and mental health practitioners as a result.
20 2021-07-24 loss of consciousness, palpitations From about 4:00 p.m. until about 10:00 p.m., Patient had a headache, extreme chills, and a fever. Fr... Read more
From about 4:00 p.m. until about 10:00 p.m., Patient had a headache, extreme chills, and a fever. From about 11:00 p.m. until 5:00 a.m., with varying intensity where she was able to sleep for an hour or so and then get woken up by the symptoms, she had at least a 103.5 degree fever, intense chills that caused her body to aggressively shake, excruciating pain throughout every part of her body that caused her to cry out in pain (she said it hurt more than anything she has ever felt), an intense migraine that was so bad it felt like her head was splitting open and her eyes torn out, shortness of breath and hyperventilating that caused her to repeatedly black out and weave in and out of consciousness, and extreme weakness to the point she could not move at all. She also said her muscles were aching and cramping and that her heart was pounding so hard it felt like it was hitting her rib cage. She wanted to call 911 because she didn't know how much longer she could hold on to consciousness, but was too weak to grab the phone, and her calls for help were weak and indecipherable. (Also, only her sister was home at the time, and she went to bed with earplugs in and couldn't hear patient.) From 5:00 a.m. to 7:00 a.m. many symptoms subsided, but there was still an agonizing pain in her kidneys (or adrenal glands?) that pulsed through her whole body. At 7:00 a.m. she woke up, and all the symptoms were gone, except for the area around her heart feeling strained. Two days later she called the nurse hotline and took ibuprofen as directed. The area around her heart gradually improved and seemed fine about two weeks later. Patient thinks she may have had Covid over a year ago because she remembers losing smell and having some chest pain that, for a couple of months, prevented her from exercising as she usually did. However, she never got tested because her symptoms were very mild. For her, getting Covid was a much better and less life-threatening experience than getting the Covid vaccine.
21 2021-03-08 lightheadedness, loss of consciousness 4 hours after vaccine I experienced vasovagal (passed out), for the rest of the day after I experien... Read more
4 hours after vaccine I experienced vasovagal (passed out), for the rest of the day after I experienced fever, chills, fatigue, body aches
21 2021-03-09 heart rate increased, oxygen saturation decreased Janssen COVID-19 Vaccine EUA day after had fever that went to 103, extreme fatigue and nausea, oxyge... Read more
Janssen COVID-19 Vaccine EUA day after had fever that went to 103, extreme fatigue and nausea, oxygen went down to 91 briefly, and heart rate in the 150s while resting.
21 2021-03-11 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt fainted wile seated. emergency services were called. she recovered quickly. we gave some candy and water. her bp was normal and osat was normal. mother drove her home
21 2021-03-12 hypotension, pallor patient was weak and pale . could not sit . low BP 91/44 HR; 43 . sever arm pain on injection site... Read more
patient was weak and pale . could not sit . low BP 91/44 HR; 43 . sever arm pain on injection site .
21 2021-03-17 chest discomfort 9 hours after the vaccine I had a sudden onset of flu-like symptoms. I had a fairly severe pounding ... Read more
9 hours after the vaccine I had a sudden onset of flu-like symptoms. I had a fairly severe pounding headache, muscle aches, and felt very hot and cold. I was warmer than normal but did not have a full fever. I was extremely fatigued. Most of these symptoms subsided in about 24 hours with acetaminophen. I am still having occasional (every other day) mild headaches and shortness of breath, heaviness in the chest, and a couch that have persisted 5 days so far.
21 2021-03-18 heart rate increased Pt reported to me on 3/18/2021 that a few hours after receiving her Janssen dose she started to have... Read more
Pt reported to me on 3/18/2021 that a few hours after receiving her Janssen dose she started to have a heart rate of 122 bpm at rest and 144 with exertion that lasted for 2.5 days. (Day 0, 1 and 2). She reported she had severe muscle aches and difficulty breathing. She did not seek medical care and her symptoms were resolved when she called me on March 18th. I instructed her to get medical care if her symptoms began again.
21 2021-03-19 fainting Patient had syncopal episode and vomiting within a couple of minutes after receiving COVID vaccine.
21 2021-03-22 pallor Client reported as being anxious about the vaccine and was pale, nauseous and light headed. 02 Satu... Read more
Client reported as being anxious about the vaccine and was pale, nauseous and light headed. 02 Saturation was 98% Pulse 91 and blood pressure 118/77. Client was released after being monitored by EMS and Dr. Advised to seek medical attention later if needed and verbalized understanding.
21 2021-03-24 chest pain Immediately after injection: dizziness, nausea, light headedness, temporary loss of hearing, blurre... Read more
Immediately after injection: dizziness, nausea, light headedness, temporary loss of hearing, blurred vision, abdominal cramps, fever. 1+ Hour after injection: severe abdominal cramps, nausea, severe headache (severe pain behind eyes specially when eyes were open), chest pains, upper back pain, pain in all joints (primarily hips), muscle aches over whole body, fatigue, chills, fever, trouble breathing, light headedness Morning After Injection: full body ache, severe fatigue, trouble sleeping, fever, chills, body sweats, slight chest pains, even more severe headache. 24 -36 hours after Injection: reduced muscled aches, fatigue, headache, pain at the sight of injection.
21 2021-03-28 lightheadedness Vasovagal
21 2021-03-31 chest pain At around 10:30pm on the day of the vaccine until I feel asleep after 2:00am, my heart hurt, my whol... Read more
At around 10:30pm on the day of the vaccine until I feel asleep after 2:00am, my heart hurt, my whole body ached, I was so cold my skin was red. My head hurt. I felt like I would pass out. Today, 4/1, I feel better but go from hot to cold and still feel aches with my head hurting earlier.
21 2021-04-01 hypotension SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a pat... Read more
SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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).
21 2021-04-02 loss of consciousness Patient lost consciousness, called 911, administered EpiPen, EMT checked Vitals and Patient refused ... Read more
Patient lost consciousness, called 911, administered EpiPen, EMT checked Vitals and Patient refused to go to the hospital
21 2021-04-04 lightheadedness Near syncope.
21 2021-04-05 heart rate increased Around 9pm was very tired with small headache. Went to bed at 10pm and laid there for an hour and a ... Read more
Around 9pm was very tired with small headache. Went to bed at 10pm and laid there for an hour and a half with my head pounding and burning. I?ve never been able to feel a fever on myself?it was so high. I also had major chills the whole time. I?d get up and hydrate and took 2 Advil around 12:30pm as no sign of sleep was coming. I put ice packs on my hot head for an hour with no relief. Meanwhile my heart rate was steadily above 100 for the whole night until about 4am when my fever went down and I was able to sleep till 7am. I thought I was going to die it was so hot and painful and pounding. In the morning the fever is gone and I am extremely tired. Currently not recommending people get the vaccine.
21 2021-04-05 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after standing up to move to the observation area, she opened her eyes almost immediately after falling to the ground and was responsive, ems was alerted to check and make sure she did not hit her head. ems assessed and patient was stable, refused medical care or transport to the hospital. left with boyfriend (she was not driving herself).
21 2021-04-06 lightheadedness, loss of consciousness History (no PII): HPI: 21 y/o F HX of vasovagal syncopial episode approximately 3 minutes s/p J&J va... Read more
History (no PII): HPI: 21 y/o F HX of vasovagal syncopial episode approximately 3 minutes s/p J&J vaccination. PT was in sitting position and did not sustain a fall or trauma during this time. PT began to lose consciousness and was unresponsive < 10 seconds. Airway, breathing and pulse were intact. Vitals given above. PT was laid down, feet elevated, alcohol swab placed under her nose to assist in revival. PT returned to a responsive state and was aware of place, day and situation. PT was able to reiterate the situation prior to the syncopial episode. PT stated this is something she has experienced in the past. PT denies any other medical issues. PT stated she had not eaten anything at all earlier in the day. Medications administered: None. PT given water and lollipop (sugar) Disposition: Transfer of care to EMS secondary to loss of consciousness < 10 seconds. PT was not transferred to hospital, PT signed AMA. PT had friend pick her up and take her home. PT was A&OX4, gait stable. PT expressed that she was no longer feeling any of the symptoms that she had at the time of the syncopial episode.
21 2021-04-07 skin turning blue, body temperature decreased Patient felt dizziness, shaking and light headed few minutes after getting the shot, forehead was ho... Read more
Patient felt dizziness, shaking and light headed few minutes after getting the shot, forehead was hot to touch but temperature was 97F, upper lip was sweating and hands were turning blue, and patient reported temporary loss of vison, patient was conscious the entire time called 911 and patient was taken to Emergency Room, Patient was later discharged and 4 hours later patient came to the pharmacy to pickup the car and drove home.
21 2021-04-08 chest discomfort Numbness in Left Side of face, so far has persisted for 6 days after the vaccine. Included Left sid... Read more
Numbness in Left Side of face, so far has persisted for 6 days after the vaccine. Included Left side of mouth, left cheek/cheekbone area, and left eyebrow to midline. Felt like there was lidocaine in my face. Dizziness: still getting bouts of dizziness while sitting down and walking, world feels like its spinning Brain Fog: struggling to maintain train of thought, memory problems Fatigued Feels like there is a knot at the base of my throat, feel it when I swallow liquids, does not inhibit swallowing but is a nuisance Fever- lasted for 3 days Chills- lasted for about 24 hours Muscle pain and aching, soreness at injection site, intense shoulder and neck tension is still present but decreasing Headache- 4 days Ventolin Inhaler needed to be taken twice during the worst of the effects, asthma symptoms, specifically coughing and wheezing, have been continuing but decreasing Felt like vaccine exacerbated asthma symptoms Chest tightness, as though someone is sitting on my chest(not one of my usual asthma symptoms)
21 2021-04-08 chest pain Body aches, dizziness, insomnia related to the pain, nausea, weakness, restlessness, headache, injec... Read more
Body aches, dizziness, insomnia related to the pain, nausea, weakness, restlessness, headache, injection site pain, chest pains.
21 2021-04-08 loss of consciousness Dizziness and passed out twice in a matter of 15 minutes. Fatigue day after.
21 2021-04-08 pallor Pt received her dose of Janssen Cover 19 vaccine administered to left arm intramuscularly by RN give... Read more
Pt received her dose of Janssen Cover 19 vaccine administered to left arm intramuscularly by RN given at 06:54 PM. Pt was seated for observation when scribe noticed pt being pale and sweaty. Sribe asked pt how is she, pt stated that she is dizzy , warm and nauseous. Scribe called RN to assess pt. Pt is alert oriented to self, time, date and location. Initial vital signs was taken by RN at 07:00 PM and it was 145/110mmhg, PR 138 ppm, RR20 cpm, Temp 98.1, Oxygen saturation of 99% at room air. RN assisted pt to lay patient down safely. No SOB and chest pain noted. Pt stated feeling better upon laying down for couple of minutes and stated that her dizziness comes and goes. Pt had no allergic reactions to any other vaccination but pt also stated that she has been feeling dizzy couple of times as her history. No history of elevated BP as well was stated by pt. Pt continuous to complain on and off dizziness, NP assess pt and Called 911 for further assistance. Repeat vitals check done by RN BP 135/100 mmhm, PR 81 ppm, RR 20 cpm, oxygen saturation 98% at room air. EMT came at 07:45 PM came assess pt, checked her vitals, pt requested if she could walk and have the EMT assist her to evaluate herself, no complaints of dizziness reported. EMT offered to bring pt to hospital for further evaluation, pt refused to go to hospital. Pt was advised to go to hospital if episode of dizziness happens again. EMT walked the pt to her car and have her sister drive. Pt left facility at 08:00 PM without any complaints. VAERS was filed and education provider RN was reported.
21 2021-04-08 fainting Received vaccine and ambulated over to the observation area where she started feeling dizziness and ... Read more
Received vaccine and ambulated over to the observation area where she started feeling dizziness and nausea and then felt faint prior to fainting. Treated with ondansetron and IV fluids. Was discharged once symptom free and able to tolerate fluids without vomitting.
21 2021-04-09 chest pain Headache started around 7 pm and progressively got worse. Took two Aleve which didn?t help in mitiga... Read more
Headache started around 7 pm and progressively got worse. Took two Aleve which didn?t help in mitigating pain. Chills around the same time, eventually developing a fever around 10. Used ice packs to try and help bring the fever down. Woke up in the middle of the night sweating through my shirt. Dizziness upon standing, leg pain and chest pain.
21 2021-04-09 chest pain CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontan... Read more
CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight was 190 pounds, and height was 158.49 centimeters. The patient's concurrent conditions included smoking, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and has no history of illicit drug abuse and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:30 to left arm for prophylactic vaccination. Non-company suspect drugs included: amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate ( form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication; and drospirenone/ethinylestradiol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced slight fever. On an unspecified date, the subject experienced chills, headache, and injection site soreness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, slight fever, and chest pain, and the outcome of sore arm, headache, chills and injection site soreness was not reported. This report was non-serious.
21 2021-04-09 heart rate increased HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; ... Read more
HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021 01:00, the subject experienced high heart rate. On 01-APR-2021 01:00, the subject experienced congestion. On 01-APR-2021 01:00, the subject experienced body shakes. On 01-APR-2021 01:00, the subject experienced vomiting. On 01-APR-2021 01:00, the subject experienced fever of 102 f. On 01-APR-2021 01:00, the subject experienced muscle aches. On 01-APR-2021 01:00, the subject experienced nausea. On 01-APR-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 102 f, high heart rate, muscle aches, nausea, vomiting, headache, congestion, and body shakes. This report was non-serious.
21 2021-04-09 loss of consciousness Patient briefly slumped over and appeared to pass out shortly after receiving the vaccine. This onl... Read more
Patient briefly slumped over and appeared to pass out shortly after receiving the vaccine. This only lasted about 30 sec to a minute before she became responsive again. Patient reported that this has happened multiple times before when she has received vaccines and was anxious (crying) prior to receiving the vaccine. An initial blood pressure reading was 100/64 at 12:50. She was then able to sit up in the chair and began feeling a little better, asking for water. A second reading five minutes later was 94/54. The patient then chose to drink some water and eat some candy she had brought and this seemed to make her feel better. Lightheadness/weakness was the only symptom she complained of. By 1:03, 15 minutes after the vaccine, she reported "feeing much better." I continued to observe her, seated, for 15 more minutes and a final blood pressure reading at that time was 115/74. Patient reported feeling normal again and went home.
21 2021-04-09 palpitations Shooting headache, fever, chills, racing heartbeat, dizziness.
21 2021-04-10 chest discomfort Started to feel woozy and weak at 5:30pm, headache with sore muscles starting at 6:30pm, went to bed... Read more
Started to feel woozy and weak at 5:30pm, headache with sore muscles starting at 6:30pm, went to bed at 7:30 when couldn?t stand up anymore. At 8:00 chills started, along with a feeling of all my muscles contracting , lost the ability for fine motor control and fell asleep at 9.pm. Woke up at 12:45am covered in sweat feeling as if I was burning with a splitting heavy headache, had fever, don?t know temperature new house so no thermometer but it sucked. dunked head in sink. Legs could barely support me so I couldn?t go down the stairs for pain medication, went back to bed. Got cold washcloth at 1:00am pain felt pretty unbearable, couldn?t make it downstairs or move at this point so I spent night in and out of sleep unable to move. Muscles still feel like rocks and my head feels like it?s stuffed with a mixture of Vaseline and nitroglycerin, every time I move it feels like my brains smashing into my skull with little explosions. Recent development within the last 5-6 hours maybe?(3:00-4:00pm) centralized over my breast bone feels incredibly painful, hurts to breath and feels like something heavy is pressing it through my chest into my spine. Not sure what to do or if this is normal but it hurts really really bad. Accurate hours because I was lucidly texting my friends to make sure I wouldn?t pass out, so I have nearly exact hours when each symptom appeared till I could no longer use my fingers.
21 2021-04-10 chest pain Minutes after shot: felt slightly faint, tingling in feet and fingers, nauseous, sense of taste was ... Read more
Minutes after shot: felt slightly faint, tingling in feet and fingers, nauseous, sense of taste was off. Nausea and altered taste lasted about 3 hours. Insomnia beginning 10 hours after shot. 14 hours after shot: headache, fever 101, pain on left side of chest/spleen area, severe left arm pain, pain in left shoulder and forearm, fatigue, loss of appetite.
21 2021-04-10 heart rate decreased, fainting Patient fainted within a minute of getting the vaccine. She walked to her seat in the observation ar... Read more
Patient fainted within a minute of getting the vaccine. She walked to her seat in the observation area. She was unware she fainted. Her BP was 123/70. She said she felt fine she had scratched her face and hit her head when she fell on the floor. 911 was called immediately. They took her out to the ambulance because her HR was low and she eventually left on her own accord
21 2021-04-10 heart rate increased Dizziness- at 12:59 am on 04/11/21 Fever of 102.7 at 12:50am on 4/11/21 Fast heart beat when getting... Read more
Dizziness- at 12:59 am on 04/11/21 Fever of 102.7 at 12:50am on 4/11/21 Fast heart beat when getting up at about 12am on 4/11/21 Headache at 5pm on 4/10/21
21 2021-04-10 loss of consciousness Fever of 101.3, bad headache, fatigue, mild cough. I passed out briefly the morning after due to th... Read more
Fever of 101.3, bad headache, fatigue, mild cough. I passed out briefly the morning after due to the fever and fatigue.
21 2021-04-10 fainting Syncope following vaccine
21 2021-04-11 lightheadedness Immediately (a minute or two) after receiving the vaccine: lightheadedness, nausea, nearly fainted, ... Read more
Immediately (a minute or two) after receiving the vaccine: lightheadedness, nausea, nearly fainted, vision started going blurry/black, sweating for about 5-10 minutes. Stayed seated until it mostly passed, then went outside for fresh air and to cool down. Put a cold rag on forehead/back of neck for half hour following symptoms. Drank water at soon as possible. For the next 36 hours after receiving the vaccine: sensitive skin, muscle weakness, tiredness, headache, body aches (including the sight of injection), chills, hot flashes. Took Advil every few hours to reduce pain, kept lights off, laid in bed to rest.
21 2021-04-11 fainting Patient had two syncopal events without incident.
21 2021-04-12 skin turning blue PATIENT EXPERIENCED DIZZINESS, FEELING HOT, SCRATHY THROAT, FEELING ITCHIY AND LIPS TURNED BLUE WIT... Read more
PATIENT EXPERIENCED DIZZINESS, FEELING HOT, SCRATHY THROAT, FEELING ITCHIY AND LIPS TURNED BLUE WITHIN 2-3 MINUTES OF ADMINISTRATION. ADMINISTERED EPIPEN. PATIENT FELT BETTER. EMT TOOK PATIENT TO THE HOSPITAL. I CONTACTED THE PATIENT SHE IS OK AND WAS SEND HOME AFTER THE HOSPITAL.
21 2021-04-12 heart rate increased Shortness of breath, rapid heart rate, rapid breathing, dizziness, and weakness
21 2021-04-12 pallor I had the typical soreness about 12 hours after the injection. No worries there. The next morning, o... Read more
I had the typical soreness about 12 hours after the injection. No worries there. The next morning, on the 10th, around 11:40 AM, I started feeling extremely dizzy. The room started spinning. I was standing at the time, and I kept standing, but other than that, I had no control. My hearing starting going fuzzy, starting with ringing in my ears until it sounded like I was underwater. My vision started blurring, as well, eventually going completely black. For a solid 5-10 seconds, I could neither hear clearly nor see at all. I was conscious, because I could think relatively clearly, and I could feel my eyes blinking and could wiggle my fingers, but that was it. Once the episode passed, I immediately sat down. About a minute later, I started having excruciating abdominal pain. The pain was wracking my whole body, causing me to go pale (as I later saw once I could hobble to the bathroom) and making me sweat. After about twenty minutes, the whole thing passed and I was left with minor dizziness and slight nausea. Now, three days later, I still have some of the dizziness, but none of the blindness, deafness, or pain has returned. All other side effects, such as soreness, have completely left.
21 2021-04-12 fainting fainted
21 2021-04-12 fainting Patient fainted and, upon waking, was hot/sweaty and generally felt unwell with several random spell... Read more
Patient fainted and, upon waking, was hot/sweaty and generally felt unwell with several random spells of nausea for about 45 minutes afterwards.
21 2021-04-13 chest discomfort, coughing up blood Chest tightness, dizziness, fatigue, hemoptysis x1, left side head pain, shortness of breath x 7 day... Read more
Chest tightness, dizziness, fatigue, hemoptysis x1, left side head pain, shortness of breath x 7 days.
21 2021-04-13 heart rate increased, fast heart rate I did not receive immediate treatment following the vaccination. This occurred two weeks after my v... Read more
I did not receive immediate treatment following the vaccination. This occurred two weeks after my vaccine. My symptoms, nausea, dizziness, mental fog, severe and 11 out of 10 full body contractions and cramps. My heart rate was fast, tachycardia and trouble breathing. My doctor said that it is allergy symptoms but I did not have any difficulty breathing before my J&J vaccine. I saw Dr. , as well as Dr. and Dr. . I also saw a lead nurse. . I am still having respiratory issues, and pain when breathing and unable to fully respirate. My Sat O2, is 99-100 on average.
21 2021-04-13 hypotension, loss of consciousness Patient passed out and we could not get her to come to. She was taken to the hospital by ambulance.... Read more
Patient passed out and we could not get her to come to. She was taken to the hospital by ambulance. Her blood pressure was very low. She became very weak. She had a horrible and very scary reaction to the vaccine. She was in the hall face down when we found her and we could not get her to wake up. When she did come to, we could not calm her. Patient normally lives by herself and luckily was with us when this happened. We can't imagine what would have happened if she was alone.
21 2021-04-13 pallor, lightheadedness Pt exhibited s/s vasovagal rxn immediately after COVID vaccination. Stated she felt "hot and sweaty"... Read more
Pt exhibited s/s vasovagal rxn immediately after COVID vaccination. Stated she felt "hot and sweaty". Had several emesis and then stated she felt better. Was diaphoretic and pale. BP remained WNL. Denied SOB/dspnea. Pt given water and assisted to supine position on cot. Stated this has happened to her in the past with a blood draw. After about 10 minutes, pt assisted to sitting position and reported s/s resolved. Color had returned and pt less diaphoretic. Pt able to stand without difficulty. Was assisted to waiting area and waited for 30 minute period with 10 extra minutes. Discussed s/s to seek emergency care for. States understanding.
21 2021-04-13 pallor Pt rec'd COVID vaccine and presented to the observation area. Sat for about 5 minute sand flagged st... Read more
Pt rec'd COVID vaccine and presented to the observation area. Sat for about 5 minute sand flagged staff down. Stated she felt "woozy and shaky". Was diaphoretic and pale. Given water. Denied other s/s. State dshe "saw blood after the shot"and became light headed. BP WNL. Drank water and fanned herself. Remained sitting upright and conscious. Denied any other s/s. After about 10 minutes, pt reported s/s resolved. Pt sat for rest of 30 minute observation period without c/o any other s/s. Stated she felt normal. Ambulated from facility without difficulty. Discussed pulling over when driving if feeling return of s/ sand calling emergency services. States understanding.
21 2021-04-13 fainting 4/10 at night - lightheaded, fever, chills, sweating, headaches -- > took Tylenol 4/11 in morning-... Read more
4/10 at night - lightheaded, fever, chills, sweating, headaches -- > took Tylenol 4/11 in morning- fever, headaches, dizziness, severe dehydration, fainting/passing out -- > taken to ER after passing out, treated with saline, other fluids, and rest
21 2021-04-13 fainting Pt with syncope a few minutes after event. Pt laid in recumbent position, recovered, continued obser... Read more
Pt with syncope a few minutes after event. Pt laid in recumbent position, recovered, continued observation with vitals, water, and cool compress. Symptoms resolves after 15-20 mins, discharged home. after 30 mins.
21 2021-04-14 chest discomfort 3 days post vaccine short of breath on exertion and chest tightness
21 2021-04-14 chest pain patient stated that she had symptoms of chest pain starting the night of 04/13/21. and following mo... Read more
patient stated that she had symptoms of chest pain starting the night of 04/13/21. and following morning she felt abdominal pain as well. (patient reported her adverse effects when she called in to request for the duplicate card for vaccination proof and per patient she was going for ER and needed her vaccination proof copy as she was not able to find her vaccination card that was provided at the time of vaccination.)
21 2021-04-14 pallor Patient laid down on floor almost immediately following injection, reportedly pale/dizzy/light-heade... Read more
Patient laid down on floor almost immediately following injection, reportedly pale/dizzy/light-headed. Patient was treated by EMS and was assisted onto gurney and gradually raised head to sitting up. Color returned and patient began feeling better - noted she also experiences syncopal episodes when giving blood. Patient's BP 137/76 immediately following incident, 124/70 at clinic discharge at 2:59pm. No other treatment administered.
21 2021-04-14 palpitations SYMPTOMS PRESENTED: SEIZURES, PALPITATIONS, FEVER, PULSE IN 125-130 FOR SEVERAL HOURS EVEN WHEN I WA... Read more
SYMPTOMS PRESENTED: SEIZURES, PALPITATIONS, FEVER, PULSE IN 125-130 FOR SEVERAL HOURS EVEN WHEN I WAS RESTING, BLOOD PRESSURE 86/66
21 2021-04-15 heart rate increased ELEVATED HEART RATE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 21 ... Read more
ELEVATED HEART RATE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 Expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced elevated heart rate. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.5 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, elevated heart rate, and headache. This report was non-serious.
21 2021-04-17 fainting RPH ADMINISTERED JANSSEN'S COVID-19 VACCINE AT 10 AM AND WITHIN A FEW MINUTES, PATIENT FAINTED AND S... Read more
RPH ADMINISTERED JANSSEN'S COVID-19 VACCINE AT 10 AM AND WITHIN A FEW MINUTES, PATIENT FAINTED AND SLIPPED OFF HER CHAIR TO THE FLOOR. PATIENT CAME TO WITHIN A MINUTE AND RPH HELPED HER TO THE CHAIR, OFFERED HER WATER AND A BANANA, AND THE PATIENT DID NOT SEEM HURT. RPH MONITORED THE PATIENT'S BLLOD PRESSURE AND COLORING/ SWEATING FOR 30 MINUTES BEFORE SHE LEFT THE PHARMACY AND HER FATHER DROVE HER HOME.
21 2021-04-18 chest pain she hurts in her body, nausea, headache. No cough, no SOB, c/o chest pain on inspiration intermitten... Read more
she hurts in her body, nausea, headache. No cough, no SOB, c/o chest pain on inspiration intermittently, more a sharp pain near the center just above the breastbone, not a squeezing or a pressure substernal Took some APAP and took alleve 20 min ago I adv that the body aches, N, HA all may be consistent with ADR to the vaccine and generally should be limited to a few days, ok to take OTC pain relievers but not in excess to bottle recommendations. Keep hydrated. Consider a hot pack. Watch the chest pain if this persists or worsens, consider HCF evaluation, though given the body pain throughout and location of the pain may be muscular.
21 2021-04-19 chest pain, chest discomfort Onset allergy type symptoms 4/5/21 worsening of symptoms chest soreness and tightness in chest after... Read more
Onset allergy type symptoms 4/5/21 worsening of symptoms chest soreness and tightness in chest after COVID19 J and J Vaccine on 04/09/21. Patient presented in our office with concerns.
21 2021-04-19 palpitations, heart rate increased HEADACHE; ELEVATED HEART RATE; POUNDING HEART; This spontaneous report received from a patient conce... Read more
HEADACHE; ELEVATED HEART RATE; POUNDING HEART; This spontaneous report received from a patient concerned a 21 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced elevated heart rate. On 13-APR-2021, the subject experienced heart pounding hard. Laboratory data included: Heart rate (NR: not provided) Elevated. On 15-APR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated heart rate, heart pounding hard, and mild headache. This report was non-serious.
21 2021-04-20 deep vein blood clot Acute deep vein thrombosis (DVT) of right peroneal vein
21 2021-04-21 palpitations SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontane... Read more
SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky 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.
21 2021-04-22 chest pain 4/17 Chest pain when she takes deep breath that spreads to her left arm 4/20-Follow up call second a... Read more
4/17 Chest pain when she takes deep breath that spreads to her left arm 4/20-Follow up call second attempt - Voicemail not set up yet; unable to leave a message.
21 2021-04-22 deep vein blood clot Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlu... Read more
Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlusive DVT of the left posterior tibial vein.
21 2021-04-22 fainting Upon receiving the vaccine, I immediately fainted (vasovagal syncope). I was unconscious for ~15-20 ... Read more
Upon receiving the vaccine, I immediately fainted (vasovagal syncope). I was unconscious for ~15-20 seconds. My apartment-mate who came with me for the shot laid me down on the floor until I could sit up again without feeling dizzy (~15 min). I also had pretty serious bruising at the injection site for ~9 days following the injection and my arm was swollen and painful (although this is a pretty normal side-effect).
21 2021-04-24 chest discomfort, chest pain chest tightness the last 6 weeks which started on 3/14/21 after receiving J&J COVID Vaccine (she rec... Read more
chest tightness the last 6 weeks which started on 3/14/21 after receiving J&J COVID Vaccine (she received on 3/8., chest pain, tightness in character, noted to be intermittent, positional, occurring mostly at night, associated with some shortness of breath, episodes would last for about one hour in duration, then resolve spontaneously resolve. No associated fevers or chills.
21 2021-04-27 chest pain, loss of consciousness Passed out for a few minutes. Chest pains 2 weeks later.
21 2021-04-28 palpitations Yesterday pt reported sore arm, swollen/red arm, body aches, fever (102F), headache, difficulty swal... Read more
Yesterday pt reported sore arm, swollen/red arm, body aches, fever (102F), headache, difficulty swallowing, palpitations, shortness of breath, gets winded walking around. This was when she spoke to triage nurse. Advised to go to Urgent Care or ED and follow up with PCP Dr.
21 2021-04-28 palpitations nausea heart palpitations fever
21 2021-04-30 fainting Janssen-Covid19-EUA Incident # 2021-033543 The client was sitting in the passenger seat after being... Read more
Janssen-Covid19-EUA Incident # 2021-033543 The client was sitting in the passenger seat after being vaccinate and had a witnessed syncopal episode. She was immediately assessed and felt better after being assessed and refused transport. The client signed out AMA. See PCR for further.
21 2021-05-02 fainting Patient had syncopal episode with left-sided headache and left-sided heaviness on 5/3/2021.
21 2021-05-03 fainting Patient received JJ COVID 19 vaccine and had a syncopal episode 2-3 minutes later that lasted for 2... Read more
Patient received JJ COVID 19 vaccine and had a syncopal episode 2-3 minutes later that lasted for 2-3 seconds. She complained of pain back of head and was given ice pack. There was no visible or palpable injury. She was brought to medical; observation area, VSS. She was monitored for 35 minutes and left ambulatory and asymptomatic with a friend.
21 2021-05-04 hypotension, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: light headed started to fall sweating called 911 paramedics took to hospital as blood pressure too long could not leave her
21 2021-05-07 fainting Patient fainted and hit her head on the floor. Once she came to she stated that she does faint some... Read more
Patient fainted and hit her head on the floor. Once she came to she stated that she does faint sometimes after a vaccine. We called 911 and the ambulance responded and transported her to the hospital. I spoke with patient later in the day and she stated that she was feeling fine.
21 2021-05-10 fainting patient fainted twice
21 2021-05-11 blood clot For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and... Read more
For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and it hurt to look up. Ten days after the vaccine I was in the shower and a large blood clot came out of my nose. It was a large clot about the size of a quarter and there was no other blood with it. The clot came out of my left nostril but it was not like a nose bleed. I went to the Urgent Care but they did not do tests.
21 2021-05-15 loss of consciousness, fainting Syncope ,temporary loss consciousness for less than 1 minute I think was so short.
21 2021-05-16 fainting, lightheadedness Pt with syncope, vasovagal reaction immediately after injection. LOC x 3-5 seconds, no injury. Obs... Read more
Pt with syncope, vasovagal reaction immediately after injection. LOC x 3-5 seconds, no injury. Observed for 30 minutes, BP improved with oral hydration and recumbent rest. Released to homecare.
21 2021-05-18 loss of consciousness Pt passed out after receiving vaccine. Patient had gone to the restroom post vaccine and passed out... Read more
Pt passed out after receiving vaccine. Patient had gone to the restroom post vaccine and passed out. Patient was given two glucose tablets and water. Rested at pharmacy for 30 minutes and was fine.
21 2021-05-18 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: patient fainted and vomiting after receiving vaccine, ambulance was called patient was evaluated and vitals were within normal limits. Patient was contacted 6 hours after event and stated she was feeling much better. patient was observed after vaccine for 1 hour
21 2021-05-19 lightheadedness Vasovagal reaction. Was observed by EMS and her symptoms resolved. She left under her own ambulation... Read more
Vasovagal reaction. Was observed by EMS and her symptoms resolved. She left under her own ambulation and was symptom free.
21 2021-05-21 pallor Patient was light-headed, dizzy, and pale minutes after receiving the vaccine. They also reported di... Read more
Patient was light-headed, dizzy, and pale minutes after receiving the vaccine. They also reported difficulty seeing (their field of vision was all bright light.)
21 2021-05-26 chest pain Patient's mother stated her daughter experienced vomiting, restlessness and burning chest. Side effe... Read more
Patient's mother stated her daughter experienced vomiting, restlessness and burning chest. Side effect concerning them both is the burning chest which has not abated since it began. Recommended patient call primary physician to determine if they need to be seen. Patient's mother reported no difficulty in breathing, just that it "burned"
21 2021-05-26 lightheadedness Patient had a near syncopal episode and nausea after being vaccinated.
21 2021-05-31 deep vein blood clot Patient developed a deep vein thrombosis approximately one month after receipt of vaccine. Of note,... Read more
Patient developed a deep vein thrombosis approximately one month after receipt of vaccine. Of note, was on an oral contraceptive prior to this. No other history of VTE or smoking, or other coagulation disorders in family.
21 2021-06-02 pulmonary embolism Pulmonary embolism on 5/26/21 - tested positive for Covid in emergency room after diagnosing pulmona... Read more
Pulmonary embolism on 5/26/21 - tested positive for Covid in emergency room after diagnosing pulmonary embolism. No symptoms of Covid until lung pain from embolism began. Hospitalized for 3 days treating PE and prescribed blood thinners for at least 6 months to prevent potential reoccurrence.
21 2021-06-03 fainting FAINTED AFTER VACCINATION BECAUSE WAS ANXIOUS; THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY, T... Read more
FAINTED AFTER VACCINATION BECAUSE WAS ANXIOUS; THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY, THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION.; POOR QUALITY VACCINE ADMINISTERED; ANXIOUS; This spontaneous report received from a pharmacist concerned a 21-year-old female patient of unspecified race and ethnic origin. The patient's height, weight, 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: 1821288, and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the reporter received 20 vials of the JANSSEN COVID-19 VACCINE which they kept in the freezer (the reporter did not know whether they received the vaccine in a frozen state or at fridge temperature). They took out 2 vials out of the freezer and moved into the fridge on the night of 29-MAY-2021, 1 vial on the night of 30-MAY-2021 and 1 vial on the night of 31-May-2021. On the same day the patient fainted after vaccination because she was anxious, the vaccine was kept in the freezer after delivery, thawed overnight and kept in the fridge till vaccination and poor-quality vaccine administered. On 01-JUN-2021 at 12:30, they took out the rest of the vials. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted after vaccination and anxious, and the outcome of the vaccine was kept in the freezer after delivery, thawed overnight and kept in the fridge till vaccination and poor quality vaccine administered were not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210605104, 20210605028, 20210605010, 20210605009 and 20210604703.; Sender's Comments: V0: 20210605120-COVID-19 VACCINE AD26.COV2.S-Fainted after vaccination because was Anxious. 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).
21 2021-06-05 fainting The patient was sitting in the vaccination booth with her mother and receiving her COVID vaccine. Ri... Read more
The patient was sitting in the vaccination booth with her mother and receiving her COVID vaccine. Right after I administered the vaccine, I asked the patient how she was doing. I didn't hear her respond and she seemed to be staring off. Then, she started leaning forward slowly and closing her eyes. I got in front of her and her mom pulled her shoulder back. That motion roused her and I said that if she was comfortable, if she could lower her mask so that she could breathe in more oxygen, so she did. I told them we should elevate her legs so I grabbed another chair and had her put her legs on it. I grabbed some paper towels and ran them under cold water and had her apply them to her neck and wrists. I grabbed an ice pack and then had her start using the ice pack instead. After about 5 minutes, the patient said that she was feeling much better. I administered the COVID vaccine to her mother and they both stayed sitting in the booth for another 15 minutes or so. When they got ready to leave, the patient got up and said that she was feeling well.
21 2021-06-10 loss of consciousness Patient received vaccine and passed out. Patient quickly recovered and felt better.
21 2021-06-13 fainting Systemic: Fainting / Unresponsive-Severe, Additional Details: pt fell off the chair, faced down afte... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: pt fell off the chair, faced down after 5 minutes of vaccine injection. 911 was called and paramedics took her to ER.
21 2021-06-20 heart rate increased On Sunday, the 13th, I started to have scratchy throat; felt like sand in my throat every time I swa... Read more
On Sunday, the 13th, I started to have scratchy throat; felt like sand in my throat every time I swallow. The following day, I started to have sinus congestion and sore throat and sneezing. Then the following day, the symptoms continued and I had to leave work early. That Tuesday, I lost my sense of taste and smell for a couple of hours but the next day they came back. I started to get better. Thursday I had high pulse and oxygen levels were a little high for the normal down to 95 and 96 and my usual is 100. I had a doctor I work with listen to my lungs and he couldn't hear anything. 15th I had a visit not with Primary care whoever was covering that day, they prescribed me with a nasal spray. ER heart rate was still high and they did blood work; X-ray; EKG; rapid Covid test and PCR negative result; everything came out fine. No treatment. But diagnosis of Upper Respiratory Infection. I had another visit with dr after ER visit for follow up.I still have the cough.
21 2021-06-20 pallor Patient started to feel light headed , cold sweat, pale and nauseated about a minute after the inje... Read more
Patient started to feel light headed , cold sweat, pale and nauseated about a minute after the injection. I had patient lay down on the floor with her feet up on the chair for about 15 to 20 minutes. After 20 minutes patient feels better.
21 2021-06-22 blood pressure increased The patient stated they were fine for the first 15 minutes after the injection, but as they were get... Read more
The patient stated they were fine for the first 15 minutes after the injection, but as they were getting up to leave I could see her color was not good and I made her continue waiting . I got out an ice pack and put on the back of her neck and she leaned forward on another chair to try to get the blood to her head. She started breathing heavier and complaining of her stomach hurting and not feeling well. She was sweating and crying. We called 911 and laid her on the floor with a cushion under her head until they arrived. The patient continued to cry and complain of stomach pain and could not open her eyes. She also had no strength to stay upright. Her blood pressure was elevated at 163/100. The patient was taken by ambulance to the hospital.
21 2021-06-26 blood clot Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00 PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pai... Read more
Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00 PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pain, 6:50 PM, 5 hours
21 2021-07-02 fainting, chest pain, heart rate increased PATIENT'S MOTHER CALLED THE PHARMACY ON 07/03/21 9:30 AM TO REPORT THAT THE PATIENT HAD A HEADACHE... Read more
PATIENT'S MOTHER CALLED THE PHARMACY ON 07/03/21 9:30 AM TO REPORT THAT THE PATIENT HAD A HEADACHE, CHILLS, FEVER (103 F), INCREASED HEART RATE (145 BPM) AND CHEST PAIN THE NIGHT SHE WAS VACCINATED (07/02/2021). ON HER WAY TO THE ER, PATIENT FAINTED.
21 2021-07-15 loss of consciousness Hives, headache, passing out
21 2021-07-16 chest discomfort SINUS PRESSURE; CHEST TIGHTNESS; CAN'T CATCH BREATH; This spontaneous report received from a patient... Read more
SINUS PRESSURE; CHEST TIGHTNESS; CAN'T CATCH BREATH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with aura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced sinus pressure. On 14-JUL-2021, the subject experienced chest tightness. On 14-JUL-2021, the subject experienced can't catch breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure, chest tightness, and can't catch breath. This report was non-serious.
21 2021-07-20 loss of consciousness Nurse was asked to come help a patient that felt dizzy after getting the vaccine. Nurse walked over ... Read more
Nurse was asked to come help a patient that felt dizzy after getting the vaccine. Nurse walked over and she was being held up by other nurses. Patient never hit her head but she lost consciousness and had jerky movements for about 10 seconds. After coming to, she could tell us her name and where she was accurately. Nurses took vital signs that were stable after event. She was taken to a holding area by wheelchair and given water/food. She said she felt much better and left 30 minutes later on a bus.
21 2021-07-27 loss of consciousness Pt is a 21-year-old female who presents as a rapid response from the: Vaccination clinic. Patient r... Read more
Pt is a 21-year-old female who presents as a rapid response from the: Vaccination clinic. Patient reports that she received her covid vaccine and then sat in the chair while sitting in the chair waiting out her observation. She started to feel lightheaded, noted stars, noted everything started to go black and then slumped over in her chair. According to the nurse/pharmacist that was there they were able to catch her and slowly side or down so there was no head injury. She was brought immediately to the emergency room. She reports that she still is feeling dizzy and lightheaded. She denies any chest pain or shortness of breath No feeling of chest tightness or throat tightness No feeling of swelling or throat closing No swelling to her lips or face No rash, urticarial or hives
22 2021-03-06 heart rate increased I felt no affects after I received the shot at 2:30 PM. Woke up with chills, violent shivering, beca... Read more
I felt no affects after I received the shot at 2:30 PM. Woke up with chills, violent shivering, became sick to my stomach at 2 AM. I fell back to sleep an hour later after covering myself with another blanket and throwing up. My Apple Watch shows at 4 AM my heart rate rose to 127 BPM when I was asleep. It is now 6 PM and I am feeling body aches, headache, stuffy nose, still a bit nauseous-- almost like cold symptoms.
22 2021-03-10 fainting The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and ache... Read more
The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and acheyness which kept me in bed all night. I got up to shower and get some food as I was going upstairs I grew very faint, my vision grew black and my hearing faded. I was able to make it to my bed then ask for some help. After taking Tylenol, my fever began to be very hot instead of chills. I was able to fall asleep until I woke back up to chills again and taking more medicine. The next morning, I was still dizzy when I walked around but the fever was gone. I was still very fatigued which made me unable to go to class or work. Day 3 I was back to my normal self.
22 2021-03-10 fast heart rate 30 minutes after vaccination in R deltoid had rash, fine red not raised on right forearm. Given bena... Read more
30 minutes after vaccination in R deltoid had rash, fine red not raised on right forearm. Given benadryl 25 mg po. within 5 minutes developed subjective tachycardia/ and shortness of breath and felt light headed. Rash on forearm improved some with benadryl. Given one epipen at the time 911 was called. She felt short of breath, she was not audibly wheezing. EMT took her to the local hospital. She was always alert and conversant.
22 2021-03-11 fainting, loss of consciousness Patient is a 22 y.o. female who received the Janssen COVID vaccine Lot# 1805020 on 3/12/2021. The pa... Read more
Patient is a 22 y.o. female who received the Janssen COVID vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15min of observation: 1050: Pt observed to have syncopal episode. Pt transferred to ground for assessment. Pt regained consciousness within 30sec of episode. Pt reports vasovagal response to needles. Vitals: 1051: Pt alert and verbal BP: 102/72 HR: 63 RR:18 O2: 99% 1100: Pt alert and oriented x3 BP:117/84 HR: 95 RR: 18 O2: 98% Reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car accompanied by parents.
22 2021-03-13 arrhythmia, chest pain Fatigue: 5pm on 3/13/21- current Extreme muscle pain throughout body: 5pm on 3/13/21- current Uncont... Read more
Fatigue: 5pm on 3/13/21- current Extreme muscle pain throughout body: 5pm on 3/13/21- current Uncontrollable shivering: 8pm on 3/13/21- 12am on 3/14/21 Swollen lymph nodes on left side of neck: 5pm on 3/13/21-current Nausea caused by pain and shivering: 8pm on 3/13/21- 12am 3/14/21 Chest pain and arrhythmia: 8pm on 3/13/21- 12am 3/14/21 (mother is an RN and checked this with stethoscope) I took Tylenol around the clock, did not make any changes to my symptoms. Called the ER and was transferred to a pre-recorded line. Called PCP and was instructed to increase fluid intake, rest, and take vitamins C and D.
22 2021-03-13 heart rate increased In a few hours after my COVID shot, I had Intense chills that made my entire body ache, then a heada... Read more
In a few hours after my COVID shot, I had Intense chills that made my entire body ache, then a headache and a rapid heartbeat, with a 101.7 fever.
22 2021-03-13 pallor Client felt faint and dizzy two minutes after receiving the dose of Janssen vaccine. Client reports ... Read more
Client felt faint and dizzy two minutes after receiving the dose of Janssen vaccine. Client reports no allergies. Client was seated in a chair, and EMTs were called. EMTs assessed the client. Client continued to feel poorly: faint, dizzy, sweaty and pale. Left client in the care of the EMTs.
22 2021-03-13 pallor Patient had a very short seizure lasting a few seconds. Then was aroused and didn't have a posticta... Read more
Patient had a very short seizure lasting a few seconds. Then was aroused and didn't have a postictal phase. Her skin color was pale, blood pressure was low at 106/70 sitting, and heart rate was slow at 60. She was evaluated by fire department paramedics and transported to ED.
22 2021-03-15 fainting pt looked a bit disoriented after administration and then fainted. after asking if okay a couple ti... Read more
pt looked a bit disoriented after administration and then fainted. after asking if okay a couple times, she came to, and said she was okay. We had her lie down on the floor and she said that made her feel better. She said she had a buzzing sound in her ears and that decreased with time. She said that is a normal symptom of when she is having a panic attack.
22 2021-03-19 heart rate increased Originally, I started with random muscle aches in my left shoulder then it went down my back (a few ... Read more
Originally, I started with random muscle aches in my left shoulder then it went down my back (a few hours after receiving vaccine). Then slightly fogginess and at night the muscle pain became worse making it difficult to sleep and started getting cold flashes. Once asleep around 12:30 I started getting muscle aches that felt like they were burning and in random spots on body along with a headache and would get random cold and heat flashes. Kept yelling out in pain all night and increased tremors in hands. Boyfriend noticed I had a fever as well and gave me ibuprofen around 3am since pain was unbearable and was difficult to sleep. Almost took me to the hospital due to the intense pain.. In morning slightly better but still frontal lobe pain and aches throughout body with raised heart rate. Cannot do much or else aches get worse including headache.
22 2021-03-22 fainting, loss of consciousness After receiving the vaccine, client lost consciousness and collapsed to the floor. EMS was summoned.... Read more
After receiving the vaccine, client lost consciousness and collapsed to the floor. EMS was summoned. Client had two separate seizures, regaining consciousness in between and after. Client was taken to local hospital for care via ambulance. Attempts to contact client on 3/21/2021 and 3/23/2021 unsuccessful.
22 2021-03-23 pallor After receiving vaccine, patient complained of not feeling well and feeling faint. Patient laid on f... Read more
After receiving vaccine, patient complained of not feeling well and feeling faint. Patient laid on floor with feet elevated. Bp 96/58, P 70, R 18. Color was pale with no signs of respiratory distress or other skin changes noted. Given cool compress and juice. Transferred to cot to monitor for half hour. Before leaving patient noted to have pink color back to skin, was tolerating sitting without feeling dizzy, and vitals: Bp 110/80, P 88, R 16.
22 2021-03-23 pallor 5 minutes following vaccination, patient became pale, sweaty, dizzy, and light headed. Vitals noted ... Read more
5 minutes following vaccination, patient became pale, sweaty, dizzy, and light headed. Vitals noted to be: Bp 88/60, P 100, R 16 no distress. Patient laid down on cot and given ice pack on neck. Patient also reported having nausea and abdominal cramps. Patient monitored for half hour. Color improved and Bp noted to improve to 110/66. Patient drove home by father.
22 2021-03-24 lightheadedness, palpitations Dizziness, NauseaVomiting, Palpitations, near syncope/tingling in extremities Narrative: Employee ... Read more
Dizziness, NauseaVomiting, Palpitations, near syncope/tingling in extremities Narrative: Employee presented to the ER for evaluation within 15 minutes of vaccine with dizziness, palpitations and feeling nauseated. She reported tingling in her legs as well. She was monitored-required IVF, pepcid and benadryl in the ER. Other Relevant History:
22 2021-03-26 lightheadedness Patient has hx of syncope. Patient was lightheaded and dizzy HR 42. Epi given. Vasovagal likely. ... Read more
Patient has hx of syncope. Patient was lightheaded and dizzy HR 42. Epi given. Vasovagal likely. Called EMS however patient refused.
22 2021-03-30 chest pain Chills, fatigue, soreness, dizziness, and sinus headache overnight after receiving vaccine. Chills, ... Read more
Chills, fatigue, soreness, dizziness, and sinus headache overnight after receiving vaccine. Chills, fatigue, soreness, dizziness, chest pain, and difficulty breathing the day after receiving the vaccine.
22 2021-03-30 palpitations Nausea, blurred vision, loss of vision, loss of hearing, out of it, heart racing, body became hot, i... Read more
Nausea, blurred vision, loss of vision, loss of hearing, out of it, heart racing, body became hot, ice packs were placed all over my body, in a couple minutes my vision came back and my heart rate started to slow
22 2021-04-04 loss of consciousness Pt passed out, diaphoretic, anxious. Quickly came to. Left with mother to go to urgent care for eval... Read more
Pt passed out, diaphoretic, anxious. Quickly came to. Left with mother to go to urgent care for evaluation.
22 2021-04-04 pallor Diaphoretic, lightheadedness, blurred vision, pallor. H2O, snack, cool rag on neck. ... Read more
Diaphoretic, lightheadedness, blurred vision, pallor. H2O, snack, cool rag on neck. Date: 3/22/2021 Problem: J&J Post-Vac Notes: Time: 1555 Pt. Diaphoretic, light headedness, blurred-vision, and pallor. BP 193/89 HR 49, temp 97.0, RR 26. Gave pt H2O, a small snack, and a cool rag for back of patients neck. Monitored pt. No s/s of acute distress. Time: 1629 Pt reported clear vision and "feeling much better. " Pt teaching on s/s of allergic reaction. BP 179/66, HR 60, temp 97.6 F, SpO2 985. Pt ambulated out of facility building independently. No s/s of distress.
22 2021-04-04 fainting Patient experienced fainting approximately one minute following administration of vaccine. Patient ... Read more
Patient experienced fainting approximately one minute following administration of vaccine. Patient reported hearing ringing in ears prior to fainting. Patient did not fall or experience any physical injury during fainting episode. Patient returned to consciousness and reported feeling hot and sweaty. Patient consumed apple juice and was monitored for thirty minutes. Patient denied the need of emergency medical care and reported feeling better throughout the 30 minute monitoring and prior to leaving the facility. Patient was given a ride home with family members. Patient blood pressure prior to leaving the facility was 113/69 with pulse of 61. Patient denied feelings of dizziness, lightheadedness, ringing in ears and difficulty with breathing prior to leaving facility.
22 2021-04-04 fainting Patient received the vaccine and upon standing fainted. She came to in about 30-45 seconds. EMS was ... Read more
Patient received the vaccine and upon standing fainted. She came to in about 30-45 seconds. EMS was called, pt was monitored for 45 minutes and released.
22 2021-04-05 pallor Patient received Covid 19 Janssen vaccine, about 10 minutes after administration patient started to ... Read more
Patient received Covid 19 Janssen vaccine, about 10 minutes after administration patient started to get really hot. We applied cold clothes to the neck and head and patient felt like she was going to vomit so we also gave her a bag just in case she got sick. She started looking very pale so we layed patient on floor. She started to panic that she wasn't going to go to work and eyes were rolling in the back of head. Called 911 for patient and I stayed with patient, I took her blood pressure which was normal. Patient became fully alert again and stated she was feeling a little better. The ems checked her blood pressure and blood sugar and released the patient.
22 2021-04-05 fainting Pt fainted in waiting area chair - was on floor - had her lie down and elevate feet, once she felt b... Read more
Pt fainted in waiting area chair - was on floor - had her lie down and elevate feet, once she felt better we moved to IMZ booth for privacy and she fainted again and did not fall out of chair - called 911
22 2021-04-06 skin turning blue Patient reports light headed, dizzy, upset stomach, cyanotic for approx 30 mins. Difficulty returnin... Read more
Patient reports light headed, dizzy, upset stomach, cyanotic for approx 30 mins. Difficulty returning to baseline, ambulance was called for further evaluation and monitoring. Unknown whether patient was transferred from the site for further care.
22 2021-04-07 loss of consciousness Patient experienced headache, chills and fever about 12 hours after injection on 04/06/21 but sympto... Read more
Patient experienced headache, chills and fever about 12 hours after injection on 04/06/21 but symptoms resolved over night. On 04/07/21 at about 36 hours after injection patient lost consciousness while in the shower for a short time. Patient felt fine after coming to and continues to have no other symptoms.
22 2021-04-08 heart rate increased, chest pain Fever- 101.6 F High heart rate - 160bpm Nausea Chest pain
22 2021-04-08 heart rate increased, chest pain Around 5 hours (8:15) after receiving the vaccine, swift onset of chills, nausea, and fever. Sympto... Read more
Around 5 hours (8:15) after receiving the vaccine, swift onset of chills, nausea, and fever. Symptoms progressively worsened and by 10pm experience rapid heart rate (110 to 130) and chest pain at rest and had trouble breathing deeply. Could not fall asleep due to difficulty breathing and headache and chest pain. At 11pm, began self-administering diphenhydramine (50mg) and Ibuprofen (400mg) every 4 hours. Was able to fall asleep at 4am. Symptoms improved upon waking at 8am, but chest pain and breathing difficulty remains as of 3:30pm April 9th (24 hours since injection)
22 2021-04-08 loss of consciousness I felt fine immediately following my shot, as well as the rest of the day. Overnight I started devel... Read more
I felt fine immediately following my shot, as well as the rest of the day. Overnight I started developing a fever which I knew was normal. However at 3 am I got up to use the restroom. I was sitting on the toilet and then next thing I remember I was on the floor with my face down. I passed out, and I am unsure how long I was out for, before I realized what happened. I have never passed out before, and do not have a history of doing so, so it is unclear why I passed out randomly.
22 2021-04-09 chest discomfort Started to have shortness of breath and tight chest. We brought her to the ER, they said it was infl... Read more
Started to have shortness of breath and tight chest. We brought her to the ER, they said it was inflamed bronchial tubes. They gave her an inhaler and prenazone to help with inflammation.
22 2021-04-09 palpitations My daughter got the shot at 1 pm on the 8th of April, 2021. (My daughter & I both got the shot at th... Read more
My daughter got the shot at 1 pm on the 8th of April, 2021. (My daughter & I both got the shot at the same shot at the same time). By 11:00 pm my daughter started complaining with feeling dizzy. She kept saying she felt like she was going to throw up, meaning she was nauseated. She was complaining with her bones hurting. We both got these symptoms at the same time. We both stayed in and out of the shower letting the shower water just run on us. I had to give her ibuprofen because she complained of a mild headache & the pain all over her body. She couldn?t sleep at all. She cried. It had her scared. I fully believe she?s having an allergic reaction to the Janssen shot. I have fully read the Janssen ?fact sheet?. My daughter was having hot flashes & cold sweats. She has ongoing symptoms & it?s been 2 days since receiving shot including fever. She was having what I thought heart palpitations. We both swelled up causing our bodies to feel tight. We both were healthy before receiving the shot. We?ve never had covid nor tested positive. We are currently going to receive a check up by a doctor. The side effects of this medication is dangerous & doesn?t compare to flu like symptoms.
22 2021-04-09 fainting COVID vaccine given at 10:58 AM. Patient had syncope (fainted) at 11:00AM. Patient did not fall bu... Read more
COVID vaccine given at 10:58 AM. Patient had syncope (fainted) at 11:00AM. Patient did not fall but was brought down to lay on floor and became conscious in 30-60 seconds. 911 was called with EMT's responding. Patient felt fine, no further faintness, dizziness, was able to ambulate on her own. Desired no further treatment. Patient left Pharmacy at 11:30 AM with no further adverse events.
22 2021-04-10 loss of consciousness, fainting Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Add... Read more
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: THis event happened approximately 30 sec after receiving the Janssen COVID-19 Vaccine. Patient was brought to the ER by firemen due to in and out consciousness. Patient was with boyfriend who caught her as she was falling. Patient did not hit her head. She did state that she has passed out in the pass once after receiving a vaccine, but not regularly. She states she does not have a fear of needles when asked by fireman.
22 2021-04-10 loss of consciousness FIVE MINUTES AFTER ADMINSTRATION OF THE VACCINE, PATIENT BECAME VERY DIZZY,FELT EXTREMELY HOT, SWEA... Read more
FIVE MINUTES AFTER ADMINSTRATION OF THE VACCINE, PATIENT BECAME VERY DIZZY,FELT EXTREMELY HOT, SWEATY AND BECAME UNCONCIOUS FOR ABOUT 2MINS.
22 2021-04-10 fainting SYNCOPE & FAINT- GAVE WATER , ORANGE JUICE & FEEL FINE IN COUPLE OF MINUTES (Pt's mom with her also ... Read more
SYNCOPE & FAINT- GAVE WATER , ORANGE JUICE & FEEL FINE IN COUPLE OF MINUTES (Pt's mom with her also & told us that pt din't eat anything from the morning)
22 2021-04-10 fainting Light headed. Fainted. Shaking uncontrollably. Extreme fatigue and body aching. Extreme sweating. Af... Read more
Light headed. Fainted. Shaking uncontrollably. Extreme fatigue and body aching. Extreme sweating. After 24 hours, all muscles very sore.
22 2021-04-10 fainting Patient received vaccination, fainted immediately following injection at 4:20pm. Safely positioned o... Read more
Patient received vaccination, fainted immediately following injection at 4:20pm. Safely positioned on the floor, vital signs assessed, BP was 77/59, pulse 55, pulse ox 99 on room air at 4:21pm; alert and oriented x4, responsive and vitals reassessed within normal limits at 4:25pm. cold compress and water provided. patient ambulated to observation area, monitored by EMT at 4:30pm. patient observed for 30 minutes, advised to download vSafe for follow guidance post discharge.
22 2021-04-10 fainting syncopal episode, clammy, diapohoretic was given water and granola bar
22 2021-04-11 blood glucose increased, fainting High blood sugar: 216 Vasovagal syncope: heart rate dropped to 40, bp 70/30
22 2021-04-11 fainting lightheadedness, syncopal episode. Evaluated by EMS-Cleared
22 2021-04-12 chest pain, fibrin d dimer increased 15 MINS AFTER SHOT I STARTED FEELING DIZZY, REALLY BAD HEADACHE, FATIGUE, AND ON AND OFF CHEST PAINS... Read more
15 MINS AFTER SHOT I STARTED FEELING DIZZY, REALLY BAD HEADACHE, FATIGUE, AND ON AND OFF CHEST PAINS. HAD TO LAY DOWN. STARTED GETTING TREMORS, DIDN'T FEEL ANY BETTER AFTER ANOTHER 20 MINS AND THEN THE DOC CALLED THE AMBULANCE TO TAKE ME TO ER.
22 2021-04-12 heart rate increased, fast heart rate Heart rate up to 185 bpm, SVT. Temperature of 104.
22 2021-04-12 hypertension Janssen COVID-19 Vaccine EUA. Vaccine burned while being injected and for about 4 hours afterwards. ... Read more
Janssen COVID-19 Vaccine EUA. Vaccine burned while being injected and for about 4 hours afterwards. Arm hurt for a good week after as well. Had a small red raised bump at injection site for about 6 days. Have not had a period for 4 years due to my birth control, got my vaccine on 03/30/2021 and then started a brown and clotty period on 04/01/2021. Period last about 9 days and seems to be gone now besides an odor. Had undescribable cramping in abdomen. Had some type of stomach bug (fever, vomiting, diarrhea) on 03/27/2021 that lasted about 72 hours. Then had another episode of diarrhea on 04/04/2021. Currently having bad headaches and right thigh cramps. Blood pressure and temperature seems to be running higher than my normal still.
22 2021-04-12 hypotension, heart rate increased Nausea, Dizziness, hyperventilation , elevated heart rate ,hypotension and anxiety
22 2021-04-12 palpitations Janssen COVID-19 Vaccine Immediately following the shot and lasting for about 48 hours, arm pain a... Read more
Janssen COVID-19 Vaccine Immediately following the shot and lasting for about 48 hours, arm pain at the site of injection. Starting at 10:30pm on the day the vaccine was received, had chills (came and went for about 12 hrs), neck pain, back pain and headache (all lasting about 24 hrs). About 24 hrs after the vaccine, had heart racing/palpitations lasting 20 minutes.
22 2021-04-13 pallor Injection site (arm) pain, headache, fatigue, full body chills, fever of 101.3, vomiting, diarrhea, ... Read more
Injection site (arm) pain, headache, fatigue, full body chills, fever of 101.3, vomiting, diarrhea, lightheadedness, pale face, dizzy. Lasted about 3 days. Tylenol was taken every 6 hours to help with fever and arm pain.
22 2021-04-13 fainting, very slow heart rate, lightheadedness History of Present Illness This is a 22-year-old female who was previously healthy with no signi... Read more
History of Present Illness This is a 22-year-old female who was previously healthy with no significant past medical history presenting to the emergency department after a syncopal event. She was getting her COVID-19 shot today (Johnson Johnson). After her shot she was texting on the phone with her mom, felt slightly dizzy and the next thing she remembers was lying on the ground. Witnesses reported that she syncopized and had some convulsive like behavior afterwards. She was not postictal or incontinent however. She reportedly hit the front of her forehead on the left side. She denies any chest pain, abdominal pain, hemoptysis, recent surgeries, immobilization or recent travel. She reports that when she woke up her hands felt a little bit tingly. When the fire department arrived they found her to be bradycardic however by the time the medics arrived her heart rate had resolved. Her blood sugar was 110 on the scene. Medics noted that she was orthostatic on the scene as well. She currently is feeling well, has no complaints. States that she has gotten dizzy before in the past with COVID vaccines.
22 2021-04-13 fainting Right after the nurse administrated the vaccine to my daughter, she complained about having numbness... Read more
Right after the nurse administrated the vaccine to my daughter, she complained about having numbness on her feet, flurry eyes, was not able to hear very well, dizziness and fainted for a short time.
22 2021-04-14 chest pain I had the Johnson & Johnson vaccine and had a bad headache two days after and still have a slight he... Read more
I had the Johnson & Johnson vaccine and had a bad headache two days after and still have a slight headache five days after. I also have pretty bad fatiuge. All symptoms started 4/5 hours after getting the vaccine including nausea, headache, chills, fever (of almost 103), chest pains, fatigue, body/arm pain, ear pain. The ear pain started 3 days after the shot. I tried calling one of the doctors in our network around and they both denied me even though the symptoms were from the vaccine...
22 2021-04-15 chest pain Started about 11:30am on April 16th, shortness of breath, heart rate in the 120s, chest pain, and he... Read more
Started about 11:30am on April 16th, shortness of breath, heart rate in the 120s, chest pain, and headache I called my campus health services and they instructed me to go to the ER. I had a positive d dimer and was given a contrast CT scan which turned out negative for blood clots. Still experiencing the same symptoms as of 8:30pm April 17th.
22 2021-04-15 fainting, pallor, palpitations PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS;... Read more
PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, around eight hours later after vaccination, the patient felt a warm in her ears and her heart was racing. She appeared as white as a ghost and the patient fainted with complete loss of consciousness for approximately less than a minute. She had regained consciousness and still had accelerated heart rate until she ate and drank water and then calmed down. On 08-APR-2021, the patient had a very painful headache when she wake up and a low grade fever. She wanted to know if she can take Motrin or Tylenol for her events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling of warmth in ears, fainting, complete loss of consciousness, and heart racing on 07-APR-2021, had not recovered from very painful headache, and low grade fever, and the outcome of appeared white was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416890-JANSSEN COVID-19 VACCINE-Fainting. 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.
22 2021-04-18 chest pain, chest discomfort per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving,... Read more
per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21
22 2021-04-19 hypertension, heart rate increased, chest discomfort, chest pain Mother gave me lot # which is Moderna lot#201A21A, but the vaccination card says Janssen which does ... Read more
Mother gave me lot # which is Moderna lot#201A21A, but the vaccination card says Janssen which does not match up with this lot#. Mother reports that she had the vaccine, had no symptoms, and then started with a fever that evening of 103. She was having cold extremities, numbness, tingling of the arms, face, legs. The fever dropped and went away and was having fatigue and getting winded doing regular activities. By Monday she continued with the shortness of breath and go increasingly worse as the days went on and also the. By Wednesday she was having chest pain, numbness and tingling of her extremities and shortness of breath. She went to the hospital, gave her IVs, says her BP was elevated and sent her home. Mother told her to sleep and see how she felt. By Thursday night 4/15/21 she screamed out because she was having chest pains and having chest and pains and not able to straighten out her hand and could not catch her breath. She was then taken back to the hospital and said that she her BP was high and said that she had the Janssen vaccine, and said that she was hyperventilation due to anxiety. Once they got her stable and released her again. Mother asked the doctor if he felt that this was normal, and could see her throat contracting and that she was stable and to go home, and he said yes and that it was anxiety and that sometimes we get ourselves worked up about things and that was causing it. The daughter has no history of anxiety, no breathing issues. They did labs and everything was okay, her counts were somewhat off but nothing felt to be abnormal. She then went to another Hospital as she was still not feeling well, and checked the other reports from the other hospital and they conferred with that information, gave her Valium and sent her home. As the evening progressed on Friday 4/16/21 she started having chest pains and her girlfriends mother is a nurse and came and saw her and called the mother and told her that she did not like how she was looking, and that her SOB and weakness in her extremities and the tightness in her chest was not right and that she felt that she had a PE. They took her to another location, she had extremely high calcium levels, and high blood pressure and her heart rate was high and she was admitted. She has been on flushes to reduce calcium, and her blood levels are improving. She is on Warfarin to prevent clotting. She has had a CAT scan and other studies and all were negative. She felt better yesterday, but she states today that she is not feeling as well, she is nauseous and gave her Zofran, has a headache, and they gave her something a little stronger than Tylenol. She is extremely fatigued and weak. Mother said that she saw her on Sunday 4/18/21 and that she was not able to walk, they had to put her in a wheelchair, and her grandfather walks faster than she can. They are presently getting her up to get her to walk and see how her strength is, 4/20/21. They are now waiting to get her levels under control and to see if she is strong enough to go home. Neurology released her from their standpoint as they did not see anything, but she is to FU with them afterwards and want to do EMG's as an out patient.
22 2021-04-20 fibrin d dimer increased ELEVATED D-DIMER; SHORTNESS OF BREATH; COLD; GOT SICK; This spontaneous report received from a paren... Read more
ELEVATED D-DIMER; SHORTNESS OF BREATH; COLD; GOT SICK; This spontaneous report received from a parent concerned a 22 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: 205A21A 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 shortness of breath. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced got sick. On 09-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: Fibrin D dimer (NR: not provided) elevated levels of 0.6. On 09-APR-2021 15:30, Laboratory data included: CT scan (NR: not provided) negative for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, got sick, shortness of breath and elevated d-dimer 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.
22 2021-04-20 loss of consciousness PASSING OUT; RUPTURED BLOOD VESSEL IN THE EYE; MIGRAINE/SEVERE VOMITING/INABILITY TO RETAIN FLUIDS/N... Read more
PASSING OUT; RUPTURED BLOOD VESSEL IN THE EYE; MIGRAINE/SEVERE VOMITING/INABILITY TO RETAIN FLUIDS/NAUSEA; TREMBLING; SWEATING; FELT SICK; FEVER OF 101F; This spontaneous report received from a consumer (father) concerned a 22 year old not Hispanic or Latino, white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient reported no significant medical history. 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, frequency 1 total, administered to left deltoid on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 20:00, the patient felt sick and was incapacitated by severe vomiting (coded as migraine/severe vomiting/inability to retain fluids/nausea), sweating, trembling, fever of 101 F that resulted in her passing out. Vomiting was so severe that patient was unable to retain fluids and ruptured a blood vessel in her eye (coded as Broken Blood vessel in eye). Patient was hospitalized on 09-APR-2021 at 12:24 am. During hospitalization she received IV fluids and medicines for migraine and nausea and multiple blood samples were collected. Patient was discharged on 09-APR-2021 around 6 AM. Patient was hospitalized for around 6 hours. Patient reported that symptoms had recovered except was still having nausea and ruptured eye vessel from severe vomiting. (it was Confirmed with patient that she had no past medical history of migraine and was referring to her headache as migraine.) Laboratory data included: Body temperature (NR: not provided) 101 F, Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from trembling, sweating, passing out, and felt sick on APR-2021, and fever of 101F, and had not recovered from migraine/severe vomiting/inability to retain fluids/nausea, and ruptured blood vessel in the eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Passing out, Ruptured blood vessel in the eye, Migraine/severe vomiting/inability to retain fluid/nausea, trembling, sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210422127-covid-19 vaccine ad26.cov2.s -Fever, Felt sick. This event(s) is labeled per RSI and is therefore considered potentially related.
22 2021-04-21 chest pain, heart rate increased Pain in one side of body, fever for 12 days, shortness of breath, elevated heart rate, dizziness, na... Read more
Pain in one side of body, fever for 12 days, shortness of breath, elevated heart rate, dizziness, nausea, chest pain, head aches, back pain. Doctor has diagnosed as delayed immune response to the vaccine.
22 2021-04-22 platelet count decreased Janssen COVID-19 Vaccine EUA 8pm 3/8/21: Nausea, vomiting, chills began; slept for 10+ hours 8 am 3/... Read more
Janssen COVID-19 Vaccine EUA 8pm 3/8/21: Nausea, vomiting, chills began; slept for 10+ hours 8 am 3/9/21: Fatigue, nausea, headache; noticed petechiae on arms and abnormal bruising on legs 8 am 3/10/21: Blurry vision, headache (unlike usual throbbing headaches, consistent pain on top of head), lightheaded/dizzy 10 am 3/10/21: Asked friend to drive me to ED at Hospital; Labs were drawn showing platelet count of 42K and I was released from ED and told to follow up with Hematologist
22 2021-04-22 fainting Fainted for 30 seconds after standing up and walking. Ambulance came to the house and recommended a ... Read more
Fainted for 30 seconds after standing up and walking. Ambulance came to the house and recommended a trip to the ER where I received an IV.
22 2021-04-24 heart rate increased minor soreness in near injection site (within fifteen minutes of injection, continuing for several d... Read more
minor soreness in near injection site (within fifteen minutes of injection, continuing for several days) severe chills, causing whole body shivering (eight hours after injection, for approximately forty-five minutes) interrupted sleep (nine hours after injection, then ten hours after injection) hot flashes (nine hours after injection, then ten hours after injection, each for approximately ten minutes) body aches (ten hours after injection, lasting until twenty-four hours after injection) elevated heart rate, hovering around 130 bpm while walking, standing, and sitting (ten hours after injection, lasting for approximately thirty minutes) dry heaving (ten hours after injection, lasting for approximately ten minutes) joint pain (ten and a half hours later, lasting until twenty-four hours after injection) mild fever of up to 100.7 (eighteen hours later, lasting until twenty-four hours after injection) Body aches, joint pain, and fever were successfully resolved with a dose of Tylenol, administered about twenty hours after injection. All other symptoms resolved on their own.
22 2021-04-25 nosebleed Nose bleed at work 12 days post vaccine, never had a nose bleed before in my life. Pain in left shou... Read more
Nose bleed at work 12 days post vaccine, never had a nose bleed before in my life. Pain in left shoulder and right leg on day 11. Persistent headache for two days. Occasional light-headedness, blurred vision, slow cognitive abilities for 2 days since nose bleed.
22 2021-04-26 chest pain, chest discomfort FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; AN... Read more
FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.
22 2021-04-27 chest pain 4/2 vaccination 4/8 severe HA, leg, arm, lower back pain, chest pain, diarrhea, bad anxiety with sh... Read more
4/2 vaccination 4/8 severe HA, leg, arm, lower back pain, chest pain, diarrhea, bad anxiety with shaking 4/9 PCM (NP) appt; CT scan of abdomen and blood panel 4/10 felt worse, nauseous. Diarrhea continued 4/11 At 11PM, pain right side of neck, to jaw, and toes turned purple. 4/13 PCM; vit D prescribed as they were extremely low, extra strength Tylenol release for leg and arm pain, ordered a D-dimer for possible blood clot. Doppler for right leg. COVID; neg 4/17 chest pain was extremely severe. Radiated to L arm. Went back to ER. EKG, CT Scan, BNP. All normal. Stated probably really bad heartburn. 4/19 Prilosec. I called my dr on 4/22 to follow up. They told me to keep eye on BP as been elevated thru this whole thing. 4/22 My chest, arm and leg pain with HA are still present despite Tylenol and Prilosec. My PCM said to come back in . She prescribed Prednisone and Pantropical and did a blood test to check for inflammation which was normal. I have been taking both medications since Tuesday. *My HA still present. My right side still has pain and I still have chest pain.
22 2021-04-28 pallor Patient started tearing about 3 minutes after received the vaccine. Her face and lips turned really... Read more
Patient started tearing about 3 minutes after received the vaccine. Her face and lips turned really pale and fainted on pharmacist's arms for 30 seconds. She wore up but still pretty confused. WE gave her water. She stayed in pharmacy with her mom for about 40 minutes and went home.
22 2021-04-29 chest pain High fever, body aches, chest pains, back pain, fatigue, sweating, chills, shortness of breath, over... Read more
High fever, body aches, chest pains, back pain, fatigue, sweating, chills, shortness of breath, over sleeping, left arm pain.
22 2021-04-29 hypertension Body shaking High blood pressure Loss of appetite
22 2021-05-02 fainting, loss of consciousness Dizziness and vasovagal episode. Hx of vasovagal and seizure x1. Patient went decorticat and immedi... Read more
Dizziness and vasovagal episode. Hx of vasovagal and seizure x1. Patient went decorticat and immediately awaken after ammonia given.
22 2021-05-04 hypertension, chest pain SEVERE CHEST PAIN RADIATING TO LEFT ARM; HEARTBURN; NECK PAIN IN RIGHT SIDE RADIATED TO JAW AND EAR... Read more
SEVERE CHEST PAIN RADIATING TO LEFT ARM; HEARTBURN; NECK PAIN IN RIGHT SIDE RADIATED TO JAW AND EAR; PURPLE TOES; FEELING WORSE; LOSS OF APPETITE; NAUSEA; CHEST PAIN; LEG PAIN; HEADACHE; ABDOMINAL PAIN; LOWER BACK PAIN; DIARRHEA; SEVERE UNEXPLAINED ANXIETY; SHAKING; LOW GRADE FEVER; ARM PAIN; COLD FINGERS / COLD TOES; LOW VITAMIN D; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 22 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: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced low vitamin d. On APR-2021, the subject experienced elevated blood pressure. On APR-2021, the subject experienced cold fingers / cold toes. Laboratory data included: Pain scale (NR: not provided) HEADACHE (6 on pain scale), RIGHT LEG PAIN ( 5 ON PAIN SCALE), CHEST PAIN (3 ON PAIN SCALE). On 02-APR-2021, the subject experienced arm pain. On 02-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced lower back pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced severe unexplained anxiety. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced chest pain. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced feeling worse. On 09-APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) NORMAL, and CT scan (NR: not provided) NORMAL. On 10-APR-2021, the subject experienced neck pain in right side radiated to jaw and ear. On 10-APR-2021, the subject experienced purple toes. Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) LOW VITAMIN-D. On 14-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) normal. On 16-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 17-APR-2021, the subject experienced severe chest pain radiating to left arm. On 17-APR-2021, the subject experienced heartburn. Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and EKG (NR: not provided) NORMAL. Other relevant diagnostics included: Mono test on 10-apr-2021 result - negative D-dimer test for blood clot on 13-apr-2021 result - normal l. On 19-APR-2021, treatment medications included: omeprazole. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL. Additional treatment medications (dates unspecified) included: paracetamol, pantoprazole, and prednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and shaking on 15-APR-2021, loss of appetite, and nausea on 12-APR-2021, and arm pain, and low grade fever, had not recovered from headache, leg pain, severe chest pain radiating to left arm, and chest pain, and the outcome of abdominal pain, lower back pain, severe unexplained anxiety, neck pain in right side radiated to jaw and ear, purple toes, low vitamin d, elevated blood pressure, cold fingers / cold toes, feeling worse and heartburn was not reported. This report was non-serious.
22 2021-05-06 fainting Patient got warm was sweating fainted temporarily lost eyesight
22 2021-05-16 haemoglobin decreased, anaemia, nosebleed, low platelet count, platelet count decreased Patient admitted for left flank pain. Was treated for urinary tract infection, although never had s... Read more
Patient admitted for left flank pain. Was treated for urinary tract infection, although never had symptoms of a UTI. No dysuria, frequency or urgency. Urine is dark. Irregular menses. Has had cough, sore throat, vomiting, headache over past week. Mild epistaxis and heavy menses last month. CBC shows anemia and thrombocytopenia. Imaging showed splenomegaly with small acute splenic infarct. Hematology/oncology consulted and TTP ruled out.
22 2021-05-16 blood vessels inflammation Vasculitis
22 2021-05-18 loss of consciousness, fainting Patient reported before the vaccine was administered that she had a history of fainting upon receivi... Read more
Patient reported before the vaccine was administered that she had a history of fainting upon receiving vaccines in the past. As predicted, she fainted within seconds of administering the Janssen vaccine. While unconscious, patient had a few mild head/neck twitches which then progressed to 2-3 full body twitches/spasms before regaining consciousness. Total time unconscious with less than 1 minute. Once fully awake and alert, patient informed me that she had a history of a seizure once before. We gently laid her on the floor and I took her vitals. Vitals were low with BP 90/49, HR 49, and O2 90%. She continued to lay on the floor for approximately 10 minutes before checking her vitals again. At that time, vitals were better with HR 60 and O2 99; I was unable to retake her BP at that time, but patient claimed that it usually was on the low side. She called her mother who agreed to come stay with her to keep watch for more events at her home. A family friend was also called to come pick her up and drive her home. Before leaving, I strongly advised patient to see a doctor to check everything out. Patient just moved here and claims to not have a primary at either location.
22 2021-05-19 fainting, loss of consciousness Fever (unknown temperature), headache, and fainted/passed out twice.
22 2021-05-21 fainting The patient fainted a minute after receiving the vaccine, woke up a minute later, and felt very naus... Read more
The patient fainted a minute after receiving the vaccine, woke up a minute later, and felt very nausiated 5 minutes after waking up. The patient expressed a lot of fear prior to the vaccine, due to a fear of syringes. Her guardian was around to help make sure that she did not suffer any injuries during syncope.
22 2021-05-24 loss of consciousness Patient received vaccine while seated and continued to sit while waiting for 15 minute observation p... Read more
Patient received vaccine while seated and continued to sit while waiting for 15 minute observation period post-injection. After about 5 minutes, patient lost consciousness while seated. She regained consciousness on her own after about 30 seconds. She remained in her chair, no injuries noted. 911 was notified and EMT arrived on scene to take blood pressure, blood sugar, and do a 4 lead EKG. Per EMT everything was within normal limits and she did not have to be transported to another facility. Patient then left with her mother. No medications had to be administered and CPR/AED were not required.
22 2021-05-25 heart rate increased, hypotension, loss of consciousness, fainting Episode of apparent vasovagal syncope a few minutes after receiving the vaccine. This was witnessed... Read more
Episode of apparent vasovagal syncope a few minutes after receiving the vaccine. This was witnessed by myself. She appeared to have loss of consciousness and collapsed onto the pavement striking her posterior head on the pavement (fortunately, she did not strike it with great force). She regained consciousness within 2-3 seconds. She had a small "knot" on her posterior scalp, but no break in the skin. No other apparent injury. She initially complained of a headache, but this resolved over the course of about 10 minutes. She initially was mildly diaphoretic and had a rapid pulse and mild hypotension, but these also resolved over the course of several minutes. A chemical ice pack was applied to the posterior scalp and neck. She had a completely normal neurologic and musculoskeletal examination. She was provided oral fluids (water and kool aid) and a snack (chewy granola bar) and kept under close observation by medical personal for about 30 minutes. Transport to the emergency room via ambulance was offered, but declined. Her boyfriend was called and came to drive her home after she had made an apparent complete recovery. Both he and she were extensively counseled regarding signs and symptoms to be on the lookout for that would indicate the need for further medical evaluation and they both expressed complete understanding and agreement. Of note, she reported that she has had episodes of syncope in the past when having blood drawn for laboratory tests, but decided not to disclose this to on site personal prior to the vaccination thinking she would probably not have a problem.
22 2021-05-31 fainting Tingling; Fainted. EMS at side.
22 2021-06-10 loss of consciousness, fainting PATIENT FELT DIZZY, FAINTED AND BECAME UNCONCIOUS (FOR ABOUT 1 MINUTE). WE THEN CALLED 911 AND PATIE... Read more
PATIENT FELT DIZZY, FAINTED AND BECAME UNCONCIOUS (FOR ABOUT 1 MINUTE). WE THEN CALLED 911 AND PATIENT WENT TO ER. SHE STAYED FOR SEVERAL HOURS AND RECEIVED HEADACHE MEDICATION AND IV FLUIDS.
22 2021-06-14 hypertension, fast heart rate Pt. received vaccine from outside facility. Pt. reports the day after receiving vaccine to ER triage... Read more
Pt. received vaccine from outside facility. Pt. reports the day after receiving vaccine to ER triage c/o of body aches, upset stomach, and headache. Pt was tachycardic and hypertensive upon arrival. Pt. left clinic at this visit. Pt followed up with PCP for a routine visit ~1.5 months later. Pt denies any symptoms except occasional body aches.
22 2021-06-20 fainting Patient fainted approximately 5 minutes after administration.
22 2021-06-24 chest discomfort PATIENT RECEIVED THE VACCINE AT 9:00AM, SAT IN STORE FOR 15 MINUTES AND LEFT THE BUILDING. AT ABOUT ... Read more
PATIENT RECEIVED THE VACCINE AT 9:00AM, SAT IN STORE FOR 15 MINUTES AND LEFT THE BUILDING. AT ABOUT 9:20 SHE CAME BACK TO THE PHARMACY SAYING SHE IS NOT FEELING WELL AND FELT WEIRD. PHARMACIST ASKED HER TO DESCRIBED THE FEELING, PATIENT SAID SHE JUST FEEL WEIRD LIKE NAUSEA AND NUMBNESS AROUND HER LEGS AND HER CHEST FELT TIGHT. PHARMACIST OFFERED HER TO SIT DOWN AGAIN AND ASKED HER IF SHE HAS ANY HISTORY OF ALLERGIES OR REACTIONS TO OTHER VACCINES BEFORE. PATIENT SAID NO REACTION TO HER YEARLY FLU SHOTS AND NEVER FELT LIKE THIS BEFORE AND STATED SHE'S ALLERGIC TO AMOXICILLIN ONLY. PHARMACIST OFFERED TO CALL THE AMBULANCE FOR HER AND GAVE HER SOME WATER. AMBULANCE CAME IN AROUND 9:40AM AND ASKED PATIENT SOME QUESTIONS AND TOOK HER TO THE ER.
22 2021-06-30 palpitations Six hours after receiving the vaccination, I woke up with a high fever and severe, uncontrollable sh... Read more
Six hours after receiving the vaccination, I woke up with a high fever and severe, uncontrollable shaking in my whole body. Something like quivering shock waves started to radiate from the center of my chest and shuddered out through my entire body, causing every muscle to shake uncontrollably; the shaking became increasingly violent. My heart was racing. I took deep breaths and applied a cool, wet hand towel to my forehead/neck to relax, but none of it helped. After about 20 minutes, the violent shaking was only getting worse, so I took one Aleve. The shaking continued for another 20 minutes. Finally, it became less frequent and I could tell I had a little more control but was still shivering. My thumbs were also numb and tingly for the duration of the shaking (about 40 minutes) and afterwards. Eventually I completely relaxed and fell asleep, but I am now sore from being so tense. Still have slight fever and aches.
22 2021-07-05 fainting Patient had a syncope and recovered in few seconds, emergency response team was called to make no ot... Read more
Patient had a syncope and recovered in few seconds, emergency response team was called to make no other adverse reaction
22 2021-07-06 loss of consciousness Patient voiced she was anxious and asked for water. Patient voiced she felt warm then became uncons... Read more
Patient voiced she was anxious and asked for water. Patient voiced she felt warm then became unconscious for few seconds. Her head was protected from injury. 911 called. No medication given. Ice pack given for cooling measures. Patient said she felt fine and refused further treatments and hospitalization. O2 saturation 99% room air. Heart rate 90bpm. No shortness of breath and no other abnormal findings noted.
22 2021-07-07 chest pain Fever within 3 hours of receiving vaccination. Chest pain and difficulty breathing
22 2021-07-13 loss of consciousness Patient received vaccine dose at 4:43pm. At approximately 4:48pm, she stood up to tell staff that sh... Read more
Patient received vaccine dose at 4:43pm. At approximately 4:48pm, she stood up to tell staff that she was feeling ok and wanted to pick up an item in the store. A staff member saw that she looked unwell and asked if she was ok and she said no. She passed out at that moment. She was unconscious for approximately 5-10 seconds. Her body became stiff and her shoulder/arm trembled during that time frame of being unconscious. She refused an ambulance. She remained in the pharmacy for 30 minutes until she no longer felt light-headed. During the 30 minutes, she felt light-headed, hot and was sweating. She said she felt fine after the 30 minute wait.
22 2021-07-22 chest pain symptoms began day after receiving Janssen CIVOD-19 vaccination. Symptoms include nausea, headache, ... Read more
symptoms began day after receiving Janssen CIVOD-19 vaccination. Symptoms include nausea, headache, body aches, light chest pain, chills. Taking Tylenol for relief of symptoms. Was seen at military sickcall for check up on 23 July 2021 at approximately 1100.
22 2021-07-27 loss of consciousness Patient received her vaccination in her left arm. (Janssen Covid-19). About 1-2 minutes after vaccin... Read more
Patient received her vaccination in her left arm. (Janssen Covid-19). About 1-2 minutes after vaccination, the patient began to black out for about 10-15 seconds. She woke up and water was provided. 911 was called and the patient began to black out again for about 10-15 seconds. She refused medical attention from 911, and began to drink more water and electrolytes. She remained on site for 30 minutes for observation. She stated she was dehydrated and has a history of fainting after vaccines and piercings. She did not disclose this information prior to vaccination. A follow up call was placed on 07/28/2021, and the patient stated she was feeling much better and only experiencing slight pain at the injection site.
23 2021-03-08 fainting, blood pressure decreased At 10:44am, Fainting, drastic drop in blood pressure, blurred vision, numb hands. That evening, chil... Read more
At 10:44am, Fainting, drastic drop in blood pressure, blurred vision, numb hands. That evening, chills and vomiting.
23 2021-03-09 fainting Syncope - fainted in observation area. Laceration above left eyebrow (2 cm x 2 cm) and on bottom lip... Read more
Syncope - fainted in observation area. Laceration above left eyebrow (2 cm x 2 cm) and on bottom lip. BPs 111/79 (pulse 104), 113/81 (pulse 98), O2 sat 100%.
23 2021-03-12 chest pain 48 hrs fever at 101 degrees Vomiting Bodyache Fatigue Chest pain Nausea
23 2021-03-12 chest pain First pain in whole arm and across my chest. Then chills and all over body aches. I also have fatigu... Read more
First pain in whole arm and across my chest. Then chills and all over body aches. I also have fatigue. It began around 9 pm and is getting worse at 11:15pm.
23 2021-03-12 loss of consciousness Patient became diaphoretic and passed out within minutes of receiving vaccination. She woke within ... Read more
Patient became diaphoretic and passed out within minutes of receiving vaccination. She woke within seconds. Returned to baseline within 15 minutes. Patient stated this has happened before with blood draws and other vaccinations. She was released into the care of her driver/sister after returning to baseline.
23 2021-03-13 pallor 1305 - pt. found in post vaccination waiting area pale, diaphoretic, and slightly slumped over. RN ... Read more
1305 - pt. found in post vaccination waiting area pale, diaphoretic, and slightly slumped over. RN notified. Rn arrived at pt's. side to find her pale and unfocused, staring with pupils slightly dilated. No LOC per medic in waiting area. medic described " 2 minutes of pt. with petite mal seizure activity". Rn did not observe any tonic seizure activity but pt. very slow to focus and answer questions. 911 notified and pt. placed in wheelchair and moved to Tx. area. Placed supine, BP 116 palp, HR 100, RR - 28. O2 started @ 6L by NC. 1310- Med Hx reveals pt. stopped oral Cymbalta 3/5/21. 1312 - Pt. more alert , focused and able to answer questions appropriately. 1315 - medics arrived and care transferred. BP - 138 palp Glucose - 95. 1320 - pt. remains stable and able to notify family by phone. !325 - Pt. transported to Hospital by ambulance in stable condition.
23 2021-03-14 blood pressure increased, fainting PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. BP WAS INITIALLY ELEVATED BUT PATIENT WAS ... Read more
PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. BP WAS INITIALLY ELEVATED BUT PATIENT WAS MONITORED AND PATIENT DID NOT NEED ADDITIONAL INTERVENTION.
23 2021-03-14 chest discomfort SOB, chest tightness. Resolved with rest
23 2021-03-14 fainting, blood pressure increased PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. BP WAS ELEVATED INITIALLY AND PATIENT WAS ... Read more
PATIENT FAINTED IMMEDIATELY AFTER VACCINE ADMINISTRATION. BP WAS ELEVATED INITIALLY AND PATIENT WAS MONITORED AND REQUIRED NO FURTHER INTERVENTION.
23 2021-03-17 chest pain Prolonged muscle aches in lower extremities. Left Chest pain, fatigue, headache, chills, loss of app... Read more
Prolonged muscle aches in lower extremities. Left Chest pain, fatigue, headache, chills, loss of appetite
23 2021-03-20 loss of consciousness Pain in arm immediately after injection, blacked out after 2 mins after injection, felt faint, shaki... Read more
Pain in arm immediately after injection, blacked out after 2 mins after injection, felt faint, shaking, very sweaty for about 15 mins after injection. Symptoms receded and felt better about 30 mins after.
23 2021-03-26 loss of consciousness Client had an unwitnessed loss of consciousness after vaccination in the hallway outside of vaccinat... Read more
Client had an unwitnessed loss of consciousness after vaccination in the hallway outside of vaccination room. Nurse manager notified by client standing in doorway between hallway and vaccination room, responded immediately. Client was standing, stated she was feeling fine, appeared slightly confused. Nurse manager began to walk client to chair, client stated "I feel like it's going to happen again," had another loss of consciousness, this time assisted to the floor by two nurses. 911 called. client taken to cot inside medical consultation station via wheelchair, vital signs assessed- BP 130/78, O2Sat 99%, HR 72., RR 18. Client reporting feeling fine, denies pain. States she was leaning against the wall the first time and slid down the wall, states she doesn't believe she hit her head, denies head or neck pain. Client given water. Paramedics arrived, assessed client, all vitals normal, client decided not to be transported to the hospital.
23 2021-03-29 chest discomfort Around 10pm on 3/26, I got a slight headache, but I am not sure if it was due to screen time or a va... Read more
Around 10pm on 3/26, I got a slight headache, but I am not sure if it was due to screen time or a vaccine side effect. Per the clinician that administered the shot, I took 2 tabs of Tylenol (one normal adult dose) with water and went to bed. At 1 am on 3/27, I woke up incredibly sore all over but especially in my joints. I was shivering badly and woke up in a tightly curled fetal position. I was unable to lie still or warm up. I eventually went back to sleep and woke up at 5 am, this time with extreme nausea and threw up everything I had eaten the day before. This went on for a couple of minutes. I was still shivering constantly and sore and achy everywhere. Especially in my knees, shoulders, and lower back. At 6 am, I was still awake and while I still had chills, my face felt hot and I took my temperature twice. First getting 100.74 then 100.86. Slept deeply for the rest of the night. At noon on 3/27 I woke up with no nausea, body aches but only in my joints but with general soreness everywhere (like after a good workout) and a temp still in the 100.7 degree range. I took 2 Tylenol tabs at 2pm. At 4pm, I only had slight body aches, a headache, and a slight brain fog left and my temp was at 98.7, so no more fever. No further problems showed up and when I woke up at 9 am on 3/28, I felt absolutely fine other than soreness at the injection site and a little chest tightness which last for about 2 days, through 3/30.
23 2021-04-03 chest pain Janssen COVID-19 Vaccine EUA I felt fine after the vaccine until that same night when my chest and n... Read more
Janssen COVID-19 Vaccine EUA I felt fine after the vaccine until that same night when my chest and neck started aching and I developed a strong headache. Ibuprofen made the aches better but the headache continued until morning and throughout the night I was unable to sleep. The following morning I have a slight fever and some minor aches.
23 2021-04-04 pallor Janssen COVID-19 Vaccine EUA Onset ~9am Friday, April 2 Symptoms: excruciating headache in occipit... Read more
Janssen COVID-19 Vaccine EUA Onset ~9am Friday, April 2 Symptoms: excruciating headache in occipital & temporal regions of head, aching joints (especially knees & lower back), cold sweats Signs: decreased appetite, pale
23 2021-04-06 loss of consciousness The patient passed out for a few seconds about 5 minutes after the vaccine administration. She was v... Read more
The patient passed out for a few seconds about 5 minutes after the vaccine administration. She was very clammy, sweaty, and alert but very groggy when the pharmacists went out to her. She also stated that her throat felt swollen and sore and that she felt like she was going to throw up. We called the EMS, and she left in the ambulance about 25 minutes after being vaccinated. We don't have any further update at this time.
23 2021-04-06 fainting Syncope, no trauma, BP. 105/61. P 80. 98% Released to home
23 2021-04-07 chest pain Chest pain. Began 8 hours after administration of vaccine at 11pm. Next day no issues until I tried ... Read more
Chest pain. Began 8 hours after administration of vaccine at 11pm. Next day no issues until I tried to eat around 4:30pm. Chest pain came in waves like something was stuck way down in my throat in my chest. Swallowing while Drinking or eating was difficult because of the pain
23 2021-04-07 loss of consciousness -Severe headache, that caused blurred and blacked out vision whenever head was moved. Also included ... Read more
-Severe headache, that caused blurred and blacked out vision whenever head was moved. Also included stabbing pain in ears as well as behind eyes. -severe diarrhea and nausea. Diarrhea and stomach cramps occured after anything was eaten or drunk (besides water) for 48 hours -fever between 101 and 102.3 for nearly 48 hours after vaccine.
23 2021-04-07 fainting Patient fainted within 15 seconds after receiving the vaccine. Patient came too within 15 seconds af... Read more
Patient fainted within 15 seconds after receiving the vaccine. Patient came too within 15 seconds after passing out. Patient was observed for approximately 30 minutes after fainting and felt well enough to go home without the pharmacy contacting the local EMS .Patient called the pharmacy when she arrived safely at home per the pharmacist's request.
23 2021-04-07 fainting At 11:32 patient noted to faint in chair and fall to the flood and begin seizing about 1 to 2 min po... Read more
At 11:32 patient noted to faint in chair and fall to the flood and begin seizing about 1 to 2 min post vaccine. Seizure lasted about 15 seconds. RN supported patients head at time of seizure. Patient was aware of where they were and noted that they were feeling nauseous and dizzy. Patient was eventually helped to a seated position where EMS transported patient.
23 2021-04-08 loss of consciousness patient experienced a wave of nausea, light-headedness, and briefly lost consciousness during vaccin... Read more
patient experienced a wave of nausea, light-headedness, and briefly lost consciousness during vaccination. When she lost consciousness, I supported her weight and she remained in the chair for approx 15 seconds until she regained consciousness. I had two technicians to assist in calling a code white and documenting the event. At 10:43 am, patient lost consciousness and regained 15 seconds later. Once I knew the patient was stable enough to support her own weight, i held her hands to make sure she was not going to lose consciuosness again. I administered an ice pack and a cool towel at 10:45 am. Code white was responded to by associates from AP and manager. I observed the patient for 15 minutes, and AP associate observed for another 15 minutes for a total of 30 minutes. The patient recovered fully and had a friend drive her home.
23 2021-04-08 loss of consciousness PATIENT COMPLAINED OF FEELING LIGHT HEADED IMMEDIATELY AFTER INJECTION OF THE VACCINE. THE PATIENT ... Read more
PATIENT COMPLAINED OF FEELING LIGHT HEADED IMMEDIATELY AFTER INJECTION OF THE VACCINE. THE PATIENT WAS MOVED TO THE PHARMACY BENCH AND WAS ASSISTED IN LYING DOWN WITH HER FEET ELEVATED. THE PATIENT WAS INSTRUCTED TO TO SLOWLY BREATHE IN AND OUT. THE PATIENT STATED THAT SHE FELT BETTER AFTER APPROXIMATELY 15 MINUTES AND WANTED TO SIT UP. THE PATIENT STATED THAT SHE DID PASS OUT FOR A FEW SECONDS. AT THIS TIME, THE PATIENT WAS FIVEN A BOTTLE OF WATER AND A CANDY BAR. THE PATIENT STAYED IN THE PHARMCY FOR APPROXIMATELY ANOTHER 15 MINUTES. A PHARMACY ASSOCIATED WALKED THE PATIENT TO HER VEHICLE TO MAKE SURE SHE WAS OK. AFTER ARRIVING AT HER CAR, THE PATIENT STATED THAT SHE WAS FINE AND DID NOT NEED ANY FURTHER ASSISTANCE.
23 2021-04-08 pallor About 5 min after vaccination (within the 15 min observation time), patient was pale, dizzy, feeling... Read more
About 5 min after vaccination (within the 15 min observation time), patient was pale, dizzy, feeling faint, sweating, and nauseous. She said she was about to pass out. She was sitting on chair with head leaning back, and resting on the wall. I raised her legs, resting on another chair. About 2 min later, she vomited. About 1 min later, she started to feel better. She asked for water, and we gave her some lukewarm water. Her face started to come back to normal, and she started to feel better and better. She sat for another 20 - 30 min, she felt better and left the pharmacy.
23 2021-04-08 lightheadedness Transient near syncopal episode.
23 2021-04-08 fainting PT FAINTED AND APPEARED TO BE HAVING SEIZURES FOR ABOUT 3 MINUTES, SHE STATED THAT IT HAPPENED TO HE... Read more
PT FAINTED AND APPEARED TO BE HAVING SEIZURES FOR ABOUT 3 MINUTES, SHE STATED THAT IT HAPPENED TO HER BEFORE! 911 WAS CALLED, HER VITALS WERE CHECKED SHE WAS STABLE AND COHERENT. SHE WAS ADVISED TO SEE HER PCP AND REPORT WHAT HAPPENED TO HER PREVIOUSLY AND AFTER SHE RECEIVED THE VACCINE.
23 2021-04-09 fainting Patient fainted shortly after getting the Janssen vaccine. She felt faint and let us know so we lai... Read more
Patient fainted shortly after getting the Janssen vaccine. She felt faint and let us know so we laid her down elevated her legs, and she fell out for a few seconds she continued to have a strong pulse. We gave her an ice pack and water after she came back and had her lay down for 10 more minutes. I checked with her a few days later she said she had fever and chills 8 hours after the vaccine but felt better.
23 2021-04-10 fainting Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unre... Read more
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: The first side effects of nausea and vomiting were reporting a few minutes after vaccination.The patient then reported some dizziness/lightheadness.Upon checking back,they changed their original report of dizziness/lightheadness to also include possible fainting.Blood pressure measurement was attempted 3 times with 2 different cuffs,but an error was displayed.It was sucessfully tested on a collaegue.EMS noted BP 120/81.Patient was coherent and conscious,albeit nervous,while conversing.
23 2021-04-10 fast heart rate At about 5 hours after receiving the vaccine at around 5 p.m., I developed a pounding headache. As t... Read more
At about 5 hours after receiving the vaccine at around 5 p.m., I developed a pounding headache. As the night continued, if I moved my head at all it would cause severe pain and a pounding headache. Additionally, I experienced shooting pains through my neck and back, I became extremely hot to the touch, yet I felt freezing cold and could not stop shivering. Then I developed severe aching and tingling from the top of my head to the tips of my toes, with excruciating lower back pain and I could feel my heart beating very fast. My entire body was tense and sore. These symptoms did not alleviate for 12 hours and I could not fall asleep due to the discomfort I was in. I finally was able to fall asleep at 6 a.m. after the aching/tingling/pain/hotness subsided (about 12 hours after side effects started).
23 2021-04-11 loss of consciousness -4 PM: intense headache -11:30 PM chills, uncontrollable vomiting -1:00 AM dizzy, fading consciousne... Read more
-4 PM: intense headache -11:30 PM chills, uncontrollable vomiting -1:00 AM dizzy, fading consciousness, full-body tingling, paralysis and stiffness of legs, difficulty breathing -2:30 AM entered ER: blood tests, Tylenol, 2 IVs -7:00 AM discharged from ER -symptoms persisted the next two days, slept most of the day
23 2021-04-11 loss of consciousness Pt. passed out, hit floor 5 minutes after vaccine. Vs 130/78, HR 68, OxSat. 98%. Pt on floor, legs... Read more
Pt. passed out, hit floor 5 minutes after vaccine. Vs 130/78, HR 68, OxSat. 98%. Pt on floor, legs elevated, water offered. Pt is now able to sit down in chair un-assisted.
23 2021-04-11 pallor Chills, shivering, fever, paleness in hands and face, vomiting, intense headache, faintness. Felt ch... Read more
Chills, shivering, fever, paleness in hands and face, vomiting, intense headache, faintness. Felt chills and fever for 1.5 hours, stood up, vomited. Vomited again 2 hours later. Intense headache overnight.
23 2021-04-11 fainting vasovagal syncope - Fainted 16 hours after receiving vaccination. Felt lightheaded when woke up. Rec... Read more
vasovagal syncope - Fainted 16 hours after receiving vaccination. Felt lightheaded when woke up. Received care from EMTs and was admitted into ER.
23 2021-04-12 chest pain, chest discomfort Approximately 4 hours after receiving the injection, I started developing a fever, within an hour it... Read more
Approximately 4 hours after receiving the injection, I started developing a fever, within an hour it had reached 103.3 F. At this point I took 400 mg of over the counter ibuprofen which helped drop my temperature slightly to approximately 102.2 F. This fever continued into the night. I took another dose of ibuprofen before sleeping, about 6 hours after the first dose. Along with fever I experienced strong shaking/chills, muscle and joint soreness, headache, dizziness, confusion, and chest pain/feeling of pressure on the chest. The day after vaccination I continued to have a low-grade fever of approximately 100 F which subsided by evening. All other symptoms subsided as well except for the chest pain. On the second day post-vaccination my only remaining symptom is the chest pain.
23 2021-04-12 heart rate increased Shaking, headache, body/joint aches, stiff neck, heavy breathing, high heart rate, dilated pupils
23 2021-04-12 loss of consciousness, heart rate increased, fainting I received the shot at 14:30, in which medical staff in the jail's medical center watched me for 20 ... Read more
I received the shot at 14:30, in which medical staff in the jail's medical center watched me for 20 minutes to ensure there were no immediate reactions. I went about my day afterward with no symptoms. At 21:30 when I went to sleep, I got some aches in my joints and took 1 dose of liquid capsule NyQuil to help with the pain and went to sleep. At 00:30, the 7th, I woke up groaning in my sleep to the extreme pain in my joints and feeling hot internally. I decided to get up and take a warm bath to ease the aches. I went and ran the bath and all of a sudden while it was running, I had a severe need to throw up, but could not naturally. Since this was concerning, I got up and walked out of the bathroom and all of a sudden in the hall I got a feeling of impending doom and that something was not right and I fainted. I laid on the floor for what I would approximate to be 5 minutes going in and out of consciousness waiting for the blood to fully return to the brain. After this, I instantly felt like I needed to survive and that I felt like I could be dying so I slowly crawled down the stairs to get to my military ID so I could call the military's nurse advice line. I had to take a break and lay on the concrete in my garage because I felt so dizzy and so hot and began to feel my vision disappear like I was going to faint again. I waited a few minutes before getting back up the stairs crawling to my phone to call. When I called them 00:58, they told me to call 911 because they believed I would be having a severe reaction, though I noted to them I did not have a rash or hives. I then called 911 at 01:08. They sent EMT's to my home which took my vitals. I had normal blood pressure, SPo2, and temp, but an elevated heart rate of just under 100 and a high respiration rate. EMT's made the decision for me to stay home since the hospital did not seem immediate in their opinion. After this I stayed on the couch for a few minutes and then felt very tired so I walked slowly to my room and fell asleep. I woke up at 06:00 for work, and arrived at 07:00. In the hour after waking up I was achy, sweating, and felt light headed. I got to work and my Sergeant told me to go home and sleep. I slept another 5 hours at 08:00 and when I woke up most of my symptoms went away other than aches and getting flush very easily for 5 days. At this current time all I notice is some random light headedness that quickly resolves and comes a few times a day at random and without cause.
23 2021-04-12 platelet count decreased patient received her J & J covid-19 vaccine on 3/14/21. She is a Pennsylvania school teacher, on 3/... Read more
patient received her J & J covid-19 vaccine on 3/14/21. She is a Pennsylvania school teacher, on 3/15/21 she developed a fever of 105F, headache, body aches, and vomiting. She was seen in the ED and d/c to home without labs. On 3/27/21 she started with unexplained bruising. Was seen by PCP 4/12/21 for unexplained bruising throughout her entire body and dizziness and CBC revealed a platelet count of 5,000. Patient was immediately advised to go to the ER for further evaluation of her symptoms.
23 2021-04-12 fainting, blood pressure decreased Feels dizzy, syncopal episode, blood pressure drop, sweaty. BP monitor by paramedics and stay low, ... Read more
Feels dizzy, syncopal episode, blood pressure drop, sweaty. BP monitor by paramedics and stay low, was transported to an area hospital emergency room or follow-up
23 2021-04-12 fainting I fainted twice the following day after my vaccine shot and hit my head against the hardwood floor. ... Read more
I fainted twice the following day after my vaccine shot and hit my head against the hardwood floor. I first fainted at around 4:00 AM on March 24, 2021 after waking up. My parents carried me down the stairs and I fainted again after that. I didn't receive any treatment afterwards. I had a fever for the entire day and was feeling dizzy and nauseous for most of that day. I haven't fainted since then but still feel a little bit dizzy every once in a while.
23 2021-04-12 fainting Fainted after receiving shot.
23 2021-04-12 fainting Syncopal Episode
23 2021-04-12 fainting syncope
23 2021-04-13 cerebrovascular accident, fainting Patient received 1 dose of the vaccine on 3/29/21. 13 days later on 4/10/21 the patient presented ... Read more
Patient received 1 dose of the vaccine on 3/29/21. 13 days later on 4/10/21 the patient presented to Hospital with an acute stroke. Patient was working out with her mother and collapsed. She presented to the ED with aphasia, right sided weakness, right nick pain and a left gaze preference. CT in the MSU was negative therefore IV tPA was given. Patient is recovering but still admitted to the Neuro ICU.
23 2021-04-13 nosebleed Fever, body pains, shivers, nose bleed, burning sensation of eyes
23 2021-04-14 chest discomfort I received my vaccine April 11th at 3 p.m and began to have a fever around 9 p.m. My fever did not ... Read more
I received my vaccine April 11th at 3 p.m and began to have a fever around 9 p.m. My fever did not go away until the next evening. On April 12th I had a fever and woke up with red little dots around my eyes. At night the fever went away. The following day April 13th I felt my chest tight and had shortness of breath throughout the day. I also had stomach pains at times. April 14th and 15th (today) my chest still feels tight and I get tired very easily. My arm is also still very sore and sensitive, I have a little bump where the vaccine was put in.
23 2021-04-14 nosebleed Fever, aches, abdominal pain, minor day nose bleed, afternoon migraines
23 2021-04-14 palpitations Headache started around 10pm. Went to sleep. Woke up at 4:30am with bad muscle aches in head, neck, ... Read more
Headache started around 10pm. Went to sleep. Woke up at 4:30am with bad muscle aches in head, neck, shoulders, arms, hips and legs. I had no appetite. I got heart palpitations, was dizzy and had the chills. I didn't think to check my temperature. I didn't start to feel normal again until Sunday evening.
23 2021-04-14 fainting Syncope
23 2021-04-20 palpitations My daughter is exactly 2 weeks out from administration. She called me today, stating her heart was i... Read more
My daughter is exactly 2 weeks out from administration. She called me today, stating her heart was intermittently racing. Felt like she has a fever, but none registered on the thermometer. Body aches, malaise present. No chest pain, shortness of breath, headache, or vertigo. She does have diarrhea x1 today. I am calling her often, to find out any other sx. I will take her for a covid test when I get off of work, if she still feels poorly.
23 2021-04-29 loss of consciousness Patient fell to floor unconscious with seizure. Mucous was coming out of mouth. Patient was placed... Read more
Patient fell to floor unconscious with seizure. Mucous was coming out of mouth. Patient was placed on side with cold gel packs place on neck and forehead. Patient regained consciousness in about 2 minutes. 911 was called. Dr. overheard page and came to assist. Patient refused ambulance when they arrived. Her boyfriend was going to take her to the ER to have the bump on head be looked at.
23 2021-04-29 fainting Fainted and fell onto ground 5 min after receiving vaccine. 911 was called, I turned down the ambula... Read more
Fainted and fell onto ground 5 min after receiving vaccine. 911 was called, I turned down the ambulance and had family take me to the hospital.
23 2021-04-30 loss of consciousness Patient reports immediately after receiving vaccine, she felt "woozy." Withing 3-4 minutes post-vacc... Read more
Patient reports immediately after receiving vaccine, she felt "woozy." Withing 3-4 minutes post-vaccination, she attempted to get out of car to get water/juice from vaccine staff and patient lost consciousness and was caught and lowered to ground by staff at vaccine site. She regain consciousness prior to being lowered on ground. VITALS at time of event: HR 60, RR 16 even and unlabored, BP 90/62 lying down. Feet were elevated until patient felt she could sit up. No c/o of n/v/diaphoresis. No dermatological changes. After lying down for approximately 5 mins, patient was able to stand and get into chair at 10:45 AM. BP at that tim e98/60, HR 74, RR 16. At 10:50 AM, patient reports she felt back at baseline in NAD. A&O x 4, her parents did come and pick up her for transport home. Patient self reported history of syncope with medical procedures and events in past.
23 2021-05-01 body temperature decreased, loss of consciousness Immediately after receiving the shot I began to have fairly intense pain at injection site. It conti... Read more
Immediately after receiving the shot I began to have fairly intense pain at injection site. It continued in waves. I began to walk around the store for the allotted 15 minutes. I began to feel very dizzy and faint. My ears began ringing and I didn?t feel well. I stumbled back to the pharmacy to ask for help. At this point I was also feeling like it was very hard to breathe. I explained all these symptoms to the pharmacists on duty and they told me to just sit down. After sitting down I still felt faint but suddenly felt the need to vomit. I stumbled to the bathroom where I collapsed in front of the toilet and passed out twice, striking my head and throat on the bowl. After awaking I was very disoriented and felt very hot and clammy. The pharmacist then came and found me and told me to once again sit down and continue waiting. After sitting down for about 5 more minutes I began to feel less dizzy and was having an easier time breathing. I left the store as the pharmacist was ignoring me and didn?t seem concerned about my symptoms. After arriving home I was tired and week and very very cold. I noted my body temp was lower than usual. I took a nap and then these symptoms continued for about 24 hours. I am now feeling much better.
23 2021-05-02 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pati... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: patient passed out due to anxiety-Mild, Systemic: Flushed / Sweating-Mild
23 2021-05-04 fainting, loss of consciousness After about 5 minutes after receiving the vaccine, the husband of the patient came to the pharmacy t... Read more
After about 5 minutes after receiving the vaccine, the husband of the patient came to the pharmacy to notify the pharmacist that the patient had fainted. The pharmacist had technician call 911 and the pharmacist went to evaluate the patient. Upon arrival, the patient had gained consciousness. The pharmacist got a BP and HR. Talked to patient until EMS arrived. After talking with EMS, the patient left with the husband.
23 2021-05-08 fainting Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
23 2021-05-09 heart rate increased HEADACHES; HEART RATE INCREASED; FEELING HOT; SORE LEFT ARM AND LEGS ACHY; CHILLS; FEELING WEAK; Thi... Read more
HEADACHES; HEART RATE INCREASED; FEELING HOT; SORE LEFT ARM AND LEGS ACHY; CHILLS; FEELING WEAK; This spontaneous report received from a patient concerned a 23 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: 207A212A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 18:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart rate increased. On 06-MAY-2021, the subject experienced feeling hot. On 06-MAY-2021, the subject experienced sore left arm and legs achy. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced feeling weak. On 06-MAY-2021 04:00, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, had not recovered from feeling hot, headaches, sore left arm and legs achy, and feeling weak, and the outcome of chills was not reported. This report was non-serious.
23 2021-05-12 fainting Patient received vaccine and fainted. Significant other was with patient at the time and reported pa... Read more
Patient received vaccine and fainted. Significant other was with patient at the time and reported patient "convulsing". Patient reported feeling numb and tingly at extremities and hyperventilating. Patient was sweating and extremely anxious. EMT arrived, assessed patient, and escorted patient out of facility.
23 2021-05-17 loss of consciousness patient passed out on floor and appeared to have seizure like symptom. Felt faint , dizzy, and flush... Read more
patient passed out on floor and appeared to have seizure like symptom. Felt faint , dizzy, and flushed. called 911. Medical team arrived and patient proceeded to get nauseated and throw up.
23 2021-05-17 lightheadedness HX VASOVAGAL EPISODE. AFTER RECD J AND J VACCINE, EYES ROLLED, UNRESPONSIVE X 30 SECS, THEN BECAME R... Read more
HX VASOVAGAL EPISODE. AFTER RECD J AND J VACCINE, EYES ROLLED, UNRESPONSIVE X 30 SECS, THEN BECAME RESPONSIVE, BP 106/76 HR 59. CODE GREEN CALLED, SX RESOLVED, NO TRANSPORT.
23 2021-05-17 fainting Pt presented to ER early the following am, with seizures. Pt reports having a small reactions immedi... Read more
Pt presented to ER early the following am, with seizures. Pt reports having a small reactions immediately after vaccine administration. Pt reports muscle stiffness, eyes rolling back, shaking, diaphoretic. Pt also reports having a second episode of syncope when she arrived home.
23 2021-05-20 chest discomfort Client experienced a brief episode of chest tightness and shortness of breath immediately after rece... Read more
Client experienced a brief episode of chest tightness and shortness of breath immediately after receiving vaccine. She gave herself her own albuterol at 935. Her chest tightness resolved within 5 minutes and was able to leave by the end of her 15 minute wait time.
23 2021-05-20 fainting I woke up around 12:30 in the morning and felt achy. I fainted twice after getting out of bed. I exp... Read more
I woke up around 12:30 in the morning and felt achy. I fainted twice after getting out of bed. I experienced severe aches and body chills. I felt fine the day after better.
23 2021-05-21 fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed us prior to vaccinati... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed us prior to vaccination that she is prone to fainting and this happens when she receives vaccine or gets blood draw.
23 2021-05-23 fainting patient received vaccine and got dizzy and fainted
23 2021-05-24 blood glucose increased I have an extreme fear of needles and we thought that the dizziness came from that and the nauseous ... Read more
I have an extreme fear of needles and we thought that the dizziness came from that and the nauseous came from that as well, that night I had a tough time sleep because my arm was so painful and over the next several days my arm had became inflamed and red we noticed that my sugar had started climbing. So I was kinda okay Monday still kinda sick and nauseous at 6:00 am that morning I started to throw up and I threw up at 6 times my mother had to call 911 and I was taken to hospital in the squad my sugar was 501 I was dka, I had to go without food and water for over a day. I had complications with the insulin and the shot was causing my sugar to rise and there were complication. I was not able to lay on my left for a week longer maybe a little longer. I think my shot was infected it started to leak white goop as well. I was on an insulin drip for a while, my pump was not working so I had to stay longer until a new pump came. I went into the er Tuesday morning and came out Thursday morning
23 2021-05-25 chest discomfort Pain in abdomen and lung pressure when taking a deep breath. Symptoms started at about 4:00pm on Sun... Read more
Pain in abdomen and lung pressure when taking a deep breath. Symptoms started at about 4:00pm on Sunday 5/23/2021
23 2021-05-25 loss of consciousness The day I got the vaccine I had been having health problems. I had been having withdrawal from one o... Read more
The day I got the vaccine I had been having health problems. I had been having withdrawal from one of my medications and I had lost weight. Right away after the shot I passed out and when I came to, I threw up a couple of times. I was taken to the ER and I had low potassium levels were low, but all other tests were normal. I had some aches pains and feverishness for a couple of days. Five days after the vaccine I had bad diarrhea several times a day. I was nauseous and feeling bad. I had an appointment with my GI doctor a week later but I had to go to the ER before that. They did not find anything in most tests. The next day I tested positive for CDIFF. I was prescribed antibiotics. I went back to the ER a third time because the Vancomycin prescription had caused severe nausea. I am still feeling bad after six weeks but it has gotten better.
23 2021-05-31 chest discomfort FEELING DIZZY; CLAMMY; TIGHNESS ON CHEST; NAUSEA WITHOUT VOMITING; This spontaneous report received ... Read more
FEELING DIZZY; CLAMMY; TIGHNESS ON CHEST; NAUSEA WITHOUT VOMITING; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient has no allergies, no drug abuse or illicit drug usage. patient was non smoker and consume alcohol sometimes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and batch number: 207A21A) dose was not reported, administered on 27-MAY-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling dizzy. On 27-MAY-2021, the subject experienced clammy. On 27-MAY-2021, the subject experienced tighness on chest. On 27-MAY-2021, the subject experienced nausea without vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, clammy, nausea without vomiting, and tighness on chest. This report was non-serious.
23 2021-06-01 fainting Patient fainted for 3-4 seconds after receiving the Janssen vaccine. Patient fainted in chair, woke ... Read more
Patient fainted for 3-4 seconds after receiving the Janssen vaccine. Patient fainted in chair, woke up after a few seconds. Per patient, has history of fainting (but not due to vaccines). Patient stated that she worked an overnight shift and had nothing to eat or drink all day.
23 2021-06-06 sinus rhythm 1530: Patient complained of dizziness X 10 mins. Patient states that she has had episodes like this ... Read more
1530: Patient complained of dizziness X 10 mins. Patient states that she has had episodes like this before when nervous or anxious. NP and EMT quickly assessed patient, and provided water. Vitals BP 108/75 HR 54 O2 99% RA. 1540: Second set of vitals 119/71, HR 71, O2 99%, BG 99 1600: Third set of vitals 130/88, HR 70, 02 99%. Patient stated she felt better and did not want any further medical intervention. Patient is with group of friends, and will be riding in an Uber back home.
23 2021-06-10 heart rate increased Patient did not feel well after receiving vaccination. Indicated that she developed a cough, shortn... Read more
Patient did not feel well after receiving vaccination. Indicated that she developed a cough, shortness of breath and increased respirations and pulse. She admitted to the hospital on 6/8/21 and was diagnosed with pneumonia.
23 2021-06-10 fainting Pt received the vaccine, when she got up to leave, she started feeling faint. She walked approx 20 ... Read more
Pt received the vaccine, when she got up to leave, she started feeling faint. She walked approx 20 ft away from the pharmacy when she fainted. Her boyfriend caught her and another bystander asked for help. The pharmacist went out to help, lowered the Pt to the floor, pt lied supine until pt became conscious. Pt was asked to stay supine for 3-5 minutes before she was helped to a chair. Pt's pupil were initially dilated, pt's radial pulse was hard to find initially. After pt was seated in a chair, her pulse was 98, pupils were perl, no N/V, no abdominal discomfort. Pt stayed seated near the pharmacy for 30 minutes for further monitoring, Pt said she felt fine, pulse 78, strong and regular, pupils perl. Pt's boyfriend took her home. Pt called vaccinator a hour later and reported she felt fine .
23 2021-06-22 chest pain 102.3 9:00pm 06/11/21 102.8 10:00pm 102.5 11:00 pm 2 acetaminophen at 1222am 102.2 -1:30am 101.1 1:5... Read more
102.3 9:00pm 06/11/21 102.8 10:00pm 102.5 11:00 pm 2 acetaminophen at 1222am 102.2 -1:30am 101.1 1:50am 100.3 2;07am 100.0 2:33am 98.3 3:49am 98.5 6:30am 2acetaminophen 6:35am 98.6 11:38am 100.4 1:28pm 100.5 2:15pm 101.0 3:00pm 2 acetaminophen 3:05pm HR & o2 96 3:06pm 100.2 3:33pm 99.5 4:01pm 98.3 4:36pm 98.3 5:09pm HR 74 o2 97 5:11pm 98.4 7:08pm 98.0 8:53pm 98.8 9:52pm 98.9 10:53pm 98.0 11:20pm 99.1 1:33pm HR 90 o2 98 1:34am 97.9 7:20am 96.8 8:54am 97.4 10:24 am sweating 96.7 10:22pm 98.2 11:38pm HR 65 o2 98 2:07am 97.3 2:09am 96.4 11:38am Fever Muscle ache/pain (lower back, arm and chest) Can barely move my arm Throbbing Headache Almost vomiting Slight dizziness Congestion Sneezing
23 2021-06-24 fainting A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine.... Read more
A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine. Around 8 am looked for the employee health nurse to get medication for nausea and headache. She was then making tea and was noted not to be feeling well and fainted. Another employee found her on the floor, and her heart rate was 115, and BP was 112/64 with a 100-degree temp Fahrenheit. A couple of hours prior, her temp was 97 degrees Fahrenheit. She looked diaphoretic, hypoglycemic, and was too weak to get off the floor, there was a maxi lift used to transfer to a wheelchair, and she was very dizzy. The only medicine taken was Pepto Bismol for nausea.
23 2021-07-07 fainting Approximately 15 seconds after administration of the vaccine the patient passed out. The patient al... Read more
Approximately 15 seconds after administration of the vaccine the patient passed out. The patient almost immediately regained consciousness and shook a couple of times. The pt. reported feeling dizzy so I moved her to the waiting area, with her mother, to wait to make sure she was feeling ok and that there were no more adverse reactions. After 5 minutes the pt. reported that her legs felt like jelly, that her head and legs felt like they were burning and that her throat was feeling dry/tight. I gave the pt. 25mg of oral diphenhydramine and immediately called 911. I monitored the patient and her breathing until the paramedics arrived. Upon arrival the paramedics took over the patient care, the pt. was eventually transported to the hospital.
23 2021-07-19 palpitations Palpitations, headaches, lightheadedness
23 2021-07-20 haemoglobin decreased, anaemia, heart rate increased Menorrhagia for 2 straight months leading to abnormal lab test with severe anemia and critically low... Read more
Menorrhagia for 2 straight months leading to abnormal lab test with severe anemia and critically low RBC and hemoglobin levels. Elevated heart rate upon exertion. Needed 1 pint of blood for a transfusion and an iron IV
23 2021-07-20 heart rate increased, ischemic chest pain High fever of 105, vomiting, sweats for multiple days. Then after that, my taste and smell have been... Read more
High fever of 105, vomiting, sweats for multiple days. Then after that, my taste and smell have been strange for months. Constant heart pain, fast heartbeat, fatigue, out of breath
24 2021-03-02 fainting Patient was given the vaccination and then waited seated for 15 minutes. At 15 minutes patient sta... Read more
Patient was given the vaccination and then waited seated for 15 minutes. At 15 minutes patient started to stand and then fainted. Patient was breathing and had a pulse. Patient was placed on back and feet elevated and 991 was called. Patient was coming too as paramedics arrived. paramedics checked vitals. Eventually patient was able to walk out on her own and did not want to go to hospital.
24 2021-03-06 heart rate increased Headache, body aches, fever, hot flashes, chills, high heart rate
24 2021-03-06 palpitations Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm,... Read more
Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm, lasting until ~11:30 pm Chills (severe) starting around 7:00 pm, lasting until 10 pm Palpitations starting around 9 pm, lasting until 11:45 pm Mild injection site pain starting 1:30 pm, still occuring (12:15 pm on 3/7/21)
24 2021-03-08 pallor Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate... Read more
Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation for 15 minutes after her vaccine. Within a minute or so patient felt light headed and like she might pass out. She notified the technician who was right there and he notified me. I assisted her to a sitting position on the floor from her chair and I was able to ease her back to a lying down position from there with her head on the floor and feet elevated above heart on a chair. Patient was able to talk the whole time. She told us at that point when she was younger she was scared of shots and had fainted when having them, but thought she was past that and did not mention it during screening. She said she was surprised to feel this way because she was so excited about getting her COVID vaccine. She had not eaten much today (a small snack) and had rushed here for her appointment without getting food. I checked her blood pressure while she was lying down and it was 94/63 and pulse of 75. She said she normally had lower end of normal blood pressure. She was pale when I started checking her, but her color began to return to normal within minutes. After 5 minutes she felt well enough to sit up and we got her a granola bar and water. She remained this way for 5 minutes and felt good, so we moved her to sitting in a chair and got her a pepperoni and cheese snack tray from the cafe. She ate this and waited for 10minutes and felt good. We walked her to her car and she felt fine. I called to verify she got home fine and she did.
24 2021-03-08 fainting, hypotension Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypote... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: Patient fainted 10 minutes after administration of Janssen vaccine. Patient was unconscious for about 15 seconds before regaining consciousness. 911 was called and EMT arrived on scene to monitor's patients blood pressure and blood sugar. Patient still reported lightheadedness so was taken to hospital by EMT/ambulance.
24 2021-03-09 heart rate decreased, loss of consciousness, blood pressure decreased After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto flo... Read more
After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto floor and +hit back of her head. She does report history of syncope after injections. BP 96/58, P48, R17, O2=98%. Alert and oriented. No deformity. Moving all extremities. Denies headache, nausea. She was on stretcher and after 15 minutes felt better.
24 2021-03-09 fainting Pt fainted in waiting area after her vaccine. She was fine after I tended to her. It was about 5 min... Read more
Pt fainted in waiting area after her vaccine. She was fine after I tended to her. It was about 5 min after her vaccination. After talking to her, it was determined that she has anxiety and she has fainted with blood draws in the past.
24 2021-03-10 heart rate increased Sunday night, my heart started pounding really hard. I went to ER - Medical Center. They did an EKG ... Read more
Sunday night, my heart started pounding really hard. I went to ER - Medical Center. They did an EKG and took my vitals. I had a fever (slight) and chills and was nauseous. Put ONDANSETRON -4 mg. The nausea didn't go away and I couldn't eat or drink without vomiting until today. I couldn't eat or drink or was very tired and groggy and miserable. Today I had another trip to the ER Medical, I got on an antibiotic and anti-nausea medication (GETHALEXIN - 500 mg for the GI) (METOCLOPRAMIGE HCL - 5 mg- for nausea) from the hospital and I had a shot that went into my immune system. They also found a UTI today.
24 2021-03-13 fast heart rate, chest pain Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was... Read more
Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was performed to search for other causes and none was found, ultimately patient was treated as moderate anaphylaxis, symptoms improved with fluids, steroids, benedryl, and she was discharged with strict return precautions and outpatient followup.
24 2021-03-19 fainting Sudden nausea and vomiting the morning after vaccine (8:30am; got vaccine at 6:10 the night prior). ... Read more
Sudden nausea and vomiting the morning after vaccine (8:30am; got vaccine at 6:10 the night prior). After getting sick, suddenly got very lightheaded and dizzy and fainted in shower. Awoke and had severe fever and headache the rest of the day after vaccine (102°F fever).
24 2021-03-23 fainting muscle aches, syncope, fatigue, dizziness for 36 hours post vaccine
24 2021-03-26 heart rate irregular About 5 hours after my vaccine I had already been asleep for around 30 minutes when I was startled a... Read more
About 5 hours after my vaccine I had already been asleep for around 30 minutes when I was startled awake by my own rapid heartbeat, it was beating so fast and hard that I could hear it and it woke me up. I reviewed my literature about the vaccine I received at the pharmacy and saw this reaction could be due to an allergic reaction but as an uninsured person I had to just wait it out to see if it would go away. I drank a lot of water and started developing a headache but my heart rate finally slowed down enough that I was no longer alarmed, but it was still faster than usual. I went back to sleep around 2am only to awake once again around 5am because I had begun to experience the worst body aches I?ve ever felt as well as nausea and a pounding headache. I live on a semi truck with no bathroom so my fiancé had to take me to my parents house so I would have access to a bathroom. I took ibuprofen and Tylenol for my pain and took 6 showers in 24 hours just to soothe my body aches. It felt worse than any flu I?ve ever had (I received the flu vaccine back in January if that matters). I was extremely ill and had no appetite and pretty much just slept and cried for about 36 hours total, but yesterday afternoon I finally felt a little better although still experiencing a terrible headache. Today I woke up feeling completely fine. I just wanted to report my side effects.
24 2021-03-29 fast heart rate, blood pressure increased Patient began having anxiety, nausea, headache, tachycardia, elevated BP. Patient was walked to nur... Read more
Patient began having anxiety, nausea, headache, tachycardia, elevated BP. Patient was walked to nursing staff for further observation.
24 2021-03-30 pallor Patient reported feeling nauseated and lightheaded a few minutes after administration, then became e... Read more
Patient reported feeling nauseated and lightheaded a few minutes after administration, then became extremely pale and head went backwards. Moments later patient's face became red and body convulsed once. Blood pressure and HR taken three times by nurse in the clinic. 2:15 pm 75/58 HR 94 2:20 pm 68/50 HR 88 2:40 pm 80/58 HR 88 Patient felt better and left 3:00 pm
24 2021-03-31 heart rate increased I got hot and my throat started to close up before I got dizzy and nauseous. Then my heartbeat spike... Read more
I got hot and my throat started to close up before I got dizzy and nauseous. Then my heartbeat spiked and I got really loopy and uncoordinated while having trouble breathing. That night I got the chills and a fever of 102.
24 2021-03-31 loss of consciousness Pt stated before getting vaccine that she might "pass out". 20-30 seconds after vaccination, she sta... Read more
Pt stated before getting vaccine that she might "pass out". 20-30 seconds after vaccination, she stated, "things are going dark" and then lost consciousness. BP was 122/80, and pt woke about around 40 seconds later. After approx 3 minutes later, she was able to sit up. Water was given and she left after a 30 minute observation, walked out on her own.
24 2021-04-02 loss of consciousness I passed out in my bathroom the morning after the vaccine shot around 5:30am. I called the doctors a... Read more
I passed out in my bathroom the morning after the vaccine shot around 5:30am. I called the doctors and they said that was unrelated to the vaccine, but I had intense dizziness and tinnitis before I passed out. I was incredibly fatigued all day long for the rest of the day and had a migraine - both to be expected. However, I am 3 weeks post-vaccine (April 3) and have been having intense muscle cramping and fatigue in my legs during exercise. I wake up with muscle soreness that goes away throughout the day and then comes back during exercise.
24 2021-04-04 heart rate increased At around 9:15 PM I started to feel nauseous and got out of bed to go to the bathroom. While using t... Read more
At around 9:15 PM I started to feel nauseous and got out of bed to go to the bathroom. While using the bathroom I felt a very strong chill come over my whole body and started shivering and got directly back into bed and wrapped myself up in a thick blanket. For 45 minutes I laid wrapped up and was shivering constantly. At 10 pm I was brought extra blankets and a heating pad but moving to get situated caused dizziness. It was about 10:30 when the shivering stopped. I was able to sleep but got up to go got the bathroom around midnight and my entire body was drained of energy and I felt that I could barely stand and walk on my own. I was dizzy and my head hurt as well. I could barely hold my arms up to look at my phone briefly. Between 11 PM and 2 AM I had 5 or 6 high heart rate alerts (over 120) according to my Apple Watch but I did not wake up to them. In the morning (Sunday 4/4/21) around 9-10 am my head still hurt and my body was very achy and I felt very hungover. All day I continued to feel achy almost with a bad cold or a minor flu. Today has been better but I have still felt pretty drained. I?ve had continuous arm soreness in the arm I got the injection - but nothing too severe. 15 minutes after my vaccine on Saturday 4/3/21 I took 600 mg of ibuprofen and around midnight of that night I took 2 of pain relief PM acetaminophen (1000 mg of acetaminophen total snd 50 mg of diphenhydramine HCI total)
24 2021-04-04 pallor At approximately 0945 this nurse witnessed patient sitting in the observation area with her head til... Read more
At approximately 0945 this nurse witnessed patient sitting in the observation area with her head tilted to the left side and her body leaning to the left. The medical assistant was with her holding her body up. Her eyes were closed and she had no color to her face and lips. She was not able to respond to questions being asked. As her head was shaking she was making grunting noises. She was diaphoretic and tremulous. This episode lasted for approximately 60 seconds. Pt then opened her eyes and was able to respond to questions asked but with a delayed response. Pt was moved to the stretcher to lay down. Her color came back to her lips and her blood pressure improved. She was responding to questions appropriately. Pt was diaphoretic for approximately 10 minutes. Ice packs and water were provided. Pt was observed by the medical assistant for 30 minutes. Her HOB was elevated gradually until she was able to dangle her feet and sit on the side of the stretcher. Pt stated that she was feeling better and was ready to go be with her roommate. Vital signs were taken and BP 91/54, HR 70, O2 97%. At 0952 HR was 62. 1005 BP 102/67, HR 57 O2 99%.
24 2021-04-05 chest pain Client complained of complained of flushed face, swelling to hands, headache, vision changes and diz... Read more
Client complained of complained of flushed face, swelling to hands, headache, vision changes and dizziness after receiving Janssen Covid vaccine (lot 1808980 exp 6/20/21). Client was walking out of waiting room and approached the PHN to inform she was not feeling well. Client assisted to closest chair, EMT joined in and started vitals as PHN did assessment. Per client started feeling mild symptoms after 5mins and by 15 mins symptoms had progressed. Client did not alert anyone until her time was done and she began to walk at 1125. Client alert and oriented, flushed face, mild diaphoresis, per client spots in vision, swelling to hands, left hand more, and headache. Client denied shortness of breath, chest pain. History of allergy to penicillin. No other pertinent medical history. Vitals 1125: blood pressure 140/98, pulse 99, oxygen 100%. Client transfered to gravity chair and given water. Client wanted to call husband to come pick her up. 1134: pulse 97, oxygen 98%. Client stated pressure behind eyes. PHN offered client benadryl, flushed face continued, headache, swelling to hands. Client accepted as husband was on his way. Benadryl 50mg PO given at 1137. Vitals 1139: blood pressure 150/90, pulse 95, oxygen 98%. Per client dizzy, felt warm across face, headache, pressure around eyes, swelling on hands and flushed face. Client denied shortness of breath. Client asked if she wanted 911 to be called for further assessment, client denied, she stated she would continue waiting. Vitals 1144:blood pressure 130/90, pulse 97, oxygen 90. Per client headache gone, no flushing, felt tired. 1148 swelling on hands was improving. Vitals 1152: blood pressure 110/80, pulse 89, oxygen 96%. No headache, just pressure on forehead, no flushing, blurry vision improving. Vitals 1157: blood pressure 126/90, pulse 90, oxygen 97%. Per client all symptoms improving. Wanted to sit straight on chair. Client stated felt well enough to go home. Pressure on head was only symptom at this time. Client given ER precautions. Husband was going to driver her home. Last vitals at 1205: blood pressure 120/90, pulse 86, oxygen 97%. Alert and oriented, stood up with no complaints of dizziness. Client walked out of facility with steady gait
24 2021-04-05 heart rate increased Started with headache, fever, chills all at once. Two hours later my entire lower back hurt like cra... Read more
Started with headache, fever, chills all at once. Two hours later my entire lower back hurt like crazy. The only thing that made it better was walking but lying down or sitting felt like the worst thing in the world. Nausea much later in the night and my heart rate was higher than normal for the most part. My resting rate is usually 57-62 bpm but this time it was ranging between 100-108bpm. Arm soreness Back pain was mostly felt on the left side and accompanied by leg pain. I?ve had back pain in the past but this was x100 worse to the point where I considered going to the ER. My final symptoms were nausea but waking up this morning I feel fine
24 2021-04-06 loss of consciousness Patient received her Janssen COVID vaccine and was sitting in a chair in the conference room when sh... Read more
Patient received her Janssen COVID vaccine and was sitting in a chair in the conference room when she slumped over in her chair and became unresponsive. Patient had just received her one dose Janssen vaccine and was sitting in a chair approximately 3-5 minutes after receiving the vaccine. She began to slump over in her chair and was unresponsive. Two RNs responded to assess the patient. Patients feet were elevated and ice packs applied to her neck and axillary areas. Patient was breathing and had a pulse. Patient responded to her name once and then passed out again. Patient was unable to respond after this. Her eyes were open. Patient was lifted into a wheelchair by three nurses and brought to a private area. Patient was warm and sweat was running down her face. Her sweater was removed and ice packs again were applied to her neck and axillary area. Patient continued to have a pulse and was breathing. EMS was called. Patient slowly began to come around and could answer questions after about 5 minutes of being unresponsive. She was confused and had no memory of what had occurred. She reported feeling light headed and seeing spots in her vision. She continued to feel light headed. EMS assessed patient. Vitals were stable and blood sugar was WDL. Patient reported feeling much better. She denied feeling light headed or dizzy any longer. She was able to answer all questions asked. Patient did not want to go to the hospital and refused transport to the hospital via ambulance. She was observed for an additional 20-30 minutes at which time her boss arrived to pick her up. She was educated on calling 911 if she began to feel light headed or dizzy again. Patient verbalized understanding. She was walked to the car by an RN.
24 2021-04-06 loss of consciousness The patient received the vaccine and was waiting her 15 minutes to make sure she didn't have any rea... Read more
The patient received the vaccine and was waiting her 15 minutes to make sure she didn't have any reactions. Approximately 8 minutes after the vaccine was administered and the patient passed out . She did not report that she was not feeling well until after she came to. She then reported dizziness and nausea. She laid on the floor in the recovery position on the floor for about 30 minutes before feeling ok enough to sit in the chair and eventually be able to walk out of the store.
24 2021-04-07 fainting, pallor Patient fainted right after receiving her shot. She woke up immediately after, though very pale and... Read more
Patient fainted right after receiving her shot. She woke up immediately after, though very pale and shaky. Patient stayed laying down for 15 minutes until she felt better and left under her own power with no problems.
24 2021-04-07 fainting Pt received her 1st dose of the J&J Covid19 vaccine. While sitting in observation the pt reported fe... Read more
Pt received her 1st dose of the J&J Covid19 vaccine. While sitting in observation the pt reported feeling dizzy and faint. BP 100/70 HR 70 O2Sat 98% . Pt was laid down. EMS called and evaluated the pt. Pt signed refusal for transport to the ED. Pt reported feeling better prior to leaving.
24 2021-04-07 fainting Patient reported feeling nauseated, lightheaded, dry heaving, near syncopal episode Patient provided... Read more
Patient reported feeling nauseated, lightheaded, dry heaving, near syncopal episode Patient provided with food and water and seen by medical team Patient stated symptoms improved and refused medical transport and signed AMA form Patient will be driven home by mother
24 2021-04-08 chest pain Severe abdominal cramps, severe chest pain, neck pain and headache, severe joint pain, muscle aches ... Read more
Severe abdominal cramps, severe chest pain, neck pain and headache, severe joint pain, muscle aches and weakness and shakiness. Started 6 hours after receiving vaccine and is ongoing at 30 hours post vaccination.
24 2021-04-08 fainting Syncope a few minutes after injection, nausea dizziness sweating blurred vision
24 2021-04-09 loss of consciousness Initial injection was recieved with arm extended out and raised in car window. Really painful inject... Read more
Initial injection was recieved with arm extended out and raised in car window. Really painful injection. Several seconds after vaccine injected I felt a wave of chills on my body and immediately started profusely sweating. Seconds after that i then began to get extremely dizzy, blacking out, trying to stay conscious for a personnel to walk by and after a few moments the feeling slowly lightened up minus the excessive sweating and chills. Personnel then told me it was just anxiety and brushed it off. I have never had a reaction like this from a vaccine before so this experience was unsettling.
24 2021-04-09 lightheadedness Patient become dizzy and very close to passing out after vaccine. As patient became closer to passin... Read more
Patient become dizzy and very close to passing out after vaccine. As patient became closer to passing out she was laid down on floor and immediately improved. After a couple minutes patient was monitored in waiting room and began to again experience dizziness and come close to passing out. We again moved her to the floor in our vaccinate room where to immediately improved. After monitoring for another 5 or store minutes patient said she was good and stayed in the store for another 15 minutes with no issues. Patient did report prior issues with dizziness following vaccines.
24 2021-04-10 loss of consciousness Client loss consciousness for approximately 2 minutes following vaccination. Client did not fall, no... Read more
Client loss consciousness for approximately 2 minutes following vaccination. Client did not fall, no other injury. Client assisted to wheelchair, taken to EMS OBS area, Vitals monitored, client recovered, vitals with in normal limits. Client left site with mother in stable condition.
24 2021-04-10 fainting Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT WAS SITTING WAITING HER 15 MIN... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT WAS SITTING WAITING HER 15 MINUTES AFTER GETTING INJECTION. HER MOM CALLED FOR HELP AND ANOTHER PERSON AND I RAN OVER AND ASSISTED HER AS HER DAUGHTER WAS UNRESPONSIVE. TOGETHER AS WE WENT TO PUT HER ON HER SIDE SHE CAME BACK AND ALL WAS OK. WHOLE EPISODE WAS ABOUT 10-15 SECONDS.
24 2021-04-10 fainting PATIENT EXPERIENCED SYNCOPE 15 TO 20 MINUTES AFTER SHOT WAS ADMINISTERED. HELD AND COMFORTED UNTIL ... Read more
PATIENT EXPERIENCED SYNCOPE 15 TO 20 MINUTES AFTER SHOT WAS ADMINISTERED. HELD AND COMFORTED UNTIL CONSCIOUSNESS WAS REGAINED. OBSERVED FOR ADDITIONAL 30 MINUTES BEFORE PATIENT LEFT AT HER OWN WILL
24 2021-04-10 fainting Five minutes after I received the vaccine, I fainted in my chair for 1-2 minutes. I awoke in a sweat... Read more
Five minutes after I received the vaccine, I fainted in my chair for 1-2 minutes. I awoke in a sweat, and the pharmacist called 911. The paramedics checked my vitals and cleared me to go.
24 2021-04-11 loss of consciousness Patient began to feel dizzy around 10 minutes of waiting after the vaccine administration. Patient ... Read more
Patient began to feel dizzy around 10 minutes of waiting after the vaccine administration. Patient then began to vomit but could not get all of the vomit out of her throat. She then passed out. Patient was lethargic and difficult to arouse. Patient's blood pressure was 122/80. Medics were called and arrived on scene and took patient to the ER.
24 2021-04-11 pallor Patient said she is scared of needles and has fainted after injections. Immediately after injection ... Read more
Patient said she is scared of needles and has fainted after injections. Immediately after injection she said she felt dizzy then she slumped in her chair and closed her eyes was unresponsive and pale for about a minute. When she responded she was slightly confused for about 30 minutes sat up drank water and put cold paper on her forehead and her back of her neck. Rested for half an hour. Then walked assessed to observation area.
24 2021-04-11 fainting Patient fainted shortly after receiving dose on 4/10. Patient did respond shortly afterwards and wa... Read more
Patient fainted shortly after receiving dose on 4/10. Patient did respond shortly afterwards and was given juice and a ice pack. Continued to monitor for some 30 plus minutes prior to releasing. Called patient around 5PM same day, patient sounded great and was doing well. Note: Patient has a history of fainting upon vaccine admin. but did not indicate to provider prior to administering vaccine. Patent called at moms request on 4/12 at 9:54 am and indicated she noted upon waking 2 hives in crevasse of arm which spread to all over body. Advised patient to call MD office for guidance and speak to live person. Spoke to doctor's office whom indicated they would address hives condition and then advise provider this provider.
24 2021-04-11 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted due to low blood sugar h... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted due to low blood sugar having skipped breakfast. Recovered within minutes after sitting down and drinking water.
24 2021-04-12 chest pain Sharp chest pain that was attributed to heartburn/acid reflux from 1 day after injection until prese... Read more
Sharp chest pain that was attributed to heartburn/acid reflux from 1 day after injection until present (04/08/2021-04/13/2021). Fever and chills 1-2 days after injection (04/08/2021-04/09/2021) Muscle pain at injection site 0-3 days after injection (04/07/2021-04/10/2021)
24 2021-04-12 nosebleed, nosebleed THREE DAYS AFTER VACCINATION, MY DAUGHTER STARTED BLEEDING INTENSIVELY THRU HER NOSE. PRESSURE WAS ... Read more
THREE DAYS AFTER VACCINATION, MY DAUGHTER STARTED BLEEDING INTENSIVELY THRU HER NOSE. PRESSURE WAS APPLIED BUT HEMORRAGE LASTED FOR 15 MINUTES. AT THE END, A BLOOD CLOT WAS EXPELLED NASALLY.
24 2021-04-12 heart rate increased Pt has experienced dizziness and intermittent increased heart rate since the day after her vaccine.
24 2021-04-12 heart rate increased First day - Wednesday: Return home from work for lunch around 12am. - leg pain (really bad, muscul... Read more
First day - Wednesday: Return home from work for lunch around 12am. - leg pain (really bad, muscular-like pain. Ache, sore. Would flare. Sometimes in knees, mostly in calves... continued until midway through the night) - fatigue (felt just a little more tired than normal, really tired by bed time: 9pm) - heightened heart rate (excitement from vaccine / apprehension for potential illness?) Second day - Thursday: - fatigue (tired all day, almost fell asleep through a couple meetings) - leg pain (reappeared in the morning, ached and throbbed. Made it difficult to relax. Was gone around 3/4pm) - headache (probably from dehydration, I was warm, but not completely a fever. Attempted to drink a lot of water, but too much made me nauseous) - chills (sporadic, barely noticeable except it agitated the headache) - nausea (I barely ate more than a granola bar and attempted to drink water and tea, but too much made me sick, especially if it had sugar - mainly drank water. Had some soup later in the day (6pm) and most of the nausea went away)
24 2021-04-12 loss of consciousness Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to v... Read more
Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to vomit, extreme nausea. Passed out, unconscious within 5 minutes of receiving the shot. Could not sit up/dizzy for 30 minutes. Nausea, weakness, dizzy, poor mental acuity/memory. Later that night, and through the night for 10 hours, severe back pain. Nausea, severe weakness, dizzy, poor mental acuity and memory, sweats and chills. The next day (day immediately after receiving vaccine) symptoms continued but lessened by 5 pm. Each day since then, the symptoms have ALL remained in a more mild form. Today is day 6 and I still have moderate back pain and occasional sweats, weakness and fatigue.
24 2021-04-12 fainting, loss of consciousness Prior to administration of Janssen Covid-19 vaccine the patient was anxious but was completely fine ... Read more
Prior to administration of Janssen Covid-19 vaccine the patient was anxious but was completely fine once the procedure commenced and concluded. After finishing explaining the possible side effects of the vaccine and handing the patient the V-Safe handout, she got up slowly and proceeded to our designated post vaccination monitoring seating arrangement. Upon concluding the vaccination process with the patient?s partner, she alerted the pharmacist that she does not feel well. To which he asked her to further elaborate on what she is experiencing. She began to say she thinks she?s going to faint as she is attempting to drink water. As she was having a drink of water she fainted. To which he responded by running over and catching her before she hit the ground, cradling her upper torso, specifically the head and laid her down on the floor with the assistance of pharmacist and her partner. In the midst of everything he instructed another pharmacy technician to call 911 for the paramedics. As she was in the process of drinking water I saw her other hand go to the region of the neck, thinking it was also an allergic reaction and administered a dose of Epi-Pen. He administered the Epi-Pen on the upper side of her thigh, directly to the skin not through clothing. There was a very brief moment where the patient began to convulse but gradually regain consciousness. The patient became lucid and was conversing with him, apologizing for the incident. He assured her there was nothing to apologize for and to which she told me she had similar incidents from vaccinations as a child. She did not mention this prior to administration of the vaccine and through conversation we believe the incident may be caused from high anxiety of needles / vaccinations. When the paramedics arrived, they assisted the patient from the floor and gave a warning that she believed she was going to faint again, and fainted in the arms of the paramedics.
24 2021-04-12 fainting Fainted once approximately 8 hours after receiving the vaccine. No other adverse reaction afterwards... Read more
Fainted once approximately 8 hours after receiving the vaccine. No other adverse reaction afterwards other than fever and chills. I have no prior history of fainting.
24 2021-04-13 fainting Patient had a syncopal episode then vomited after she woke up
24 2021-04-14 chest pain Vomited, ran a fever and chills, sweated through multiple pairs of clothes in the first 24hrs. 2nd 2... Read more
Vomited, ran a fever and chills, sweated through multiple pairs of clothes in the first 24hrs. 2nd 24hrs had sinus headache, chest pain, and nausea. 5 days later still experiencing nausea and joint pain.
24 2021-04-14 blood clot Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Diz... Read more
Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: blood clots in stool-currently under care of primary care physician for clot formation investigation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: patient reported blood clots in stool on 4/11/21 and 4/12/21. Patient was flushed, dizzy and faint after clot was found. Patient has no significant history of hemorriods or colorectal conditions.
24 2021-04-15 chest pain Report hair falling out 2 weeks post vaccination and bruising of the right and left arm -noticed on ... Read more
Report hair falling out 2 weeks post vaccination and bruising of the right and left arm -noticed on 4/15/21 1 month and 6 days post vaccination. Report of chest pain 1 month 6 days post vaccination described as a pinch lasting 2 minutes. Denies SOB, leg swelling, headache or blurred vision. Treatment: Instructed to see primary care doctor
24 2021-04-17 heart rate increased, fibrin d dimer increased, chest pain Started having chest pains, shortness of breath, and rapid heart beat that evening. Persisted for th... Read more
Started having chest pains, shortness of breath, and rapid heart beat that evening. Persisted for the next 2 weeks so I went to the doctor to have a D-Dimer test on 4/15/21. Test showed elevated D-Dimer.
24 2021-04-18 chest pain pt had chills aches , chest pain, headache
24 2021-04-21 chest pain CHEST PAIN; DIFFICULTY BREATHING; BODY PAIN WHEN DO AN ACTIVITY; FEELING SLEEPY; LITTLE DIZZY; ACHIN... Read more
CHEST PAIN; DIFFICULTY BREATHING; BODY PAIN WHEN DO AN ACTIVITY; FEELING SLEEPY; LITTLE DIZZY; ACHINESS; WHEEZING; TIGHTNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gluten allergy, and sulfa allergy, and other pre-existing medical conditions included the patient had no medication allergy. The patient was previously treated with iron pills and birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced body pain when do an activity. On APR-2021, the subject experienced feeling sleepy. On APR-2021, the subject experienced little dizzy. On APR-2021, the subject experienced achiness. On APR-2021, the subject experienced wheezing. On APR-2021, the subject experienced tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, difficulty breathing, body pain when do an activity, feeling sleepy, little dizzy, achiness, wheezing and tightness was not reported. This report was non-serious.
24 2021-04-23 heart rate increased NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST H... Read more
NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol. 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 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep 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.
24 2021-04-26 loss of consciousness Dizzy and passed out. Amonia applied,feet up and head supported. Ambulance called and patient trans... Read more
Dizzy and passed out. Amonia applied,feet up and head supported. Ambulance called and patient transported in stretcher. Five mins later patient awake and stable . Patient discharge home with significant other.
24 2021-04-27 chest pain Extreme fatigue, headache, chest pain. Had to call in sick to work because of extreme side effects.
24 2021-04-27 pallor Patient sat for her 15 minute observation. About 3-5 minutes into sitting she reported "not feeling ... Read more
Patient sat for her 15 minute observation. About 3-5 minutes into sitting she reported "not feeling well". Pharmacy staff responded with cold compress, water, and advised to lower head if feeling faint. Patient appeared sweating and pale but shortly after drinking water and removing clothing she quickly improved. It is my opinion the patient was anxious and over heated.
24 2021-04-29 hypotension, fainting, loss of consciousness History of fainting, showed signs of fainting, then had multiple seizures, LOC, incontinence, hypote... Read more
History of fainting, showed signs of fainting, then had multiple seizures, LOC, incontinence, hypotensive, normal HR. Taken by ambulance to hospital. Unknown results or whether admitted patient was admitted.
24 2021-05-02 fainting Pt fainted after receiving the Covid vaccination. She was assisted to the Observation area per w/c. ... Read more
Pt fainted after receiving the Covid vaccination. She was assisted to the Observation area per w/c. She fully oriented & BP 121/71. Pt left with no assistance. No known adverse reactions.
24 2021-05-02 fainting Patient fainted about a minute after receiving the immunization
24 2021-05-03 chest discomfort ANXIETY; NERVOUS; SHORTNESS OF BREATH; CONDITION AGGRAVATED; CHEST TIGHTNESS; This spontaneous repor... Read more
ANXIETY; NERVOUS; SHORTNESS OF BREATH; CONDITION AGGRAVATED; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chest tightness. On 24-APR-2021, the subject experienced shortness of breath. On 24-APR-2021, the subject experienced condition aggravated. On an unspecified date, the subject experienced anxiety, and nervous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, shortness of breath, anxiety, nervous and condition aggravated 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
24 2021-05-03 hypotension Diziness, Nausea, vomiting. Hypotension. Symps resolved after 10 mins. BP 90/50 70 18 O2 sat 99% R... Read more
Diziness, Nausea, vomiting. Hypotension. Symps resolved after 10 mins. BP 90/50 70 18 O2 sat 99% RA
24 2021-05-03 fainting Patient fainted, was fine in 30 minutes
24 2021-05-06 loss of consciousness, fainting patient fainted as soon as I administered the vaccine to her. she did not fall because she was leani... Read more
patient fainted as soon as I administered the vaccine to her. she did not fall because she was leaning against her friend. I offered to put her on the floor but she declined. she put her head between her knees and got her consciousness right back. EMT was called but pt told her she was fine and no assessment was done.
24 2021-05-08 loss of consciousness Patient was a walk-in COVID-19 applicant. She filled out her form and told me she's very scared of n... Read more
Patient was a walk-in COVID-19 applicant. She filled out her form and told me she's very scared of needles and has fainted in the past from getting a vaccine. I asked whether she was comfortable receive vaccine at pharmacy setting and she said she really wanted the Janssen COVID-19 vaccine to avoid getting two shots. She appeared calm and the administration of the vaccine went smoothly without any issues. During the 15 minute observation period, patient's mother and technicians alerted me she has fallen over. I quickly instructed by technician to call 911, while the other paged CODE WHITE and I rushed to the patient. Her father helped me lie her down on their back (supine) and I elevated the patient s feet onto the chair. I took of her mask to listen to make sure she was breathing and she quickly regained consciousness and looked right at me. I had her take some deep breaths for me to make sure airways were clear and helped her sit down in a chair. I asked her to stay an additional 15 minutes to ensureshe is feeling fine. She decline emergency personnel from coming to the store. She was fine and left the store after 15 minutes. I will follow up with her to make sure she's doing well on 05/10/21.
24 2021-05-08 fainting, hypotension About 3 minutes after vaccine administered noticed patient hand twitching, asked if they were okay a... Read more
About 3 minutes after vaccine administered noticed patient hand twitching, asked if they were okay and got a head nod, then patient went unresponsive and fainted. Called for help and called 911. Laid patient down and elevated her legs and in a few seconds after patient came too. When the EMT got here checked her BP and it was low, observed her for about 5-10 minutes and her BP went up to normal. Patient left after about 30 minutes feeling fine
24 2021-05-10 loss of consciousness, hypotension, fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: patient fell over and passed out a few minutes after administration, possible seizure occured. EMT services were called and patient declined to go with them.
24 2021-05-14 nosebleed Nose bleed, joint pain, projectile vomiting, head ache that feels like I've been shot in the head
24 2021-05-15 low blood pressure Pt with mild orthostatic hypotension 48 hours after receiving vaccination, feeling "dizzy".
24 2021-05-16 chest pain, pulmonary embolism The patient presented with chest pain on 5/15/2021. She had a 9 hour drive on 4/30/2021, and had the... Read more
The patient presented with chest pain on 5/15/2021. She had a 9 hour drive on 4/30/2021, and had the J&J vaccine on 4/11/2021.
24 2021-05-16 fainting patient had fainted a couple minutes after receiving vaccine due to a panic attack from getting a va... Read more
patient had fainted a couple minutes after receiving vaccine due to a panic attack from getting a vaccine and fell the floor. patient was observed and emergency squad was called to make sure patient was ok and was subsequently discharged from their services after observation.
24 2021-05-19 loss of consciousness, lightheadedness client stated feeling dizzy few seconds after injection and had vasovagal response and passed out fo... Read more
client stated feeling dizzy few seconds after injection and had vasovagal response and passed out for approx 3 seconds, v/s remained stable, client required no further treatment, observed for a total of 35 mins, client states feeling better after 5 mins. left facility in stable condition, ambulating w/o assist, accompanied by mother ( who also received injection w/o incident)
24 2021-05-20 blood pressure decreased, fainting Patient temporarily fainted, and immediately came back, she was sweating, was given gatorade. Check... Read more
Patient temporarily fainted, and immediately came back, she was sweating, was given gatorade. Checked her blood pressure it was initially 87/58 at 4:21 pm. Sat with her and checked pressure again at 4:30 pm, and bp had returned to 113/75. she was fully recovered by 04:45pm and she left the pharmacy.
24 2021-05-25 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
24 2021-05-26 chest pain BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADA... Read more
BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.
24 2021-05-29 fainting Faint and fell.
24 2021-05-29 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
24 2021-05-30 fainting patient fainted within minutes of vaccine; recovered after being laid on floor and legs elevated
24 2021-05-31 blood clot BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 year old female. The pat... Read more
BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 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, therapy start date were not reported, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced blood clot and was hospitalized (date unspecified) and it was reported caller said his brother would called to provide more information regarding the patient's case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210552268-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
24 2021-06-02 loss of consciousness Pt received janssen Covid 19 vaccine 518pm. Pt went to the waiting area chairs and within 2 minutes ... Read more
Pt received janssen Covid 19 vaccine 518pm. Pt went to the waiting area chairs and within 2 minutes she was losing consciousness. Myself and another customer were able to lower patient to the floor (did not hit head). She lost all muscle tone, consciousness and bladder control (urinating on herself/floor). Sternal rub was able to get the patient to regain consciousness. Took blood pressure at 522pm and was 152/95 with pulse of 95. Arm was hot to touch and patient was sweaty. Placed a cold pack on injection site and fanned pt until EMS arrived for evaluation. EMS loaded pt on a stretcher and took to ambulance to evaluate heart rhythm.
24 2021-06-07 chest pain, inflammation of the heart muscle, chest discomfort, troponin increased 24 yo G2P1001 at 34w5/7 with EDD 7/9/21 received TDAP vaccination and Janssen COVID vaccination on 6... Read more
24 yo G2P1001 at 34w5/7 with EDD 7/9/21 received TDAP vaccination and Janssen COVID vaccination on 6/2/21. Presented to hospital 6/4/21 complaining of squeezing chest pain. Elevation of troponins. CT chest negative for pulmonary embolism or other pathology. Maternal echocardiogram negative for cardiomyopathy or structural heart disease. Leading diagnosis myocarditis with patient treated with IV steroids and hospital observation. Discharged home safely 24 hours following admission.
24 2021-06-09 chest pain HEART BURN; CHEST PAIN; DIZZINESS; FOGGINESS; CONCENTRATION ISSUES; FATIGUE/ TIRED; HEADACHES; This ... Read more
HEART BURN; CHEST PAIN; DIZZINESS; FOGGINESS; CONCENTRATION ISSUES; FATIGUE/ TIRED; HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included rash, itchy, and gastrointestinal issues, and concurrent conditions included depression, egg allergy, chicken allergy, non alcoholic, non smoker, stress, and family problems, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced heart burn. On 16-APR-2021, the subject experienced chest pain. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced fogginess. On 16-APR-2021, the subject experienced concentration issues. On 16-APR-2021, the subject experienced fatigue/ tired. On 16-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Negative, Chest X-ray (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, heart burn, dizziness, headaches, fogginess, concentration issues, and fatigue/ tired. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
24 2021-06-17 loss of consciousness, fainting 24 y old female suffered from syncope 10 min after vaccination. Pt lost consciousness for 20 sec. Pt... Read more
24 y old female suffered from syncope 10 min after vaccination. Pt lost consciousness for 20 sec. Pt was held up by boyfriend and did not fall to the ground. Patient was put in supine position on the ground, regained consciousness immediately after lying down. Pt stayed in this position for 10 min and was then assisted to a chair where she remained for another 10 min. She was given water and a candy. Pt stated she felt fine and that she was ready to go. Paramedics arrived but, pt was not transported to a hospital as per her request. BP 110/75, P 66, RR 16
24 2021-06-25 skin turning blue, pallor About 4 hours after receiving the vaccine, I began to feel very nauseous and awful. I ended up throw... Read more
About 4 hours after receiving the vaccine, I began to feel very nauseous and awful. I ended up throwing up twice. I went extremely pale. My lips and fingers were blue. I was incredibly cold, shaking and simultaneously felt hot. I also almost blacked-out. The shaking lasted for about an hour. I continued to feel sick and exhausted for about a week, but felt much better after the first day.
24 2021-06-26 palpitations The first day I?d say about 3-4 hours after getting the vaccine I noticed a headache, was also fatig... Read more
The first day I?d say about 3-4 hours after getting the vaccine I noticed a headache, was also fatigue, and slightly dizzy (pretty common side effects.) as the days went on I noticed that the headaches would not go away, they did with taking Ibuprofen and Tylenol, but would return 4 hrs after taking. Monday (6-14-21) I really noticed that my neck was stiff feeling, I was getting really bad random bruises on my legs, I would get really ?airy? feeling in my head, dizzy, my heart would start racing, and my hands would get really sweaty, I also felt hot even in colder temperatures. Made an appointment Monday (6-14-21) to get bruises checked out thinking it was from something unrelated, Tuesday (6-15-21) I made an appointment to make sure I didn?t have the blood clot they did a full work up, and noticed that my blood sugar was abnormally low (58) I do not have a history myself of diabetes or ever been suspected of being prediabetic. Tuesday (6-15-21) was definitely the worst of it. Later on in the day while I was working I was seeing black spots out of the corners of my eyes, I could hardly stand, I could hardly breathe (felt like a horrible panic attack,) my heart was beating so fast I felt like it was going to burst, my hands were extremely sweaty and I felt like my body was shutting down, I had a horrible headache, I could barely drive, and when my mom was taking me to the ER, I could barely lift my arms up. Went home as my blood sugars were then fine and I was feeling okay. From that day forward I noticed that at 6:30pm every night I would get these same side effects. Saturday (6-19-21) the pattern finally broke, I no longer felt like I was dying (I wish I was exaggerating.)
24 2021-07-02 heart rate increased Immediately after recieving vaccination patient got light headed and sat down. Patent vomitted and ... Read more
Immediately after recieving vaccination patient got light headed and sat down. Patent vomitted and said was going to pass out. We monitored blood pressure/HR and it was repeatedly between 130-150/110-125 with HR 115 to 130. Patient stated her HR runs high and she had this happen once prior while giving blood. After resting for about 30-45 minutes with ice packs on neck/head patient felt well enough to leave with husband.
24 2021-07-06 chest discomfort myalgias, fatigue, chest heaviness after receiving the Johnson and Johnson vaccine at about 9:00 a.m... Read more
myalgias, fatigue, chest heaviness after receiving the Johnson and Johnson vaccine at about 9:00 a.m. Patient states that she went to bed at about 9:00 p.m. And began to feel flu-like symptoms. Patient is not having any shortness of breath or difficulty breathing. Ed medications- Motrin
24 2021-07-14 heart rate increased Muscle aches in quads where muscles were previously sore Overall muscle depletion Loss of balance N... Read more
Muscle aches in quads where muscles were previously sore Overall muscle depletion Loss of balance Nausea Concussion symptoms Felt drunk Headaches from temples to back of head(the pain does not connect in the middle) Shortness of breath Delayed reaction time Felt like I couldn?t move fast enough when I was driving Sweating Depth perception is off Increased heart rate Unable to focus quickly
24 2021-07-19 blood clot in the brain, cerebral haemorrhage, deep vein blood clot Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, deat... Read more
Lower extremity deep vein thromboses, pulmonary thromboses, cerebral thromboses and hemorrhage, death
24 2021-07-19 fainting Patient experienced vasovagal syncope at approximately 4:38PM on 7/20/21. Soon after receiving the J... Read more
Patient experienced vasovagal syncope at approximately 4:38PM on 7/20/21. Soon after receiving the Janssen COVID-19 vaccine, the patient experienced syncope. Within the first few minutes of the reaction, patient fainted two to three times. Patient was seated at the time of the reaction, and was further supported by spouse and myself. After approximately 5-10 minutes, patient was able to walk while supported to a quiet area of the store where she was able to comfortably lay down. Patient was also provided water and an ice pack. Around 30 minutes from the initial reaction, patient was able to stand and walk on her own. Patient was monitored for 35 minutes at the pharmacy by two staff members and her spouse. All the color had returned to her face and she reported feeling much better. No medication was administered to the patient. Patient and spouse were instructed to seek emergency care if symptoms returned.
24 2021-07-25 chest pain About 3 hours After I got my vaccine I couldn?t see straight I was vomiting non stop couldn?t keep f... Read more
About 3 hours After I got my vaccine I couldn?t see straight I was vomiting non stop couldn?t keep food or water down . Had pain in my chest and shooting pain down my back and dizziness ? I had a health visit with my doctor and he ordered me a iv to get fluid in my body
24 2021-07-25 fast heart rate, chest discomfort Patient presented to ED with weakness found to be Covid + and tachycardic. Attended funeral and was... Read more
Patient presented to ED with weakness found to be Covid + and tachycardic. Attended funeral and was exposed to a COVID+ person. 2 days laters she had runny nose and lost her sense of smell, developed tightness in her chest, nausea and headaches. Feels very weak, lightheaded, short of breath, also has c/o fevers, denies chills or sweats.
24 2021-07-28 loss of consciousness Patient become sweaty, weak, had a loss of hearing and passed out. Happened within 2 minutes of rece... Read more
Patient become sweaty, weak, had a loss of hearing and passed out. Happened within 2 minutes of receiving vaccine.
25 2021-03-04 chest discomfort Blurred vision, dizziness, itching, tightness of chest, headache.1340 c/o itching nose/chest tightne... Read more
Blurred vision, dizziness, itching, tightness of chest, headache.1340 c/o itching nose/chest tightness along with anxiousness BP 124/80, HR 60, RR 18, SpO2 98% RA. Resp. easy/even. Denies difficulty with swallowing. C/o Blurred vision at this time. 1349 States that chest tightness is resolved. Continue to c/o blurred vision. States that after receiving vaccination she almost immediately had an instant headache. 1356 States that itching is now resolved, along with tightness of chest/blurred vision. States that her headache remains. 1408: BP 116/76, HR 68, RR 18, Continue c/o headache. No other complaints at this time. Staff nurse suggested pt get a ride home. Pt denied need for a ride stating that she was fine other than the headache. 1413 Pt released to go home. Pt reminded to call PCP for any further adverse reactions.
25 2021-03-05 loss of consciousness Violent muscle aches that were not settled by medication, far beyond normal muscle aches from illnes... Read more
Violent muscle aches that were not settled by medication, far beyond normal muscle aches from illness. Began exactly 6 hours following vaccine and continued for approximately 12 hours. Fever for 24 hours. Fatigue, black outs.
25 2021-03-06 fainting Fever 102 degrees 12 hrs after injection lasting 8 or so hrs. 34 hrs later dizziness and faintin... Read more
Fever 102 degrees 12 hrs after injection lasting 8 or so hrs. 34 hrs later dizziness and fainting lasting a short while.
25 2021-03-08 hypotension, fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient described feeling nauseas about 10- 15 minutes after vaccination then patient fainted. Patient regained alertness a couple minutes after fainting but was still weak and unable to get up. Paramedics came and patient was found to be hypotensive after 15-20 minutes patients blood pressure restored and she was at full alertness and paramedics signed her release.
25 2021-03-09 pallor, loss of consciousness, heart rate decreased, loss of consciousness, heart rate decreased, pallor Within seconds of receiving the vaccine I began to feel slightly dizzy. By the time I walked across ... Read more
Within seconds of receiving the vaccine I began to feel slightly dizzy. By the time I walked across the room to the observation table I was feeling lightheaded. They sat me down, gave me water and a cookie, but about 2min after the injection the dizziness was so intense that I began to black out. I was unconscious for about 1-2min, then came to but my vision was still unclear. I was taken via wheelchair to the paramedics on the opposite end of the gymnasium, and at this point I was heavily perspiring and very pale but still coherent. I felt my vision and dizziness significantly improve after being able to lay down. I was transported to the hospital for observation but had much improved by the time I arrived. An EKG, bloodwork, and cardiac tests were recommended to discern possible underlying heart related conditions, but I declined because I already had a PAT for thyroid surgery scheduled the next day that would be running those same tests. This reaction was likely due to not having eaten for several hours prior to the vaccine. After about an hour I felt well enough to drive myself back home and dealt with mild aches and pains that evening, chills, and a low grade fever all of which resolved themselves by the next morning.
25 2021-03-09 fainting Pt contact initiated. On scene to for a 25 y/o female pt with a chief complaint of syncope. Pt was s... Read more
Pt contact initiated. On scene to for a 25 y/o female pt with a chief complaint of syncope. Pt was sitting upright in chair in no apparent distress. Pt demeanor is calm. GCS 15, Aox4. Pt stated she felt dizzy and had a syncopal episode. Pt fell on floor from sitting position. Pt found on floor prone. Pt rolled over to right lateral recumbent position. Pt hit head and has approximately 1 cm abrasion on right anterior face. Controlled bleeding with gauze and bandage. Airway is patent. Speech is clear and even with no noted slur or abnormality. Breathing is non labored and regular with adequate chest rise. Radial pulses with steady rate and rhythm. Skin is intact, warm, and dry. Eyes PERRL. No JVD, tracheal deviation, or peripheral edema. Negative DCAPBTLS other than noted. Pt is able to ambulate. Gait is steady. Pt denies headache or blurred vision, shortness of breath or difficulty breathing, nausea or vomiting, chest pain, dizziness, tingling or numbness in extremities, or any other complaints at this time other than noted.
25 2021-03-10 heart rate increased Janssen COVID-19 Vaccine EUA Chills- morning of 3/10 Aches- all day Fever- afternoon of 3/10 High He... Read more
Janssen COVID-19 Vaccine EUA Chills- morning of 3/10 Aches- all day Fever- afternoon of 3/10 High Heart Rate- 130-150 resting Headache- all day Fatigue- all day
25 2021-03-11 chest discomfort - Low grade fever for 72 hours w/ high of 100.5°F. Nausea for 36 hours w/ abdominal cramping after ... Read more
- Low grade fever for 72 hours w/ high of 100.5°F. Nausea for 36 hours w/ abdominal cramping after eating for 72 hours. Diarrhea one day after vaccination and again 4 days after vaccination. Extreme fatigue for 48 hours. Headache that came and went for 72 hours. Chills/clammy-ness for 96 hours. Muscle/joint aches starting two days after vaccination and continuing until 4 days after vaccination. Chest tightness starting 2 days after vaccination and continuing 5 days after vaccination. Runny nose/sinus inflammation starting day after vaccination and continuing for 5 days after vaccination. - Pain in injection site for 48 hours. - Symptoms were debilitating for 48 hours and were manageable after that point.
25 2021-03-11 lightheadedness 25 yo F with presented for Janssen (Johnson and Johnson) Covid-19 vaccination at the drive up clinic... Read more
25 yo F with presented for Janssen (Johnson and Johnson) Covid-19 vaccination at the drive up clinic a on 3/10/21. Patient is part of group 3. Patient with no allergy history and no history of previous allergy reactions to vaccinations. Patient given 0.5ml Janssen Covid19 vaccination in left deltoid at 1407 (Lot # 1802070). Patient assigned to be observed for 5 minutes. After observation(?), while moving her car to in the parking area/clinic, the patient stopped at traffic control to tell them they did not feel well. Traffic controller told patient to pull over to the side. Simultaneously the car proceeded to move forward, over the curb and hit the stop sign. Patient was alert but c/o dizziness when staff arrived at vehicle to assess. EMS called. No other information available for further followup. Vasovagal event? No medical records are available for this patient
25 2021-03-14 lightheadedness, fast heart rate Patient received Janssen vaccine by registered nurse and was completing her 15 minute waiting period... Read more
Patient received Janssen vaccine by registered nurse and was completing her 15 minute waiting period. She began to feel faint and an employee of our facility caught her as she experienced a near syncopal episode. She was promptly placed in Trendelenburg position and vitals obtained. BP was 90/58 with mild tachycardia to max of 130-140 bpm. Patient was given supportive treatment and monitored. BP improved to 110/70 after 5 minutes and 120/72 after 15 minutes. Patient continued to feel very dizzy and weak, however, and became tachycardic and diaphoretic each time she attempted to move to a seated position. After 1 hou