chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35 year old male without a significant health history, who had his second dose of the Pfizer vaccine 4 days prior to admit on 4/30/2021. Since his second vaccine dose, he started having generalized chest/abdominal aching, chills, body aches, nausea/vomiting. On the day of admission, he awoke with numbness in his right and left upper extremity. In the ED, his ECG showed NSR with anterior and inferior ST elevation. Troponin elevated to 3.99, trended down. Echo  normal. Cardiac MRI suggested myocarditis. He was started on colchicine 0.6 mg BID with resolution of his symptoms.
This spontaneous report was received from a clinical supervisor referring to a 6 month old patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 11-FEB-2019, the patient was vaccinated with ROTATEQ dose 1, oral, lot # R021216 and expiration date 25-APR-2020 (dosage schedule, anatomical location were not reported). On the same day, a six months patient was administered 1 dose of ROTATEQ that was reconstituted with dexamethasone. No adverse effects. The outcome of product preparation error, product administered to patient of inappropriate age, and no adverse effects were unknown. The causality between the aforementioned events and ROTATEQ was unknown.
Headache, muscle aches, fever, and a metallic taste in mouth 10 mins after shot was given
On 8-23-2021 at 115AM while at work is when the first symptom happened. I felt flushed and had cold sweats, body went into slow motion. Like when I walked it felt like I was wading through mud. Called security, they called 911. Transported by EMT's to emergency surgery to implant stent into LAD region of heart. I spent 1 day in ICU, move to room day 2, go released on 3rd day. Now I have a damaged heart with a stent. I'll need to take blood thinners for life due to a blood clot going to my heart. This event, is the one and only symptom that I had. This is 138 days from vaccine to this event.
Rash on right upper arm. size of a paper bill. The rash occured five days after the initial shot. It is raised, has heat to it and does not blanche. It is sore and itches. I am also having nerve pain in arms and legs. The nerve pain is extreme and hurts.
Bleeding during bowel movements; Nausea; fever; This is a spontaneous report from a contactable other health professional (HCP). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 which was prior to vaccination. There were no concomitant medications. On 08Mar2021, the patient experienced bleeding during bowel movements, nausea and fever. The patient was hospitalized for 4 days. The patient had colonoscopy as treatment for the event. The outcome of the events was recovering. The patient was not tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea and fever and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect. Conversely, the reported bleeding during bowel movements is unlikely related to the suspect vaccine. More information on the patient's medical history, concurrent medical conditions would be helpful for the Company to provide a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Patient received the 1st COVID vaccine (Pfizer Lot #EW0185 expiration 05/22/2021) at 1426. Patient alerted EMT at 1503 that his palms were feeling sweaty, and he was feeling a discomfort in the right side of his chest on inspiration. PHN responded. Patient?s skin was appropriate to skin tone, and warm to the touch. Patient was alert and oriented and was breathing and speaking with an even tone. Vital signs were taken at 1505 (oxygen 99% heart rate 73 blood pressure 156/102). Patient stated that he was feeling anxious about the vaccine prior to receiving it. Vital signs taken at 1510 (Oxygen 98% heartrate 67 blood pressure 138/78). Patient stated that his palms were not sweaty anymore. At 1514 patient stated that the discomfort was a ?little better.? Blood pressure taken at 1516 (136/78). Patient offered water. At 1523 patient stated that he took a sip of the water and the discomfort came back more intense and was a ?burning? feeling traveling up his right lung. Patient pointed to his right collar bone area when asked to point to where the pain was coming from. At no time did the patient complain of difficulty breathing or shortness of breath. Vital signs taken at 1526 (oxygen 97% heartrate 68 blood pressure 150/90). Patient stated that the feeling would come and go. His stepsister who was accompanying him went to grab his mother from outside at 1530. EMS was called at 1537 by PHN. EMS arrived at 1539. Patient and mother refused transport to hospital and signed AMA at 1551. Patient and mother advised to follow up with primary care provider. Mother stated that they were taking him to the hospital as soon as they left. Patient and mother advised that if life threatening symptoms accrue on the way to the hospital to call emergency services. At 1553 the patient stated that the pain was ?gone for now.? Patient left at 1553 with mother and stepsister unassisted with a steady gait. Patient has no medical conditions, is not taking and medications and does not have any allergies.
Pt vaccinated with MMR approximately 30 seconds after shot administered, pt had a episode of convulsion, syncope lasting approx 10 seconds.
approx 10 days p/immun devel hives all over body (primarily extremities) which have persisted until now-no correlation w/diet-responds fairly well to OTC DPH;
My friend had a rash on her back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My friend had a rash on her back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (My friend had a rash on her back). At the time of the report, RASH (My friend had a rash on her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-033406 (Patient Link).   Reporter did not allow further contact
Pt recv vax on 5-6-98; on 5-8-98 pt seen by Dr. and dx=cellulitis at the injection site (redness, tenderness, warmth).  Pt tx=Augmentin 400 mg for 10 dys.  As of 5-19-98 pt exp some mild tenderness remaining.
Pt received ENGERIX B vaccine IM in both R and L deltoids on 5/4/09. At approx 2:30 PM 5/6. Pt wake from ncp and noted her right arm was numb- no redness, swelling or pain was noted in the left arm. Pt was seen in local ER, instructs to take Tylenol and apply heat to site. Numbness was gone by 5/7 AM.
Irritable Bowel Syndrome flare-up;   Abdominal pain, more gas than usual, bloating.  Lasted about 3 weeks.  This is unusual, there were none of the usual triggers for me (no extra stress, no unusual dietary items, etc.).
Member was given a dose (0.5 mL) of expired Anthrax.  Expired by one month.  No adverse reaction was noted.
08/29/2018 Arm very sore-(R) hand stiff-joints catching and locking in (R) hand; very weak, not able to grasp items or pick up items. Very painful, trouble sleeping.
Patient was in for their 19 year WCC 1/5/22. Patient was asked if they would like to get their COVID Bivalent at the appointment, and they were in agreement with receiving it. Administered COVID Bivalent and Men B at the end of appointment and reviewed them with patient before administration. Patient's mom called on 1/6/22 asking why the patient received the bivalent when they had already received it 10/2022. Looking into chart, a bivalent historical vaccine had been missed when reviewing what they were due for due to it not flagging in certain windows. The patient's PCP will call the patient's mom back to review the event. No further action needed.
Patient fell out of his chairs and customers and pharmacy associate described his reaction as a seizure. He was not conscious and convulsing.
Blisters on palm of hand march 2021 second dose taken may 2021 bullous reaction September 2021 on feet near ankles and soles and rash generalized on arms, buttocks, back, and legs. GP first diagnosed bulllous pemphigoid and oral  prednisolone treatment initiated 24/09 20  mg 7 days .  30th September worsening blisters prednisolone continued for 3 weeks and doxycycline added 100 mg whilst waiting for urgent advice from a dermatologist. Advised blood tests and skin biopsy but only blood tests were carried out.
A COVID vaccine that was administered to patient past expiration time. Vaccine was drawn up and refrigerated but it expired on 7/27/2021 at 9:45 pm and was given on 7/28/2021 at 11:50 am. It was in refrigerator the entire time.
He got his vaccines, he had a sore arm, pain in the arm to the point that hard to work, headache, tired and fatigued.  On 8/31/22 at 2:00 he collapsed and fell down, could not stand up.  He went to the bathroom and went back to bed.  The next morning all of his texting was jibberish and his sister contacted his wife who came and checked on him, and he was not able to talk well, had a droopy face, numbness on the left side of his body.  They took him to an immediate care and they sent him to local Hospital.  He was sent for a CT scan where it showed a fairly large stroke in the right temporal lobe in his brain.  He has a quarter sized dead damaged spot in his brain.   He did see a neurologist while in the hospital, PRIVATE.   She put him on the aspirin and the BP medicine and Atorvastatin 80 mg as his cholesterol was a little bit high, but not out of control and put him on that precautionary.   One week after that he developed some  numbness at night and went to his PCP, who referred her back to the neurologist and they did an MRI.  This showed that the previous stroke was continuing to bleed slightly.  They continued to watch that.    Within the last 3-4 weeks he experienced about 3-4 days out of the week with extreme memory problems.  There was one when he lost 1/2 a day.  The memory problems that day were bad enough that he went to the hospital, sent for another MRI and 3 other clots in his brain were discovered.  At this point he is just taking the other medicines that he was put on previously.  He has an appointment to return to see her within the month.    He has some memory issues, he cannot do paperwork and math problems.  He has been advised by his neurologist that she does not want him to drive.  He does not have a history of stroke prior to this.  He has been pretty healthy and has yearly blood work and his BP has been a little elevated but nothing he needed medicine for.  Last year his cholesterol was OK, but it was OK and was not put on anything for that at that time.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 82-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 20th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 21st February 2018, the patient experienced fatigue, pain and myalgia. On an unknown date, the outcome of the fatigue, pain, myalgia and feeling bad were recovered/resolved. The reporter considered the fatigue, pain and myalgia to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: Before 10 am, the patient received SHINGRIX in the left deltoid. The next day the patient experienced fatigue, myalgia, felt achy (did not want to get out of bed) and tired. Less than a week after vaccination, the patient felt lousy for 1 to 2 days. The healthcare professional was unsure when symptoms subsided but the patient said it was after a couple days. The healthcare professional was unsure if the patient took anything for his symptoms.
I had Moderna for my first 2 doses and chose Pfizer as my booster.  My arm soreness is MUCH LESS severe this time, but  I woke up today, 1 full day after my shot with flu-like symptoms. (I had a flu shot 1 month ago).  I have strong fatigue, pressure/tightness  behind eyes and nasal sinus area. A bit of a chest ache across breast area, neck ache, shoulder ache.   Fatigue is bad. Very sleepy.
He fell after his first dose and Rite Aid called the paramedics who took his blood pressure and wanted to go to the hospital.; He had difficulty swallowing after the vaccine; black eye; This is spontaneous report from a non-contactable consumer. This consumer reported that a male patient (brother) in his 60's received the first dose of at single dose for COVID-19 immunization on 16Apr2021. Relevant history and concomitant drugs were unknown.  The patient fell after his first dose and called the paramedics who took his blood pressure and wanted to go to the hospital. his brother felt was a psychosomatic. He had difficulty swallowing after the vaccine. The neighbor text me a picture of him with a black eye after he fell. Outcome of the events was unknown.    No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
Syncope. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Itching in arms and rest of body, felt like throat was tightening up, lips felt funny. 12/4/2009 ED records for 11/9/2009, patient with c/o's itching, sore throat and throat closing, IVF, IV benadryl, solu-medrol, dc'd on prednisone and zyrtex. Dc Dx Allergic reaction
Right tricep area was swollen, red, and warm to touch; and a hive approx 2 1/4 inches diameter was noted. Area felt itchy. Employee reported this when she came to work, after having it checked by another RN. 10/7/09 called saying swollen red area, itchy at site of varicella vaccine (RTR). Recommended ice pack & ibuprofen. Called back later 10/7- 2 to 2 1/4" hive @ site, hot, red, itchy concerned & very unconfortable. Ref to Dr. Referred to urgent care facility as workers comp case. Told not life threating & not an unexpected reaction continue ibuprofen & ice pack. Was given an antipraritic pres as well well. 10/8-swelling rednessdecreased. Taking antipruitic. 11/6 had Hep B # 2 in RDT. Nothing abnormal noted. Applied ice pack and tried not to scratch the area. Employee was very uncomfortable and worried, had area checked by an ARNP, who called employee health back. Employee health nurse contacted Medical Director, who arranged for employee to be seen by our worker's comp. provider.  Employee was asked to continue the use of the ice pack as necessary to avoid scratching the area, and given a prescription for Fexofonadine 60 mg. one BID prn pruritis (#20).
Shot at 8:24, at 1700 left arm , injection site pain 6/10.  20:33 sharp joint pain to right knee and left great toe.  Then over the next  30 minutes start to have chills, no fever and  joint pain 9/10 to bilateral knees, hips, shoulders, elbows, wrists.  22:00 extreme fatigue as well.  Slight HA 3/10. had difficulty falling asleep but once I did, was able to sleep thru the night.  This morning Joint pain 5/10, fatigue 6/10 and HA 1/10.  No chills or fever. injection site discomfort 2/10
On June 09, 2021, I developed large floaters in my eye and had big black dots obscuring my vision. I saw a surgeon. He did an eye exam and a retinal scan. On June 11, 2021, I had surgery to correct the issue.
After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s.; increased fatigue; muscle aches; I ran a consistent temp of 99.8 to 100.3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jan2021 17:15 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug Allergy". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Jan2021, outcome "recovered with sequelae", described as "After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s."; FATIGUE (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "increased fatigue"; MYALGIA (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "I ran a consistent temp of 99.8 to 100.3". The patient underwent the following laboratory tests and procedures: blood pressure measurement: elevated, notes: blood pressure was elevated for approx 21 days at 180's to 190's over 140's; body temperature: 99.8 to 100.3, notes: I ran a consistent temp of 99.8 to 100.3; sars-cov-2 test: negative. Therapeutic measures were not taken as a result of blood pressure increased.  Clinical information: The patient has received Dose 2. The patient has not receive any other vaccine in four weeks. No Other medications were received within in two weeks .No treatment was received No prior COVID vaccination. No Other medical history. COVID tested post vaccination was Yes.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event blood pressure increased cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The morning after vaccination my eyes had discharge, bloodshot eyes, and had some swelling of the eyelids. The eye discharge  was treated with warm washcloth in the morning to loosed and wash away. I used saline eye drops to keep the eyes moist and to lessen the irritation.  When I tested positive for Covid 19 on or about January 18, 2022, my eye symptoms worsened. I went to Medical Center, my provider that day was a PA. She diagnosed conjunctivitis and prescribed an antibiotic eye ointment. I still sometimes experience eye discharge at night, but not painful.
Vaccine administered at inappropriate site; lots of pain in injected arm; muscle pain (legs and buttocks); shortness of breath/ little worse than normal; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID-19 BOOSTER) for prophylaxis.   Previously administered products included MODERNA CORONAVIRUS 19 VACCINE with an associated reaction of no adverse event (1st, 2nd and 3rd dose received on an unknown date). Concurrent medical conditions included shortness of breath (she has had shortness of breath before (but not every day)).   On 26th July 2022, the patient received the 1st dose of Shingrix (intramuscular) and the 4th dose of MODERNA COVID-19 BOOSTER. In July 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, muscle pain and increased shortness of breath. On 26th July 2022, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, muscle pain and increased shortness of breath were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   The reporter considered the pain in arm and muscle pain to be related to Shingrix. It was unknown if the reporter considered the increased shortness of breath to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: The reporter was the patient. She did not use email.  The patient received a Shingrix shot and Moderna Covid-19 shot both were in the left arm the day before reporting date. The reporter did not have the lot number of the Shingrix administered but did provide the pharmacy contact information, which should have that data on file.  Patient reported a lot of pain in the injected arm as well as muscle pain in her legs and buttocks.  The patient also reported that she was having more shortness of breath (S.O.B.) than usual for example when she was walking from one room in her house to the next room her S.O.B. was little worse than normal.  She stated that she has had shortness of breath before (but not every day) and in fact was hospitalized (at one point) due to shortness of breath but the doctors had not been able to determine the cause.  The doctor indicated that there was no problem with her heart and has referred her to a pulmonologist. Because she had 3 previous Moderna Covid-19 vaccines, in the past, with no problems she was attributing the side effects she was experiencing to Shingrix. In July 2022, less than a week after receiving MODERNA COVID-19 BOOSTER, the patient experienced pain in arm, muscle pain and increased shortness of breath. It was unknown if the reporter considered the pain in arm, muscle pain and increased shortness of breath to be related to MODERNA COVID-19 BOOSTER. Additional Supportive Information: The patient received both vaccines in left arm on same day, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Patient came back the next week in clinic with full blown chicken pox symptoms, diffuse itchiness and multiple vesicles
No additional AE; more than one year having passed since the first dose; This spontaneous report was received from the patient's mother and refers to her daughter a 10-year-old female patient.  The patient's concurrent conditions included Guillain-Barre syndrome. Her medical history, and concomitant therapies were not provided.      The patient was 9 years old and had her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in approximately February of 2021 for prophylaxis (dose, route of administration, lot#, and expiration date were not reported).   The mother could not specify which specific date she had the first dose. She could not rule out the possibility of more than one year having passed since the first dose (Frequency: 0, 6 to 12 months) (inappropriate schedule of product administration). The mother stated that her daughter had not had any symptoms since receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).