chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines were administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 20 years 10 months.  It was unknown that prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  It was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines.  Treatment medications were not reported.
Right arm with redness and swelling, headache and stomachache and fever of 101F. Nauseated and with congestion.
This was my first shot in the series, so I didn't anticipate any side affects. I got the shot around 3:40 pm on Friday. By the next day  I had a fever, chills, then sweating (back and forth for hours), body aches, very sore arm (sore enough it kept me awake for two nights),  fatigue, and a general feeling of being "sick". On Sunday,  the fever was gone, but a headache took its place. The other symptoms were still there. When I woke on Monday morning, I felt back to normal (with very mild soreness in my arm). However, on Monday I was walking uphill on the same route I'd taken the previous two days and ran out of breath to the point I had to stop and focus on breathing for several minutes. That's never happened to me before and I walk that route a lot. Though I was uncomfortable, none of these symptoms was bad enough to visit a Dr. I just wanted to report these side effects so people know that you can get them after the very first shot in the series.
12/18 afternoon: asthma attack. This was the same as previous asthma attacks and occurred after my normal triggers (exercise in cold air). Symptoms resolved completely with albuterol. I was coughing continuously and strenuously for about 10 min before using albuterol.  12/18 evening: low-grade fever (100.1 F, baseline is <98) with chills. Also with altered mental status/delirium, which is  typical for me while febrile. There was also nausea.  12/19: fever decreased to 99.2 F with normal mental status. New general malaise, worsened nausea. Single episode of vomiting, large volume of bile with some blood (streaks of fresh blood, larger volume of coffee grounds emesis mixed with bile). After vomiting I noted tachycardia to 130s--140s but this is a typical finding for me post-vomiting.  12/20: No further vomiting. Subsequent 2 bowel movements with moderate melena, since resolved. Fatigue and cold extremities, improving.
Feels like flu or COVID; Fever; Chills; Bad headache; Didn't feel good on Saturday; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like flu or COVID), MALAISE (Didn't feel good on Saturday), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), LEVOTHYROXINE, MONTELUKAST, METFORMIN and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Didn't feel good on Saturday). On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like flu or COVID), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, MALAISE (Didn't feel good on Saturday) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like flu or COVID) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Clinical course: 10 year old 6 months after COVID second vaccine dose tested positive for COVID. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was Hepatitis A Vaccine,  He had a Seizure with a fever of 100.8 at the time. Seizure lasted 5-10 seconds or so, had a postictal state. Came to ED, ibuprofen given, monitored no other seizure, no sign of other source of fever or seizure.  He also had a red rash on his upper legs. Went home
AA received booster vaccine, sat for 15 minutes then reported feeling nauseous and wanting to go home and not stay for triage. AA was advised to stay for triage. She had not eaten anything or drank anything all day, just finished an 8 hour shift. Refused to eat anything initially, drank a small bottle of water, agreed to eat one piece of dark chocolate. AA reported to continue feeling light headed. VS BP 111/81 , repeat 99/72, 96/83 standing. HR  86-103. O2Sat 97%. AA declined EMS evaluation. AA signed release from responsibility form. However stayed with staff to rest, ADNS agreed to drive AA home if she was not feeling well later in the evening.
Fainting, jerking, loss of consciousness, low blood pressure (73/34), low heart rate (30s). Laid down, ice, rest.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL. The patient developed dizziness after vaccination. On an unspecified date the patient recovered from dizziness. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Patient explained that she developed a red rash on the left arm deltoid area on Tuesday June 18, she went to the urgi center and the doctor gave her cephalexin. The area did not gets smaller on Wednesday June 19, she went back to the same urgi care doctor and on Thursday June 20, he prescribed clindamycin. The patient states there is no other reaction, no itching, no fever.
Left shoulder - sore, hot, swollen, red. Tx was with ice, TYLENOL and heat. 4/22/13 - full recovery.
Pt awoke with trismus, bilat. UE & LE trembling and twitching, anxiety, insomnia. His HR was 98 with RRR.  He was very pale in appearence. PE completed (no cardiac Sxs--no R,M,G heard). Pt to ER for evaluation and HC Dr. notified (Immunologist at MC). Dr. was initially concerned about a cytokine storm.  ER W/U and labs all normal. D/C Dx: anxiety and possible vaccine adverse event. Rx with diazepam.  F/U with the fellow from Immunology svc.
sickness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant and Cancer. Concomitant products included TACROLIMUS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
Rec'd ped DT on 8/11/06. Developed high fever of 103.7 that persisted x days. Parent alternated Motrin and Tylenol. Fever 102.3 on day 5. Also had redness, swelling, Knot and soreness in arm where injection was given.
Patient began to experience shingles like outbreak from the back of his neck to his forehead. Patient also had shingles like outbreak approaching his left eye. Patient went to visit doctor's office and Dr. confirmed a case of shingles. Patient was prescribed valacyclovir, and followed up with a visit to his ophthalmologist who also prescribed TOBRADEX ointment and ZIRGAN.
Employee developed face/neck flushing, pruritis, and shortness of breath following receipt of COVID-19 vaccine.  There was no swelling of the lips, tongue, or throat.  She was moved to the ED for additional monitoring (not registered).  She was monitored for an additional hour in the ED.  Her flushing decreased and SOB improved.  She was released from the ED with no intervention needed.  The patient had a history of allergic reactions to multiple injectable meds and vaccines in the past.
tremor, cough, chills, body aches, severe pain on both arms starting from 1am on 2/23. As of reporting still coughing and having a headache. tremor and chills resolved about 1 hr from symptom onset
General malaise and fatigue beginning around 12pm the day following my 2nd dose of vaccine, temperature was around 99.5 degrees F. Symptoms worsened and were accompanied by a severe headache that began around 8 pm on the same day. Around 11:30 pm the same day symptoms were at their worst, severe fatigue, headache, and malaise. Temperature was around 102 degrees F.  Tylenol PM Extra strength was taken around 11:45 pm on the same date. The following day by around 12 pm symptoms had dissipated, other than some mild pain at the injection site.
Information has been received from a physician concerning a 23 year old female patient who on an unspecified date, was vaccinated with the first 0.5ml dose of GARDASIL (lot # not reported).  Subsequently, the patient developed swelling at the injection site, pain and swelling from elbow to neck.  It was reported that the patient developed swelling at the injection site, pain and swelling from elbow to neck after getting each dose of GARDASIL.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
CoughWheeze, Reports repeated asthma attacks.. Narrative: Hx of asthma. Reports repeated asthma attacks the evening of the vaccine. Resolved with inhaler use. She states this is very out of the ordinary for her. "It reminded me of when I found out I was allergic to PCN." "The same thing happened."
Vaccination site warmth; Vaccination site pruritus; Vaccination site erythema; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling ), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling ) and VACCINATION SITE PAIN (Vaccination site pain). On 20-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 16-Jun-2021, VACCINATION SITE SWELLING (Vaccination site swelling ) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
fast heartbeat/heart rate was too high; This is a spontaneous report from a contactable consumer (parent). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date were not provided), via an unspecified route of administration on 05Apr2021 at the age of 20-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported on behalf of her daughter (patient) who received the 1st dose of the Pfizer covid vaccine on Monday, 5Apr2021. The previous day, she went to donate blood as she usually does. However, she was denied due to a fast heartbeat on an unspecified date. She hasn't ever been declined in the past. She walked to the place as she usually does. Stated that they told her that her heart rate was too high on an unspecified date. Stated that they took it a second time and it was too high for them to take her blood. Stated that her daughter normally has low blood pressure like her and had to stay there afterwards for a little while so she will not pass out. The reporter wanted to know if the heart rate would be associated with the blood pressure. Wanted to know if this could be from the vaccine even though she had it back on 05Apr. Clarified that she had the Covid 19 vaccination. Wanted to know if her daughter needed to go and get this checked out. patient would like to know whether her daughter should ask the vaccination provider to take her blood pressure when she returns for the 2nd dose of the covid vaccine and was Informed that it is not a recommendation of Pfizer's but she may request it at the vaccination providers discretion. Patient wanted to know whether her daughters side effect: a fast heartbeat, was related to the covid vaccine. Patient would like to know whether there are any reporting to do for her daughters experience. Reporter seriousness for heart rate was too high was unspecified. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
November 17, 2021 (day after vaccination) Migraines and visual auras (3:30pm - 7:00pm) Stomach cramps and vomiting (6:00pm - 7:30pm) Cluster seizures (7:30pm, 8:22pm, 9:05pm, 10:45pm) Valtoco 10mg administered
Shortness breath, coughing, drowning in mucous, feels as though lungs are full of mucous
SHOULDER PAIN; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: diarrhea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe adult crohn's disease.  On MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and shoulder pain as not related. This report was non-serious.
Mom to HD on 8/24 patient, localized arm swelling 3.5" by 5.5", warm to touch, c/o localized swelling & pain. Instructed use of intermittent cool pack (provided) use of OTC ibuprofen or TYLENOL after seek pharmacist advise on dosage. Told if worsens to seek medical attention. RN left message on parents phone without return call on 8/27-28. No further contact with parent or child.
Patient states she has had blurry vision  and pain in her eyes when she moves her head for approximately a week after receiving the vaccine.
PAINFUL BRUISES WHEN TOUCHED/WHEN THE BRUISES COME OUT A LOT OF PAIN IN THE AREA; MUSCLE PAIN IN LEGS; LEFT LEG PURPLE AND BLACK; PURPLE AND GREEN BRUISES ON ABDMONEN/ON GOING BRUSING ON BODY; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included knee surgery, and blood clot. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced purple and green bruises on abdmonen/on going brusing on body. On 21-MAY-2021, the subject experienced left leg purple and black. On an unspecified date, the subject experienced painful bruises when touched/when the bruises come out a lot of pain in the area, and muscle pain in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from purple and green bruises on abdmonen/on going brusing on body, painful bruises when touched/when the bruises come out a lot of pain in the area, and muscle pain in legs, and the outcome of left leg purple and black was not reported. This report was non-serious.
Swelling of the eye, treated with antihistamines. Swelling is subsiding.
On the day of vaccination started having palpations around 7 pm while playing video games, called 911 and seen in ER. Had card..w/o. No rash, no SOB, no lips swelling, no choking. HR was around 130's. Had flu vaccines in the past.
This spontaneous case reported by a healthcare professional, describes the occurrence of peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A and 008B212A) for COVID-19 vaccination. Concurrent medical conditions included high blood pressure. Concomitant products included insulin for an unknown indication. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful). At the time of the report, peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful) resolved. The reporter did not provide any causality assessments, laboratory data was provided or treatment information. The patient received both scheduled doses of mRNA-1273 prior to the events. The action taken with the drug in response to the events: not applicable. Reporter did not allow further contact.
mild headache; generalized fatigue; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sales representative. A 39-Years-old female patient received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on an unspecified date  as dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient had no known allergies. On an unspecified date, patient had mild headache and generalized fatigue for 48 hours. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
postpone the second dose due to the A Fib; Atrial fibrillation; fast heartbeat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 01H021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Chronic obstructive pulmonary disease and Shortness of breath. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, ALPRAZOLAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and HEART RATE INCREASED (fast heartbeat). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib). On 28-Jan-2021, HEART RATE INCREASED (fast heartbeat) had resolved. On 25-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included "senadril," "hidrocloric," and medication for irregular heartbeat. The onset of the fast heartbeat was 1 and a half hours after the vaccine dose. Treatment medication included the medication for irregular heartbeat. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-079299 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated medically confirmed to yes, patient medical history, concomitant medication and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested. US-MODERNATX, INC.-MOD-2021-079299:crosslinked case