chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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.
patient called today c/o redness and very painful right arm even 8 days after immunization.
68 YEAR OLD MALE COMPLAINED OF A HEADACHE OR MIGRAINE. ONSITE EMS/PHYSCIAN RESPONDED. BP 110/76    HR 76      97% O2 ON ROOM AIR HE REFUSED FURTHER EVAULATION OR CARE. RELEASE HOME AGAINST MEDICAL ADVICE
Over course of 22 days, + erythema, with minimal induration throughout erythemic area, minimal T, + blanching on pressure. +/- pruritus.
Patient was admitted to local Hospital on 1/22/22 for COVID pneumonia. This is considered a breakthrough case.
Patient presented with unusual bruising to upper leg.  Instructed patient to seek urgent medical attention.
Macular erythema, pruritis, warmth. Treatment: BENADRYL.
Diarrhea for 3 times; Fever of 100.4; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4). At the time of the report, DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.4 (High) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Insomnia Hospital on 4/3/21 recommended Unisom (no effect) PCP prescribed Trazodone and then Doxepin ( no effect) Psychiatrist prescribed Seroquel  - wake up several times a night still can?t sleep through the night and very groggy next day started 8/21/21 still waking up several times a night.
Patient received Moderna Vaccine on 1/10/2021. Then received Pfizer COVID vaccine on 8/1/2021. Lot #- EW0178. Then patient received another dose of Pfizer vaccine on 8/22/2021 as documented on this report.
Patient reports a rash at injection site about 1 inch in diameter. Very itchy, red, swollen and hot at site as well  Patient developed severe itching on large portion of back, ears and scalp. Rashes began a few hours after receiving injection. No trouble breathing other than what is normal due to her asthma.
About 36 hours after immunizations, pt seemed less interactive, not smiling as much. Started with facial grimaces. No irritability, still eating O.K. Symptoms have generally resolved. Growth still an issue.
This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age, race and ethnicity received PREVNAR 13 at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unknown date, 5 days after the shot, the patient experienced pneumonia. Hospitalization was required. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017113220 same reporter/different patient, same product, same event.
We gave a Covid shot to the patient when the parents were requesting for a flu shot.  No adverse reactions reported at the time of the incident.
I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had heart palpitations, then a tingling feeling in my left arm. After the second shot, I felt like my balance was off if I laid down or looked down and then pulled my head up. That went away after the first day.  Starting the following day, I had some chest pain over my heart, and at times, I would have a burning sensation in my heart. At times, I also felt a tingling down my left arm (sometimes out of nowhere). I would be very short of breath. These symptoms were on and off for the first two weeks after I took my shot. They have since completely gone away.
Petechial hemorrhages, ITP, Platelets extremely low, Borderline dizziness on sudden movements
Pt recvd 2nd dose HIB vax 21AUG91 & exp tonic-clonic activity; pt taken to ER; flaccid; taken to another hosp dec movement of extremities; hemiparesis; weakness; 7SEP91 febrile sz & aseptic meningitis; gastroenteritis, bronchitis, epileptic
patient was given 12 month vaccinations mmr, varivax, vaxneuvance at 9 months instead of at 12 months  by mistake . patient was held for 20 min after the vaccinations were given. there was no adverse reactions to the vaccinations. the only issue was that they were given early for what is concidered the time frame to receive these vaccinations.
pt recvd vax 16AUG93; mom states skin eruptions appeared around inject site on lt arm immed following inject; also had PPD; 7-8 erythema papular; rash itch; poss allergic react;
No additional AE details; TE evaluation states vaccines have been administered to multiple patients/temp ezcursion occured March 23; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-APR-2022, the patient was vaccinated with an improperly stored dose of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength, exact dose, and anatomical location of administration were not provided) (product storage error). There was no adverse effect reported (no adverse event). Administered dose of vaccine experienced the temperature excursion of -14 degrees Celsius for 3 hours. There were no previous temperature excursions. The viability of the vaccine was verified at Merck hotline. The reporter also stated that there was a device or device component malfunction (discrepant information, as varicella virus vaccine live [oka/merck] [VARIVAX] is not a medical device or medical device component product).; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA008004:
A 47 year old female consumer reported that she received an influenza vaccine on 9/26/00. On 10/4/00, she experienced sneezing and nasal congestion.
PT REPORTED ON 9/25/2012 THAT HE HAD NERVE PAIN AND HAD SPOKEN TO 2 DRS WHO SAID IT WAS A RESULT OF THE ZOSTAVAX VACCINATION. BOTH DR'S SAID TO INFORM PHARMACY, WHO SHOULD REPORT SIDE EFFECT.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003CZ1A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Iron deficiency (managed with mult-vitamin) on 11-May-2019, Carotid body tumor (none - followed by ENT surgeon. will repeat MRI in December after delivery) on 01-Jul-2020, Alcohol use (prior use,4 drinks/ month) on 31-Dec-2019, Postpartum hemorrhage (live, full-term birth complications-postpartum hemorrhage (mother)) on 31-Dec-2015 and Postpartum hemorrhage (live, full-term birth complications-precipitous delivery; postpartum hemorrhage (mother)) on 11-Feb-2017. Concomitant products included PRENATAL MULTIVITAMIN + DHA for Pregnancy.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 22-Sep-2021. On 05-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-May-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Pregnancy test: positive (Positive) Positive. On 19-Feb-2021, Ultrasound scan vagina: pregnancy positive (normal) Single live intrauterine pregnancy confirmed.         The patient had an Anatomy scan on 05/05/2021 and were WNL. The patient had Maternal Serum AFP on 04/02/2021 and the results were  WNL.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: patient demographics updated, historical conditions ,lab data  updated,2 nd dose added, concomitant medications added
After each dose of vaccine my menstrual cycle would start early (within 3 days of the shot) then it would last longer and be heavier. Subsequent menstrual cycles (in between doses) would last longer. After the booster shot I experienced menstrual bleeding for 6 weeks and a healthcare provider put me on to hormonal birth control to control the bleeding.
On Wednesday, October 13, 2021 started experiencing dizziness, vomiting, could barely stand up. My wife called the ambulance, I was diagnosed with Vertigo and discharged on October 16, 2021. The ENT is still trying to determine if this was inner ear related that caused this to happen.
Shots done on Tuesday August 11, 2009, mother reports lump on L leg near injection site, still present today.
Child received vaccine (PENTACEL) at 11:00 AM, intramuscular injection into right thigh.  Child showed signs of pain at injection site, refusing to stand or walk; decreased appetite; and lethargy.  Child was put to bed at 7:00 PM and at 8:30 PM. parents heard a choking sound over the monitor.  Found child in bed choking on vomit - although no vomit was found elsewhere.  Child's eyes were rolled back.  His body was completely limp.  He was pale and completely unresponsive.  Would not awaken when gently shaken and called by name.  Parents called 911 and child remained unresponsive up until the paramedics arrived.  Child then started to cry and resumed normal muscle tone and normal pallor.  Child's temperature during the episode was 100.5 F.  Total time of episode approximately 30 minutes.  No treatment, other than infant dose of Ibuprofen, was administered.
After receiving the second dose it was more painful than his first dose; This is a spontaneous report received from a contactable male consumer (patient) from a Pfizer sponsored Program COVAX US Support. A male patient of an unknown age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation and experienced after receiving the second dose it was more painful than his first dose. On an unknown date, the patient experienced after receiving the second dose it was more painful than his first dose. The patient reported that after receiving the second dose it was more painful than his first dose. He was calling about the Pfizer covid 19 vaccine. The patient wants to know if he still needs to take the booster shot. The patient stated he was concerned about the delta virus because it was running rampant. The side effects were negligible for him. He has been getting vaccines since he was a child. He has to hang up his nephew was calling him. No further details provided. The outcome of the event was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up attempts completed, No further information expected.
Lump moved to arm pit of injected arm; Lump moved to left breast; Redness at the site of injection; baseball size lump at site of injection; pain in arm; Developed nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included IBUPROFEN 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 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and NAUSEA (Developed nausea). On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (baseball size lump at site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). On 22-Feb-2021, the patient experienced BREAST MASS (Lump moved to left breast). On 24-Feb-2021, the patient experienced AXILLARY MASS (Lump moved to arm pit of injected arm). At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and NAUSEA (Developed nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Body oil, massage and Ibuprofen.
Couple weeks after the second dose of vaccination i had flare up and had my periods every two weeks. It lasted about a month.
Within 24 hours after receiving immunization infant began to have loose watery stools x 4. Orangish brown in color with specks of bld noted. (No hard stools at all). Blood in stools for about one week. No other symptoms.
Extreme tenderness, hot to the touch, redness in vaccination area radiating up toward collarbone, and down arm but not past elbow.  Joint stiffness, foot spasms (1X), general feeling of aching in joints.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 20Apr2021 as dose 2, single (Lot number: 039A21A), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Discoid lupus erythmatosis" (unspecified if ongoing), notes: Discoid lupus erythmatosis; "Menieres Disease" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (08Jun2022) Unknown results, notes: tested on Wednesday, 08Jun2022 and the line was barely visible; (11Jun2022) Positive, notes: tested positive again the morning of 11Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Completed 10 prescribed doses of Paxlovid from 02Jun2022 to 07Jun2022, for Treatment of COVID-19. Patient tested on Wednesday, 08Jun2022 and the line was barely visible. On Friday, 10Jun2022 patient felt the symptoms returning in the evening. Patient tested positive again the morning of 11Jun2022.
Fatigue, headache, rash and swelling upper leg, occasional high temp of 99,  night sweats, dark urine, swollen lymph nodes(gone now)
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a single dose vial of GARDASIL (dose, lot # and route of administration were not reported) that was exposed to 23F for unknown period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Foster mom woke baby up from a nap for a feeding at 730PM. As she was transferring baby out of the carrier, she notes that he stiffened up and  "went into extension." He also "foamed at the mouth," producing "lots of bubbles." His eyes were "open and not moving." FM thinks that they may have been deviated to one side but she cannot quite remember. She denies jerking of the extremities and color change. She did not notice whether pt was breathing during the episode or not. She turned pt on his stomach so that he would not choke, and he remained in extension. The whole episode lasted around 30-60 seconds, per FM. It was witnessed by both her (she is a physical therapist), and a friend who is a Labor and Delivery nurse, and they both thought that it looked like seizure-like activity. This has never happened before. FM checked his temperature after the episode and it was 99.4F. After the episode, FM states that pt was "irritable and sluggish." She observed him closely for about a half an hour and then fed him, which he tolerated well. He continued to be sluggish throughout the day, and then was back to his baseline by the next day. He has been interactive, moving all extremities, and feeding well since.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The reporter initially called to report improperly storage conditions for improperly stored PNEUMOVAX 23. Subsequently, it was reported that on 25-FEB-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L029306 and expiry date on 26-MAR-2017, (route, strength, dose and frequency were not reported). No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Malaise, joint pain, headache, shortness of breath at rest, increased heart rate 90-110 x 2 weeks.
onset of redness, hot to touch, swollen-itchy lt arms @ site of DTAP inj 24hr post vax;redness & swelling worse 4APR97 (redness 3"x 4";
Pain at injection site worsened, got more red and developed rash. Also light headed, short of breath and fatigued. Has continued for 9 days. Only took tylenol a few times with no result.
rectal temp of 104-105.9 10 hrs. after vaccine, stuffy nose, cough, fussy
1/21: Fever for 4 days, spiked at 103.5. 1/24: Went to Dr. Tested for strep, flu and ear infection, all negative. Faint rash noticed. 1/24: Faint rash noticed on belly, slightly more noticeable everyday. As of 1/31 is more noticeable, only on belly area and looks like mild mump like rash.  My little was extremely miserable 1/22-1/25, not sleeping and not acting like herself. I am still bothered by how she is reacting to the shot and nervous that this will keep causing problems.
Injections provided 6/11. Pt developed rash 6/12 over body-papular rash. Pt also was taking Tylenol and Topical Nystatin
pt recvd vax; lab tests done;in 91 HBsag neg & anti-HBs neg; 8mar93 anti-HBs pos & anti-HBc pos;
received the Pfizer vaccine and still got Covid; received the Pfizer vaccine and still got Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I received the Pfizer vaccine and still got Covid". The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I became very short of breath, about two weeks after receiving the vaccine. I didn't know if I was having a heart attack or if it was maybe lung disease. I felt tired too. I had a doctors appointment with Dr. and she informed me, after doing an EKG, that I had atrial fibrillation. I have been put on Eliquis, 5mg, twice daily for my A-fib. In August, I will be going in for an echocardiogram. In November, I will be seeing a cardiologist.
Moderna COVID-19 Vaccine EUA: Patient received vaccine and began to feel woozy. The started itching on their chest, back, arms, and hands. The patient then was sent to the emergency department. Symptoms were just itching, no rash, no swelling. During re-evaluation, patient was stable and was discharged to home with a prescription for Medrol Dose pack.
Rash all over, urticaria like, no vesicular lesions yet. Also behavior change for 1-2 hrs, resolved later.
Swelling and rash below injection site with itching.  Rash is reducing with less itch after 4 days.
Received Pfizer 2nd dose vaccine on 01/20/2021 at 7:00 AM in the patient's right arm - around 5:00 PM the same day, the patient's knees started feeling wobbly, worse on left than the right. Knees continued to swell with limited motion, discomfort on bending, no point tenderness, and a negative meniscal exam. Swelling was worse on the left. X-ray normal. Worsening symptoms continued that limited standing and walking. Labs done on 2/2/2021 came back positive for Lyme disease and reactive arthritis. Swelling initially improved when patient was put on doxycycline, but worsened significantly after physical use. MRI showed large effusion in the left knee consistent with Lyme and a small focal lateral posterior horn meniscal tear not consistent with effusion. Effusion was drained March 1st and was PCR positive for spirochetes. WBC in effusion was 3400. Patient switched to amoxicillin and knee showed improvement by March 12th, 2021.