chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 55-year-old adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 at 12:15 PM (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Patient other medical history was none. The patient had no covid prior vaccination. The patient known allergies were none. The patient concomitant medication(s) included Paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On 06May2021 at 12:15 PM after the vaccination, the patient experienced chest pain. The patient underwent lab tests and procedures which included EkG (electrocardiogram): result unknown on an unspecified date in 2021. Unspecified therapeutic measures were taken as a result of chest pain. The patient outcome of the event was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
It was reported that a pt rec'd a TD adult vaccine on 4/7/00. Reportedly sometime after the vaccination the pt developed a large red area, very painful, hard knot at the injection site. From correspondence rec'd on 5/2/00 additional pt, vaccine administrator and responsible physician information was provided.
Onset of rash 3/30/03. No exposure to ill persons known. No apparent pruritus. Temp 99 deg. Green nasal D/C. Rash nape of neck, 2 on forehead, several on ??? pubic. All erythematous, several vesicular center. Approx 20 skin lesions. Given Amoxicillin, Cardec DM, Tylenol, Benadryl if scratching.
Redness, swelling, rash, skin felt hot (noticed approx 6 hours later and approx 4-6 inches below vaccine site).
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included FLUARIX (FLUARIX was given in the opposite arm, but no events were noted in that arm). On 6th October 2018, the patient received the 1st dose of BEXSERO. On 11th October 2018, 5 days after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were unknown and the outcome of the injection site swelling was resolved with sequelae. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site itching to be related to BEXSERO. Additional details were provided as follows: The case was reported by the mother of the patient. The age at the vaccination was not reported. The patient received BEXSERO in an unknown arm. FLUARIX was given in the opposite arm, but no events were noted in that arm, just the BEXSERO arm. The mother of the patient did not know which arm her daughter was injected with BEXSERO and her daughter did not specify.
states about 8PM when changing diaper pt stiffened body, eyes looked funny, started choking-lasted a few seconds; then acted as if in pain; was fussy for the next 6 days then took to MD 24NOV92;
Starting about 6 hours after extremely bad head ache, constricting muscles, chills, extreme thirst, dizziness, extreme tiredness all lasting about  24 hours. Chills left first, then thirst, muscles.  48hr post injection still extreme head ache and dizziness
severe brain fog; peripheral neuropathy; gut issues; cognitive issues; blurry vision; vision issues other than blurred vision;
Extremely swollen throat, excruciatingly sore, could not swallow own saliva, very puffy eyelids, localized rash, first noted at 4am 3/6/07 woke me up,  took 4 capsule 3/5 at 8am mild reaction 3/04/07 at 4am. Swelling reduced over day 3/6/07 throat still sore.
Patient received 4 vaccines in bilateral thighs. He left the clinic with father, but returned within 5-10 minutes with epistaxis, pruritus of trunk, sneezing, coughing, breathing problems, periorbital edema, wheezing. BENADRYL given by mouth, then epinephrine via SQ injection. Observed about 60 min with recovery. Prescribed ZANTAC, BENADRYL and ORAPRED. Follow up visit on 5/26, complete recovery.
Spoke with PUI who has been feeling fatigued for a couple weeks now. On 9/16 PUIs symptoms intensified to the point where she went to hospital where she was admitted and released 9/20. She is still symptomatic with cough, aches, congestion, sore throat, and headaches. PUI is fully vaccinated, tried to get the vaccine booster but was ineligible. PUI has COPD, no other preexisting medical conditions.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiry date and route were not reported). On 12-DEC-2016, the patient was vaccinated with GARDASIL 9 (dose, lot#, expiry date and route were not reported) to continue the series of HPV vaccine. No adverse effects reported. Additional information has been requested.
Extremely light headed/Feel like gonna pass out when I stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up) in a patient of an unknown age and gender 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, the patient experienced DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up). At the time of the report, DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Pt developed acute onset chest tightness and difficulty swallowing about 1.5 hours after his vaccination, and about 10 minutes after the completion of a test dose of iron dextran. He was acutely distressed. He was treated with IV benadryl and IM epinephrine. The difficulty swallowing resolved, but chest tightness persisted. Trial of nitroglycerin did not improve his pain so pt was given IV hydromorphone. After approximately 10 minutes he was  relaxed and breathing comfortably, but still endorsing chest pain.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a female of unspecified age. 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) dose was not reported, 1 total, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient had done antibody test 3 times on 16-JUN-2021, 13-JUL-2021, 11-AUG-2021 respectively and the results was negative for all the tests (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirm immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189404; Sender's Comments: V0: 20210824390-covid-19 vaccine ad26.cov2.s-confirm immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This report is for 1st of 11 patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), dose 1 via an unspecified route of administration on 17Dec2020 and dose 2 via an unspecified route of administration in Jan2021 (Lot number: unknown), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after two weeks of second dose, the patient experienced unusually high number of COVID infections in fully vaccinated employees. The physician further stated they may need some kind of investigation here because they are seeing high viral loads in these individuals and symptoms. The patient was well after two weeks. The outcome of the event was unknown.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19.
chills dreaming of surrounded by fires, restless, nausea rolling over, vomitting on an empty stomach 3AM; threw up breakfast 7AM; sleepy x 12hrs;
Headache, Myalgia, Fever, slight shortness of breath after walking a flight of stair on day 4 post vaccine Narrative:
Left arm with severe edema, arm is now three times it's normal size. Overall joint pain, pain and redness at site, hot to touch.
Information has been received from a Licensed Vocational Nurse (L.V.N.) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 15-MAY-2015 the patient was vaccinated with a dose of incorrect stored RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Thursday 11/11: headache, dizziness, fatigue fever of 102.3 Friday 11/12: headache, dizziness, fatigue fever of 103.4 Saturday 11/13: above symptoms not present
PT ARRIVED AT CLINIC AT 14:20, WITH C/O FEELING COLD AND WEAK. VITAL SIGNS COMPLETED,  PT STATES WEAKNESS RESOLVED BY TIME SHE LEFT CLINIC. PATIENT EDUCATION  COMPLETED.
53 YO F REVACCINE 8D POST-VAX EXQUISITE PAIN AT SITE, FATIGUE, FEVER; 15D POST-VAX PUSTULE DRAINING, 1-2CM; REDNESS 7CM, INDURATED, PAINFUL.  DIGITAL IMAGES PENDING.  WORKING/FINAL DX: MAJOR REACTION.
Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that 21 patients received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022 Moderna Covid-19, Lot Number 030H21B, Expiration Date-23-Mar-2022 for all patients involved.  It was reported that the first 9 patients received Moderna Covid-19 vaccine on 02-Mar-2022 past its 30 days Beyond Use Date. The patient received Moderna Covid-19 vaccine on 02-Mar-2022 wt. was not known, expiration date 20-Mar-2022. The reporter also mentioned that they didn't know which dose the patient received the invalid dose on and didn't know which arm the patient received the Moderna Covid-19 vaccine in. The reporter doesn't have any other adverse events or side effects to report.  Reportedly, the reporter wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24-Jan-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
Developed progressive itching, generalized, Increasing numular eczema with itching, but itching was not limited to the areas of dermatitis. Symptoms started about a week after Moderna booster. Went first to dermatologist on July 15. Given triamcincalone 0.1%, discontinued all meds for 1 month, started Allegra 180  QD and benadryl 25mg at his. Refrained from use of the pool, which I ha been using for 19 years. Symptoms greatly improved over that month. (Trimamcinalone less effective than oral meds). In retrospect, previous covid #2 shot was on 11/9/21 and I began itching with new onset numular eczema in December. It was not until the booster that I began to think about the correlation with  the covid shot. Today, 12/9/2022, I have 3 eczematous lesions that remain (out of 12-15 previously), and no generalize itching. I still use triamcinalone occasionally. I had my bivalent booster today and will observe for any symptoms.
Patient was given his 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.   Patient has been notified of the vaccine administration error.
Sudden extreme fatigue and mild nausea for about 2 hours. Then felt tachycardia and palpitations. Heart rate was checked by medical professional in household and was found to be 120 and irregular. This lasted approximately 2 minutes. At this time also felt shortness of breath which lasted 30 minutes. Once the tachycardia and shortness of breath ended, I was getting chills and continued to have nausea and extreme fatigue. Since the vaccination my arm has continued to be very sore. When I woke up on 1/8/2021 I am still very fatigued and still have a sore arm.
Papular rash resembling varicella 6 days post Proquad vaccine.
Low O2 saturations, dusky pale appearance, delayed response to stimulation, apnea
Sick; Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (not ongoing), notes: went through breast cancer and chemotherapy over 2 years but she still goes through blood work; "Chemotherapy" (not ongoing), notes: went through breast cancer and chemotherapy over 2 years but she still goes through blood work. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "Sick"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: Over 2 years but she still goes through blood work. Patient got very sick with Pfizer COVID 19 1st vaccine which was 5 months after chemo. 1st vaccination gave her shingles 2 weeks later and had to go to the hospital at that time. They advised not to take the 2nd or if so wait 8 weeks. Patient waited 8 weeks and got the 2nd one that also put her in the hospital, and she lost 13 pounds and got so sick it was like she had COVID. Patient has not received the booster because of her reactions. Caller states she is hesitant about all these vaccines, they may work for people, but she does not want to put herself out there to get a problem she doesn't have. Not sure if the pneumonia vaccine would be a good fit for her. Caller no longer has breast cancer, but she still has side effects due to chemo treatments she was given.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt c/o onset of SOB & throat tightness 10min p/vax given;no hives or wheeze noted;
I received the Pfizer vaccine first dose on 8/9/21 at 915 am and around 11 pm that night I could feel an irregular rapid heart rate (120?s), felling hot and flushed, my face felt full and tingly, I felt dizzy and off. I had trouble falling asleep and staying asleep that night. The next day I went in to see my primary care physician where I had lab work and an EKG done. The EKG came back abnormal so I was referred to a cardiologist where I had an echocardiogram and 14 day monitor in place. 8 days out I now feel dizzy and off some of the day, and numbness in my right forearm and hand.
In the summer of 1998, the patient developed a mild case of chickenpox. On 09/19/2000, the patient "broke out in chickenpox again" that was described as a red, itchy rash with approximately 20-25 lesions on head and trunk of body. The patient sought unspecified medical attention. In follow up the patient's physician's office reported that they were unaware of any adverse events related to varicella virus vaccine live. It was noted that there were no telephone messages or office visits related to adverse events.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-OCT-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Patient experienced skin erythema around injection site, nausea, vomiting, and diarrhea after receiving Pneumovax 23 vaccination on 9-20-16 with LOT: M024673.
got my vaccine Saturday morning 4/24/21 - woke up in the middle of the night on Tuesday morning around 2am to my lower left leg from the knee down cramped up. Woke up to the same pain and continued all day Tuesday to the point of not being able to walk well . Wednesday morning went to urgent care to be treated due to extreme pain. Did an ultrasound and they diagnosed me with DVT - found two blot clots in my left calf and back of the knee.
Administered vaccine to Patient  for Moderna CV19 Booster Dose. Booster dose was given in the Outpatient Pharmacy Consult Room. Patient tolerated administration of vaccine without issue, instructed to wait 15 minutes for follow-up, and address any potential concerns with pharmacist if needed. After 15 minute wait period, patient started feeling hot, dizzy, faint, and anxious. Patient denied any adverse events in the past with vaccine intolerance or administration.   Pharmacist decided the best option was to consult Rapid Response to have an evaluation for the patient. Patient had asked if she could ambulate herself however pharmacist decided it would be best to have medical attention brought to her. Dr and RN from ICU staff had presented to the outpatient pharmacy for follow-up. Vitals were taken twice. Patient deemed stable by Medical Staff and patient was able to leave.   Patient was about 10 weeks along in pregnancy per patient report.
The adverse event is related to early labor and delivery of a baby following the COVID booster shot. At the time of the booster, I was 35 weeks and 1 day pregnant. This was my fourth pregnancy; my first two pregnancies ended with babies delivered vaginally at 39 weeks,  6 days and 40 weeks, 2. days. My third pregnancy ended in miscarriage at 8 weeks. There had been no complications with this pregnancy, and I was measuring to my exact due date of December 5, 2021. The day following the booster,  I felt mild symptoms of fatigue. My water broke at midnight on 11/4,  and a healthy baby boy was delivered vaginally at 10:00 a.m. that morning.  He weighed 5 pounds, 12 ounces. He required no time in the NICU.
Case number PHHY2011US68635 is an initial spontaneous report received from a health care professional on 28 Jul 2011. This report refers to a female patient of unknown age group. She was given only the MenA powder conjugate component of MENVEO (batch number: X10051 and expiry date: Jan 2013) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on 21 Jul 2011. No other adverse reaction was reported.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age. The 2 patients were inadvertently administered 0.5 ml GARDASIL (lot # 666595/0096Z) intramuscularly on 15-OCT-2012 that had expired on 14-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
Child said he felt warm, had slight stomach nausea, severe blurry/distorted vision. Child lost all color in lips.  This all happened in the span of 5 minutes and went away just as quickly. Watched carefully and gave glass of water to drink. Fine for rest of day.