chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/17/21 after 3 days, starts itching  on left arm then next day  few scattered  rashes on both arm.. on 1/22/21 redness both lower extremity no itchiness. Then on 1/25/21 rashes appears on  both upper thigh,,still with few rashes on both upper arms and lower leg..1/29/21 with rashes + itchiness. 1/31/21. Pronounced Rashes on both upper arm , both legs up to inguinal area , raised rashes at the back of both  knees plus severe itchiness. Went to hospital, Dr. said it is not due to vaccine because it supposed to not last x 2 weeks for the rashes if it?s from vaccine. Dx: urticaria. Dr dismissed the fact that it all started when I got the vaccines
Information has been received from a health professional concerning a 4 year old female pt who on 12-JUN-2000 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 14-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598,  WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00619, and WAES0405USA00619). No additional information is expected.
A sudden onset of acute pain in right leg upper thigh. Roughly it was above the knee and the width of a hand is where the pain was focused. It lasted for almost a month. It has subsided greatly as it was excruciating for the first three weeks.
Parent noted redness and swelling within 24 hours of vaccine administration. Within 48 hours client began transient episodes of hives. Hives episode recurred over a 2 day period. Parent denied fever, difficulty breathing.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient appears to have had a seizure immediately after administering the third vaccination (the moderna bivalent).  Patient was fine with other two vaccines, but upon injection of the third vaccine slumped over in the chair and began to seize.  I moved the patient to the floor on her side and a staff member called 911.  Within a minute the patient was conscious again, speaking, and claiming dizziness.  I asked her to remain lying down, which she did until EMS arrived a few minutes later.  During the short wait for EMS she was able to converse perfectly clearly with me and called her mother and boyfriend to meet her.  She departed on the stretcher with EMS.  At that time she was declining to go to the hospital, saying her boyfriend was on his way.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients of an unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 14-JUN-2022. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that, the patients who were fully vaccinated and boosted contracted the COVID-19, coded to suspected clinical vaccine failure, and suspected covid-19 infection (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination.  No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000234975. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220618178-COVID-19 VACCINE AD26.COV2.S- SUSPECTED CLINICAL VACCINE FAILURE. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Got the shot, then shingles twice/ suspected vaccination failure; shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and was rewarded with shingles twice. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The patient was injected in the left arm with FLUZONE HD. The patient started to bleed and arm swelled to about the size of a dime/nickel. I stopped the bleeding and recommended ibuprofen/tylenol for swelling/pain and ice. I called the patient later to make sure swelling had subsided. Patient stated that the swelling had gone down and that he had little pain, but there was still a small knot on his arm.
Patient complained of headache and sore throat that started after she received the vaccine and persisted for one week. She sought care at an immediate care center. Was tested for Covid, Flu and strep throat which were all negative. Instructed to hydrate, get rest, healthy diet and take Tylenol/Motrin as needed.
Right arm pain deltoid runs to neck, aching constant. Headache last two day from when form was completed.
Second dose administered 3 months after the first dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose). In June 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: FU received- no new information
On 4-11-07 mother stated child cried a lot after Hib on 4-4-07
lmproperly stored PROQUAD administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-JUL-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T016990, expiration date 11-NOV-2021 experienced the temperature excursion of 6 to 14 degrees Fahrenheit (7.3F) for 37 minutes. On 24-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T016990, 0.5 mL subcutaneously x 1 dose (formulation, strength, frequency and route of administration were not reported) or prophylaxis (product storage error). No product quality complain reported. On 14-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (9.9F) or 2 hours and 11 minutes. On 15-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (6.6F) for 59 minutes.
suspected vaccination failure/had both shots, had shingles 2 times since; have had shingles 2 times since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at 49 years of age).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles at 49 years of age and when he/she turned 50, the patient had to get on a waitlist for vaccination.  Successfully the patient had both shots in required amount of time, but have had shingles 2 times since. The patient would say they were not as severe of cases, but no fun. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Age group was captured as per reported information.
Pfizer vaccine was administered outside of the clinic - reported by patient   ACUTE PULMONARY EMBOLISM 8/14/2022 ACUTE PULMONARY EMBOLISM
Became dizzy within 30 minutes,  then body shakes (not chills), palpitations and a skyrocketing bp and pulse. My throat was also sore (but not constricted).   I work in a medical facility and was brought to the Emergency Department. I was monitored with an EKG and given steroids and benedryl intravenously.   I was discharged from the ED after a few hours and told to return to an emergency room if symptoms got worse again.   My blood pressure continues to be somewhat elevated and heart rate feels rapid at times. Also intermittent dizziness., along with other common post vaccination side effects.
I am currently 5 weeks 4 days pregnant with one previous miscarriage. This pregnancy is due on Dec. 12th. It might be a coincidence but the same day I got my 2nd dose, I started to spot in the same way I did with the previous pregnancy that ended in miscarriage which didn?t happen until 9 weeks.
Beginning Friday, June 3, I developed fatigue, mild headache, sore throat and nasal congestion. That worsened over Saturday and Sunday. Monday morning June 6, I called into work and had my lab tech swab me in the parking lot. The PCR test came back positive. I called the pharmacy who we work with and prescribed PAXLOVID. I prescribed that myself and took that for 5 days for the standard dose. During those 5 days, my symptoms included fatigue, cough, nasal congestion, sneezing, some diarrhea, fever of 101. By Thursday I started to feel better and by Friday I was almost normal again June 10. I then returned to work the following Monday, June 13, with wearing a mask. Now feeling fine.
Pt had a fever of 104 and labored breathing.  Flushed face and bulging eyes. Called nurse and nurse instructed mom to call 911.  Oxygen and tylenol was administered.  Pt was better when he arrived at ER.  Fever for 2 days.
Blood clots ( DVT in right leg and three pulmonary embolisms in right lung), symptoms appeared around 4/5/2021 and diagnosed on 4/9 and 4/10.  Also started experiencing diarrhea during the same time period.  Being treated with Xarelto and Azithromycin.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-DEC-2017, the patient was treated at a medical clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No adverse event; HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes.; Dose were administered after the excursion happened.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:unknown.     In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes.). In August 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes.) and POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No pqc was reported. HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes. Maximum temperature reached was 21.4°F. This was the first and only excursion. It was reported that patient did not  experienced any adverse events according to HCP. No treatment medication was reported. This case is reported for patient 4th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736913 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736913:Master case
Fever of 100.4, chills, occasional body sensations like a jolt of electricity (as if weaning off of an anti-depressant)started at 2:00 pm of day 2 and lasted until early morning of day 3, stiff neck/muscle ache on 4/7/21
Client complained of feeling lightheaded.  Client evaluated by EMS on site.  V/S per EMT BP 90/40, R 14Min, HR 72. Evaluated after 15 min. observation.  Client verbalized she was feeling better.  Sent home with her parent.
Diverticulitis Received call from Vsafe. Lady asked if my diverticulitis had occurred before or after my first vacination. I told I believe it was after my first shot. She advised my to go on line and report it.
Patient reported that she has a rash that started 11/04 on her arms... now she has the rash all over her legs arms scalps and the side of her face... bumps are very itching and red... also developed a lump in her arm pit as well as back her neck...
I received injection at 1332 in L arm. Within 5 minutes I began to feel tingling in the left side of my neck and the tip of my tongue was numb. I waited about 5 min to see if sx would diminish and notified clinic staff at 1344. Physician and nurse immediately responded to assess. At 1350 I looked in mirror and neck was red from L side of neck to center. As physician was again assessing symptoms we both watched the redness spread to the right side of my neck. By this time my lips were also numb and I began feeling mild full body tingling. Physician and I entered clinic and I received epi-pen injection at 1404.  The redness in neck resolved within a few minutes and the total body tingling also resolved. Nurse noted mild swelling around upper lip but it also quickly resolved after receiving epi-pen injection. EMS were called. I was evaluated by EMS and deemed stable. I had 2 epi-pens in my possession as well as Vistaril and an inhaler so I declined being treated at emergency room I left clinic at 1430. On my drive home, I noted that area above upper lip and nose were numb. I also began experiencing numbness of soft palate of roof of mouth. I arrived home shortly before 1500 and took a Pepcid and a dose of Vistaril. I reported reaction to the health department and Moderna on 3/9/21. I was evaluated by my personal physician on 3/9/21.  I continue to have numbness on tip of tongue and lips 3/10./21. Per Moderna personnel, they were unable to tell me how long to expect symptoms to last and I continue to treat with antihistamines and monitor.
three of their team members have Covid, and they all got it from different people; three of their team members have Covid, and they all got it from different people; This is a spontaneous report received from non-contactable reporter (HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Exposure to COVID-19" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "three of their team members have Covid, and they all got it from different people". Additional information: adverse event: Friend who works partly remote and partly at hospital says that three of their team members have Covid, and they all got it from different people. Though I do not know them personally, there is a high chance they are all vaccinated to some extent, though manufacturer and dosage is unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown) to the reported events COVID-19 and drug ineffective cannot be excluded.   However, the vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be re-assessed should additional information becomes available.,Linked Report(s) : US-PFIZER INC-202200028597 same reporter/drug/AE, different patients;US-PFIZER INC-202200028596 same reporter/drug/AE, different patients;
pt recvd vax 10AM started running temp @ 3PM went to 104.2 R; did not dec w/APAP but came down to 102 R on Sunday; pt cont to whine @ intervals throughout noc; fussy & irritable for next 3 days; MD called felt pt not to receive DTP anymore;