chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My sister just dies from it; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (My sister just dies from it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Follow Up received include no new information; Reported Cause(s) of Death: Unknown cause of death
Menstrual cycle was early by two weeks; Menstrual cycle was heavier than normal.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 12Jul2021 at 17:30 (at the age of 49-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 19Jul2021, the patient reported that her menstrual cycle was early by two weeks and was heavier than normal. The patient was on that new schedule at the time of reporting even after the second dose on 02Aug2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events menstrual cycle was early by two weeks and was heavier than normal was unknown at the time of this report.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/18/2021, 02/15/2021, and 11/03/2021. The first two doses were administered at the facility indicated in Item 15 of this form. The third dose was administered at medical center.   The individual tested positive for COVID-19 on 01/26/2022 and had several acute care visits (no evidence of hospital admission) on  01/28/2021, 01/29/2021, and 01/31/2022.  The individual was described as "asymptomatic" in the clinical notes from 01/27/2022. However, the individual was transitioned to comfort care only on 01/31/2022 and died later on that same day. The individual had a Do Not Resuscitate Order in place.
Patient noticed knot or lump at site of injection last PM when friend grabbed his arm. Remains 90mm in diameter ordered Aristocort cream topically BID X pretreat for next dose. Allegra 180mg 2 tabs a day before nest dose.
Approximately 45 minutes after returned to site w tachypnea, low grade temp 100 degrees, normal 98% O2 sat, and recurrent moderate rigors that waxed and waned. Hemodynamically stable w tachycardia, cool extreme and diaphoretic.  No rash, rigor, airway compromise.  Transferred to ER by ambulance.
Symptoms started around 3/30/21, after her second COVID vaccine. Presented to ED with evidence zoster in the V1 distribution of the ophthalmic nerve. Rash on the face was classic for zoster and involved swelling of her eyelids. Started patient on treatment for zoster infection. On acyclovir 10mg/kg q8h.
Pt vaccinated with TD began with burning in legs, the overall intense shaking, tremors - lasted approx 1 hr next day total soreness/weakness w/2wk of strong muscle contractions spasms & pain. Chest pains during this time.
Information has been received from a 33 year old female patient with a dose of varicella virus vaccine live. There was no concomitant medication. On 03Nov03 the pt developed a site reaction on her arm. The pt stated that she had a two and a half inch diameter that was swelled, bruised and itchy. The pt also developed three chickenpox on her body. Her physician recommended using an oral diphenhydramine HC1 (Benadryl), colloidal oatmeal (Aveeno bath), and icing the affected area. On 07Nov2003, the pt stated that the bruise was looking better and was less itchy. The pt was reported to be recovering with sequlae. There was no product quality complaint involved. Follow up information from a physician indicated the Caucasian pt was vaccinated on 23Oct2003 at 15:30 in the left deltoid with a first SC dose of varicella virus vaccine live. On 03Nov2003 at 08:00, the pt developed a rash at the injection site. There were no adverse events following prior vaccination. Laboratory tests were not performed. Within two weeks, the pt recovered from the rash at the injection site. Additional information has been requested.
Patient has nausea, chills x 48 hours after vaccines. Then the morning of 9/12, patient developed gross hematuria.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # R017639 with expiration date on 20-JUN-2020; lot # R023504 with expiration date 16-AUG-2020; or lot # R009411 with expiration date on 29-MAR-2020 (reported as 29-JUN-2019), (strength, dose, route, anatomical location were not provided) for prophylaxis. The vaccines were exposed to the following temperature excursions: In the range 15°F to 46°F (26.28) for 1 hour and 35 minutes; in the range 15°F to 46°F (24.15F) for 71 minutes; and in the range 15°F to 46°F (25.52F) for 118 minutes. There was previous temperature excursion in the range 6°F to 14°F for 230 minutes, and in the range 15°F to 46°F (21F) for 3 hours and 50 minutes. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. Follow-up information was received from the reporting nurse on 25-MAR-2019. It was reported that only one patient was vaccinated. On 18-MAR-2019, a patient who is currently 4 years-old (unknown gender), was vaccinated with (improperly stored) VARIVAX, lot # R017639 with expiration date on 20-JUN-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis.
Day 3 Under arm swelling extremely sore to move. Day 4 Arm tightness along artery, More swelling breathing discomfort from swollen lymphoid. Day 5 Shoulder tightness causing neck pain and headache.  No more soreness from injection site. Unable to live arm without extremely tearing feeling from muscles under arm down to elbow and flank around arm pit.   Taking Motrin
Crying nonstop for 4 hours. Very irritable and difficult to console. Also, swelling at the injection site. This occurred both times the vaccine was administered, and was worse the second time.
Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlusive DVT of the left posterior tibial vein.
itchiness on her neck on the left side; redness on her arm; Spotty rash on her arm; itchiness on her arm; A spontaneous report was received from a consumer concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spotty rash on her arm, itchiness on her arm, redness on her arm, itchiness on her neck on the left side.  The patient's medical history was not provided. Concomitant medications reported were simvastatin, rivaroxaban, levothyroxine, multi vitamin for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events spotty rash on her arm, itchiness on her arm, redness on her arm. On 18 Feb 2021, the patient experienced the event itchiness on her neck on the left side. Consent for safety to follow up with her given.Consent for safety to follow up with her healthcare provider- yes, her primary care doctor retired last week and doesn't know any other information. Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event, spotty rash on her arm was resolved. The outcome of events, itchiness on her arm, redness on her arm, itchiness on her neck on the left side was unknown.
Rough Shot!/Then I developed silent shingles/Suspect vaccination failure; Then I developed silent shingles; Severe right sided neck pain; Debilitating.; Burned like fire; fever/for 3 days; body aches for 3 days/painful months; This case was reported by a consumer via media and described the occurrence of suspected 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), shingles, fever, general body pain, neck pain, debility and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, neck pain, debility and burning sensation were unknown and the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever, general body pain, neck pain, debility and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced fever, body aches for 3 days, developed silent shingles, severe right sided neck pain from an old auto accident that had lo g healed, debilitating and burned like fire. The reporter reported that should have left well enough alone and lasted 6 extremely painful months. The patient said I am not an anti-vaxer. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt's obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt's death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003.  Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease.  Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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-APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000242092.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
loss consciousness; another episode collapsed; loss consciousness; another episode collapsed; cut her head open; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (batch/lot number EP8737 and expiry date unknown) at 48 years of age as dose 2, single for covid-19 immunization. Medical history included Heart murmur, vertigo on left side every year and a half. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took dose 1 of bnt162b2 administered in the left arm on 26Mar2021 12:00 pm (batch/lot number ER8727) at 48 years of age for Covid-19. The patient informed that day after the first vaccine positional vertigo started bad in both ears; on 06Apr2021, she loss consciousness and had seizure symptoms hit a light pole while driving. The vertigo was just now subsiding since 27Mar2021. The patient informed that after 2nd dose (2021) she had another episode (loss consciousness) collapsed in her brother's kitchen, cut her head open and had 6 staples put in her head. The events were reported serious as hospitalization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment which included IV and Keppra. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
sore arm; This is a spontaneous report from a non-contactable consumer Patient's wife). A 64-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on right arm on an unspecified date as an unknown single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications was not reported. It was reported that, patient had it also and he only had a sore arm, not bad and he was shoveling some snow today (date unspecified). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Hives reported on both forearms including pruritis; Denies any shortness of breath; Has malaise and headache and slight cough; Patient is planning to take Diphenhydramine 50 mg every 6 hours until symptoms subside.
Around noon, the injection site pain started.  Around 5:30pm, fatigue, body aches, fever and chills set in and continued through the night.  Upon waking the next day at 9am, fatigue, body aches, and chills were lessened significantly.  Around 2:30pm, I took 2 advil and the body aches and chills went away shortly after.  Fever/sweaty feeling continued into the evening and overnight.  Woke up the next morning feeling much better (thank god!) and all symptoms gone.
This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot # J003785 and expiration date: 28-MAR-2015. She states that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Hives; Blisters and lesions on both hands(knuckles) and both elbows; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows). At the time of the report, URTICARIA (Hives) and BLISTER (Blisters and lesions on both hands(knuckles) and both elbows) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications provided were steroids/antihistamines.   This case was linked to MOD-2021-073526 (Patient Link).
9/23/11 child was brought in by parent after she was sent home with chickenpox. Parent wanted to know if rash was chickenpox. Child had rash on neck, abd and back. Most lesions were drying but did find one vesicle on abd. Parent state child started breaking out 9/16/11.
Foster mom reports her arm was slightly swollen next day, but deltoid area was red and very warm to touch area also was bruised-recovered with problems. No treatment to area.
NOTE: Reported Adverse Event is death of vaccinee's male infant/NOT VACCINEE. Infant male pronounced dead on 11/04/01 at age 2 months. (Born on 7 Sept 2001.) Autopsy opinion: Cause of death was interstitial pneumonitis and adrenal hemorrhage. Pathological findings include interstitial pneumonitis with intraalveolar extension. Adrenal hemorrhage was noted as well.
After patient received 3 Immunizations patient immediately passed out.  Patient required laying on back, oxygen at 2L and sternal chest rub.  Paramedics were called. Oxygen was increased to 4 liters, Blood pressure and pulse were normal ekg strip was normal. Paramedics were able to work with pt. Pt ambulated to car to home with mom and dad without difficulty was orientated. Spoke with mom on 4-17-17 she stated pt was seen for other things by family physician on 4/18/17 and mom stated Dr. believed it was adrenaline the reason he passed out. At the time of injections, Pt was fighting and had to have dad hold him with assistance from mom and secretary.
Pt stated she experienced dehydration, dizziness, fever, vomiting, and fainting spells.
Congested in the morning in her chest; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. In January 2021, the patient experienced RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough). At the time of the report, RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough) outcome was unknown.            No concomitant medications or treatment details reported.; 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.
This is a spontaneous report from a Pfizer-sponsored program, Branded Concept Quant GM phase 2, from a contactable consumer. A female patient of an unspecified age, race and ethnicity  received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient developed central nervous system lupus on an unspecified date and she could not walk. Outcome of central nervous system lupus was unknown, the patient still could not walk at the time of the report. Even if the reporter though that it might not have been caused by the vaccination, this scared enough him/her to find out a lot more before getting the vaccine. No follow-up attempts are possible. No further information is expected.
Swelling; Chills; Fever; Body aches; Rash on chest; This is a spontaneous report from a contactable healthcare professional. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12May2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient has taken unspecified concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, the patient experienced swelling, chills, fever, body aches and rash on chest. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling, chills, fever, body aches, rash on chest was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
8 days after shot a rash developed on the same arm just below the injection site. Warm to the touch and itches. Approx 3x2? in size. The injection site became itchy and is red right around the site and is scabbed over.