chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART ATTACK; MULTIPLE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned 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, batch number: Unknown) dose, start therapy date were not reported ,1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated that, On an unspecified date her mother had multiple blood clots due to which she had heart attack. Patient was on blood thinners and did not survive. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from heart attack and had not recovered from multiple blood clots. This report was serious (Death).; Sender's Comments: V0: 20210648060-covid-19 vaccine ad26.cov2.s -multiple blood clots , heart attack . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; This is a spontaneous report from a contactable consumer(patient). An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Unknown), first dose via an unspecified route of administration, administered in left arm on 31Mar2021 as single dose for covid-19 immunization. Patient was 83 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. On an unspecified date reporter mentioned that muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade. She puts rubbing alcohol, a Salonpas patch, and extra stregnth Tylenol for it. She is not associating it with the vaccine, but would like to know if she can receive her 2nd dose on her right arm. She is scheduled for it on Wednesday, 21Apr2021. Therapeutic measures were taken as a result of events. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2016US028954, is an initial spontaneous report received from a pharmacist on 02 Nov 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly, on 02 Nov 2016. The pharmacist stated that, the patient was administered a dose of expired FLUVIRIN from last year's formulation. No adverse event was reported following this administration error. The case was lost to follow up at initial.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 21-SEP-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot# K025766, expiration date: 08-JUN-2016 (dose and route were not reported). No adverse effects reported and there was no Product Quality Complaints (PQC) involved. Additional information has been requested.
Fever; vomiting; Tired; Headache; Doesnt have an appetite; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, CHILLS, FATIGUE, PYREXIA, and VOMITING in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, FATIGUE, PYREXIA, VOMITING, and FATIGUE in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient stated  a few hours after vaccine she started to feel bad. She had a lot of pain in her right arm. Her right arm has been surgical repaired. The lymnnodes under her arm was so painful that she could not bring her arm down. Dr. Said that she is having a reaction to the vaccine. Every Lympnode  on her body is swollen. Dr has also taken  her off work.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of PROQUAD (lot#J009885 expiration date: 12-FEB-2015) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 25 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced shingles following dose one of Shingrix. The reporter stated that the healthcare professional noted a rash initially. Rash was diagnosed as shingles. The reporter consented to follow up.
pt was very pale, eyes rolled back & stiffened out & began to sz rhythmic twitching of extremities lasting 3-4 mins; pt remained unconscious for 3-4 mins;when pt came to began to shake c/o being cold, pale
Approximately 30 minutes after receiving the vaccine, pt. c/o itching and redness on neck and arms.  Pt. also c/o "tongue tingling."  Blood pressure: 192/96, Heart Rate: 78, O2 sats: 97% on room air.  Assessed by APN.  No Epinephrine or Benadryl given at POD.  EMS took patient via ambulance to be evaluated at  Medical Center.
sensitivity on the back; itchiness on the back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (sensitivity on the back) and PRURITUS (itchiness on the back) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (sensitivity on the back) and PRURITUS (itchiness on the back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (sensitivity on the back) and PRURITUS (itchiness on the back) outcome was unknown.        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.
8/17/2021 Client received Pfizer #1 in a homebound mission.   9/7/2021 Homebound team contacted husband for Pfizer #2 and he informed the team that she was in the hospital after a stroke. 9/92021 Team notified that client had died.
Prolonged rash (Currently at 19 days) - treated with antibiotic, BENADRYL, oral steroids.
wouldn't eat p/4AM 24DEC93; coughed, cried, fussy from 12:00 (noon)PM; cried from 6AM til 1030PM @ that time took to ER because hadn't eaten in 18 hrs;
Dizziness, spreading numbness from arm to top of head, weakness, all only on left side. Docs said they have seen this same reaction once before.  After 45 minutes, felt able to drive but on the drive home left side of face and mouth went totally numb and swelled up., strange chemical taste in mouth. Very cold and tired.  Went to bed early, slight sore throat.  Numbness gradually disappeared over the following morning.  Still have a sore throat.
Pt recvd vax approx 10AM; tc from mom approx 230PM states pt rt thigh is swollen entire front of thigh; referred to PMD; PMD stated cold water compresses to rt thigh;
1 hr post vaccination-suden onset blistering rash on chest, emesis X 2, prolonged crying, hoarse cry. Began to self-resolve over 102 hrs; re-seen in office-only rash remained at 4 hrs.
patient had received Pfizer  for primary series dose 1 and dose 2. As of today, 7/18/22, pt received Moderna 1st booster (6-11yrs old)
Restless sleep; Fever; Chills; Body aches; Tired; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, tired, restless sleep on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had horrible stomach cramping and diarrhea and I lost consciousness. My husband called the ambulance - paramedics came and took to ER Hospital. They gave me IV fluids. They did not send me home with any treatment. I was very weak and dizzy after they released me but better. That was the only time that has happened. It took about three days until I was back to doing things.
Pt c/o pain and swelling, that has been improving, from left to right shoulder area since 11/26/07 when he had immunizations here at medical center. He states he had a Tetanus shot on right arm and Hepatitis B on left arm. States that felt pain as he walked out of the door at medical center but the next morning he couldn't get out of bed and his fiancee, now his wife had to help him up. That next morning he felt like neck was going to 'snap'. Since then, pain has persisted from left to right shoulder. He reports area was swollen and stiff with extreme 'pain of muscle'. Pt states that there was 'air in the syringe'. Pt states he asked the nurse 'what was that?' and states she said 'there was air in the syringe.' he also states that "MA at PT said there was air that went in and was cause of swelling-aspiration.'. He states that as a result he did not enjoy his honeymoon out of country and 'couldn't perform'. States that he went to the emergency department on 11/29/07 as a result of the pain and was given medicine that made him feel 'out of it' out of country-ibuprofen and a muscle relaxant 'flexeril' (unknown mg for both). He states that he 'can't answer' if medicine helped 'because it puts you to sleep.' Since then he had a standing PT appt. scheduled by his neurologist for 'back and lower legs', related to his epilepsy. However, he has been treated by PT for his neck and receives stretches and electrical stimulation sessions 1-2 times per wk since January '08. He states that sessions have helped. In addition he decided to continue going to a masseuse for neck massages, which he had been attending previous to receiving his immunization at medical center. He continued to go because he thinks it'll help 'even more'. States that pain originally was a 5/5 and now a 3/5. Worse when he moves neck around but more so when he brings right ear to right shoulder. Pain is felt on right proximal shoulder/base of neck/back area-pinching. Denies numbness and tingling now but states there was 'numbness after the shot to the part of his back/neck/shoulder area'. Pt states that he is most concerned with talking to medical direction so that he can discuss having another reception and honeymoon because as a result of the above incident, he did not enjoy his wedding.
Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter was calling regarding a lot number of vaccine that a facility in their health care system received in Oct-2021. The Lot number of the vaccine was 010A21A. The Nurse said that 5 patients received the expired vaccine and that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The Nurse said that they had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that showed the expiration date as 14-Oct-2022.  The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date of administration of vaccine was 02-Feb-2022. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided.
Swollen lymph nodes under right arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and acid reflux. The patient had known sulfa allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 received other medications (unspecified) within 2 weeks of vaccination. On 20Mar2021 at 10:00, after one week of vaccination, the patient experienced swollen lymph nodes under right arm. The patient did not receive any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes under right arm was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Macular eruption on thorax, abdomen & extremities suggestive of varicella rash. Itching, extensive, onset 3D after vaccine.
Fever 100 degrees, muscular/joint aches and pains, rash at injection site and fine reddened rash under chin.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 1:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:24 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.61 for dose administered on 03-Mar-2021 and 76.69 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.
Pt fainted all of a sudden at the counseling window. She plopped her head down for split second then she fell on the floor. She woke up right away within few seconds. she didn't remember she fainted. She was pale. I provided her water and some biscuit, and she got better in 15 minutes or so.
Information has been received from a 79 year old female consumer with emphysema who on 06-OCT-2005 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot number unknown).  On 06-OCT-2005 the patient experienced rash after getting injection.  The patient mention that the rash started below the injection site and spread down the arm.  The caller indicated that by the next day, 07-OCT-2005, the rash was gone and only some discoloration was left.  At the time of the report it is unknown if the patient recovered from discoloration.  No product quality compliant was involved.  No further information is available.
Patient stated that a 102 degree fever and swelling started to occur a day after the vaccine was administered.  Patient said that her arm was very red and extremely swollen.  Called pharmacy and the pharmacist on duty at the time advised her to take Ibuprofen, Benadryl, to ice the area, and to apply hydrocortisone cream to the area.  I followed up on Friday (12/13).  Patient said that the swelling had gone down and is almost back to normal.  I recommended to continue to take Benadryl and Ibuprofen until the swelling was gone and to ice for 1 more day.
Patient complained or localized discomfort of site 05/27/07 Site marked by RN  . large erythema / warm to touch / swelling approx 3 cm diameter noted on Right upper gluteal. Patient complained of right  femoral discomfort. Right femoral groin check by RN ,  no redness noted . Tenderness upon palpation. Slight lymphnode edema. Denies numbness/ tingling of right lower extremity. Color ? sensation / motion within normal limit of right lower extremity. Denies any change of respiratory , shortness of breath.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (Merck) VARIVAX (dose, route and lot number not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I have a very itchy rash that looks more like bug bites or big welts kind of like hives but it's not all red. It is very bumpy on patches of my skin. Extremely itchy. I've had scarletina with strep in the past but it didn't looks like this. Ive used calamine, hydrocortisone cream, and taken benadryl but nothing takes the intense itchiness away.