chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiffening for 1 minute the evening after vaccination.  06/13/07-vac rec received information entered in VAERS record faxed to CDC.  6/22/07 Received hospital medical records which reveal patient admitted 5/23-5/25/07 for observation after febrile seizure & r/o sepsis w/u.  Cultures neg.  IV antibiotics d/c after 48 hrs.  Had been seen 5/9 in endocrinology clinic for low TSH which normalized spontaneously. FINAL DX: Enterovirus meningitis.
patient noticed a peripheral flash of light and a new floater in right eye.   Went in for an eye exam right away and it was diagnosed as PVD (posterior vitreal detachment).   Three days later, had the same symptoms in  left eye.
Headache for 2 days and nose bleed that lasted 25 minutes in left nostril.  Nose bleed started the evening that vaccine was given.  Patient had received Pfizer vaccine (one dose) on February first and then caught Covid-19 three weeks later.  Her doctor at emergency room told her to start the series over again.  She wanted to then get Moderna since she had such bad side effects with Pfizer brand.
CoughWheeze dry cough, no wheezing; body aches. congestion, diminished sense of taste and smell on 1/12 and 1/13, all resolved by second dose.  Narrative:  dry cough, no wheezing; body aches. congestion, diminished sense of taste and smell on 1/12 and 1/13, all resolved by second dose.
Received flu shot at 3:00PM on 11/11/05 and by 7:00PM started to have asthma symptoms and had to use albuterol spray.  Eyes then became very swollen (nearly shut) and crusty.  Then got chills and very rapid heart beat
11/20/14 17 yr. received MCV4 and Tdap vaccine then walked to lobby with mom at side and became dizzy. He sat in chair. RN laid him on floor with legs elevated and gave juice. Child awake all through episode. Pulse 64 and Reg. Child walked to car without help and mom drove home.
Felt like my stomach was hard and my belly was distended. Hurt to touch my stomach. And a sore arm
PATIENT GOT 1ST DOSE OF MODERNA ON 04/09/21 AND BELIEVED THE SECOND ONE WAS DUE 04/23/21, ARRIVED AT FACILITY AND WHEN BEING PROCESSED IT APPEARS COORDINATOR AND THE LIST WAS MISSED.
atrial flutter; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 (Lot number: EW0177) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Suspect Product: , First vaccine: , Date: 27Apr2021, Time: unknown, NDC/expiration: unknown, Lot: ER8736, Site: right arm), administration date: 27Apr2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: ATRIAL FLUTTER (non-serious) with onset Aug2021, outcome "not recovered", described as "atrial flutter". The event "atrial flutter" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller states he had the vaccine, both shots, reclarifies as the Pfizer Covid 19 vaccine. Caller states he had atrial flutter after the second vaccine. Caller enquires if anyone reported this event. Caller asked if  it related to the vaccine. Caller states he had seen a cardiologist for his arterial flutter, and it was diagnosed on his Apple watch when he had some discomfort. Caller states he had testing done, and it was confirmed as flutter from 48-165 beats per minute, not fibrillation. Caller stated the flutter was more rhythmic and sequenced then the fibrillation.   No follow-up attempts are possible. No further information is expected.
Chills, fever, sweating, aches and pains all over body. Inability to sleep. Horrible headache. Sore arm. Most adverse events went away after 3 days but headaches and inability to sleep have continued for 10 days.
Discovered reddened area (L) upper arm and sent picture to mother via phone who advised a BENADRYL cream. Not used here today with >2x the circumference of the initial reddened area.
Information has been received from a clinical coordinator at a doctor's office concerning a female who was vaccinated with a first and second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  Subsequently, the patient fainted after receiving both doses. The patient recovered. There were no relevant diagnostic test or laboratory data.  Additional information has been requested.
No additional  reported; administered after temperature excursion; This spontaneous report was received from a nurse prescriber 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 an unknown date, the varicella virus vaccine live (oka/merck) (VARIVAX) lot # U008180 experienced the temperature excursion of possibly -11.6 degrees Celsius (C) for unknown time. The reporter was unsure of exact temperature and time. On 17-NOV-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U008180 has been verified to be a valid lot number, expiration date was not reported, but upon internal validation established as 12-MAR-2023 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No adverse event was reported (no adverse event).
inflammed by evening on 28JUL93 necrotic ulcer formed around inject site 3 days later & went to ER & given med;
pt had wheezing, coughing, nasal congestion @ time of vax;20MAY fussy, irritable, coughing;22MAY98 fussy, coughing, crying;25MAY98 adm for apnea;poss whooping cough;
patient was given vaccine at 3pm, vaccine had expired beyond it's 6 hours time limit at 2:09pm but was not disposed of prior to being given to the patient.
Massive heart attack after 2 days after 2nd injection. Coded twice, once on life flight and once at emergency room. Attempted to remove clot with  clot buster after/during heart cath.  Only have 35% heart function, feel weak, nauseous and wearing life vest defibrillator for 3 months.
rx was administered subcutaneously in error it should have been intramuscular, no adverse reactions was reported by patient
Confusion, short term memory, disorientation, and poor concentration starting at 6:30pm on the day after the 1st injection; immediate effect of dry mouth since the injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1283), on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic Type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: positive home antigen test after completing 5 days of treatment of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.Paxlovid was taken from 13Apr2023 to 17Apr2023.
4/10/21 4:30pm severe migraine, numbness in fingers and toes, fever, nausea   4/11/21 severe migraine, nausea 4/12/21 severe migraine, nausea, vomiting
Adverse reaction included redness, warmth, and pain at site. Treatment alternate OTC TYLENOL and MOTRIN use cold compresses to alleviate pain and warmth.
1st Vaccine 1/6/2021; 2nd Vaccine 2/3/2021 in the am; developed SOA, fever, and cough 2/3/2021 night; seen at ED 2/4/2021 for reported symptoms and d/c' home same day.
Medical Assistant administered Dtap- IPV for routine vaccine. Medical Assistant noticed expiration date after the administration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Previous cancer history" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 12 weeks old male patient, born at 34 weeks gestation who on 31-MAR-2009 was vaccinated orally with the first dose of ROTATEQ. Since 05-APR-2009 the patient has been experiencing six watery stools per day. A stool culture was performed. Results were not reported. The patient was seen at the practice. The physician reported that the patient's sibling also received ROTATEQ vaccine and was experiencing the same adverse event (WAES # 0904USA03555). Follow-up information was received from a nurse who reported that both patients received ROTATEQ vaccine (lot # 663400/1693X). The patient's stool culture was negative. The nurse did not know the patient's current status. Follow-up information has been received from the physician concerning this 12 weeks old male patient, born at 34 weeks gestation who on 31-MAR-2009 was vaccinated orally with a dose of ROTATEQ (lot # 663400/1693X). There was no illness at the time of vaccination. The physician reported that since 05-APR-2009, the patient had diarrhea for 2 weeks. The patient had a stool culture performed to rule out bacteria as the cause of the diarrhea. The culture was negative. Subsequently, the patient recovered on approximately 24-APR-2009. Additional information is not expected.
Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.; No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 1-decade-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.) 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 EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.).    Patient age was reported between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  Vial size was reported as unknown blue Cap. Vial did not undergo temperature excursions.  Treatment information was not provided.  This case contains information about patient 3rd out of 5 child patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master Case(Patient 1)
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose and lot # not reported) which were improperly stored. No adverse effects were reported. Additional information has been requested.
skin reaction; itching; red tiny; slightly raised bumps on his torso/rash; fever; malaise; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a male patient who received Herpes zoster (Shingrix) (batch number H3MJ9, expiry date 13th September 2021) for prophylaxis.   The patient's past medical history included hypersensitivity (he did had a hypersensitivity history to medications) and abdominal discomfort (noting mycin containing medications cause some gastroentestinal discomfort). Previously administered products included INFLUENZA SHOT with an associated reaction of malaise (flu shots in the past (manufacturer unknown) that caused fever and malaise but this was more intense than that).   On 16th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th June 2019, 1 days after receiving Shingrix, the patient experienced fever and malaise. On an unknown date, the patient experienced skin reaction, pruritus, red rash and raised rash. The patient was treated with topical steroid nos (Topical Steroid). On an unknown date, the outcome of the skin reaction, pruritus and red rash were not recovered/not resolved and the outcome of the fever and malaise were recovered/resolved and the outcome of the raised rash was unknown.   The reporter considered the skin reaction, pruritus, red rash, fever, malaise and raised rash to be related to Shingrix.  Additional details were provided as follows: The caller stated that he received Shingrix and within 24 hours he experienced a fever of 101.4, and malaise that resolved after 2 days. Ten days ago, he began to have red tiny, slightly raised bumps on his torso, arms and legs that looked like mosquito bites. He noted he was also itching. The patient was told by the Dermatologist that this was a reaction to the Shingrix and has been advised not to get the 2nd.  The reporter did not consent to follow up.  Emergency room visit required. The health care professional declined for follow up and noted he would call back with any updates.
Narrative:  Patient received Pfizer vaccine first dose on May 19th and had issues on may 21st. Balance problem and left eye blurred vision. second dose was given on June 9th and Patient experienced same symptoms and right eye gaze problem and she said she diagnosed with Six nerve palsy. Primary Doctor and ophthalmologist were seen this patient
Interchange of vaccine products; Death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (death), outcome "fatal"; DEATH (death), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. On an unspecified date (post 1 week of vaccination), the patient died from an unknown cause of death (dose number in series 2). The reporter seated that "My brother died a week after he got a booster. His first vaccine was J&J, booster was Pfizer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
pt  claims she has high covid antibodies  titer and have really serious inflammatory reaction to covid vaccine.  her md believes its sequelae from vaccine and wanted us to report it
at 2pm following vaccine, one of Patient's eyes rolled back into her head.  At 7pm that evening she started vomiting. She vomited 3 times that evening. the following day 9/25 she was lethargic, not eating much and threw up at 5pm. She threw up in her crib the night of 9/25 into 9/26. Not eating or drinking much and not peeing much. She is still very clingy and cuddly today 9/29 which is very out of character for her. She's high energy and an explorer typically. We went to Urgent Care on 9/26 thinking she would get IV fluids. since she had a pee diaper that morning, they did not see a need for IV fluids. They prescribed Zofran for nausea and I did not administer it because the throwing up seemed to be subsiding then.
NINE DAYS AFTER patient RECEIVED THE VACCINE SHE DEVELOPED A RASH ON HER SHOULDERS.  RASH SPREAD TO 50% OF HER BACK, RASH CONTINUED DOWN HER ARMS.  NO LYMPH NODE INVOLVEMENT.  RASH WAS RAISED, RED, VERY ITCHY, WARM TO TOUCH.  RASH IS STILL PRESENT AND NEW AREA DEVELOPING ON BACK OF UPPER LEFT LEG.  patient NOTED SEVERAL DAYS BEFORE RASH APPEARED SHOULDERS WERE VERY ITCHY.
Swelling, redness, and hot to the touch radiating down her arm. Pt says the area has been growing this this morning. The area is away from the injection site. Pt is afebrile and reports no other symptoms.
This spontaneous case, initially received on 06-Nov-2017, from a pharmacist, concerning a 21-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 05-Nov-2017, the patient was administered FLUVIRIN (dose: dose less than 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 179940P, expiry date: 31-May-2018). It was reported that, during administration with needle to the patient's arm some of the vaccine leaked down on to the patient's arm and was not exactly sure if the vaccine came out around the injection site of the skin (explicitly coded as incomplete dose administered). Reportedly, there was no way to determine the leakage, but it was between the syringe and needle. The pharmacist could not confirm if it was an incorrect technique or if there was a leakage issue of the syringe (explicitly coded as syringe issue). This case was associated with PTC reference number: 1025997. The complainant was unable to provide information or a sample to support this case, however, complainant information does suggest the issue could be user-related. This was the only complaint received so far for FLUVIRIN batch 179904P and according to trend analysis, there was no indication of a trend for the manufacturing campaign for leaking syringes. Based on the information available, a product defect could not be identified or attributed, therefore, the complaint was not justified. The reporter considered this report as non-serious. Non-significant follow up received 14-Nov-2017: The PTC (product technical complaint) reference number 1025997 was updated. Follow up received 14-Dec-2017 and 02-Jan-2018 (combinedly processed): The event syringe issue was added. The pharmacist could not confirm if it was an incorrect technique or if there was a leakage issue of the syringe. The complainant was unable to provide information or a sample to support this case, however, complainant information does suggest the issue could be user-related. This was the only complaint received so far for FLUVIRIN batch 179904P and according to trend analysis, there was no indication of a trend for the manufacturing campaign for leaking syringes. Based on the information available, a product defect could not be identified or attributed, therefore, the complaint was not justified. Narrative was amended accordingly. Update received on 11-Nov-2018: Non-significant case correction (14-Nov-2017): The term "QA reference number' was changed to 'PTC Reference Number' in the notes section of the additional information tab.
Vision is blurring/Can't watch television; Can't read; Everything at distance is double vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 492021) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision). At the time of the report, VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) outcome was unknown.