chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For 3 days, he didn't remember anything; He was cold; Next day after receiving 1st dose, he felt like zombie; The following day, he was sleeping almost all day/ He slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030C21A) for COVID-19 vaccination.     Concomitant products included PREGABALIN (LYRICA), ROPINIROLE, GLIMEPIRIDE, PANTOPRAZOLE, ROSUVASTATIN, MAGNESIUM, NICOTINIC ACID (NIACIN) and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie) and SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day). On an unknown date, the patient experienced MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold). At the time of the report, FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) 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.   No treatment medication reported
Get sick the day following the injection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Get sick the day following the injection). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023. This case was reported by a patient via interactive digital media. It was reported as do you always get sick the day following the vaccination. Follow-up would not possible as no contact details were available.
Child had FLUMIST 9/23/13. Began having vomiting/diarrhea 9/24/13 AM. Resolved after 3 hrs.
4/34 (12%) aSOTRs reported infection 6-12 months post-D3; 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), 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: "Adolescent solid organ transplant recipients" (unspecified if 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 "4/34 (12%) aSOTRs reported infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Antibody test: 1275 IU/ml, notes: At 3 months, those infected 6-12 months post-D3; 927 IU/ml, notes: Mean 6 month antibody titers among those infected 6-12 months post-D3; SARS-CoV-2 antibody test (1927-2500): Unknown results, notes: (maximum: >2500 U/ml). at 1-, 3-, and 6-months post-D3.  The reporter considered "4/34 (12%) asotrs reported infection 6-12 months post-d3" related to bnt162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile ,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
REDNESS, SWELLING, HIVE-LIKE REACTION IMMEDIATELY BELOW SITE OF INJECTION.  SIGNIFICANT IN SIZE - ABOUT 3" X 2" AREA.
Redness, edema marked with erythema since yesterday 7/29/04. Child energetic and attentive to adults. Not fussiness or whining or crying. No distress of emotional/physical manifesting at time of exam.
Rash, swellness on arm, headaches, pain in kidney area,  low libido, low production of semen, scarring on the arm where vaccine was injected.
Within five minutes of leaving the facility I was in my car taking a drink of water from a bottle. My left jaw got a strong cramp in it and I couldn't drink the water. I rubbed the gland area under my chin and tried to take another drink. The same thing happened. I tried one more time...same thing. I continued to rubbed the area and the problem went away after about three minutes. This has never happened to me before.
Receiving lower than full dose of the vaccine because of leaking; Content leaked out on her arm  and the pharmacist stated that it happened because of the needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle). At the time of the report, UNDERDOSE (Receiving lower than full dose of the vaccine because of leaking) and DEVICE CONNECTION ISSUE (Content leaked out on her arm  and the pharmacist stated that it happened because of the needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
It has been reported that on 1/26/02 the pt experienced warmth and itching of upper R arm, noted rash gradually increased in size. A cream was used for the itch,( Benadryl 25mg every 4-6hr). Rash 110X80mm - R arm- slight swelling - mild pruritis.
She was nervous before receiving the vaccine and felt lightheaded afterwards. While in the waiting room she vomited. She later drank water and  after sitting down she recovered.
12/15/21 presents to ED for "shortness of breath". PMHx of "esophageal reflux, HTN"
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 1, single (Lot number: EW0178), in left arm and on 23May2021 as dose 2, single (Lot number: EW0167) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I contracted Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.Patient had started taking Paxlovid on 24Apr2022  for the treatment of COVID 19 and stopped on 28Apr2022  No follow-up attempts are possible. No further information is expected.
My arm hurt after the second dose as I expected.  It is more than 2 months after that shot and my arm still hurts. The pain has moved into my shoulder. I had a massage thinking that would help it and I've been to a chiropractor. Nothing is helping.
Health child (per doctor) had vaccine on 10/17/17 at 2:30pm. On 10/18/17 at 6:30am, child woke with fever, vomiting and diarrhea. Ibuprofen was offered and refused at 7am. Temperature was taken axillary and found to be 101 at 8:30. Child refused anything to drink or eat. An ounce of milk was ingested at 9am, but vomited up 10 minutes later.  Temp taken again at 9:25am axillary and found to be 99.
Swelling and redness along vessel line of left UE, left deltoid was admin site. Soreness, tenderness, no nothing.
pt complained of pain in the arm starting 2 days after the vaccine was administered and difficulty moving the arm
Patient woke up at 8:00 am with a headache and complaining he was not able to taste anything. No problems chewing or swallowing. No swelling of tongue or difficulty breathing. Grandmother was instructed to give him some Tylenol and seek medical treatment if he is not better or worsens by our nurse.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 15-MAR-2013 at 04:20 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at-1 was 130.50 hours (also reported 17 hours -1, 337, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012L20A and 016M20A) for COVID-19 vaccination. Concomitant products included INTERFERON for Leukemia, METOPROLOL, AIRBORNE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog). At the time of the report, VACCINATION COMPLICATION (got sick from the vaccine/ Half a dose put down/ in bed for two days), FEELING ABNORMAL (Patient felt that it was going to kill her) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not walk her dog) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No medical history was provided by the reporter.No treatment medication was reported.Concomitant medications included Centrum, TUMS, Cranberry Supplement with ongoing status.The patient stated that her family had immune issues and genetic issues. She further stated that, she and her brother got sick from the vaccine. She felt it was going to kill her. She couldn't walk her dog. Half a dose put her down so she doesn't know if she should stick with Moderna. She herself and her brother were in bed for two days. This case was linked to MOD-2021-434808 (Patient Link).
She had no reactions. The vial was expired due to error of invalid expiration date on packing
Patient received vaccine in a mass vaccination effort by the local school system. After receiving the vaccine patient reported to supervising school nurse she immediately felt weaker, faintish, breathing hard, increased heart rate, and dizziness.  Fire Department paramedic was on site and evaluated patient. Patient reported her systolic blood pressure was as high as 210 mmHg.  Patient was transported to hospital via ambulance at 06:45 pm on 3/11/21. Unknown tests performed.  Patient reports receiving IVs and medications for blood pressure while in ER.  On 3/12/21 patient emailed administration of school where she works stating she was feeling better. Per patient reported on 3/12/21 the emergency room MD did not find any significant issues but advised patient to follow up with a Primary Care Physician. Physician sent patient home on amlodipine 10 mg once daily for hypertension.  Patient called pharmacy on 3/22/2021 and stated she continued to have issues with blood pressure and had gone to the hospital again and stayed overnight. She has not been able to get an appointment with a primary care physician but was going to try to schedule an appointment later on the same day (3/22/21).
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled lot product was administered to patient.  The patient was administered this lot number, but no adverse event reported.  The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Engerix B from recalled lot which led to recalled drug administered and drug dispensing error. This was one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
I have a large red, hot rash at my injection site that has developed 10 days after my dose. My arm is slightly sore as well.
Irritable, crying, screaming, flush cheeks, fever of 99, loss of appetite
No adverse effects; patient was administered GARDASIL 9 two years ago/The second dose was administered today; This spontaneous report was received from a nurse prescriber, referring to a 15 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  In September 2017 (reported as "two years ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On 10-SEP-2019 (reported as "today"),  the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# R029512, expiration date 08-JUL-2021, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported.
DEATH; HEART ATTACK; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. On an unspecified date, five days after the vaccination, the patient died from unknown cause of death. It was stated by the reporter that "I am aware of some horrible jab statistics. In my immediate circle of friends, 2 heart attacks (1 died 5 days after her jab) 3 strokes". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220208980, 20220208918 and 20220208988.; Sender's Comments: V0:20220208979- COVID-19 VACCINE AD26.COV2.S-Death, Heart attack. This event is considered Unassessable. The event 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from a 45 year old female a licensed practical nurse who in 1995 was vaccinated with 3 doses of RECOMBIVAX HB. It was reported that after 3 doses of RECOMBIVAX HB she did not seroconvert. She received one additional dose and then seroconverted. Unspecified medical attention was sought. Hepatitis B antibody titers were performed. No product quality complaint was involved. Additional information has been requested.
Severe chest pain that lasted (on scale of 1-10 = 8) lasted for 36 hrs then  slowely diminished. Still painful 4 days later - no breathing issues Significant joint pain (on scale of 1-10 = 7) lasted for 24 hours
Breakthrough case admission after 5 vaccines Moderna 2/17/21 Lot# 023M20A;  Moderna 3/17/21 Lot# 002B21A;  Moderna 10/13/21 Lot# 032F;  Moderna 5/31/22 Lot3 058a22-2A;  Moderna 11/16/22 Lot# 015H22A
This is a 89y.o. male with significant past medical history  hypertension, CAD, atrial fibrillation, and PPM that presented to the hospital with chief complaint of shortness of breath. He reports for the past 3 days he had has worsening shortness of breath and lower extremity edema. Endorses associated symptoms of nasal congestion, orthopnea, and wheezing. He denies any fever, chills, chest pain, palpitations, cough, abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary complaints.    In the ED, patient normotensive, afebrile, stable SPO2 on supplemental oxygen. BNP 2905. COVID detected. CXR with trace pleural effusions and airspace disease. He has been admitted for further evaluation and management with cardiology consultation.    Patient seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9, (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Have kind of pain goes in my hand; Arm Sore; Couldn't sleep both sides whole night; problems starts from shoulder on way to wrist on both sides; it's painful; Experiencing leg inside my knees full of air when walking; From my knees all the way down abnormal; Inside my mouth kind of swelling and really sore; Inside my mouth kind of swelling and really sore; Muscle pain on both sides very hurting pain; messing muscle in both arms are bothering; This is a spontaneous report from contactable consumer (Patient). A 55-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown) via an unspecified route of administration on arm left on an unknown date (at the age of 55-year-old),as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: unknown), via an unspecified route of administration on arm left on an unknown date as dose 1, single for COVID-19 immunization. Consumer stated that she was experiencing some kind of pain, she just had a Pfizer shot about a week ago and she thought that's going to go away after 2-3 days but never go away, goes in her hand arm is still sore she couldn't sleep whole night both sides, her problems start from her shoulder on the way to her wrist on both sides painful and the leg inside her knees like full of air when she was walking, it was she was experiencing like that, like we know starting from her knees all the way down, it was abnormal and also the other thing was like inside her mouth kind of swelling and really sore for some reason she didn't know. When paraphrased the concern, consumer stated, a kind of swelling and sore inside her mouth, muscle pain on both sides very hurting pain for the whole week now. she thought was going to go away after 2 to 3 days or night or later its still, she was experiencing it she doesn't know she has to go to Hospital or just need the recommendations. The consumer added she was just wondering what she needs to do, need a recommendation from them for we know if other people experiencing what we ware recommending or she has to wait a little bit more or what to do. She didn't know and messing was specially the muscle in both arms are bothering a lot. The patient did not receive any treatment for adverse event, no Advil, no Tylenol, I didn't take anything. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of with ZOSTAVAX vial 19400 PFU (dose, route of administration, lot number and expiration date were not provided) for prevention of shingles.  On an unspecified date in December 2016, the patient developed a case of shingles (herpes zoster) on an unknown location which was an unknown amount of time after receiving ZOSTAVAX. The patient visited the physician but it was unknown whether a treatment was given for the adverse event. At the time of the report, the outcome of herpes zoster was unknown. The causal relationship between herpes zoster and ZOSTAVAX was not reported. Additional information has been requested.