chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a burnt out and exhausted feeling on the first day around 7PM. Right around 10PM, I started getting really sick. I was urinating every half hour to an hour. I was checking my blood sugar and it was fine. I was having headaches. Lots of dizziness. I was having a lot of repeat symptoms. I was having sinus drainage, sneezing, and coughing. I had abdominal pain. I had fluid in my head. I had a fever and chills around 10PM. I was feeling very sick to my stomach. I wrote a note to my principal. I was experiencing fever (99-100), trouble holding down most of my food, headache, nausea, and chills. I was given a shot of Toradol at the clinic. They ran a flu and COVID test. The doctor said it could also be related to the vaccine. I was shivering really bad. I was having problems with my motor functions. I was really having a bad time walking around. I almost fell a few times. I was really bad off. I was having excessive migraines. The exhaustion was unreal. Around 10:15am, I was still feeling some exhaustion. I still had stomach problems. I was throwing up really bad. I threw up so much that I filled a 3-gallon bag. It was very violent. Once I got to urgent care, they ran a UTI test. They tested me for all kinds of viruses. I was having abdominal pain. I was quarantined. They said I had a drug induced fever. This has been life changing for me. My wife has to kind of help me around the house. I have trouble typing now. This has caused a ton of stress. I still check my blood sugar every day. I am struggling with my weight. I was at 235lbs before the vaccine, but after I am now at 270lbs. I was barely eating because I couldn't keep anything down. I was shivering really bad and very dehydrated from throwing up. I drank Pedialyte a few times because I couldn't keep regular food down. I received a letter from concern from my principal. I have dealt with so much stress from it affecting my career. I have had to talk to the management and HR. I am still having abdominal issues.
Red macular rash confluent started on legs now on legs, trunk. No itching, no other sx except felt tired after 4-5 hrs after shot. Only rash now as of 10/29/04 no change.
pt recv vax & cracked skin on fingers came in contact w/moisture fr top of vial from dose had been drawn; 1 wk later devel swollen glands in carotid & neck area;
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 55-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medications in two weeks reported as No. Paxlovid used as COVID 19 treatment started on 02Jun2022 and stopped on 07Jun2022. Patient tested positive with home tests day two through 8 with symptoms including fever and cough, tested negative day 10-12 feeling much better. Symptoms and positive test results days 12-16. New symptoms fever (lower than earlier infection) with severe congestion. Known allergies reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a medical assistant concerning a 67 year old female who on 13-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot #657766/0620U).  On 15-SEP-2007 (2 days after vaccination) the patient developed shingles on her back.  The patient's shingles on her back persisted.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Received Heplisav-B Inadverently As Third Dose 6 Weeks After Second Dose Engerix; Received Heplisav-B Inadverently As Third Dose 6 Weeks After Second Dose Engerix; Initial Report Received on 06-Jul-2023  A medical assistant reported that a 56-year-old male patient (race and ethnicity unknown), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the third dose in the series, 6 weeks after the second dose.  Medical history and allergies at the time of vaccination were not reported. No adverse reactions to previous vaccines were reported.  Allergies at the time of vaccination included amoxicillin, Vicodin, and trimethoprim.   On 14-Jul-2021, the patient received a dose of Engerix (no details provided).   On 23-Mar-2023, the patient received a dose of Recombivax (no details provided).  On 04-May-2023, the patient received HEPLISAV-B vaccine (Lot # 941588; expiration date 31-Aug-2025, NDC # 43528-003-05) as the third dose in the series, 6 weeks after the second dose with Recombinvax. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Red rash with blisters on left side of head/lower jaw/neck upper to hairline. Lesions spread then became crusted and over 3 week period have dried to a dark scab. Lesions did not itch but were very exqusitely painful and she said had a deep burning sensation especially if were touched. She ran low grade fever early on. She was seen by a physician and was given antivirals orally, steroid injection and did use a compounded cream for pain. OTC ADVIL in large quantities.
Hives on left arm 4:40 p.m. Disappeared by 9 p.m. Abdominal cramping (severe) and bloating noticed Sunday, 4/04/2021, roughly 8 a.m. Symptoms consistent with allergic reaction to red meat (alpha gal syndrome).
high pitch ringing in my left ear; I felt extreme burning go up my arm and into my face and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:00 (Lot number: ER8737) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG. The following information was reported: TINNITUS (non-serious) with onset 13Apr2021, outcome "not recovered", described as "high pitch ringing in my left ear"; BURNING SENSATION (non-serious) with onset 13Apr2021, outcome "not recovered", described as "I felt extreme burning go up my arm and into my face and chest". Therapeutic measures were not taken as a result of tinnitus, burning sensation.  Additional information: The patient was not diagnosed with prior and since the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Erythema, swelling and tenderness at site. Temperature of 38 Celsius. Left axillary swelling and tenderness with motion. Numbness and swelling in sternal notch.
pt recv vax 20JUN97 &  felt dizzy, weak, nauseous w/fever, h/a;mild relief from sx p/taking Ibuprofen;still w/mild h/a;also c/o pain @ inj site extending down arm;
Mom called from Idaho on her way back to Oregon. Son developed fever 4 days ago with runny nose, fever continuous. Mom notice this morning (1-11-02) a rash on torso and rash just starting on face. Mom thinks may be rosacea. Child not in daycare. Mom giving Motrin for fever. OHN informed could be vaccine reaction (MMR, Varicella) PHN advised if fever persist beyond 5 days to contact physician for evaluation. Mom agreed.
DTAP-HIB combo given before 15 months of age.  No side effects reported.
After receiving the vaccine, within 10 min I developed a headache that lasted no more than 20 min. The day after, I developed a sore throat (don't think it's related to vaccine) in the morning and gradually got worse in the day.
Portal Vein Thrombosis; This is a spontaneous report from a contactable consumer (the patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 9809), via an unspecified route of administration in left arm on 10Feb2021 at age of 47-year-old at single dose for COVID-19 immunisation. Medical history included back pain/stenosis and high cholesterol. No known allergies. The patient did not have COVID prior vaccination. Concomitant medications (Other medications in two weeks) included oxycodone taken for an unspecified indication from an unspecified date; docusate sodium (COLACE) taken for an unspecified indication from an unspecified date; pregabalin (LYRICA) taken for an unspecified indication from an unspecified date; atorvastatin calcium (LIPITOR ORIFARM) taken for an unspecified indication from an unspecified date; naloxegol oxalate (MOVANTIK) taken for an unspecified indication from an unspecified date. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247) via an unspecified route of administration in left arm on 20Jan2021 08:00AM for COVID-19 immunisation. The patient experienced portal vein thrombosis on 26Mar2021. The event resulted in: Emergency room/department or urgent care, Hospitalization (for 3 days), Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the event included treated with Anti Coagulation. Nasal Swab test was done on 02Apr2021 with result of "negative". The outcome of the event was recovering.
Pt experienced fever of 99.9F axillary on day of and day after vax. 2 days of fussiness, not prolonged , but did have a high pitched cry.
Hysterical, high pitched crying which was inconsolable for 3 hours.  Additional was having difficulty catching breath due to extreme crying and appeared disoriented, dazed, glazed and confused for 3+ hours during crying episode.  Swelling and redness at injection site for 3 days following injection.  Swelling of soft spot near base of head (near neck) for 3 days following injection.  Irritability, fussiness, congestion and cough for 4+ days following injection.
Felt tingling in RUE (resolved), followed by throat tingling. Patient self-medicated with Benadryl 25 mg PO. Felt throat tightening - consulted with provider, who gave Benadryl 50 mg IM. Vitals within normal limits. Resolved.
4/3/2021 - severe headache, nausea, and vomiting. I experienced fatigue in subsequent weeks.  4/6/2021 - virtual nurse visit. Lab work. Low vitamin D identified. 4/13/2021 - 11;30 PM - numbness on right side 4/14/2021 - 12:00 PM - numbness on right side (arm, face, tongue, toes), weakness - right leg. Called nurse triage and was advised to go to emergency room. Was admitted as a stroke alert. CT, MRI, echocardio - all negative. Diagnosed with parasthesia. Medical records indicate I had a TIA. Discharged on 4/16/2021. 5/05/2021 - Hospital follow up visit with neurologist. Prescribed baby aspirin for TIA and additional lab work to rule out blood disorder.
bell's palsy; A spontaneous report was received from a consumer concerning a female patient of 54-years-old who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.   The patient's medical history included Bell's palsy in the past (15 years ago). No relevant concomitant medications were reported.   On 02-Feb-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02-Mar-2021, the patient was diagnosed with Bell's palsy. Treatment for the event included steroid and antiviral medications.   Action taken with mRNA-1273 in response to the event was not reported.    The outcome of event Bell's palsy was considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.  However, patient's prior medical history of Bell's palsy may have been contributory.
Myoglobinuria, elevate liver function tests (rxn began 2hrs /p vax may not be related)
At 3pm began sneezing, coughing, itchy, goopy eyes and throat swelling.
Severe shoulder pain that has persisted 11 days after vaccine with little improvement. Limited range of motion of left arm. Lifting my left arm up or across my body causes severe pain.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 14:47, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
diarrhea; Chills; fever; headache; muscle aches; fatigue; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 13:00 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: FC3183, lot unknown: False, administration date: 19Aug2021, administration time: 02:30 PM, dose number: 1, vaccine location: Left arm), administration date: 19Aug2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "muscle aches"; FATIGUE (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 11Sep2021 02:30, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, headache, myalgia, fatigue, nausea, vomiting.  Additional information: The patient had not received other vaccine in four weeks and received other medications in two weeks. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction). At the time of the report, VACCINATION COMPLICATION (Reaction) 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 relevant concomitant medications were reported. No treatment information was provided.
Patient stated on 4/15/21 at the pharmacy that she still has a headache and neck stiffness from the vaccine. still taking tyelnol over the counter to treat headache
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving.   This case was linked to MOD-2022-448109, MOD-2022-449351, MOD-2022-449369, MOD-2022-449379, MOD-2022-449382, MOD-2022-449386, MOD-2022-449392, MOD-2022-449397, MOD-2022-449407, MOD-2022-449412, MOD-2022-449425, MOD-2022-449432, MOD-2022-449436, MOD-2022-449442, MOD-2022-449446, MOD-2022-449452, MOD-2022-449456, MOD-2022-449462, MOD-2022-449464, MOD-2022-449470, MOD-2022-449476, MOD-2022-449479, MOD-2022-449484, MOD-2022-449491, MOD-2022-449496, MOD-2022-449500, MOD-2022-449509, MOD-2022-449514, MOD-2022-449515, MOD-2022-449517, MOD-2022-449520, MOD-2022-449524, MOD-2022-449527, MOD-2022-449529, MOD-2022-449531, MOD-2022-449537, MOD-2022-449541, MOD-2022-449544, MOD-2022-449546, MOD-2022-449548, MOD-2022-449555, MOD-2022-449558, MOD-2022-449562, MOD-2022-449565, MOD-2022-449573, MOD-2022-449581, MOD-2022-449597, MOD-2022-449610, MOD-2022-449621, MOD-2022-449634, MOD-2022-449651, MOD-2022-449660, MOD-2022-449684, MOD-2022-449697, MOD-2022-449706, MOD-2022-449713, MOD-2022-449719, MOD-2022-449729, MOD-2022-449733, MOD-2022-449740, MOD-2022-449524 (Patient Link).
pulmonary embolism; pulmonary infarction; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Jun2021 12:00 (Lot Number: ER8724) at the age of 38-year-old as DOSE 2, SINGLE, for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 29May2021 11:00 (Lot Number: ER8729) at the age of 37-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient developed a pulmonary embolism, pulmonary infarction both on 21Jun2021 with outcome of recovering. Therapeutic measures were taken as a result of both events with anticoagulation and blood thinner medication. Events reported as serious with life threatening. Events caused doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient is not pregnant.   No follow-up attempts are possible. No further information is expected.
Injection site pain, Nausea, Swollen Lymph nodes, Fatigue, Diarrhea
Patient stated that since receiving & completing Gardasil vaccines in 2012 she has had irregular periods, reported that menstrual cycles would go from 28 days to either 2 - 6 weeks and would be either light, normal, period; lasting about 7 days. Normal flow now, but they are spread out 3-6 weeks apart and lasts 6 days.
This case was reported by a nurse and described the occurrence of fever in an 18 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/2/03, the patient received an injection of Infanrix. On 9/10/03, eight days post-immunization, the patient's parent telephoned the physician to report that the patient was experiencing fever, malaise, and an injection site reaction characterized by redness, swelling, and induration. The events resolved on an unspecified date prior to 9/17/03.
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day  the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
she wobbles; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (she wobbles) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced GAIT DISTURBANCE (she wobbles). At the time of the report, GAIT DISTURBANCE (she wobbles) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.  It was reported that patient required MRI as she wobbled.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080185 (Patient Link).   Reporter did not allow further contact
LEFT ARM AT AND BELOW VAC SITE 20 X 15 CM RED RAISED AND WARM INDURATED REACTION-CELLULITIS.  PARENTS NOTICED RASH EARLIER TODAY.  PATIENT PUT ON:  SULFAMETHOXAZOLE-TRIMETHOPRIM 200 MG-40 MG/5 ML SUSPENSION  200-40 mg/5 mL Suspension 15 mL PO twice daily; for 10 days
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil (yeast). The patient immediately experienced numbness on one side of body. The patient's recovery status was unknown. Additional information has been requested. It was reported that another female experienced numbness on one side of the body immediately after receiving Gardasil (yeast) (WAES0703USA04280).
Information has been received from a nurse concerning a 26 year old female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient experienced "vomited eight hours with no fever". Subsequently, the patient recovered (date unspecified). No further information is available.