chrisvoncsefalvay/vaers-outcomes huggingface dataset:
.5cc of Sanofi Pasteur Influenza Virus Vaccine, Lot UH486AD was administered to patient immiediately once vaccination was administered, administrator, noted that patient became pale, as she began to faint, administrator assisted patient to the floor, administrator reports patient was unconscious for approximately 3-5 seconds. Immediately, 4 RN's were at the scene of the incident. A cool pack was placed behind clients neck,  Vitals were obtained blood pressure 98/56, respirations 18, pulse 72, clients color started to return and she was orientated times 3. Dr. came to clients aid and also assessed client vitals and found them to be With-in Normal Limits. Client was then assisted to sitting position on the floor and then to sitting in the chair. Client was given crackers and water. She reported she had not ate since lunch at about 11:30 and then had Volleyball practice immediately after school and then came to get her flu shot. Dr. again reassessed her vitals, he reported they remained with in normal limits and were unchanged from laying, sitting to standing.  Client reported she was feeling "fine". She was assisted by her mother to the waiting area of the post vaccination area, she waited another 15 minutes and denied any concerns at that time and left the facility. 10/12/11 RN, followed up with Mother at 11:34 am mother reported "patient is doing just fine.  We went home right afterward, she did feel like she was going to vomit though!  She slept for a while and then ate.  She's feeling good today.  I want to thank you for all of your help yesterday.  I tend to panic when my kids are hurt.  All of you were so very helpful and I knew that we were in good hands.  Thanks for checking on us too.  Have a great day!" .
Within 24 hours of his second DTaP vaccine my son suffered a hgih temperature and generalized lethargy. By day three he was exhibiting cold/flu like symptoms with high fever, lethargy and general irritability.  On the 4th day following his DTaP vaccine, my son was in the hospital diagnosed with viral meningitis.  He was given vancomycin in case the meningitis was bacterial.  Luckily, we were able to take our son home after 5 days in the hospital.  Following, he has been sick more than he has been well with RSV, ear infection, and upper respiratory infections.  He has currently been diagnosed with Mitochondrial disease, which may also be a result of the vaccine insult.
I can't walk; Out of breath/hard time keeping my breath; Can't keep my balance or anything; Can't stand up more than 6 minutes now; Tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Blood pressure high.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired). At the time of the report, GAIT INABILITY (I can't walk), DYSPNOEA (Out of breath/hard time keeping my breath), BALANCE DISORDER (Can't keep my balance or anything), DYSSTASIA (Can't stand up more than 6 minutes now) and FATIGUE (Tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After 7-10 days receiving the second dose the patient started having adverse events. The patient was being laid off from work since May 2021 and states that he had no Past medical history and reports no use of concomitant medications. He does not take any medication to help relive the possible Adverse events.
Started feeling "woozy" Sunday night (vaccinated in the am), woke up in the middle of the night with a pounding headache, 101.4 temperature (taken orally), chills, body aches.  Fever would break,  sweats, then teeth chattering chills.  This would cycle until Tuesday afternoon.  The "woozy" feeling persists, although not as intense.
I had intense dizziness in the day directly following my 2nd shot.  I was not able to walk without stumbling when I initially got out of bed.  The dizzy spells for a consistent basis lasted about 24-48 hours.  Dizzy spells are intermittent now but more  My menstrual cycle became heavier after receiving the vaccine series.  Additionally, I acquired PMS symptoms (breast tenderness) that I do not ever recall having in the last 20 years.  This has been in the 7 days immediately preceding my period in every month since receiving the vaccine.
Admit date: 3/7/2023   Expected discharge date and time: 3/17/2023 ?   Admitting Physician:  MD Discharge Clinician:  MD PRESENTING PROBLEM: Acute renal failure (ARF) [N17.9] AKI (acute kidney injury) [N17.9] Anemia in other chronic diseases classified elsewhere [D63.8] COVID [U07.1]   Hospital Course:  85-year-old with past medical history significant for CLL, CKD5, B-cell lymphoma, hyperlipidemia, DM 2, cardiomyopathy who was admitted to facility on 03/07/2023 for symptoms of weakness, cough, cold, nausea.  Was noted to be in AKI CKD 5 with a creatinine of 7.86 (baseline between 4.3-5.3).  Was positive for COVID-19 r.  Chest x-ray showed peripheral vascular congestion without pneumonia.  Patient was admitted to internal medicine with Nephrology on consult.   Post admission patient was started on gentle IV fluids.  Nephrology was consulted.  Hemodialysis was offered to the patient but she refused.  Currently on gentle IV fluids driven by Nephrology.   Patient continued to remain on room air.  However given severe symptoms Started on Decadron 6 mg orally daily.  Was not a candidate for remdesivir with her AKI.   Hospice was offered to the patient which she refused initially.  Palliative following along for goals of care discussion.     Ultimately patient's renal function continued to worsen.  Patient was treated for tracheobronchitis as well.  Patient was treated with IV fluids for renal failure worsening chronic kidney disease.  Patient admitted to Facility 3/7/23 to 3/17/23 for AKI and Anemia.  Patient transitioned to comfort and care and passed on 3/18.
administered after temperature excursion of 31.0F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in an unspecified number of  patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal TIV Dresden (Fluarix) (batch number 2235P, expiry date unknown) for prophylaxis and Flu Seasonal TIV Quebec (Flulaval) (batch number 2235P, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported immunization coordinator for multiple patients.  The age at vaccination was not reported. Immunization coordinator reported that the administration of Pediarix, Kinrix, Havrix, Engerix B, Rotarix, Boostrix, Fluarix and Flulaval after below temperature excursion of 31.0 degree F. Health care professional was unable to provide any adverse event information for the  vaccinations at the time of call.  This adverse event had affected multiple patients from October 2020 to June 2021. The reporter had provided phone number and email address. The reporter was ok with the safety team to follow-up about the adverse event information. Note- Referring sales data sheet was also out of scope, therefore reported batch number (2235P) was captured in both Fluarix and Flulaval.
Information has been received from a physician concerning a 25 year old female patient who on 20-OCT-2006 was vaccinated with her first dose of Gardasil. The patient experienced her menstrual cycle a month late, and changes in flow and also spotting with less blood after receiving her first dose. On 21-DEC-2006 the patient received her second dose of Gardasil and experienced her menstrual cycle 10 days late. On 16-APR-2007 the patient received her third dose of Gardasil. It was reported that the patient developed the same menstrual cycle symptoms after each dose. Medical attention was sought. The patient recovered. Additional information has been requested.
Child had a reaction after getting a Rabies shot in ER. Reaction started 2 minutes after shots given. Benadryl given. Symptoms-swollen feet, legs and slight rash. Symptoms subsided 1 hour after Benadryl taken.
Non-menstrual vaginal bleeding, bright red (no clots). This has lasted for 6 days. No associated pain.
SEVERE/ EXCRUCIATING PAIN IN LEFT SIDE OF BODY; COULD NOT WALK; PAIN AT RIGHT KNEE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced severe/ excruciating pain in left side of body. On 16-MAR-2021, the subject experienced could not walk. On 16-MAR-2021, the subject experienced pain at right knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe/ excruciating pain in left side of body, pain at right knee, and could not walk. This report was non-serious.
Administered without the proper diluent; Administered without the proper diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comments: The reporter reported that a dose of Menveo had been administered without the proper diluent.  The Health care professional told that it was unsure when the patient had received that vaccine and even who the patient was. Health care professional realized that this adverse event might had happened because a vial of liquid was left in the fridge but there was no powder vial left to reconstitute. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo without the proper diluent, which led to  wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pt recvd vax & exp unspecified adverse reaction; No further details were provided;
MMRV vaccine rec'd 8/20. Mom 1st noticed hives 8/21. Given Benadryl a few times which helped. Also had nausea/diarrhea. No vomiting. Has had cough/congestion on/off for a while- in daycare. Seen in office 8/24- hives on exam but overall less since started. Advised Zyrtec if not controlled w/ that will add pepcid
Beginning at 11:30 PM I began to experience chills. I spiked a fever throughout the night and slept very little. Beginning around 2 PM I experienced aching joints comparable to arthritis. About that time I also began to experience sinus congestion and pain Which was similar to having a significant sinus infection. By 8 AM the fever was beginning to break but the aches and sinus congestion remained, and stomach pain arose. Throughout the day, there were episodes of fever. Stomach pain resolved around noon. Congestion and aches and fever were largely resolved by 4pm, at which time two Tylenol were taken, with only occasional low fever episodes. I slept well that night and felt fine the following morning.
Severe vertigo one week after vaccine. Turned into an intense vibration in center of head that rattles my eyes so I cannot see clearly and my teeth (I have lost one molar tooth). I can no longer walk without losing my balance.
Immediately after receiving the vaccines I began to feel exhausted.  I could barely function and had three days off, so I went to sleep and didn't wake until the next afternoon; 30 hours later.  I recall looking at the date on my phone, being confused, and my boss asked if I was okay, since I hadn't moved for over a day.  I used the restroom, drank a bottle of water and went back to sleep for another 24 hours.   I had itching, bruising, soreness, and pain at the injection site.  The soreness spread all over my body and lead to aching which really increased in the left arm (the injection arm), which caused limited mobility.  The most significant reaction was severe fatigue and exhaustion.  Within an hour, I began to get a headache and had extreme fatigue. -Itching: continued for a few days -Bruising at injection site for over a week -Pain at injection site continued through  the week -Muscle soreness causing limited mobility of left arm (the injection arm)  -Soreness and aching pain throughout entire body which continued over a week. -Severe fatigue and exhaustion  for over one week.  4 days later, when I flew next, I was was extremely fatigued and just wanted to sleep.  I slept every minute I could for the next week. -Headache  (Throughout entire head, it was painful and detracted from my ability to concentrate).  After a week, it was still a dull headache. -Bumps on the back side of both arms which have continued over four years.
pt was walking away & felt eyes blur & tightness in throat; pt told to sit & AP 152/94 P95- 5 mins BP 139/89, P84 throat fine; on phone c/o h/a x 2-3 days; pt treated by MD for syncopy;
Crying unconsoleably for 4-6 hours. Redness, rash from knees to ankles approximately 24 hours after vaccines. Treatment: Motrin.
Patient received Covid vaccine 1st dose: unknown mfg a few days after kyphoplasty s/p vertebral compression fracture then reported new onset delusions.  Patient has baseline brain damage and used midazolam for sedation for kyphoplasty 02/12.  Patient has been admitted on 02/22 AMS and has since been improving.  Neither Dr. or Pharm D. have further information about covid vaccine specifications.  Patient's household would need to be contacted
Patient came to the ED with shortness of breath and was admitted to the hospital with Covid pneumonia and treated with remdesivir.
Patient received Fluzone on Monday 10.21.08, and died on Tuesday pm on 10.22.08  12/18/08 Autopsy report states COD as sudden unexplained infant death.  Manner of death is undetermined.  Report also states patient getting over cold w/runny nose & cough, no fever, on day of vaccination.  Had been put to sleep on back & found on stomach in crib.
Patient came in around 01:50pm on 04.19.18. Chief complaint was experienced pain radiate down the left arm and numbness, and it started 2 days after the shot was given. No pain for first 2 days. The pain continuous when trying to lift something.
Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Herpes Zoster onset at day 4 post vaccination. Rash on left thoracic dermatome as well as on right shoulder. Patient prescribed Valacyclovir 1000MG BID.
Patient was given PREVNAR 23 vaccine on 10/17/18. Today - 10/18/18 patient reported to primary care office with very swollen right shoulder joint, unable to complete full ROM, low grade fever, swelling/redness at injection site on right deltoid.
SHAKING; FREEZING; TEENSY BIT GROGGY; FEVER; BAD HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On MAR-2021, the subject experienced shaking. On MAR-2021, the subject experienced freezing. On MAR-2021, the subject experienced teensy bit groggy. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced bad headache. On MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.4 Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, freezing, teensy bit groggy, fever, and nausea on 14-MAR-2021, and had not recovered from bad headache. This report was non-serious.
Sore arm; Fatigue on the second day of vaccination; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills) had resolved.            Concomitant medications were not provided by reporter. No treatment information was provided by reporter.
On Wednesday Jan 13, 2021 patient experienced soreness equal to the one experienced after receiving vaccine on Jan 5, 2021. The left arm was sore and itchy.  The following day, Thursday Jan 14, 2021, at approximately 2020 hrs patient felt very warm and took temperature which read 101.3 and within an hour rose to 105.2 Patient was able to mitigate the fever immediately by taking Tylenol and using cold compresses through the night. Patient followed up with medical professional with regards to symptom on Friday Jan 15, 2021.
pt recv vax 16SEP96 & 7OCT96 pt devel approx 100 lesions in a band around waist;pt also devel a mild URI;pt was seen by MD & dx w/shingles;30OCT96 rash of herpes zoster was resolving;
Adverse reaction after his first Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot). At the time of the report, VACCINATION COMPLICATION (Adverse reaction after his first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication provided. No treatment information provided.
Information has been received from a physician via a company representative concerning a female in her early 20's who, on an unspecified date, was vaccinated with a dose of Gardasil. It was reported that the patient experienced neck pain and stiffness after the injection. The pain was reported to have lasted much longer than expected. Additional information has been requested.
pt recvd vax & devel f w/ t 105 heading to a febrile sz;
right arm pain; swelling; inappropriate schedule of; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 5th July 2019, the patient received the 2nd dose of Shingrix. On 5th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The batch number for Shingrix was not reported. The patient received Shingrix on right arm. The patient experienced injection site pain and injection site swelling which was ongoing till the time of reporting. The patient received 2nd dose of Shingrix past the six month period which led to lengthening of vaccination schedule. The reporter consented to follow up.
Constant ache in arm between elbow and shoulder.  Tender at injection area. Can't raise my arm without pain.  I am seeing my physician 9/24/09. Vaccination was given by pharmacist.