chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received an extra dose of Polio with no adverse event; Initial information received  on 31-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an 15 months old and unknown gender patient who received an extra dose of polio with no adverse event while receiving vaccines IPV (VERO) [IPOL] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot U6940BA, expiry date: 21-May-2022, dose, form, strength: not reported) and received suspect IPV (VERO) (lot U6940BA, expiry date, dose, form, strength: not reported) both via unknown route in unknown administration site for Immunisation.  On an unknown date the patient received an extra dose of polio with no adverse event (extra dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (unknown latency) following the administration of IPV (VERO). It was reported that they gave a 15 month old the pentacel because he needed the DTap but he was not overdue for the Polio.  Action taken: not applicable.   Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Huge lump on right underarm.  Used pain medication and cold/hot compress for the pain and sensitivity. Fully recovered after one week.
Pt recvd booster dose of rubella on 2OCT90 & on 13DEC90 serological testing revealed a positive test for measles antibody & a neg test for rubella antibody;
No additional AE; Medical assistant calling reports 2 doses of expired PROQUAD were administered to 2 patients.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 18-MAY-2022 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (recombinant human albumin rHA) (PROQUAD) (lot number T029102 has been verified to be a valid lot number, expiration date 23-FEB-2022) (strength, dose, frequency, route of administration, and anatomical location were not provided) as prophylaxis.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006084:
only did a single dose/ did not complete the two dose series; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Ther age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was provided.
Information has been received from a registered nurse concerning an older than 8 month old patient who on an unspecified date was vaccinated with the third dose of ROTATEQ (lot# not reported). The patient was not experiencing any known symptoms. Additional information has been requested.
Within 10 seconds of vaccine, I got tunnel vision, and i leaned over in my chair to allow the blood to return to my head.  I black out completely, and some time thereafter I was able to hear voices over my head but could not move or respond.  Once i was able to move my head and mouth, i realized i couldn't breathe.  I wheezed and tried to open my lungs but struggled to get sufficient oxygen.  Upon catching my breath, I laid back down and laid on my side to ease the feelings of nausea.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer case US2019042406). On 4th March 2019, the patient received the 2nd dose of SHINGRIX. On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities. On 5th March 2019, the patient experienced fever, feeling unwell, swelling arm and muscle pain. On 7th March 2019, the patient experienced sores mouth and fever blister. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, erythema of extremities, feeling unwell, swelling arm and muscle pain were unknown and the outcome of the sores mouth and fever blister were not recovered/not resolved. It was unknown if the reporter considered the fever, erythema of extremities, feeling unwell, swelling arm, muscle pain, sores mouth and fever blister to be related to SHINGRIX. Additional details were provided as follows: The patient's arm was red the night after the second dose of SHINGRIX. The next day the patient felt ill. One day after receiving SHINGRIX, the patient experienced fever, feeling unwell, swelling and muscle pain. After 3 days the patient experienced mouth sores and fever blister.
Redness and swelling occurred on the same day after the injection. 2 days after, noted a "red band" across her arm,  itching and warm to touch. Will treat symptomatically with OTC medications. If not better, advised patient to come in for an evaluation.
stroke; Initial information was received on 30-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case is linked to cases US-SA-2021SA330912(CLUSTER) and US-SA-2021SA330928(CLUSTER).  This case involves a (unknown age) female patient who experienced stroke (cerebrovascular accident) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious stroke (cerebrovascular accident) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event stroke.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a (unknown age) female patient who experienced cerebrovascular accident (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Generalized itching which worsened until 3 am, 8/31/16. Patient got up and applied hydrocortisone cream. No rash. Patient stated skin reddish (she feels from scratching).
Frozen Shoulder/Adhesive Capsulitis - Started gradually with mild pain with certain motions in March 2021, gradually increasing over t the next two months to severe pain  with  sudden movements and  substantially limited range of motion (unable to move arm behind back at all, or lift more than 75 degrees to the side, 90  to the front. Severe difficulty sleeping, as pain is increased at night.
Approximately 5-10 minutes after vaccine was given patient stayed in store but shopped around and passed out in the aisle while shopping. He quickly came to and did not hurt himself in the fall. EMS was called and arrived. They evaluated the patient and the patient's blood pressure was low. They administered an IV and took the patient and not to a healthcare facility.
Information has been received from a healthcare worker referring to a 5 month and 5 day old male patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with the second dose of oral, ROTATEQ (lot # K019372 with expiration date of 16-JUL-2016, dose and strength unknown). There was no concomitant medication. On the same day the patient vomited immediately after the vaccine was given. Outcome of vomiting was unknown. On 26-AUG-2015 the patient began to experience severe diarrhea and sought medical attention by seeing the physician on the same day. Treatment recommendations by the physician were to keep the patient hydrated and the physician would order some unspecified diagnostic tests for the patient. No lab diagnostics studies were performed yet at the time of reporting. The outcome of diarrhea was not recovered. Additional information has been requested.
Approx 5 min p/DTP/OPV/HIB pt became listless w/pinpoint pupils responsive only to painful stimuli;
arterial closed and partially blocked; Vasculitis; Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer; Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer; dose received : 3 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 20:00 (Lot number: 32030BD) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing); "Known allergies: sulfur drugs" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 044B21A, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 17Apr2021, when the patient was 60 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 007B21A, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 20Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (prolonged hospitalization, disability), INTERCHANGE OF VACCINE PRODUCTS (prolonged hospitalization, disability) all with onset 29Oct2021 20:00, outcome "unknown" and all described as "Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer"; IMMUNISATION (prolonged hospitalization, disability) with onset 29Oct2021 20:00, outcome "unknown", described as "dose received : 3 Pfizer"; ARTERIAL OCCLUSIVE DISEASE (prolonged hospitalization, disability) with onset 04Nov2021 12:00, outcome "recovering", described as "arterial closed and partially blocked"; VASCULITIS (prolonged hospitalization, disability) with onset 04Nov2021 12:00, outcome "recovering", described as "Vasculitis". The patient prolonged hospitalization for off label use, interchange of vaccine products, immunisation, arterial occlusive disease, vasculitis (start date: 2021, discharge date: 2021, hospitalization duration: 7 day(s)). The events "arterial closed and partially blocked" and "vasculitis" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of arterial occlusive disease, vasculitis. Reported Event included Vasculitis, arterial closed and partially blocked. Digit #4 will have to be amputated, partial or 3/4. Treatment received for the adverse event included Steroids and Viagra. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL9261) at the age of 76 years as dose 1, single and administration date 26Feb2021 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "she takes her thyroid and cholesterol medications" (unspecified if ongoing); "she takes her thyroid and cholesterol medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: Reporter seriousness for first and second dose: sore arm: Unspecified. The patient received all three of her Covid 19 vaccines at the Clinic site. She was thinking about getting the flu vaccine in a couple weeks. She was asking if anyone else is having the same reaction as her. The patient did not received any other Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). The patient did not have any AE(s) following prior vaccinations and no Medical History (including any illness at time of vaccination) No follow-up attempts are possible. No further information is expected.
increased heart rate about 5 min after the injection, felt hot.  Heart rate increased, tingling in arms and felt cold in arms.  Occurred two times.  stayed about 45 min in the room
Dysuria, urgency and frequency. Negative Urinalysis 11/18/16. Symptom persisted till 11/21/16 to resolve without treatment other than fluids and cranberry juices.
sick to my stomach; out of breath; pain in arm; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to my stomach), DYSPNOEA (out of breath), PAIN IN EXTREMITY (pain in arm) and FATIGUE (feeling very tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0451B21A, 001B21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Kidney failure (stage 3 kidney failure).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ABDOMINAL DISCOMFORT (sick to my stomach), DYSPNOEA (out of breath), PAIN IN EXTREMITY (pain in arm) and FATIGUE (feeling very tired). At the time of the report, ABDOMINAL DISCOMFORT (sick to my stomach), DYSPNOEA (out of breath), PAIN IN EXTREMITY (pain in arm) and FATIGUE (feeling very tired) outcome was unknown.            she was not authorized by her physician to get 3rd dose. she decided to get the dose on her own. she got the vaccine as she has high blood pressure and stage 3 kidney failure, Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-308166 (Patient Link).
This spontaneous report was received from a pharmacist refers to 5 or 6 patients of unknown age and gender. The pharmacist reported that in the thousands of ZOSTAVAX doses that he had given, he had only seen 5 or 6 injection site reactions. He stated that he did report the first injection site reaction, but he had not reported the subsequent injection site reactions since that initial report. No additional information was provided about these other injection site reactions, and the pharmacist did not have time to discuss these previous injection site reactions further. The outcome of the 5 or 6 injection site reactions was unknown. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Large red raised rash at injection site.  Itching that spread from arm to entire torso and has gotten progressively worse over the last 2 days.  Also, have muscle aches, fatigue and malaise for two days.
HBV was given on a routine WCC on the regular 3 day recommended follow up from the Hospital on 5-11-06.  Weight had returned to almost birth weight and the baby was not jaundiced and eating well.  Sunday am 5-14-06 while in the hospital I was asked to go to the ED regarding a resusitation attempt on this infant who was found in the bed unresponsive.  Resusitation was unsuccessful. 7/7/06 Received ER medical records which reveal patient arrived in full arrest & was unable to be resuscitated.  9/15/06 Received autopsy report which reveal COD as SIDS./ss
Nauseous, diarrhea, heart feels bad, breathing is difficult, headache, fever, body ache
Going on week two continued difficulty breathing. I have been doing breathing treatments and inhaler. Dry cough, some wheezing, some tightness in chest at times when breathing is harder.
This spontaneous report was received from an other health professional refers to a patient of unknown demography. On 25-SEP-2013, the patient was vaccinated with first dose of GARDASIL (route and frequency was not reported). The reporter stated that the second dose in GARDASIL was not administered until 27-DEC-2013. No adverse effects were reported. The outcome of second dose in GARDASIL series was not administered until 27-DEC-2013 was unknown. Additional information has been requested.
Patient is a 75-year-old male with left sudden sensorineural hearing loss started 11/4/21. He had his Moderna vaccine booster the day before. He had no problems with the first two vaccines which were also Moderna. He woke up this morning and noticed he couldn?t hear on the left. No otalgia, otorrhea, vertigo. He has been noticing some mild pulsatile tinnitus on the left for the past few days. He has history of a scuba diving accident in 1978 after which he found that he has difficulty clearing his ears beyond 15 ft. No history of ear infections, ear surgery, head trauma, noise trauma. His father had presbycusis. He shot guns in his youth with hearing protection.   He was found to have left mild to moderately severe sensorineural hearing loss with decreased word discrimination score. MRI Brain showed right posterior temporal lobe cavernoma found on MRI.   He was started on prednisone 60 mg taper 11/4/21 with improvement in hearing after a few days. He opted to stop prednisone after 3 days. He had some hypertension due to medication. Hearing loss recurred 11/10/21 and he was restarted on prednisone 60 mg 11/11/21 which he finished.   Repeat audiogram showed left declined hearing with no discernable WDS. He started left intratympanic steroid injection 12/2/21 and has had 3 injections (12/10 and 12/17). He also had bilateral PETs placed 12/2/21 to facilitate both injections and hyperbaric oxygen. He is undergoing hyperbaric oxygen therapy with facility.
Numbness in the left arm, trunk and leg. Diagnosed with bilateral cerebellar strokes on 4/13/2021.
The day after the first dose my Crohn's symptoms flared up, I had diarrhea cramping and abdominal pain. My Crohn's had been under control for a year before the vaccine. It was persistent for two weeks. I was prescribed a muscle relaxer by my doctor and I used Tylenol for the abdominal pain. The flare up was a little less severe than my usual flare up and it settled back down after my next infusion at three weeks after the vaccine. I had the second dose I had a low grade fever for a few hours and no GI issues. Second Dose Lot 028L20A Date 01/30/2021.
Pt received DTaP #4 in right deltoid using 25 5/8" needle. 2 days after shot, developed an area on right arm where shot was given a 3" long x 2" wide area of redness, hardness and hot to touch. Child weighs 48 pounds. Recommended use of age appropriate Tylenol or Motrin and Benadryl and cool compress.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with nsaid's (Nonsteroidal Anti-Inflammatories) and non-drug therapy (Heat Therapy). On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. The patient was treated with nonsteroidal anti-inflammatory drugs (NSAIDS) and a heating pad for 1 week. The reporter wanted to know, what was the mechanism that caucused such severe arm pain at the injection site. For tolerance to next dose, refer case US2019GSK025564.
Swollen, erythymatous, sore & hot to the touch near & surrounding injection site. (4" x 6" area!)
pt recv vax 23JUN97 & pt had a sl upper resp infect @ the time of vax;pt devel a maculopapular rash on stomach, back, rt upper extremity, neck, abd, upper lip & rt posterior thoracolumbar area;