chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At daycare - staff noted seizure activity and called county ambulance service. Transferred to medical center. Repeat seizure activity occurred. Transferred via ambulance to another hospital. Temperature at medical center - 101. 9/18/2007 MR received for ER visit 9/10/2007 for c/o seizure activity at daycare with additional episode in ER.  Generalized seizure in ER lasting ~5 minutes with post-icatal state after.  Eyes deviated up and to R. Temp 101'.  DX: Febrile seizure. Transfered to another facility.   MR received for o/n observation with DX:  Febrile seizure. Right Otitis Media. Pt transfered to this facility for higher level of care. Follow-up: Spiked fever of 104 first night of admission. Ear - "pink." WBC increase. Being treated with IV ROCEPHIN.
Information has been received from a registered nurse concerning a pt who on 10/17/00 was vaccinated and one day post vaccination, the pt  developed injection site cellulitis described as redness and swelling at the injection site. The pt was seen by a physician and treated with Zithromax.
bad headache; weakness in the legs; extreme nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache, lower extremities weakness of and nausea. On an unknown date, the outcome of the headache, lower extremities weakness of and nausea were recovered/resolved.   The reporter considered the headache, lower extremities weakness of and nausea to be possibly related to Shingrix.  Additional details were provided are as follows: The case was reported for reporter's aunt. The age at vaccination was not reported. The patient received a dose of Shingrix and had bad headache, weakness in the legs and extreme nausea. The patient had an extreme reaction to Shingrix and within 18 months probably received the vaccine. The reporter thought that events came on later of the vaccination date. The patient went to the emergency and just ran basic tests and no conclusion was there other than it must have come from the vaccine. The reporter assumed that within 24 hours she was back to normal. The patient was not treated by a health care professional. The reporter did not consent to follow-up. The case has been linked with case US2021167540, reported by same reporter for different product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167540:Pharma case (Flonase)
Sudden, intense Chills, bowel evacuation, nausea, inability to stand, hot flashes and then on and off for 8 days, and counting, even with medication.  These symptoms started after 8 days from the shot and the original effects (flushing, muscle cramps, weakness) which occurred immediately following the shot.  It has now been 16 days from the shot and my symptoms are on-going.
Cold radiating sensation in arm at injection site one week post vaccination. Cold sensation has now (2 weeks post vaccine) moved to the base of the neck. Not cold to the touch, just feels very cold.
Following flu shot complained of body aches and numbness and tingling of the lips. Got better after 30 min.
COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status, cardiomyopathy, septic shock, and multiorgan failure; also tested positive for haemophilus influenza.
The patient developed swelling and warmth at the injection site. The patient had a local reaction to the vaccine in her left leg.
Vaccine leaked from the injection site; 2 vaccines on the same leg flu and MMR; Vaccine leaked from the injection site; Vaccine leaked from the injection site; 14 month old patient received two booster doses of infanrix hexa(in JUNE and JULY 2022).; This case was reported by a nurse via call center representative and described the occurrence of injection site leaking in a 1-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number J39G3, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and MMR (MMR vaccine) for prophylaxis.   On 17th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine. On 17th November 2022, immediately after receiving Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine, the patient experienced injection site leaking, vaccine administered at inappropriate site, exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered. On an unknown date, the outcome of the injection site leaking, vaccine administered at inappropriate site, exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine.   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: 17-Nov-2022 Reporter's Comments  Nurse called to report that on 17th November a 1-year-old female patient received 2 vaccines on the same leg flu and MMR and one of them leaked 4-5 drops but did not know which vaccine it was. The consented to follow up. HCP did not have information on the patient or vaccine, did not know if it was a prefilled syringe or vial. Follow up accepted via email. Additional Supportive Information: 1 year old patient received flu vaccine and MMR vaccine on same leg and one of then was leaked 4-5 drops, which led to injection site leaking, vaccine administered at inappropriate site, exposure via skin contact and inadvertent exposure to vaccine and incomplete dose administered.
HEADACHE; This spontaneous report received from a parent concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included penicillin allergy and breaks out in welts all over. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to right deltoid on 22-MAR-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
got COVID; This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 047AZ1A, 046B21A and 012H21B) for COVID-19 prophylaxis.     Previously administered products included for Vaccination: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII.   On 20-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis). The patient was treated with CLOBETASOL ongoing since an unknown date for Psoriasis, at an unspecified dose and frequency. At the time of the report, COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that by the middle of June patient gradually started to notice her elbows were red and her hands were itchy. She thought she had poison ivy. She tried using poison ivy medication with no changes. This rash then progressed to her hands and feet. She saw her general practitioner who stated it looked like psoriasis and prescribed Clobetasol (a steroid). If she uses the steroid it goes away, but the second she stops using it the symptoms return. Had an appointment with a dermatologist but got COVID before that appointment, and so was unable to make her appointment.
pain; localized reaction of redness; swelling of over the size of a golf ball; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 67 years old female patient who experienced pain (vaccination site pain), localized reaction of redness (vaccination site erythema) and swelling of over the size of a golf ball (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2020, the patient received a dose 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ483AB (expiration date-30-JUN-2021) via intramuscular route.  On 22-Oct-2020, on same day, after received a 0.7mL dose of Fluzone High Dose Quadrivalent and it immediately caused a localized reaction of redness (vaccination site erythema), swelling of over the size of a golf ball (vaccination site swelling), and pain (vaccination site pain).    The patient was held on observation, no breathing or any other issues were reported, so she was discharged the same day of the vaccine.    No lab data was reported.  Final diagnosis was swelling of over the size of a golf ball, localized reaction of redness and pain.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for all events.
Severe runny nose/congestion, stomach cramping, severe diarrhea, low temperature (really cold hands and feet) irritability, rash on face
Pt states that site pf administration for flu vaccine was not cleaned with an alcohol pad prior to administration. That evening pt noticed rash and went to ER, where she was informed that she got a staph infection at the site of flu vaccine administration. Treated with KEFLEX.
Upon vaccinating the patient with J&J patient became dizzy, lethargic, & altered mental status. We proceeded to call fire rescue who got on scene within a few minutes.  Fire rescue proceeded to attend patient. No further incidents. Vaccine was given at 10:05 AM. Symptoms started at about 10:15 AM. Fire rescue was called at 10:20 AM.
Zoster rash left sacroiliac. Eval and treated 01/17/2014.
Pain in every joint.  Uncontrollable shaking of limbs. Chills.
PEDVAXHIB was administered after a temperature excursion; This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 01-DEC-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T037651 has been verified to be a valid lot number and expiration date was 20-JUL-2023; strength, dose and route were not reported) for prophylaxis after a temperature excursion of 46.9 Fahrenheit (F) for 30 minutes (product storage error). Previous temperature excursion was reported as 48 F for 30 minutes.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000969:
Given vaccine at 10 pm noted R arm swollen at site, painful and warm to touch, states "I can't lift my arm" around 4am. Ice packs applied to site.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Experienced nausea beginning 5-6 hours after injection. Continued to experience nausea for two more days & had diarrhea off and on for 7 days. Injection site formed an egg-sized red welp with fever in it which lasted for most of one week. Had extreme gum sensitivity with bleeding and burning tongue beginning two days out from injection until over 10 days later.
No Adverse event but 3rd dose of Shingrix given when only 2 were needed.  Patient stated she hadn't had the series and dose was given 12/17/21.  She had the 2 shot series already back in 2018
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a four- years old male patient who was inadvertently administered with a 0.5 ml single dose of ACTHIB] (lot number: UI912AAA; expiry date: 14-Nov-2019) via unknown route in the left thigh on 17-Dec-2018 instead of IPV (VERO). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; FLUCELVAX QUADRIVALENT for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to extra dose administered and wrong product administered. It was reported that the patient had received all ACHIB vaccinations and on 17-Dec-2018 was supposed to receive Ipol but instead got an extra ACTHIB. The patient did not experience any adverse reactions. 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 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. List of documents held by sender: none.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 28-MAY-2015, the patient was vaccinated with improperly stored ROTATEQ, 2 ml, oral. No concomitant medication was reported. Temperature excursion was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Approximately 10 hours after the injection I started with chills, headache, muscle pain and tiredness. My arm was also very sore at the site (even a sheet on my arm was painful).  This lasted through most of the day after the injection too (all of Thursday, injection was Wednesday morning)  Want to note I had NO side effects after the first booster of the Zoster.  I'm completing this form Friday morning and feel 100% recovered.
On the morning of October 25, eight days after vaccine, I experienced blurry vision in my left eye.  Sight continued to deteriorate over the next few days.  Began treatment with injections on or about November 9.  .  Diagnosed with a central retina vein occlusion and branch retina artery occlusion.  Specialist at medical center indicated vaccine as a risk factor.   Loss of eyesight is permanent in my left eye due to eye stroke shortly after covid vaccine.  I wish to be contacted.
Patient received vaccine on 4/10/21. Went to ED, got IV placed due to side effects.  Came to clinic on 5/4/21 with right arm pain. Found to have occlusive cephalic vein clot.
3-4 weeks after receiving flu shot 10-26-10 and 10-19-11 patient noted client congestion and sinus pain. Seen by PMD. Patient took flu shot in 2009 but did not take H1N1 that year. Concerned about the flu shot correlation with symptoms listed.
Suspected vaccination failure; my father has had it more than once/ had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient had shingles more than once, even after the shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient received vaccine Monday, October 16th, 2017 at 4 PM, and the following day patient had upper and lower extremity jerking and was unresponsive for 3min. She spontaneously regained consciousness but felt sleepy and slept for 20 to 25 min. Mother notice that patient had 102 F temperature and gave her ibuprofen oral. After six hours her fever was 102.5 and she another episode that lasted less than 5 minutes. She had a large wet diaper. She was irritable and cried for several minutes. She came to the ER where she was admitted.
He presented with a sharp pain on the right side of his throat about 5-10 minutes after getting his 2nd dose of the Pfizer vaccine. He reported he had swelling of his throat  when he eats shellfish and he does have an Epi Pen at home but he doesn't carry one with him. He said Benadryl usually also helped. I told him we had Benadryl if he wanted to take a dose and he did want to receive it before leaving. I confirmed with the patient that Benadryl did not make him drowsy and that after taking 25 mg, he said he would be fine to drive and doesn't get drowsy with that medication. I did administer 25 mg of liquid diphenhydramine. His throat was feeling better before giving the dose and he also mentioned that it might have been him just getting worked up over getting the vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA  Sleeplessness
Arthritis symptoms: ankles, wrists, hips, shoulders--bilateral. Enough to slow down my walking and arm actions. No heat, no erythema, no swelling--painful joints only. Started about 4 hours after injection. Mild nausea. Mild headache. No fever. Motrin taken at 2000 same day did help. Pain still present today (10.08.2022)
Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 38-years-old), administered in Arm Left on 23Mar2021 08:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included eosinophilic oesophagitis (Eoe), multiple allergies, Latex, bees, pollen, animals, eggs, corn, and wheat. No history of COVID prior vaccination. Concomitant medications included chlorthalidone, lisinopril, pantoprazole, bupropion hydrochloride (WELLBUTRIN), all taken for unspecified indications, start and stop dates were not reported. The patient experienced appendicitis on 23Mar2021 08:15. The patient was hospitalized for appendicitis for 1 day. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Mar2021 (Nasal Swab, Negative). Therapeutic measures were taken as a result of appendicitis which included Emergency Appendectomy. The outcome of the event was recovering. Event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Facility type vaccine was Hospital. No other vaccines in four weeks.  Information about the Lot/batch number has been requested.
This spontaneous report as received from a pharmacist via field representative refers to seven patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, strength, dosage and route unknown). On 02-JUL-2014 the patients experienced a large painful, inflamed, reddish, patchy rash after receiving PNEUMOVAX23. The outcome of the events was unknown. Additional information has been requested.
The pt experienced a rash to the back, neck and chest, erythematous, maculo-papular and diffuse.
Pregnancy one: 01/04/2019 -09/29/2019. 7lbs 2oz  Pregnancy two: 09/17/2021-11/04/2021 Miscarriage.
On Thursday following shot. Legs of both legs became itchy. Felt like they were on fire.  skin was still clear. . After applying a some  steroid cream it settled dawn and I went to sleep. Next morning I awoke with spots on my legs, and over the last few days, there were deliniated spots  everywhere  on my body - front and back - with the exception of my face. I thought it was measle, though my temperature was nomal (no fever) . I've not been able to contact my doctor.    The spots have becom less definite and delineated, have grown into one another.. In general they're not teribly itchy, but they're everywhere. I'll see my Doctor tomorrow. I have spent the days in bed, not feeling my usual self.  I feel a little better today but the spts (rash are everywhere.
This spontaneous report was received from the registered nurse regarding a 4 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 14-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
pt recvd vax & had t 103; did not respond to apap; mom reported incessant crying; more apap given; quieted & went to sleep; now just cranky;
Changes in menstrual cycle. I now experiencing hot flashes throughout the length of my cycle and stronger muscles aches on shins, knees, and thighs of both legs.  Hot flashes are unusual for someone my age! The hot flashes last about 20 minutes before my body cools down again. The muscle aches tend to last for a few hours before they go away for a bit and resume.