chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dermatographia developed about 1 week after booster shot across entire body. Treated with Zyrtec for 8 months. Around 4/1/2022 Optic Neuritis symptoms developed in left eye and then progressed to right eye 8/12/2022.  Multiple MRIs, an MRA, CT scan, a lumbar puncture, and many blood tests have not been able to identify another cause for the optic neuritis. Two rounds of high-dose IV steroids have also been unsuccessful at treating/improving the Optic Neuritis.
I am 69 years old and just had my second dose of PNEUMOVAX 23. My arm became red, hard and extremely sore with swelling all the way to my elbow. My deltoid muscle has never been so sore. I have felt sick and no appetite. Two days later the soreness is still there but the swelling is beginning to dissipate. This is the worse vaccine I have ever had.
vertigo; This case was reported by a pharmacist via call center representative and described the occurrence of vertigo in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number LL2G7, expiry date 22nd October 2022) for prophylaxis.   On 5th May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was recovered/resolved.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional details were provided as follows: The pharmacist did not have exact dates on when the vertigo started and when it resolved. The reporter consented to follow up.
This prospective pregnancy case was reported in a literature article and described the occurrence of genitourinary symptom in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed genitourinary symptom. Serious criteria included other: serious per author. Additional event(s) included vaccine exposure during pregnancy. The outcome of genitourinary symptom was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The investigator considered that there was a reasonable possibility that the genitourinary symptom may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This prospective pregnancy case was reported in this literature article and described the occurrence of genitourinary system disorders in a female aged above 10-year who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy the patient experienced genitourinary system disorders. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between genitourinary system disorders and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Experienced fever, slight headache, mild fatigue, nausea, back aches, mild dizziness, day after vaccine.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 071F21A, 011M20A and 042L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Iodine allergy, Drug allergy (Morphine), Food allergy (Dextrose makes fluid build up in lungs), Food allergy (Corn syrup and all corn products), Fructose intolerance, Fish allergy, Allergy to nuts, Atrial fibrillation since 10-Jun-2020, Pancreatic exocrine insufficiency since 01-Jul-2021, Hypertension since 01-May-1966 and Arrhythmia. Concomitant products included APIXABAN (ELIQUIS) from 14-Jun-2020 to an unknown date for Anticoagulant therapy, METOPROLOL from 14-Jun-2020 to an unknown date for Arrhythmia, EPLERENONE from 14-Jul-2020 to an unknown date and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]) from 01-Jun-2002 to an unknown date for Hypertension, PANCREATIN (CREON) from 01-Jul-2021 to an unknown date for Pancreatic exocrine insufficiency.   On 17-Jan-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2022, Polymerase chain reaction: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746629:Same patient, different variant
Severe rash over entire back ,chest pain with fever, extreme fatigue , loss of appetite, swelling in both legs
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Febrile sz; Admitted to Hosp w/temp 102-103F; No family hx of sz or allergies;
This case was reported by a consumer via call center representative and described the occurrence of small intestine adenocarcinoma in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included decreased white cell count and lymphoma. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a month after receiving SHINGRIX, the patient experienced small intestine obstruction (serious criteria hospitalization and GSK medically significant) and feeling miserable. On 26th November 2018, the patient experienced small intestine adenocarcinoma (serious criteria hospitalization and GSK medically significant). In August 2018, the outcome of the feeling miserable was recovered/resolved. On an unknown date, the outcome of the small intestine adenocarcinoma was recovering/resolving and the outcome of the small intestine obstruction was unknown. It was unknown if the reporter considered the small intestine adenocarcinoma, small intestine obstruction and feeling miserable to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. The patient first experienced intestine blockage on a trip in August 2018, and he had four days of misery due to the blockage. When the patient returned, he continued to have regular screenings for lymphoma through Computerized tomogram (cat scans) and Positron emission tomogram (PET) and his most recent cat scan was in December 2017, which was showed nothing. They were doing lymphoma routine scans. On 26thNovember 2018, 98 days after vaccination, the patient was officially diagnosed with adenocarcinoma of the small intestine, through an endoscopy after suffering from some intestine blockage by the tumor. The patient had surgery to remove the tumor and was hospitalized starting on 3rd December 2018 for eight days. The patient did not know when the tumor started but believed that somewhere between December 2017 and November 2018. He was scheduled for chemotherapy in January 2019.
child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 22-JUN-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 22-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose administered 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 Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient, same reporter US-GSK-US2023AMR142498:different patient, same reporter US-GSK-US2023AMR142502:different patient, same reporter US-GSK-US2023AMR142500:different patient, same reporter US-GSK-US2023AMR142501:different patient, same reporter US-GSK-US2023AMR142496:different patient, same reporter US-GSK-US2023AMR142499:different patient, same reporter US-GSK-US2023AMR142497:different patient, same reporter
Mild-Moderate chills and aches. Onset ~20 hours after injection; lasted approximately 10-11 hours.
Itchy, rash around injection site - slightly sore.  Web searched - thought to be "Covid Arm".     Also, some discomfort in neck area.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified thyroid medication and blood pressure medication. Treatment Medications were not provided by the reporter.
Post vax, the pt developed weeping, red, sore skin on buttocks. A small diffuse sandpaper rash along inside length of arms, along upper torso and on left forearm. Treated with Fluocinonide cream. Scaly lesions on buttocks, persistent.  Follow up 10/25/2000: "Patient partially recovered from adverse event.  Flaking, psoriatic lesions on lower termini of both buttocks.  More lesions on left buttock, recurrent sandpaper rash on left forearm.  continued yellow discoloration of bedsheets and t-shirts from upper torso.  Patient received further anthrax shots since reported event.  The event from that was localized sandpaper rash inside of tricep on shot arm, snuggling."
This report is regarding the Pfizer COVID-19 vaccination the patient received on the above date, which was lot number FD0809. Guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that the patient received is valid.
I just wanted to update you that patient had a pretty significant reaction to the flu shot that she received at her annual visit. I just wasn't sure how to go about reporting it so that the powers that be who collect records are aware. Patient developed an area that extended from her elbow to her shoulder and caused pain in her forearm. It was hot and red and lasted for 5 days before it was resolved. I did take her to urgent care because I was concerned about the degree to which it swelled and how hot it felt, but we were instructed to monitor and ice it. Just FYI for the CDC or whoever else these things get reported to.
pt recv vax & devel Stevens-Johnson synd/hypersensitivity rash 60 days later; No further details were provided;
Does shingles shots causes cramps; This case was reported by a consumer via call center representative and described the occurrence of cramp in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th January 2023, the patient received the 2nd dose of Shingles vaccine. On 6th January 2023, less than a day after receiving Shingles vaccine, the patient experienced cramp. On an unknown date, the outcome of the cramp was unknown.   It was unknown if the reporter considered the cramp to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment:  The patient self-reported this case. The patient reported that he/she received 2nd dose of Shingles shots and experienced cramp. The reporter wanted to know does Shingles shot causes cramp. The reporter did not consent to follow up.
This spontaneous report was received from  a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with a dose of GARDASIL 9 injection, lot # M041990, expiration date: 28-JUN-2019 (strength, route and dose were not reported) for prophylaxis. The temperature of excursion with dose of GARDASIL 9 was between 47 to 77 Fahrenheit degrees for 192 hours. No previous temperature of excursion was performed. The temperature of excursions were detected by a data logger. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1706USA009345.
Woke up with intense pain, felt like a ball of fire in my neck and muscles in the shoulder girdle area.  Started to have muscle weakness on left side down arm. Had nerve pain and ongoing tingling and prikcling. Which then affected left leg as well. Also had prickling nerves in face  etc.
4/20/21 ER HPI: 67 y.o. female who presents with complaint of shortness of breath since yesterday night when she went to bed and describes it as heaviness associated with lower chest pain both back and front.  Patient says shortness of breath is worse with lying down and with activity.  Patient also complained of cough that is nonproductive.  No fever or chills, no nausea vomiting and no abdominal pain.  Patient has been off her Coumadin is since for 04/09/2021 for back injection for back pain.  Patient said the the shortness of breath is similar to the last time she had blood clot.
Administration error, wrong vaccine given and wrong dose given of vaccine. Patient received 0.5 mL of monovalent Moderna as a booster dose instead of bivalent Moderna vaccine.
Information has been received from a nurse practitioner concerning a 17 year old female patient with a broken toe who on 17-JUN-2009 was vaccinated IM with the first 0.5 mL dose of GARDASIL. On 17-JUN-2009 the patient fainted after receiving GARDASIL. The patient sought unspecified medical attention. A couple of minutes later the patient recovered. Additional information has been requested.
Onset of severe headache & stabbing pains on right side of head behind the ear, followed by paresthesia in same area, which moved to complete right side of head and ear.  Lasted for 8 hours.
fever 103 began @ 230PM; mom gave APAP & t105.4 w/mild irritability @ 3AM; pt fine the next day; mom did not take child to MD or ER;
Large red, warm, inflamed area on arm where vaccination was given for over a week. Patient describes the area getting larger/warmer over the course of the week.
Patient noticed redness when removing band aid on 10/10/11. Redness gradually got worse. Became raised & side about 3 x 2 inch. Was brought to my attention on 10/12/11. Called physician & they called patient. Was to go in if got worse.
Pt recvd vax 26JUL93 & 203 wk later devel weakness of extremities; pain w/palpation & movement, fever (99-100), poor feeding, irritability; hospitalized 16-17SEP; EMG studies suggestive of polyneuropathy such as GBS & anterior horn cell dis
Vomitting for 8 hours. Unable to eat for following 24 hours. Remains nauseous each time food is consumed
Patient got Pfizer covid 19 vaccine as fisrt dose  on March 6, 2021 from other place. But she got Moderna  vaccine as second dose from my pharmacy on May 25,2021.
Gradual onset of extreme tiredness, lethargy approximately 2 months later followed with legs & upper arms heaviness.
Information has been received from a physician via a company employee referring to a 4 year old female patient. The patient's pertinent medical history and drug reactions/allergies were unknown by reporter. Concomitant therapies included a dose of poliovirus vaccine inactivated (unspecified), a dose of hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis vaccine (unspecified), a dose of tetanus toxoid and influenza virus vaccine (unspecified) on 19-OCT-2018. On 19-OCT-2018, the patient was vaccinated with a dose of VARIVAX (route, strength, batch/lot # and expiration date were not reported) and a dose of M-M-R II (route, strength, batch/lot # and expiration date were not reported) for prophylaxis. The physician reported that the patient's mother called the office on 02-NOV-2018 and reported that the patient "had a varicella like rash" and "sent a picture". The physician reported that "he diagnosed it as varicella and prescribed BENADRYL elixir 5ml 2 to 3 times a day". The outcome of varicella was unknown. The causality was not reported.
3 days after 1st vaccine dose I developed neuropathy in my left foot.  Most of bottom of foot was/is numb,  For first five days it was center of sole of foot, then moved to heel and ball/toes.  It remains numb and mostly unchanged.  (This foot has mild motor nerve damage from a severe ruptured disc 30 years ago.) I initially did not associate the vaccine with this symptom.  But on February 12 I had the second dose, and precisely 3 days later developed neuropathy in right foot (numbness, not as pronounced as left foot) and tingling in forearms/hands.  That was about 6 weeks ago.  Symptoms remain persistent but not worsening.  No history of neuropathy prior.
Post herpitic neuralgia; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 70-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.      On 20-MAY-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced post herpetic neuralgia and was treated by a healthcare provider. The outcome of the events was unknown.  Causality assessment was related.
extreme pain in the arm; her entire shoulder in pain; limited range of motion; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date.).   On 06-SEP-2023, the patient received the 2nd dose of Bexsero (left arm) .5 ml. On 07-SEP-2023, 1 days after receiving Bexsero, the patient experienced pain in arm (Verbatim: extreme pain in the arm), shoulder pain (Verbatim: her entire shoulder in pain) and mobility decreased (Verbatim: limited range of motion). The patient was treated with ibuprofen. The outcome of the pain in arm, shoulder pain and mobility decreased were not resolved.   The reporter considered the pain in arm, shoulder pain and mobility decreased to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm, shoulder pain and mobility decreased to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 - 25-OCT-2023 It was stated that the patient received 2nd dose of Bexsero and on the day of the visit did not had any other complaints, nor did she receive any other vaccines during the visit.  The day after receiving vaccine she reported feeling extreme pain and decreased range of motion in the arm where the vaccine was administered. The patient went back to the clinic complaining of her entire shoulder in pain with limited range of motion. The patient was not prescribed a prescription medication, but the patient's notes said that the patient was advised to continue ibuprofen and alternate heat and ice. Within the Note, there was no mention of the adverse event resolving. When asked, the healthcare professional thought that the adverse event was very likely due to the vaccine administration, given the temporal association. This case is linked with US2023AMR148956, same reporter.; Sender's Comments:  US-GSK-US2023AMR148956:Same reporter, Different patient
3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.