chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was posted from a consumer and was received via a company representative referring to female patient who was approximately 12 to 13 years at the time of vaccination. In approximately June 2013, the patient was vaccinated with a dose of GARDASIL (dosage, dose number, route of administration, lot number and expiration date were not provided). No other suspect or concomitants therapies were reported. On an unknown date in June 2013 (reported as 3 years ago) shortly after vaccination, the reporter stated that "the GARDASIL almost took her daughters eye sight", it was also stated that the patient went through many possible prognosis such as Leukaemia, migraines, seizures and many other things in the body. Additionally, on unspecified date, the reporter stated that different laboratory diagnostic tests were performed such as 2 Lumbar puncture (spinal taps), 2 full body Nuclear magnetic resonance imaging (MRI), a Computerised tomogram (cat scans), a Electroencephalogram (EEG), numerous X-ray and blood work every 2 hours for day, however, the results were not reported. Furthermore, the reporter referred that the patient was set on a Lyme disease regiment besides, the treatment given included morphine drip. At the time of the report, the outcome of leukaemia, migraine, seizure, unspecified adverse event, Lyme disease and visual impairment was unknown. However, the causality between seizure, migraine, leukemia, adverse event, Lyme disease and GARDASIL was not reported. Upon internal review, the events of seizure, leukaemia and Lyme disease were considered as medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
clinics administered 957 booster doses inclusive of both manufacturers (Pfizer (877 doses) & Moderna (80 doses)) after the ACIP guidance provided on 9/1/2022 stating that the monovalent formulations were not approved for booster dosing. Prior to the new guidelines, monovalent formulations were approved for booster dosing. While this is not a event that would cause harm to the patient, the administrations were outside of the new guidance. CDC partners confirmed that one VAERS report should be submitted.
incorrectly reconstituted Menveo / Lyophilized vial was reconstituted with sterile diluent; incorrectly reconstituted Menveo / Lyophilized vial was reconstituted with sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 20th October 2023) for prophylaxis.   On 4th October 2022, the patient received Menveo. On 4th October 2022, 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: 04-Oct-2022 Reporter's comment: The nurse reported that the patient received a dose of incorrectly reconstituted Menveo on 04th October 2022. The lyophilized vial was reconstituted with a sterile diluent. There were no symptoms reported. The consent to follow-up was granted. Additional Supportive Information: The nurse reported that the patient received a dose of incorrectly reconstituted Menveo and also the lyophilized vial was reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
About a week after receiving the first dose of Moderna, I developed large welts: first on my chest, the on my back, then my hip, my neck and back again. This has been on-going since first onset on March 14. Each day, a new welt appears in a different location. Aside from being itchy and painful, I've been feeling a bit run-down, too. I have been self-treating with Benadryl.
This spontaneous report as received from a physician via a company representative refers to a 69 year old female patient. Patient's current condition included asthma. Patient had history of allergy (hives and shortness of breath) to BEXTRA. On 20-DEC-2013 the patient was vaccinated with ZOSTAVAX (dose number, dose and route of administration were not reported) (lot number reported as J008529; expiration date: 12-OCT-2014) (reported as shingles vaccination). Concomitant therapies included LYRICA, montelukast sodium, RESTASIS, ropinirole, tramadol hydrochloride, venlafaxine hydrochloride and losartan potassium. On 20-DEC-2013, the patient experienced itchy palms and redness all over the body and rash all over her body after receiving ZOSTAVAX. No laboratory diagnostic studies were performed. No product quality complaint was involved. The patient went to the emergency room in a hospital where she was given BENADRYL and prednisone (formulation and route of administration were unspecified) to treat the reaction. The patient was not admitted overnight. The outcome of itchy palms and redness all over the body and rash all over her body was reported as recovering/resolving. The causality of the events in reaction to the suspect product, ZOSTAVAX was not reported. Additional information has been requested.
5:05pm chest pain, itching, paresthesia, sweating.  gave patient 50mg benadryl.  chest pain resolved and itching and paresthesia decreased.  bp = 124/64.  patient reports resolution of symptoms.  Monistored until 5:30pm and allowed to leave.
Onset blurred vision, unresolving headache. Saw eye MD 11-8-13, ER 11-9-13, had MRI and labs, saw primary care MD 11-12-13 - BP was increased, gave me Lisinopril I was really stressed because of my blurred vision and constant headache, 11-27-13 eye MD, prism added to glasses to help vision 11-27-13 diagnosed 4th cranial nerve paralysis believed to be caused by post viral or flu vaccine. 12-9-13 saw PCP, dc lisinopril, add NORVASC, had labs HgbA1C 6.5, repeat MRI 12-11-13 - normal, 12-16-13 eye MD and 1-31-14 still recovering. See eye MD every month.
Pt recvd 2 doses of Engerix-B MAY91 & JUN91; following 2nd dose of vax devel hives, swelling, redness throughout body & SOB; tx antihistamines & events resolved w/in 24 hrs;
Day after shot: Patient had flu-like symptoms Day 2: Rash on the left side of body (same side of administration site). No reports of pain, no difficulty breathing, no swelling, no fever. After 1 week: rash spread. Called us on 7/30/2019: Advised patient to take Benadryl and monitor.  At follow up with patient, no signs of improvement after 2 doses of Benadryl at night and no improvement of symptoms in the morning.  Then, advised patient to see his primary care physician for evaluation.
Testing positive for covid; Testing positive for covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.   A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GJ6665, Expiration Date: Jun2023) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0162), in left deltoid, on 29Apr2021 as dose 2, single (Lot number: EW0176), in left deltoid, on 10Dec2021 as dose 3 (booster), single (Lot number: FH8030), in left deltoid and on 20May2022 as dose 4 (booster), single (Lot number: FM9992), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Mild BPH" (ongoing), notes: Start: Before getting the covid vaccines; "increased cholesterol" (ongoing), notes: Start: Before getting the covid vaccines; "Hypertension" (ongoing), notes: Start: Before getting the covid vaccines; "Blood pressure abnormal" (unspecified if ongoing); "Non-smoker" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased (ongoing); VALSARTAN taken for blood pressure abnormal (ongoing); TAMSULOSIN taken for benign prostatic hyperplasia (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2023, outcome "unknown" and all described as "Testing positive for covid". The event "testing positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: Patient had mild to moderate symptoms and was treated with Lagvrio instead. Prescribed to take 2 tablets twice a day, started 12Jul2023. Patient had all the doses in the morning. Patient didn't visit emergency room and didn't get hospitalized. He did not display clinical signs at rest. He monitored O2 Sats at home and it was always above 93%. Never had shortness of breath or difficulty breathing and didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient neither required the initiation of new medication nor any other treatment or procedure.; Sender's Comments: Based on the known the information available the Causal relation between the events VACCINATION FAILURE,  COVID-19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300252242 same reporter/vaccine, similar event and diff patient;US-PFIZER INC-202300251733 Same reporter/drug/events and different patient;US-PFIZER INC-202300252281 same product, different dose, different patient;US-PFIZER INC-202300251737 same product, different dose, different patient;
pt states she has NOT been vaccinated with the Covid vaccine however she gets tightened chest, swollen lymph nodes, constricting neck muscles, her ovaries start tingling and throbbing, has syncope, migraines, brain fog, and the beginning stages of anaphylactic shock where she feels like she cannot breathe when she is near someone who has had the any Covid vaccine.  She has a reaction from people shedding the Covid vaccine and so she keeps an Epi pen with her at all times.  She can be around the Covid vaccinated after about 6 months since the shedding seems to be gone at this point.
No reaction in my arms nd was given properly. I iced it. The next am, passing feeling of nausea. it was over 10 mins. My stomach was not feeling well in mar 2021. by the spring my bowel habits were changing. I did a colonoscopy two weeks ago. I was losing weight and my stomach was getting worst and I changed my diet. More of the lower part of my stomach. Discomfort in my tummy and loss of appetite. 114 to 99 pounds. They took out a growth in a colon - polyp. I saw the doctor in Feb & May2021.
Information has been received initially from a pharmacist concerning a 67 year old female who on 19-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On approximately 02-APR-2008 (about 2 weeks later) the patient experienced chickenpox rash on arms and trunk which the rash was itchy, a sore throat, fever and redness at the injection site. Follow-up information received from the nurse practitioner indicating that the patient had the rash for 3 or 4 days. The patient was recovering at the time of the report. In regards to the patient receiving medical attention, she consulted with the pharmacist. No product quality complaint. Additional information has been requested.
sick for 8 weeks after that; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who was sick for 8 weeks after that (illness), while the patient received vaccine Influenza Vaccine.  The patient's past vaccination(s) included influenza vaccine. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site and expiry date unknown) for prophylactic vaccination.  On an unknown date, the patient was sick for 8 weeks (illness) (Unknown latency) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report was received from a healthcare worker refers to approximately 16 year old patient of unknown gender. On 10-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008942, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 26-APR-2019 the patient was vaccinated with improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Pt reported to our clinic 1 day after vaccine (PNEUMOVAX) received. He complained of an extremely sore arm/unable to lift the arm until following morning. The pain is reduced and he moves it freely now. Took pain meds and applied ice packs. No redness, swelling or infection.
Immediately had strong metallic taste, accompanied by mild nausea.  Began drinking lots of water, which did help.  Lips became numb, but did not swell, no difficulty breathing or tightness in chest.  Symptoms were mild, so no treatment was needed., so I went home to rest and hydrate.  Continued to drink lots of water.  Felt very fatigued and lips were numb for 4-5 hours post vaccine.
After 15-30 minute after vaccines given, pt developed red splotchy rash (non papular, non macular). No oral/throat swelling. Brompheniramine 1 mg given (BENADRYL unavailable). Rash resolved within 15-25 min. Vitals remained stable / pulse ox 100 / no oral swelling or wheezing at discharge.
I experienced Hyperthyroidism and then later hypothyroidism.  NO PREVIOUS THYROID ISSUES
Information has been received from a nurse practitioner, concerning a 11 year old female patient, who in December 2009, was vaccinated with the first dose of GARDASIL (dose and route not provided) (lot number 665547/1318Y). Other vaccines administered the same day included ADACEL, which was given right before the GARDASIL dose was given. In December 2009, immediately after the first dose of GARDASIL was given, the patient was flushed, had a rash on her face and neck and was shaking. The nurse practitioner reported that these symptoms lasted for 15 minutes and then resolved. It was unknown if the patient sought medical attention. Additional information has been requested.
Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative:  Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: The vaccine occured at 12 pm. The patient was given the vaccine and counseled. She stated she felt  naseaus and "felt like the room was closing in" on her. She was advised to wait in the pharmacy for 15 mins. Shortly after, she fainted and slumped over. She was blacked out for about 30 seconds then became responsive. Pt was evaluated & was still breathing - CPR was not preformed. Her BP was monitored and feet elevated until paramedics arrived. Everything was normal and refused further care.
Pt was nervous prior to receiving vaccinations and after 5th immunization pt stated "I feel weak". Color from lips went pale. Gave pt orange juice. Pt's mother said daughter had not eaten since breakfast. Applied cold compress to neck. Took vital signs. Vital signs within normal range. MD notified. MD assessed pt. MD released pt to parent. Advised pt. to eat prior to vaccinations per MD.
Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
received dose two of Shingrix one month after dose one; experienced a fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On 15th April 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.   Additional case details were reported as follows: The age at vaccination was not reported. The age group was selected as ana adult as per vaccination indication. The patient experienced fever after vaccination. The patient received dose two of Shingrix one month after dose one, which led to shortening of vaccination schedule. The reporter did not consent to follow up.      Lab Comments: on an unknown date body temperature recorede
1-3 days after vaccine I had pain and soreness at the injection site and upper extremity, which was very tolerable.  Approx. 5 days after the vaccine my entire upper arm, above and below the injection site, became erythematous, warm, with a hardened area, and extreme pruritus. The redness, warmth and hardening lasted 6 days with just a slight redness approx 2 inches below the injection site. The pruritus is greatly improved but still present.
During daytime of 3/25/2021, began to feel discomfort on the left arm. The discomfort worsened to inability to move the left arm, left hand, or fingers. Admitted to the emergency room, then hospitalized for 3 days. Diagnosed as an Ischemic Stroke.
covid vax completed Feb 2021, MVA motorcycle fell, broke foot Apr 21, Prostate Cancer on casodex and Lupron May 21 w/ bilat PE May 2021, splenic art infarct, hep v thromb, SMA thromb w/ rethromb post embolectomy
This spontaneous report was received from an office manager concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ oral route (strength, dose, lot number and expiration date were not reported) for prophylaxis. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA010092: US-009507513-1709USA010092.
Vaccine administered w/o diluent.  Parents informed to monitor closely and call with concerns.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 07-NOV-2011, the patient was vaccinated IM with the first dose 0.5 ml dose of GARDASIL (lot# not reported), second dose on 23-JUL-2013 (0.5 ml, IM, lot# not reported), and the third dose on 23-SEP-2013 (0.5ml, IM, lot # not reported). No adverse effect reported. Additional information is not expected.
Fever of 104 degrees Fahrenheit; Muscle Aches; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional. A 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) dose 1, intramuscularly administered in deltoid right on 12Aug2021 08:15 (Lot number CN1583; Expiration Date: Aug2022, NDC number: 0005010005) as 0.5 mL, single for immunisation in physician office; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP, Sanofi-Pasteur) dose 1 intramuscularly in left deltoid on 12Aug2021 (Lot Number: U6969AB; Expiration Date: 04Mar2023) at unknown dose for immunisation. The patient medical history and concomitant medications were reported as none. No Family Medical History Relevant to AE. The patient experienced fever of 104 degrees Fahrenheit, muscle aches, nausea, headache on 13Aug2021 with outcome of recovering. He also required a visit to the ER. Patient was admitted due to all of the adverse events listed. Nausea medication and ibuprofen or Motrin was given at the Emergency room. There was no admission to the hospital. Events were reported as medically significant. Patient's symptoms all started less than 24 hours after receiving the vaccine. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Information has been received from a physician concerning a 15 day old patient who in December 2007, was vaccinated with a dose of ROTATEQ. As far as they know the infant experienced no side effects. The patient was a little over two months when it was realized that the event occurred and have not continued the series with ROTATEQ at this point. Additional information has been requested.
9x6cm area of blanching erythema & induration; 2 days p/inject around inject site-local hypersensitivity react vs celluliitis in rt thigh; tx w/anti-histamines & ATB