chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt's mother brought him in today with redness noted to his Rt leg where he received his MMRV injection on 7/14/15. Pt's mother states his leg started getting red later in the evening that same day. Pt has not been running a fever and his leg is not warm to touch at this x. Pt's mother instructed to apply cool compresses to area several x's a day and if redness starts to spread, to take pt to doctor for evaluation and treatment. Mother verbalized understanding.
took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body; have generalized joint and muscle pain; have generalized joint and muscle pain; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body), MYALGIA (have generalized joint and muscle pain) and ARTHRALGIA (have generalized joint and muscle pain) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 067H22A and AS7140C) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (does not have allergic reactions to any vaccine).   On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body), MYALGIA (have generalized joint and muscle pain) and ARTHRALGIA (have generalized joint and muscle pain). At the time of the report, INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body) and MYALGIA (have generalized joint and muscle pain) had not resolved and ARTHRALGIA (have generalized joint and muscle pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  The events occurred one week after getting the 2nd bivalent Moderna vaccine. Caller stated that they already consulted with their HCP on 15May2023 and was given an anti-inflammatory but they did not mention that they had the vaccine.   This case was linked to MOD-2023-724866 (Patient Link).   Reporter did not allow further contact
Local swelling, pain, tenderness, warmth, Tx 48 hrs, now a little better. Right deltoid Max. Diameter 6x8cm.
Had vaccine and 5 hours later got very ill. 48 hours after, a horrible headache started and hasn't gone away since. It has been a total of 23 days.
Rheumatoid arthritis; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID:857327) on 04-FEB-2022, referring to a 33 year old female patient.  The patient had none allergies, and none illness at the time of vaccination. None prescriptions, over-the-counter medications, dietary supplements, or herbal remedies taken at the time of vaccination were reported.  On an unknown day in January 2019, and on 12-JUL-2019, the patient was vaccinated with 2nd and 3rd doses respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the left arm (strength, lot #, expiry date, route of administration, and indication were not provided).   On an unknown date in 2019, after 2ns shot, the patient experienced shoulder pain and inability to move arm.  Shoulder pain progressed and was reported to doctors who said it was nothing.  On 15-JUL-2019, the patient experienced shoulder pain that made her call off of work.  Joint was stiff for at least 3 days.  Over the last months pain and inflammation had spread to neck, both shoulders, fingers were swollen and had spread to feet.  After pain had not stopped, inflammation getting worse, fingers being swollen and feet starting to swell, the patient got blood work done.  Blood test results showed that the patient had rheumatoid arthritis (conflicting information: date reported as "results received on 20-JAN-2019").  As a result of adverse event, the patient required doctor/healthcare professional office/clinic visit At the time of reporting, the patient had not recovered from the event of Rheumatoid arthritis.   The agency considered this case as serious with disability criteria. The agency did not give the causality assessment between the event and the suspect vaccine.  As of 14-FEB-2022, no further information was available.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. In or around 02 FEB 2015, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered facial paralysis (considered a symptom of Bell's Palsy or Ramsay Hunt Syndrome), Bell's palsy, and Ramsay Hunt Syndrome. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Treatment and outcome of events was not recovered. Causality assessment was related. Upon internal review, Bell's palsy and Ramsay Hunt Syndrome were determined to be medical significant. Bell's palsy and Ramsay Hunt Syndrome were considered to be disabling. Additional information has been requested.
Initial dose on September 15th, 2020 / and contracted shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient do not have a history of contracting chicken pox. The patient took the initial dose of the Shingrix Vaccine from healthcare provider and contracted shingles. The patient was prescribed Valtrex to address the symptoms. The patient's doctor told to contact GlaxoSmithKline to determine if the patient should take the second dose or not.
Initial report received from a nurse 18 October 2013. A 27 year old female patient, whose medical history were not reported, had received a dose of FLUZONE (Lot number UH926A6, intramuscularly on left deltoid) on 11 October 2013. On 11 October 2013, after receiving vaccine the patient experienced dizziness within one minute of injection. Patient also experienced throat feeling tight, hot sensation, and feeling of tingling down her spine and had rash on chest. Corrective treatment included BENADRYL 50 mg. Concomitant medication included low dose of beta blocker. At the time of this report the outcome of adverse events were resolved. Documents held by sender: none.
The pt first developed a quarter sized red knot on thigh and then it increased in size with slight swelling.
I received the shingles vaccine & my arm immediately developed a large itchy red swollen patch encircling my arm and an even redder patch with blisters at the injection site. I'm also experiencing some pain-like soreness.
patient was given PNEUMOVAX 23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 15-OCT-2020, the patient was vaccinated with a recalled, improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # S036495 with expiration date 13-SEP-2021) via an unknown route for prophylaxis. No other adverse event information was given at this time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Large (around two inches in diameter) red lesion  occurring on left arm at about eight days after injection. Still there after 16 days. No pain. Somewhat itchy.
info from incident rpt-approximately 5 minutes after receiving Moderna Vaccine at the  employee clinic,  pt c/o nausea, and dizziness.  Pt began dry heaving and hyperventilating, became very weak and ? LOC for a few second.  Symptoms resolved in about 45 minutes without medicine.  No hives or angioedema noted, no difficulty breathing once she stopped hyperventilating; telephone call with employee: states got vaccine on 12/24- within 15 minutes felt dizzy, face "felt big", passed out, was put on stretcher, woke and vomited,  was still feeling nausea so went home; had fever the next day, lost appetite, feeling fatigued, nausea, yesterday (12/29/20) felt weak -states was covid + in March 2020, had another test recently which was negative, ? whether can get the second vaccine.   consult allergy - ok for vaccine 30 min watch ;
At first baby starts spitting up and fussy; increases to vomiting over next couple of days; took into clinic for check on 7/21/11 - presumed to be expected side effect of vaccines. Then projectile vomiting begins. Mother took back to clinic on 7/22/11 - admitted to hospital for surgery on 7/23/11 for Dx pyloric stenosis. What caused it? Live Rota Vius vaccine??
The pt had delivered a baby on 9/25/99 and was noted to be rubella virus negative. 11 days post vax the pt experienced arthralgia and presented to the ER the next day. Pt was diagnosed with viral infection described as full blown rubella. The pts child was exposed to her infection. No further information is available.
POOPING BLOOD; REALLY BAD STOMACH PAIN; SHORTNESS OF BREATH; TIRED; This spontaneous report received from a consumer concerned a white patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, once total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient felt tired. On 10-APR-2021, the patient experienced really bad stomach pain. On 10-APR-2021, the patient experienced shortness of breath. On 13-APR-2021, the patient experienced pooping blood.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 11-APR-2021, and had not recovered from really bad stomach pain, shortness of breath, and pooping blood. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429185-covid-19 vaccine ad26.cov2.s-pooping blood. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pain at injection site/painful; This case was reported by a consumer and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. 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 case details were provided as follows: The age at vaccination was not reported but could be 66 or 67 years. The patient experienced injection site pain. For tolerance after 2nd dose refer case US2019AMR159021.
Information has been received from a 25 year old female patient with papilloma viral infection, without developed of genital warts before her first vaccination with GARDASIL vaccine (yeast), and no known drug reactions/allergies, who on 20-FEB-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 20-APR-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), 5 ml. Lot# was not provided. There was no concomitant therapy. The patient reported that in May-2008, after the vaccination she experienced a few lesions. The patient sought unspecified medical attention. At the time of the report the patient was expecting to receive her third dose of GARDASIL vaccine (yeast) on 20-AUG-2008. Additional information has been requested.
About 2 minutes after shot was given...I felt very strange.  Being highly sensitive to any medication I felt severely over medicated. Informed Pharmasist.  Went home..unable to settle down.  Kept getting head rushes and nervousness. Finally at 4:30pm called 911.  Blood Pressure was 187....heart rate over 90.   Went to ER.  12 hours plus of feeling horrible.  Discharged from ER with BP at 167.....10Pm.  Took 3-4 days to feel normal.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21,pfizer,Lot#EL3248 2nd dose: 01/29/21,Pfizer,Lot# EN5318 Diagnosed covid positive:07/13/21 Exposure:Community Symptoms:Asymptomatic.
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 02Apr2021 at 10:30(at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination.   Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced shingles to left flank. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles to left flank and included treatment with valtrex. The clinical outcome of the event shingles to left flank was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
non specific aching, reddened cheeks, low garde temp, itching @ site of inj, swelling & redness starting 24hr p/vax;seen in office 3 days p/dx w/mild cellulitis tx w/ATB;
At time of injection 4/25, throat felt immediate tingling but not impairing breathing, my lips did become numb but again no trouble breathing or heart rate change.  At about 15 minutes had mild itching no rash.  Left site went home, over next 2 hours mucous membranes- mouth, inside ears, throat and perinium area felt hot worseing.  My outer skin- back, arms, legs, neck and face and hands itching to point of scratching.  Took 100mg of benadryl and 400mg of Advil and topical Lidocaine. Drank fluids.  Next morning 4/25, eyes pasted shut and sore arm, residual itching to left arm, hand and neck, used lidocaine creme. 4/26 eyes pasted shut in am, residual itching, neck on left side felt swollen under jaw and side of neck.  4/27 entire neck now feels swollen, started sudden attack of vomiting, was sent home from work, they did palpate my lymoh nodes swollen on both sides under jaw and sides of neck.  Extreme fatigue and vomiting with sore throat, fever 99.8, itching worse.  This extended into 4/28 and now into 4/29 but now able to keep liquids down, itching is less, neck not as swollen, no throat pain. No fever
This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced elevated blood pressure. On SEP-2021, the patient experienced swollen lymph nodes in neck/swollen lymph nodes in groin. On SEP-2021, the patient experienced spiked fever. Laboratory data included: Blood pressure (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spiked fever, elevated blood pressure and swollen lymph nodes in neck/swollen lymph nodes in groin was not reported. This report was non-serious.
arm sore (Left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore (Left)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOMEFLOXACIN HYDROCHLORIDE (CONTRA [LOMEFLOXACIN HYDROCHLORIDE]) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm sore (Left)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (arm sore (Left)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication include contra - indication for generic.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2012, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JUL-2013, the patient was treated at the clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering (emotional distress), and other damages. The outcome of the events was unknown. Causality assessment was related.
This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (1st dose received on 29th April 2018). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were received as follows: The age at vaccination was not applicable for this report. On 29th October 2018, the patient was due for 2nd dose of Shingles vaccine but could not find. The patient started to look in August 2018. According to the patient's pharmacist, the patient had a year to got the second dose. The patient was thought it was six months. The patient was asking\about the efficacy of the vaccine when the second dose was longer then six months. The patient know that it was about 90 percent within the six month window. The patient asked the pharmacist regarding the vaccine availability in future and the pharmacist replied that it might be in January. The patient pharmacy was on the locator and know they did not have any.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 10-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.