chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 20 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Neck pain. It leads to dizziness; weakness in the right and left arm. Head pressure.
Left deltoid injection site had 40mm L x 25mm W of redness, warm to touch, no oozing, no drainage, 24 hours post DTaP injection. Pt denies nausea, vomiting, or abdominal pain. Small insect bite approximately one inch above injection site was discovered by pt's mother.
Acquired COVID -19 on 9/1/2021 with cough, chills, sweats, rhinorrhea, sinus congestion, loss of taste, loss of smell, fatigue, weakness, headache, dizziness, light headedness, chest pain.
Received 2nd dose 2 weeks after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C218) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Following the application of  Live, Intranasal Influenza Vaccine, I experienced basically all symptoms associated with a flu: sore throat, running nose, elevated temperature, elevated temperatures, weakness, loss of appetite. This lasted for 4 days now and is developing into a bronchitis now. The symptoms were so severe that I  was not able to continue work as an MD in the Neurology Department.
This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 29-MAR-2013 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneous (strength, lot number, expiration date and site of administration were not reported). It was reported that the patient received the second dose of ZOSTAVAX on 29-SEP-2014, subcutaneous (strength, lot number, expiration date and site of administration were not reported). There were no concomitant medications reported. There were no known adverse effects. The patient's present status was reported as no known adverse effects. It was unspecified if the patient had sought any medical attention. There was no product quality complaint (PQC) involved. The outcome was unknown. The action taken with ZOSTAVAX was not applicable. The causality was not reported. Additional information has been requested.
Awoke to a black eye on my right eye. It is in the corner of my eye closest to my nose. As of today Sunday 04/18/21 I still have the black eye.
after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen; after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen; started having increased redness; lower back pain; she responds "generally agree" with statement "generally it's been hard to cope with ra and sometimes i feeldiscouraged/depressed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster) , single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "She had shingle", start date: Apr2021 (unspecified if ongoing), notes: she had shingle; "Rheumatoid arthritis" (unspecified if ongoing); "The left side of her head is still itchy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 (1st booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen"; ERYTHEMA (non-serious), outcome "unknown", described as "started having increased redness"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; DEPRESSION (non-serious), outcome "unknown", described as "she responds "generally agree" with statement "generally it's been hard to cope with ra and sometimes i feeldiscouraged/depressed".  Additional Information: Date of Event: See event. Describe event, problem or product use error: Patient reports her md advised her that if she is feeling well, she only needs to take xeljanz 5 mg tab daily and not twice daily as prescribed by MD. She had shingles Apr2021 and feels that shingles never went away, the left side of her head is still itchy. After she had her second covid booster 09Apr2022 her shingles symptoms started to worsen and she started having increased redness. She has lower back pain that started last week, she is unsure if pain is related to arthritis or due to over exertion while exercising. She responds "generally agree" with statement "generally it's been hard to cope with RA and sometimes I feel discouraged/depressed." Improved since start of therapy. Advised to update MD with new/worse symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2012US024673 is an initial spontaneous report received from a nurse on 10 Dec 2012: This report refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014) intramuscularly at a dose of 0.5 ml on 04 Dec 2012. This vaccine had experienced multiple temperature excursions below 36 degree Fahrenheit (F). On 15 Nov 2012 the temperature reached 34 F, on 29 Nov 2012 and 26 Nov 2012 it was 32 F to 36 F and on 04 Dec 2012 it was 33 F. The excursions happened for unknown time periods. The reporters did not know if the product was frozen at any time. No adverse event was reported following this administration error (incorrect storage of drug).
Exceptionally heavy menstruation after second dose of Pfizer vaccine with exceptionally painful cramping.
Pentacel had been reconstituted with Quadracel and administered to a patient with no reported adverse event; pentacel had been reconstituted with quadracel and administered to a patient withno adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and it was reported that  Pentacel had been reconstituted with Quadracel and administered to a patient with no reported adverse event and the vaccines involved were DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jul-2022, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, at dose of 0.5 ml once ( lot: UJ673AA ; expiry date: 27-Apr-2023) via intramuscular route in the left thigh for immunization.   On 28-JUL-2022 the Pentacel had been reconstituted with Quadracel  (lot and expiry date: not reported) and administered to a patient with no reported adverse event (product preparation error) (extra dose administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Quadracel was administered accidentally   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated intramuscularly with lot # (669579/0595AA; exp date 30-AUG-2012), 0.5 ml dose of PNEUMOVAX 23 on 14-SEP-2012. The patient received the dose 14 days after it expired. The patient did not experience any adverse effects. Additional information has been requested.
Hard lump developed at injection site, red rash, and warm to the touch.  Honestly, it may have been here sooner but just noticed it today.  Took pictures if needed.  Sore if you press on it, which is why I probably just noticed it.
Received 2nd dose of vaccine at 11:00am.  Symptoms started at 9pm: severe body aches, chills, headache, low grade fever of 99.7F. I took motrin and went to bed. Woke up multiple times with chills and sweating. When I woke up: worsened headache and fever  of 100F. Will take tylenol and get more rest. Had to call out of work for my midnight shift tonight.
Fever the following day + worsening of lichen planus rash (which patient had developed 2 months prior and was getting better)
Altered me natural cycle; late period; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the left arm on 26May2021 at 12:00 (at the age of 24-years-old) as dose 2, single for COVID-19 immunisation at a pharmacy or drugstore. The patient has no relevant medical history and no concomitant medications. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. 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 26May2021, the patient experienced altered menstrual (reported as me natural) cycle and late period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;w/in 2 days exp gastrointestinal upset w/ n, v & d;
Patient took 1st dose at 8 am on 1/18/13. At 1 a.m. she experienced severe cramps. She is lactose intolerant.
Patient passed away at a nursing facility listed above one day after receiving Pfizer booster. Public Health notified on the day VAERS submitted.
not feeling well; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced MALAISE (not feeling well) and MYALGIA (body aches). At the time of the report, MALAISE (not feeling well) and MYALGIA (body aches) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given. Action taken with mRNA-1273 in response to the events was not applicable.
Soar arm; taste of iron or metal in my mouth; tingling in arm/fingers; This is a spontaneous report from a contactable consumer (patient) who is a Pfizer colleague. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL3247, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 at 13:15 (at the age of 39 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and  prior to vaccination was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 02Mar2021 at 14:00, the patient experienced "Soar arm" (as reported), taste of iron or metal in her mouth and tingling in arm/fingers. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 77 Monovalent doses administered after the BUD to patients 12 and up. It was reported that 37 doses from Lot 059H21A, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A were administered. No treatment information was provided.
he had a temperature; Felt bad for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered" (2021), described as "he had a temperature"; MALAISE (non-serious), outcome "recovered" (2021), described as "Felt bad for a couple of days". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Suspected event: Abnormal LFTs. She did receive the flu vaccine the same day as COVID (unsure of manufacturer). Had positive COVID PCR 10/22. On 10/24 IgG positive, while IgM negative. No respiratory symptoms. Per MD, there is no other explanation is found for the new rising liver functions. She proposes this may well be a vaccine reaction; autoimmune response similar to that seen with a myocarditis. Originally brought to the hospital on 10/22. On 10/20 she was lethargic after receiving the vaccine and had a fall at home. Pt declined transport at that time. Pt continued to have general weakness and threw up twice so caregiver brought her to ED due to ongoing generalized weakness.
Patient complaining of itchiness around the face and all over her body. Denies any shortness of breath or difficulty breathing. Patient had this reaction 27 minutes after 1st dose of the covid vaccine. Patient was awake and alert.  Benadryl 50 mg IM given on the left deltoid. Vital signs: B/P= 147/94, HR= 67, RR= 18, Oxygen sats= 98%.
Information has been received from a pharmacist concerning an 82 year old female patient who on 30-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The pharmacist reported that the patient returned to the pharmacy at an unspecified time the weekend (17-JUL-2010 or 18-JUL-2010) to report that she had a chicken pox-like rash on the stomach and back and a different, very painful shingles-like rash on an unspecified foot. Pharmacist reported that the patient self-treated with BENADRYL and Hydrocortisone cream. At the time of this report, the patient was recovering from chicken pox-like rash and shingles-like rash. The patient sought medical attention. Additional information has been requested.
24MAY97 830AM -24hr all swelling gone by 8AM 25MAY97;lt swollen parotid gland;
reports 2 days following her 1st Covid 19 vaccine she had left leg ache and small nodule/lump on her left leg, reports she "massaged it out", denies redness or swelling but states leg feels sore. Also reports palpitations beginning on 6/4, full body pain, fever, nausea. She presented to the pharmacy today and appeared in no acute distress and arrived with her husband to report the event.
Breakthrough cases determined by a positive PCR test on 05/03/2021.    Cough, itchy throat, flu-like symptoms.
Neck constricting till I thought I wasn't going to be able to breathe, severe headache, strange taste in mouth, two fingers on right hand tingling, soreness in arm where  shot was given and the armpit of same arm.  This started 30 minutes after shot was administered and lasted 10 minutes.
Pt c/o of severe pain in arm in which inject was given; Also complained of feeling bad;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-OCT-2013, the patient was administered PNEUMOVAX23 intramuscularly, lot number: J007059, expiry date: 31-JUL-2014).  On 10-MAR-2017, the patient was inadvertently vaccinated with PNEUMOVAX23 intramuscularly, lot number: M029681, expiry date: 22-JAN-2018. No adverse effect was reported. Additional information has been requested.
Kidney stone that was blocking his urinal/kidney stone before the shot but not as severe; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone that was blocking his urinal/kidney stone before the shot but not as severe) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stone.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone that was blocking his urinal/kidney stone before the shot but not as severe) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Kidney stone that was blocking his urinal/kidney stone before the shot but not as severe) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) Discovered Patient had kidney stone that was blocking his urinal.. On an unknown date, Protein urine: abnormal (abnormal) protein in his urine..         Concomitant product use was not provided by the reporter.   No treatment information was provided.  Patient stated that 21 days after the 2nd dose he had severe pain in the pelvic area. He went to the emergency room, they did CAT scan and discovered he had kidney stone that was blocking his urinal. He had kidney stone before the shot but not as severe. There was also protein in his urine.  Company comment: This is a spontaneous case concerning a male patient of unknown age, with a history of Nephrolithiasis, who experienced the serious (due to medically important condition) unexpected, event of Nephrolithiasis after the second dose of mRNA-1273 vaccine. The patient reported severe pelvic pain 21 days after vaccination, went to the emergency department, where a tomography was performed showing a kidney stone and urine analysis with proteinuria. The patient had kidney stones before vaccination although not as severe, suggestive of exacerbation of pre-existing condition. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-476114 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with a history of Nephrolithiasis, who experienced the serious (due to medically important condition) unexpected, event of Nephrolithiasis after the second dose of mRNA-1273 vaccine. The patient reported severe pelvic pain 21 days after vaccination, went to the emergency department, where a tomography was performed showing a kidney stone and urine analysis with proteinuria. The patient had kidney stones before vaccination although not as severe, suggestive of exacerbation of pre-existing condition. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt had syncope, loss of consciousness for 1 or 2 minutes. Ammonia inhalant used to arouse patient. Pt remained in clinic for 30 minutes to assure patient was feeling better.