chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 17 months old patient.   On 08-SEP-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1710USA015222: US-009507513-1710USA015221: US-009507513-1709USA012770:
RED, ITCHY RASH AROUND INJECTION SITE, SLIGHTLY WARM TO THE TOUCH STARTED THE DAY AFTER INJECTION AND CONTINUED FOR ADDITIONAL DAY
08/07/2010 Had low grade fever, body aches. 08/08/2010 still fever and body aches but notice his head felt funny. 08/10/2010 low grade fever came home from practice totally exhasted and went to sleep. Around 9:00 PM started complaining of headache had fever of 100.7. 08/11/2010 On and off again fever and intense headache that would get better for a little bit but not completely gone. Fever reached 101.7 the evening of 08/11/2010. Felt a little better on 08/12/2010 but headache was still there just not as intense. 08/13/2010 patient woke me up at 4:00 AM and said mom I cant take this anymore my head hurts. I gave him Tylenol since he had had Motrin before that and the headache would not go away. He ended up vomiting around 6:30 AM. He vomited again around 7:30 AM. So I took him to the emergency room since the headache would not go away.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)
Persistent, incontrollable crying for 48 hours after getting, 4 month's vaccines, DtaP, HiB. Prevnar, IPV
Left arm got hard and swollen under the skin where she got her vaccine. There was no bruising on skin. She sat for approximately 20 minutes with a cold compress on her arm over the swollen, hardened area. She complained about being dizzy after about approximately 15 minutes of her observation period. Her blood pressure was taken and it was approximately 130/80. She sat down for about 10 more minutes and left when she was no longer dizzy. She did not report any more symptoms. Denied pain in her arm. Did not report issues swallowing or breathing.
On 10/10/19 at 10am, I suddenly got very hot, couldn't stand, intense clammy and sweating, blurred vision, nauseous, shaky, pale, light headed and anxious. I came close to passing out but didn't. It lasted about 20 minutes and then the symptoms started to fade. Four days later I had chest pains and ended up in the ER
Arm is red, sore, and feels hot.   This started one week after the shot.  Arm was sore previously, but was not swollen or red until one week after.  Also, my throat started to hurt right after the shot.
Expired Adacel was given to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (nurse) via Agency (Reference number- 00481678) and transmitted to Sanofi on 18-Feb-2021 .  This case involved a 46 year old male patient who received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number: C5566AA] via an unknown route at an unknown administration site for prophylactic vaccination which was expired on 13-Feb-2021 (expired product administered). (Latency: At the same time of vaccination)  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.   It was reported that, reporter was wanted to safety concerns if any.   At the time of reporting, the patient did not have any side effects also no treatment specified at the time of reporting.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nausea, vomiting, diarrhea starting at 2230 until 0100. Body aches, chills, fatigue, difficulty concentrating until 12/25 afternoon
red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: FLU Shot. Past adverse reactions to the above products included No adverse event with FLU Shot.    On 29-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face). At the time of the report, RASH MACULAR (red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face) had not resolved.        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 had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The patient had monovalent dose 1 on 13-FEB-2021 and dose 2 on an unknown date. The patient took monovalent booster dose on unknown date. After 2 to 3 weeks after receiving the Moderna shot in AUG2023, the patient started having red spots on both legs, and arms, 1-2 red spots on the stomach, and 3 red spots on his face. The patient was not on any maintenance medications and does not have a Medical History of any chronic disease. No treatment medication was reported.
New onset thyrotoxicosis. She had thyroid labs previously drawn 9/2020 which were within normal limits but she does have a history of goiter with thyroid nodules.
This solicited report was received from an MR moderator, and refers to a 45 year old female enrolled in a Market Research Program. The patient's medical history, concomitant medications wand concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose number, dose, route of administration, lot number and expiry date not reported). After receiving the HPV vaccine, the patient fainted (syncope). The doctor's office called for an ambulance. At the time of the report, it was unknown if the patient had recovered from the event. The reporter did not provide a causality between fainting and therapy with GARDASIL 9. Additional information has been requested.
pt recv vax 19oct96; pt died 15oct96, not necessarily related, pt had terminal CHF disease
Shortly after shot my index finger (same arm shot was in) started to bruise around the bottom, started to swell, and was warm to the touch. This continued for about 3 days which is about the same course of time I had the normal symptoms. Could barely function with headache, body aches, extreme weakness and fatigue. extreme nausea and stomach pains. Sweating and hot and cold  flashes. Since then I?ve also had random fevers with extreme hot checks. Twice last week once the week prior. These were very random.  The finger was very odd and was instructed to report.
posterior tibial vein non-occlusive thrombus. RLE pain starting 4/23, diagnosed 4/26
Approximately 12 hours after shot #2 - moderate malaise, chills, leg aches, slight headache.   Symptoms persisted for about 20-24 hours, gradually resolving.
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored GARDASIL 9 lot # M042853 with expiration date 17-JUL-2019 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported. Sender's Comments: US-009507513-1708USA000956: US-009507513-1708USA005614: US-009507513-1708USA005615: US-009507513-1708USA005617.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
It was a terrible headache few hours after vaccination, so I took ibuprofen PM and went to sleep. The headache is not as strong but right now after 5 days, I still have headache at left temple of my head and it never stop.
Pt recvd vax & exp h/a leading to Bell's Palsy;pt treated w/APAP & Isopto tears;Md indicated that pt was treated w/PT for Bell's Palsy;pt still has partial weakness on the rt side of face;MD stated appears has permanent partial impairment;
administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient was administered MenCYW liquid conjugate portion only of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccine was not reconstituted with the lyophilized MenA portion. The nurse did not have any patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter
HEADACHE; SEVERE BODY ACHE; FEVER; CHILL; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced severe body ache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced chill. On 08-MAR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chill, and vomiting, and had not recovered from headache, and severe body ache. This report was non-serious.
Pain up and down right arm, into right shoulder, and up into right side of neck. Vaccine was administered on right arm.
SEVERE DEBIL;ITATING HEADACHE, NAUSEA, BODY ACHES,  MALAISE, CHILLS, VERY SORE INJECTION SITE
Sore throat, rapid heart rate, uneven heart rate, exhaustion, bad headache, increased sensitivity to heat - all eventually diagnosed as hyperthyroidism. Also extreme inner ear pain - not yet diagnosed. All started about 5 days after 1st COVID vaccine. Diagnosis of hyperthyroidism happened about two months later (5/18/2021) when I finally went into an ER.
& days after receiving the vaccine, the client reports that she had a rash at the injection site. The rash lasted for 3 days. She followed up with her PCP and per client, PCP stated that was normal.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 at 11:00 as dose 4 (booster), single (Lot number: FE3590) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies: Nitrofurantoin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was received Paxlovid with lot number FK9894 via oral route of administration from 23Aug2022 to 28Aug2022 for the treatment of Covid- 19.  No follow-up attempts are possible. No further information is expected.
burning sensation over sternum with heaviness in chest; burning sensation over sternum with heaviness in chest; Burning in chest; Insomnia; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills/ pain in joints; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) , intramuscular on left arm on 15Jan2021 07:00 at a single dose  for COVID-19 immunization. The patient's medical history included known allergies to penicillin and avocado, attention deficit disorder (ADD), exercise induced asthma and osteoarthritis. The patient was not pregnant at the time of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and ibuprofen. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 16:15 intramuscular on left arm for COVID-19 immunization. No other vaccine in four weeks. On 15Jan2021 1500, the patient had pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills on same day at 2200. With ibuprofen and Tylenol throughout 16Jan2021, pain went away only to return in ribs and pelvis that evening as well as a return of intermittent chills. On 17Jan2021, pain in joints gone but patient had burning sensation over sternum with heaviness in chest and continued intermittent chills. Burning in chest comes and goes as well as the chills, the chills started from base of skull and wave downward to ankles multiple times lasting a few minutes to as long as 30 to 40 minutes. Insomnia starting 16Jan2021 and persists. No COVID prior vaccination and no COVID test post vaccination. The outcome of the event insomnia was not recovered, and other events was recovering.
Pt admitted to rehab for strengthening after being in the hospital.  Has history of ESRD and on dialysis.  Exposed to COVID and tested positive.
no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     HCP did not describe Medical History or condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 5th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, 5 out of 8 patient
It was reported in a published report, title stated above, regarding a case in litigation concerning a male patient (a minor, age not given) who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB thimerosal containing (manufacturer unspecified). It was reported by a physician in his expert report that RECOMBIVAX HB thimerosal containing did cause the patient's transverse myelitis. According to the reporter, "The vaccine caused an autoimmune disease through the process of molecular mimicry whereby in forming antibodies to the antigen in the vaccine, the body then proceeds to attack itself. The onset of patient's TM (transverse myelitis) six weeks after vaccination falls within the two month acceptable time limit for causation established. A number of case reports posit the same biologically plausible theory and timing that the physician described in his report. Additionally, the government did not file an expert report but instead filed a request for ruling on the record September 25 "denying that compensation was appropriate, but choosing not to expand further resources to defend the case." A special master said that general causation was established in an omnibus hepatitis B proceeding she presided over, in which the appropriate time frame was expanded to eight weeks post vaccination. She had the question whether the vaccine caused transverse myelitis in the patient, whose age was not given. The representatives from the petitioner and the respondent information were provided. Upon internal review transverse myelitis were determined to be another important medical events. Additional information has been requested.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA 25 U/.5ML 10x1 (ped) (Lot # K012457, expiration date 04-JUN-2017) route, dose and anatomical location were not informed. Information regarding concomitant medication was not provided. No adverse effects were reported. On an unknown date, the VAQTA had a temperature excursion for 96 hours, the lowest recorded temperature was 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion", the storage criteria and the storage type were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.