chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/29/13 given MENVEO (had MENVEO 7-9-07). C/O chest congestion, SOB that evening. Worked out 5PM wt lifting, only ate soup that PM.
Dose was given too soon.  1st dose of Moderna given 5/5/2021
At approx 1:15pm client got dizzy within 30 seconds of receiving vaccines. His head et eyes rolled. Had to bring client to ground. Cool compress / water given.
10 months since first, got second; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November2021(10 months ago)).   On 12th September 2022, the patient received the 2nd dose of Shingrix. On 12th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK receipt date: 12th September 2022 Reporters comment: This case was reported by a patient via interactive digital media  It has been 10 months since patient's first Shingrix.  The patient got my second on the reporting day. The patient asked would he/she need another. Additional Supportive information: The patient received the 2nd dose of Shingrix late which led to lengthening of vaccination schedule.
Onset about 1 minute after vaccine, patient was dizzy, nauseated, cold sweats, and low blood pressure. After drinking some water, sitting for a few minutes, and eating some lunch, patient was feeling 100% better.
Pt complained of sore and swollen red mass at site of injection. Patient sought care from PCP who diagnosed pt with nerve damage and cellulitis due to injection site being too low
Death on 9/24/21. Pfizer administered on 9/10/21. Jand J on 3/12/2021
Sore throat,-lasted a week,/sweating, chills, -a few hours, /nausea a few hours/, headache, fever, - on and off for  2 weeks,/ vertigo,, sore arm, fatigue,body ache -2 weeks.
2-3 days after vaccination, complained of low grade fever, arthritis, myalgia. Improved. Then around June 16, had HA on L side, got so severe, when to ER on July 4. Seen in ER and released. On 7/7/10, was sluggish in mentation and was admitted to the hospital. MRI was supportive of mild encephalitis. Labs sent to State Health Dept and will be sent to CDC
vision loss; painful rash; Information has been received on 15-JUN-2020 from a lawyer, regarding a case in litigation, and refers to a currently approximately 64-year-old female patient (pt). No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 11-OCT-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for vision loss and painful rash, resulting from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was considered to be medically significant.
Myalgia, Arthralgia, Fever, CHILLS, FATIGUE Narrative:
Patient reported feeling dizzy, then trouble breathing (shortness of breath) later at night, as well as light-headed.
8 days post vax, mom noted a fever (up to 104) and raised bumps continuing for 2 days until visit with MD who advised Tylenol for fever and Benadryl at night. Also a baking soda bath.
Patient called on December 4, in the evening, and wanted to let us know that her arm was very sore, and that she felt the immunization was given too high up on her arm, very near her shoulder bone and was concerned that it might have hit her bone and will come in to our pharmacy to discuss more tomorrow (December 5th, 2018).
Medical Assistant administered the HPV9 vaccine in error to patient. The vaccine which was ordered by provider was the Influenza vaccine. MA immediately made her supervisor aware of situation. CDC was consulted about any adverse reaction to be expected. Mother of child was informed any reaction would be mostly localized to injection site. Patient monitored by provider and nurse. Patient did not have any symptoms while in office.
pt recvd vax on 20JAN93 & several days later pt devel dime size area (appears to look like an smallpox scar p/smallpox vax)-small amount of pus; father states scab @ inject site;
(Approximate timings) 1 hr. after vaccine: chills; later that evening: intense aches and pains, escalating fever; at night: excruciating (level 8-9) pain in joints and entire body inside and out including skin and behind eyes, first ever sudden onset shooting pain deep in brain going straight down (blood vessel or artery), not alleviated by max. Excedrin migraine extra strength or usual aspirin dose, unable to sleep or get up to go to bathroom; symptoms mostly alleviated 24 hrs. later but mild/moderate headache persisted since then; shooting pain deep in brain returned approx. 2 weeks later and lasted less than 24 hrs. (would have immediately went to hospital if JJ blot clotting concern was reported at the time, esp. considering stent and May Thurner blood clotting concerns); 3.5-4 wks. after vaccine: first ever hay fever/allergies (nonstop runny nose, sneezing, sinus pressure, headaches) - sudden onset, no history of allergies to anything at any time or any level, no family history of allergies.
This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (HAIR LOSS), ILLNESS (SICK), LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), FATIGUE (TIRED) and PYREXIA (FEVER AFTER SECOND COVID SHOT) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Ankylosing spondylitis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ALOPECIA (HAIR LOSS), ILLNESS (SICK), LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), FATIGUE (TIRED), PYREXIA (FEVER AFTER SECOND COVID SHOT) and FATIGUE (TIRED AFTER SECOND COVID SHOT). At the time of the report, ALOPECIA (HAIR LOSS) and FATIGUE (TIRED) was resolving, ILLNESS (SICK) had resolved and LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), PYREXIA (FEVER AFTER SECOND COVID SHOT) and FATIGUE (TIRED AFTER SECOND COVID SHOT) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. The reporter did not provide causality for the events of TIRED, SICK, LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA, TIRED AFTER SECOND COVID, HAIR LOSS and FEVER AFTER SECOND COVID SHOT with Humira and Moderna. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No adverse event; Administered a dose from a potentially punctured vial (blue cap); Patient received Bivalent vaccine as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that patient was basically a healthy baby.  Previously administered products included for Product used for unknown indication: Hib. Past adverse reactions to the above products included No adverse event with Hib.    On 20-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 20-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. The vial might have been potentially initially punctured on 19-JUL-2023. Treatment details was not reported by the reporter.
Pt recvd booster dose of Tetanus tox 28JUL92 & calleed 30JUL92 c/o reddness, swelling @ site, & warmth;
Bilateral renal agenesis of fetus detected at routine 20-week anatomy scan on 8/27/2021. Determined to be fatal for fetus. No treatment available. Dilation began using laminaria on 9/7/21, followed by D&E on 9/8/21.
Itchy swollen red feet  Has been going on for an hour. Treated with Benadryl and calamine lotion and will try to sleep
polymyalgia rheumatica; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient did not have COVID prior to vaccinations. The patient had no known allergies. Concomitant medication(s) included: CRESTOR; ELIQUIS; FLECAINIDE; LISINOPRIL; ZINC. 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 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 30Dec2022, outcome "recovered with sequelae". The event "polymyalgia rheumatica" required physician office visit. The patient developed symptoms of polymyalgia rheumatica confirmed by rheumatologist. Symptoms started 3 days after the vaccination was received. Therapeutic measures were taken as a result of polymyalgia rheumatica which included prednisone.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Polymyalgia rheumatica  and the use of suspect product Comirnaty  cannot be fully excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
About 7 hours after receiving the vaccine I developed a painful migraine. The pain was very intense behind my left eye like there was a needle being poked in from behind.  Some nights the pain is so bad it hurts to lay my head on a pillow or I wake up all through the night because of it. I took tylenol the first 4 days then stopped. I tried to see an urgent care about it but they told me they couldn?t help me due to the vaccine type.
SORE ARM; This spontaneous report received from a parent concerned a 4 decade old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Patient MRN 1277090  Per recovery RN notes: "C/o lightheadedness. BP 73/34 1641 101/70 1643 88/52, pulse 62 1645 94/54, pulse 57 1650 122/75, pulse 60 Was sent home with father"
About 3 days after the vaccine, I was kept up at night with a rapid heart rate. It is still there. It actually went up to 105. My O2 levels went down to 89/90. This morning my heart rate is a little better and my O2 levels are around 94. I have increased my use of my albuterol inhaler to about 2/3 times a day. I have also doubled my use of Daliresp.
SUSPECTED CLINICAL VACCINATION FAILURE; CONTRACTED COVID-19; PROBLEMS WITH LIVER AFTER TAKING JANSSEN COVID 19 VACCINE; PROBLEMS WITH PANCREAS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 25-OCT-2021 and 26-OCT-2021. 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, and batch number were not reported) dose, 1 total, start therapy date were not reported 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 an unspecified date, the patient had problems with liver after taking the Janssen Covid-19 vaccine and problems with pancreas. The patient also claimed that the vaccine was not effective as patient contracted Covid-19 (suspected clinical vaccination failure, suspected Covid-19). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with liver after taking Janssen Covid-19 vaccine, problems with pancreas, contracted covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198940.; Sender's Comments: V0: 20211047596-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Nurse administered only the liquid component of Menveo in January 2022.; Nurse administered only the liquid component of Menveo in January 2022.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date 30th June 2022) for prophylaxis.   In January 2022, the patient received Menveo. In January 2022, 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 Information: GSK receipt date: 19-Apr-2022 Reporter's comment: The nurse administered only the liquid component of Menveo in January 2022. The reporter did not have relevant information regarding the patient.  The reporter stated that it could be one of 5 patients. The reporter was doing an ongoing investigation. The reporter gave consent for safety team follow up. Additional Supportive Information: The nurse administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Ran a fever of 104.1 with severe joint pain throughout (knees, ankles, elbows, shoulders, toes, fingers, wrists, hips)
42Y female presenting with arm pain after covid vacination received second dose of moderna on 4/9/2021 on her left arm pain and redness around vaccine side on day one, then second day redness in site of old bcg vaccine which then spread throughout the deltoid on the right side, also feels swollen +pain and redness without significant itchiness
pt recv vax 3AUG95 & 6SEP95 pt was found to be pregnant;@ week 16 & 36 ultrasounds were nl;during pregnancy pt devel gestational diabetes;MAR96 devel sinus infect & in APR95 devel URI;
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX23 lot number M402785, expiration date 06-JUN-2018 (dose, route of administration and anatomical location were not reported) were administered to the patients. No adverse effects were reported. On unknown dates, the doses were stored in the temperature 33.6 degrees Fahrenheit (F) for 19.5 hours which was detected by a digital data logger. No previous temperature excursion was reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005227:
Fever (max temp 38.7C), chills, myalgias, fatigue, sweats. Symptoms began 10 hrs after vaccination and lasted until 36 hrs after vaccination. Unable to work the following two days.
This 49 year old male was brought into MEDICAL CENTER by ambulance on 12/17/2021 at 0148 complaining of SOB and chest pains. Upon arrival he became unresponsive, CPR lasted for 1 hour with no change in rhythm until the death was pronounced. Previous visits noted for HTN, sleep apnea, cardiomegaly and obesity (350#). Unknown PCP or NOK information. Decedent told medics he got his COVID booster 3 days ago and started to exhibit SOB and chest pains since then. No signs of recent injuries, trauma or acute drug/alcohol intake. Labs put on hold for ME pick up... PER DR. at MEDICAL CENTER: Patient is a 49 y.o. male who presents with shortness of breath. History is obtained from record review paramedics and minimally from the patient due to his severe respiratory distress. Patient has reportedly been short of breath for the last 3 days it started within several hours of getting a Covid booster injection. Symptoms became severe today and he called the paramedics. Paramedics found him tachypneic hypotensive tachycardic ill-appearing placed on supplemental oxygen and transported here. Record review shows a history of obesity, obstructive sleep apnea, leg edema, nonhealing ulcer and hypertension patient reportedly came from home, history was limited due to the patient's severe respiratory distress. Patient did deny pain. Past medical history surgical history medications allergies family history social history and review of systems are all extremely limited due to the patient's severe respiratory distress on arrival and cardiac arrest several minutes after arrival.
Right in the center of chest is tender; feel like it's muscle pain when I push on it; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got his second shot Tuesday (Apr2021), woke up this morning (15Apr2021) and right in the center of chest is tender. He wanted to know this is because of the shot. It does feel like it's muscle pain when he pushed on it. Outcome of the events was unknown.
Pt states he had fever of 99.5 and chills and body aches that started the day after vaccination and continued for 7 days after
This case was reported by a healthcare professional and described the occurrence of pounding headache in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical condition included allergy to amoxicillin and erythromycin. On 17 November 2011 the subject received a dose of BOOSTRIX (unknown route, right arm) and almost immediately after vaccination experienced pounding headache. On 17 November 2011, the event was resolved in about an hour. The lot number was reported as AC528073AA from the reporter; however, based on safety lot number review, the lot number was updated to AC52B073AA.
when patient got the flu shot had at least 5 sinus infections a year; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown age and gender) who experienced sinus infections (at least 5) a year (sinusitis), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; dosing details and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sinus infections (at least 5) a year (sinusitis) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient had not had that poison for three years then and had not been sick once before that.   It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: Not provided   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Result of assessment was not reported.  There will be no information available on batch number for this case.
1 1/2 wk post vax pt devel paralysis;dx w/GBS post flu vax on life support;ventilator, plasma tx;
Fatigue, body aches, diarrhea, nausea, vomiting.  Took Tylenol, ibuprofen, and zofran.   No fevers prior to administration of antipyretics.