chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mom got a Covid-19 vaccination on Thursday 11/4. It was given by a nurse at Dr office. On Tuesday, 11/9/21 my mom called me to take her back to Dr. office because she was given an expired vaccination. She said she needed another one on Tuesday and it couldn't wait. I tried to talk her into to talking to someone from the health department, Pfizer or an infamous disease doctor. She insisted that we she needed to go right away and she does what Dr. tells her to do. It turned out that Dr. knew nothing about the expired shot or the second one. She told us that Dr. was on top of it and she said it was safe for her to get the shot. We realized something was wrong when she did not let us come in contact with anyone else at the office. She made the follow up appointment. When my mom got the first shot on 11/4, we went to the check out desk to make the appointment for the second vaccine  I started calling around and my sisiter did too. We learned that Dr. is not famaliar with protocols is someone was given an expired shot and the nurse did not tell him. The second-first shot was in the system as a Covid shot but the first one had a different code. By calling the CDC we learned that she never reported the expired shot being given on 11/4/21. She also took the first covid immunization card. She told my mom to give it to her so that she didn't get them mixed up.
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 14-FEB-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
It couldn't be fully administered because they said it hurt; Patient was given a dose and it couldn't be full administered; This spontaneous case was received on 09-Oct-2023 from a pharmacist (reference number: SEQW23-03138) and concerned a 57-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included unspecified cholesterol medication.  On 06-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine innact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm,) as a every year shot. As reported, the patient was given a dose and it couldn't be fully administrated because it hurt (explicitly coded 'Incomplete dose administered'). The batch number reported was 944465 and the expiry date was 22-Jun-2024.  The outcome of event of 'vaccination site pain' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: Due to plausible temporal relationship and location of an event, causal role of Flucelvax Quadrivalent is assessed as possibly related for vaccination site pain, while incomplete dose administrated is assessed as not related per company's conventions.; Sender's Comments: Due to plausible temporal relationship and location of an event, causal role of Flucelvax Quadrivalent is assessed as possibly related for vaccination site pain, while incomplete dose administrated is assessed as not related per company's conventions.
Information has been received from a Licensed Practical Nurse referring to a 12 month old female patient without pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination. On 17-APR-2015 at 11:00, the patient was vaccinated with her first dose of (Merck) VARIVAX (lot # K003420, subcutaneous in the right thigh (RT), dose, expired date were unspecified). Concomitant vaccines administered on the same day included MMR II, PREVNAR, and LIQUID PEDVAXHIB. The patient was given (Merck) VARIVAX which had been noticed that freezer temperature was above recommended temperature for safety storage. No adverse reaction occurred. Sibling's experience has been captured in MARRS# 1504USA018771. Additional information has been requested.
During 15 minute observation after administration of vaccine, patient complained of lightheadedness, dizziness and throat tightness. Patient states that she is a diabetic and has not eaten all day. Rapid response was called and notified. Rapid response nurse check vital: BP : 121/67, HR:70, Resp: 20, O2 sats 98% on RA. Unable to check blood sugar due to the fact she is not inpatient and declines to go to the ER for blood draw. Family medicine aware and notified by rapid response nurse. Family medicine advised patient to go to ER for immediate care. Patient states she feels better after staying in clinic for ~75 minutes and declines need for emergency room visit.  Patient was educated on signs and symptoms to monitor in case of an emergency and to call 911 and/or go to the ER if needed
she was doing okay and had not experienced any side effects from receiving the expired vaccination; On 29Jul2020, she received a Proquad vaccine that expired 23Jul2020; This spontaneous report was received from a certified medical assistant referring to a 5-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On an unspecified date in 2016 (reported as "when she was 1 year old"), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 29-JUL-2020, she received the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter subcutaneous injection for vaccination, lot# S002490, expiration date 23-JUL-2020.  The second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was expired at the time of administration. At the time of the call, the patient was "doing okay" and had not experienced any side effects from receiving an expired vaccine. As of 29-JUL-2020, it was unknown if she would receive another measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2008USA000238:
Injection site was itchy; Injection site was swollen; Round red rash around the injection site; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE RASH (Round red rash around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE RASH (Round red rash around the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE RASH (Round red rash around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
12 hours after 2nd covid dose of moderna, developed fever (temp 102), nausea, headache, fatigue, chills, rapid heart rate (140 bpm), sore arm, body aches. Started vomiting and could not hold down food, water, or meds for 12 hours, vomiting multiple times per hour for 6-8 hours. After 12 hours of side effect onset, I was able to hold down 1 gm tylenol, fever subsided, 98.5 temp, and side effects were all gone by hour 14 post side effect onset (24-26 hours post vaccine).
Patient had tested positive for COVID 19 at LTCF 14 days ago and he had been isolated.  He was started having some diarrhea issues and he was also not eating much because of the nausea.  He also had weight loss and MMR was called.  He was found to be 88% on room air and placed on 2 L and he improved to 92%.   He already had two Pfizer vaccines this year and 2 weeks ago he also had a booster shot from Pfizer.  When the patient came in here, the patient's most of the workup was unremarkable, but he did have a D-dimer elevation, positive for COVID-19.  Chest x-ray showed bilateral pneumonia, infiltrates were consistent, but nondiagnostic for COVID-19 infection.  The patient was then admitted to a COVID floor.  We started him on some Flagyl, IV fluids. His stools were negative for C diff.  We did start him on remdesivir and dexamethasone. DVT prophylaxis was done on Heparin .  Also started him on doxycycline.  The patient has finished a course for remdesivir.  He was discharged in stable condition.
Started period on 22May2021. Still on it as of 08Jul2021. Non stop.; Started period on 22May2021. Still on it as of 08Jul2021. Non stop.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 12:00 (at the age of 15-years-old) (Batch/Lot Number: CP7533) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have any medical history. There were no concomitant medications. The patient's period had started on 22May2021 12:00 PM and was still on it as of 08Jul2021 non stop. The patient had not received any other vaccine within four weeks and other medications in two weeks. Patient did not have any known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that patient did not have pregnancy at time of vaccination. Patient did not receive any treatment for adverse events. Outcome of events were not recovered.   No follow up attempts are possible. No further information is expected.   Follow-up attempts are completed. No further information is expected.
Came in to see MD on 10/7/2016 for edema to left arm from shoulder to fingers. Recent Left ACL tear from playing soccer with use of crutches. Nexplanon implant in Left arm. Ibuprofen used following vaccines.
On 3/19/21,  I woke up with numbness and tingling in left hand all day. 3/20/21 to Present Date, 3/24/21, The numbness and tingling continued and has not gone away.   Things fall out of my left hand when it goes numb.  Tonight I dropped a dinner plate.  Please advise how I can stop the numbness and tingling as I am left handed.   3/19/21, I contacted Dr.  office, and informed the Nurse of my reaction.  She checked with Dr. , and I was told this could be a reaction.  Thank you for your assistance.
BAD HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, 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 subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad headache was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient called in the day before the reporting that she was experiencing a rash after receiving SHINGRIX. The patient had the rash for 3 days. No additional details were available. The reporter did not consent to follow-up.
Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2022, received third 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 HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in stool) had not resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Blood in stool was assessed as reasonable possibility for cosuspect humira. No treatment medications were reported. 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.  Company comment- This spontaneous case concerns a male patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 at an interval of 29 days and third dose 10 months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 at an interval of 29 days and third dose 10 months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
p/pt returned home ond ay of receiving vax pt vomited 3 times that day only; no fever, no rash, or other sx's noted by mom; (mom reported incident to clinic on 8SEP92);
Narrative:  Patient died following 1 dose of COVID vaccine 02/10 COVID vaccine dose #1 02/12 admitted to ED with altered mental status, confusion, severe weakness, malnutrition; discharged to SNF 02/25 admitted to hospital from SNF due to respiratory distress, was intubated, BP to 74/50 03/08 pt remains admitted, supposed discharge 03/15 on hospice care 03/25 pt passed away, unknown cause Likely that COVID vaccine did not contribute to or cause patient's death, but was caused by advanced age (95 y/o) in combination with co-morbidities. Patient did not experience ADR to vaccine but was hospitalized 2 days later with weakness and confusion. Illness progressed until patient's death, but likely due to sepsis and pneumonia. No diagnosis of COVID noted.
Had been given typhoid, meningococcal and chicken pox. About 16 mins later. Pt c/o swelling hands and itching. No redness, no hives, no bruising sores. BP 140/90, HR 80 RR18, Watch for next 2hrs, pt better no issues.
Patient with 3 COVID vaccinations who admitted to hospital with complications of COVID. Provider d/c note:  "COVID infection - Improving clinically on IV remdesivir day #5 and decadron day #5. Not requiring oxygen. Plan for discharge today after completing 5 days of remdesivir. She is not requiring supplemental oxygen at this time".
Heaviness and cramps in both forearms and legs when at work and in bed.  Also cramp back of head.  All symptoms intermittent.  States that none of this occurred prior to the MPOX vaccination.
This case was reported by a physician and described the occurrence of injection site induration in a 4 year old female subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 5/2/2006 at 8:am, the subject received 5th dose of Infanrix in the left thigh (lot AC14B035AA). On 5/2/2006, the subject also received the 2nd dose of measles, mumps and rubella virus vaccine (MMR II, lot 0151R) at an unspecified site of administration. On 5/3/2006, 1 day after vaccination with Infanrix, the subject experienced erythema and induration at the injection site of Infanrix . The subject was seen at a physicians office and was treated with cetirizine hydrochloride Zyrtec, prednisolone Prelone and cephalexin. The physician considered the events were disabling because the child missed school, and clinically significant (or requiring intervention) (OMIC). The events resolved on or after 5/3/2006 and on or before 5/12/2006. The physician considered the events to probably be related to vaccination with Infanrix.
Health is declining; confusion; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow); Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,pooping; loss of speech; loss motor skills; tremor; This is a spontaneous report from a contactable consumer (parent). A 26-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 15:45 (at the age of 26-years-old, non-pregnant) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine-Other. Facility type vaccine other- Temporary site run by the military. Medical history included autism and intellectual disability from an unknown date and unknown if ongoing. Concomitant medications included gabapentin, topiramate, cetirizine hydrochloride (CETIRIZIN), montelukast, vitamin D, trazodone, sertraline hydrochloride (ZOLOFT) and chlorpromazine hydrochloride (CHLORPROMAZIN): all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to Kepler. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in arm left on 10Mar2021 at 16:45 (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunization and did not experience any reaction. No other vaccine was received in four weeks. On 02Apr2021 at 06:30, patient's health was declining, now hospitalized; difficulty eating (had to be reminded to chew/swallow), drinking, peeing, pooping, loss of speech, loss motor skills, tremor, confusion and was still suffering. Events resulted in emergency room and physician office visit. The seriousness reported as Hospitalization and Hospitalization prolonged, Life threatening illness (immediate risk of death from the event). The patient's hospitalization was prolonged as a result of this event (no days hospitalization was 12 days). It was unknown if patient received treatment for the events. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.  Information about lot/ batch number is available. Additional information has been requested.
Right arm erythema 24 hours after PNEUMOVAX given. ? cellulitis. Vancomycin.
Pt received Moderna vaccines on 03/08/21, 04/05/21, and 08/25/21. On 11/04/21 while hospitalized, pt developed a fever on 100.2. Pt noted to be experiencing chills. COVID test resulted positive.
Shot administered 11/19 and following night the patient had an itchy eyeball, dry throat, dry mouth, felt very nauseous and dizzy, had a headache and decreased vision.
Tingling lips 15 minutes post injection, lightheadedness and headache 30 minutes post injection, followed by flank pain and right arm pain 20 minutes beyond that.  Vital signs stable. Patient was given IV Benadryl 50mg, Solumedrol 125mg IVP, IV fluids. Patient was monitored for 4 hours. Symptoms resolved and she was discharged from the facility and advised to call us if symptoms recurred.
Case number PHEH2014US016835 is an initial spontaneous report received from a nurse on 20 Aug 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that on 19 Aug 2014, the patient received an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: M12101) without reconstituting it with Men A lyophilized conjugate. No adverse reactions were reported following the inadvertent administration. Following an internal review of the data received on 20 Aug 2014, it was identified that the event verbatim MenCYW-135 liquid component administered without Men A lyophilized conjugate was erroneously coded to incomplete course of vaccination and hence the event was now correctly recoded as inappropriate preparation of medication.