chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash Narrative:  Developed ~3x3 inch circular rash distal to injection site, started 3 days after vaccination and persisted for about 2-3 days. Assisted with Benadryl and low dose topical hydrocortisone. Area on underside of arm described as pruritic (not over area). Not associated in induration, erythema, sloughing. No other adverse effects noted.
patient received a third dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 29-month-old male patient who received HAV (Havrix) (batch number 2yX23, expiry date 10-FEB-2025) for prophylaxis.  On 12-JUL-2023, the patient received the 3rd dose of Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: patient received a third dose of Havrix). The outcome of the extra dose administered was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK receipt date: 12-JUL-2023 The medical assistant reported that a patient received a third dose of Havrix and wished to know how to proceed. Information about the event, patient and vaccine was given. The vaccine administration facility was the same as primary reporter. A patient received a third dose of Havrix, which led to extra dose administered. The reporter consented to follow up.
Info has been received from a pharmacist concerning a 56 year old female who on 10/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641531/1352L). Concomitant therapy included a dose of the influenza virus vaccine (manufacturer unknown). On approx 10/15/2002, the pt developed a local reaction at the injection site and a fever of 100F. Unspecified medical attention was sought. Additional info has been requested.
Localized burning; White patch near injection site; Not administered in deltoid, was not at a 90 degree angle; A spontaneous report ), was received from a consumer concerning 55 year old female patient who was administered Moderna's COVID-19 vaccine had experienced burning immediately after injection (PT: vaccination site pain), a white patch near the injection site (PT: vaccine site discoloration), and Incorrect route of product administration. (PT: Incorrect route of product administration)  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient experienced localized burning immediately following vaccine administration. The burning subsided after 10 minutes. Once the burning subsided, the patient noted a white patch near the vaccination site that was present for 24 hours.  . Action taken with mRNA-1273 in response to the event(s) was not provided.  The events, localized burning resolved on 06 Feb 2021. The event, white patch near injection site, resolved on 07 Feb 2021.; Reporter's Comments: This report refers to vaccination site pain, vaccination site discoloration and incorrect route of product administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded..
Continuous headache everyday since vaccine. Migraines have become more frequent, more severe , more debilitating and less typical. Brain Fog, fatigue. Pain and weakness in arms and legs. Numbness and tingling in fingers and toes. Continuous pain in neck and back.
Fever, chills, body aches, tired, sure arm at injection site, started 15 hours after shot and continued for 24 hours
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted after receiving his first dose of the shot. He was very pale and sweating but responsive to questions. Monitored his blood pressure and had him sit and drink water. After 15 minutes his color had returned, stopped sweating and was totally alert/oriented. Per patients mother he had just come from school and had not eaten much that day which she belived to be a contributing factor
A non-serious spontaneous report of "a child got some FLUMIST in his eye" was received from a registered pharmacist concerning a 44 month old male. The patient's medical history was not reported. On 02 Dec 2009, during administration of FLUMIST, the patient moved his head, and portion of the vaccine was squirted in his eye and face. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
was over the six month window; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called to verify that if a patient has gone over the 2-6 month time frame for second dose of Shingrix they did not have to restart the vaccine series. Till the time off reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the husband (no information) of the consumer, called today stating the patient was over the six month window, and was wanting to know if the patient needed to restart the series.  The reporter consented to follow up.
This child had a maculo-papular rash 180 noted on 04/01/01, started initially on extremities, then trunk and face. It was initially small, then generalized on the 2nd day associated by fever, itching, and fussiness.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
pt states that left arm began hurting immediately after vax; it hurt all the way down pt arm. pt states that the nurse gave vax on top of shoulder; now one month later pt states she is unable to use arm. pt has not seen MD
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 27-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number N025428 and expiry date 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA004452: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA008119: US-009507513-1811USA008123.
expired 1st dose of engerix B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received HBV (Engerix B) (batch number N754X, expiry date 11th November 2021) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Engerix B. On 15th November 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that a patient received an expired 1st dose of engerix B, which led to expired vaccine used. The reporter did not consent to follow up.
Client c/o 4-5 hr post Rabavert vaccine dose #2, muscle pains/ soreness left arm, leg, shoulder-did not sound like neurological-She did get dose #3 on day 8/5/04 with milder pain arm, neck, shoulder, no leg.
Rare case of severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Rare case of severe diarrhea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included GABAPENTIN for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA (Rare case of severe diarrhea). At the time of the report, DIARRHOEA (Rare case of severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Blood pressure medications and diabetes medication. Treatment details was not reported by the reporter.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
pt recvd vax & devel deep aching in rt shoulder & elbow, & numbness & tingling; pt also devel headache & queasy stomach; pt has a dec sensation on a dorsum of hand in the absence of hand weakness; MD felt was having a local rxn to the vax;
Mom states noticed puffy red area to L arm on 11/8/11 afternoon. States afternoon of 11/9/11 the whole left arm was puffy and very red. Denies any pain or elevated temp. States carried child to local ER. States MD stated having "local reaction"  Steroid shot given in ER and also gave prescription for oral Benadryl.  States morning, 11/10/11,  his arm still red but less puffy.
vaccine administered during the 2nd dose had temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
c/o chills, headache and joint pain. Started evening he received inj 9/4 and continued -> 9/7/08.
Information has been received from a physician concerning a 13 month old female with no allergies who on 08Apr2004 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot #646901/0952N). Secondary suspect vaccinations on that same day included a dose of varicella virus vaccine live (Oka/Merck) (MSD) (Lot #647269/1101N). Other concomitant therapy included amoxicillin and albuterol. Illness at the time of vaccination included and ear infection. the physician reported that on 28 Apr 2004, the patient had changes in her gait and was hospitalized later that same night as a diagnosis of cerebellar ataxia was made. At that time, a computed axial tomography (CT), spinal tap, complete blood count (CBC) and a urine test were performed (results not provided). The physician also reported that some petechiae was noted on the patient's face and neck, but it was unknown if it was a related symptom or from the the patient crying during procedures. On 29Apr2004, at 0200, the patient showed improvement but hours later her condition declined but was noted to be better than the previous day. Later that same day, a repeat CBC was normal and a toxicology screen was negative. Additional information has been requested. Follow up on 05/25/04 states: "Upon follow up the physician stated that the child developed cerebellar ataxia and had a rash when her blood was drawn. At that time, petechiae were noted on the pt's face and neck, but it was suspected that it was related to the pt crying during the procedure. The child's CBC including platelets, PT and PTT were all normal. No other etiology was discovered, however, the physician felt it was unlikely that it was secondary to the vaccines. The physician also felt that the pt's "recovery was so quick that it may have been a potential ingestion that caused the ataxia." The physician stated that "although the urine drug screen was negative it would not necessarily have capture all agents." The pt was discharged from the hospital and was seen on 05/03/04 and displayed no residual effects. Subsequently, the pt had recovered. The results of the PCR analysis of the CSF were negative for VZV. No further information is available.
I woke up that Saturday - sore throat, cough, congestion a lot of fatigue - lasted four days. That following Thursday I saw DR. (who is a PA in my office) - pain in my ribs when I coughed - he thought it might be a pulled muscle and he gave me muscle relaxers. I took over the counter Day quill and nigh quill and Mucinex. By last weekend, I woke up and felt much better.
Patient is a 90 y.o. male patient of MD with history of TN, GERD  presented with generalized weakness with cough and shortness of breath.   Acute Respiratory Failure with hypoxemia-resolved COVID-19 nfection Sepsis without organ dysfunction  Vaccinated Presented with tachypnea and leukocytosis   Hemodynamically stable, not requiring vasopressors.  Lactic acid 1.9 on presentation COVID-19 symptoms: 10/4/22 COVID-19 test positive date: 10/5/22 CXR with no acute cardiopulmonary process Continue 2 liters/min via Nasal Canula; currently on room air Spo2>95% Fluid status euvolemic Blood cultures NGTD  UA no evidence of infection  D-dimer 0.63 , fibrinogen 484 CK 81 LDH 182  COVID-19 precautions for 10 days Albuterol via HFA q6PRN Tylenol prn for fever Continue IV Decadron; switch to oral Decadron remaining days total 10      Hypokalemia - resolved  K of 3.3 and Mag 1.9 on presentation Replace and recheck  Repeat K of 3.7 (10/07)   HTN  SBP 140s  Continue home medication regime    Pre -diabetes  HgbA1c 6.4 month ago 6.5 on admission      GERD  Continue home PPI
complained of chest pain, was in afib rvr treated with cardizem. Positive for covid . pt discharged home once heart rate controlled.
Evening after vaccine, pt felt pain in Left arm above elbow to shoulder.  Next day, pt noted 3" diameter red area on upper arm but below vaccine site.  It was warm, painful and grew larger. She developed another, smaller red area under her arm above elbow. Rash slightly raised, nonitchy.  On 09/24 pt saw PA who gave her antihistamine and stated that she'd had a reaction.
small lump; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (small lump) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (small lump). At the time of the report, SKIN MASS (small lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Complained of achiness, headache and lethargy x 24 hrs post injection. (Pt also notified medical center advise).
He had a fever, cough, fatigue, racing heart (155-185BPM) and difficulty breathing one evening. We went to the hospital the next morning. They gave him some medications and fluids and discharged us a couple of hours later. His respiration rate was around 50. They tested him and he came back positive for COVID-19. They didn't prescribe him anything after discharge. Currently, he still has a cough and pretty congested, but he's no longer testing positive for COVID-19.
pt recv vax & 2 days later pt did not feel well & went to bed;pt died in sleep;no hx/evidence that pt exp heart arrhythmia, chest discomfort, fatigue or weakness during the interval between vax & death;no autopsy performed;COD unk;
Headache; Sore arm; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on an unknown date (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy and known allergies to bee. Concomitant medications included diazepam (MANUFACTURER UNKNOWN), ibuprofen (ADVIL), multivitamin and vaccinium spp. (CRANBERRY SUPPLEMENT); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced headache, sore arm and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of headache, sore arm and fever were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At approx. 07:30, employee called inquiring about side effects of HBV that she was given. She stated that she became disoriented and dizzy after leaving the health office. Peers stated her color was pale and she was clammy and feeling faint. Continued complaints after escorted to the health office. Had a headache and was dizzy. She was alert and oriented when she arrived. Stated a little short of breath but resolved on the way over. Fingers and hands were tingling and numb. Vital signs remained stable and was also able to say she felt better. After this, complained of paresthesia worsening and employee maintaining she "felt funny" and began to appear anxious. Treated with Epi-pen dose and symptoms resolved. Consulted with her private physician, who strongly advises against dose #3 of Hep-B.
Admit for fall, syncope at home. COVID+ and found to have COVID PNA. Tx w/abx, steroid, remdesivir, baricitinib, O2. Hx COPD, Afib, emphysema. Acute on chronic resp fx. She is now improved and has achieved maximal hospital benefit. She is being discharged to facility to continue recovery
This case was reported by a consumer and described the occurrence of uncontrollable crying in an 8-week-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. A physician or other health care professional has not verified this report. The pt received hepatitis B vaccine (unknown manufacturer) at birth. On 11/18/2003, when the pt was 8 weeks of age, he received the 1st dose of Pediarix in his right leg and "immediately started crying." Pediarix was administered as the 2nd dose of hepatitis B vaccine. The same day, the pt received an injection of Haemophilus influenzae type b conjugate vaccine (unknown manufacturer). Approx 30 minutes post-immunization at 3:00 PM, the mother reported that she fed her son and was able to calm him down. Approx 90 minutes later, at 4:00 PM, the pt "started crying uncontrollably and would shake his right leg like it was hurting and scream." The mother noted that her son cried "so hard that he started sweating and would gasp for breath between sobs." She contacted the physician via telephone and was instructed to treat him with acetaminophen and a bath. Approx 2 hours later at 6:00 PM she stated her son "calmed down, but did not sleep well that same night." Approx 12 hours later, on 11/19/2003, the pt had an axially fever of 100 degrees F and developed 2 red spots on his leg and "two hard balls under his skin," at the injection site. The injection site reaction resolved 2 days post-immunization. At the time of reporting, 11/21/2003, all other events were unresolved.