chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time.  She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies).  Patient did complain of nausea and dehydration.  Discharged on 3/9/21.
Left armpit is sore and swollen, this did not happen with either of the initial two injections. Not 100% clear on the above lot number, the writing is not super clear on my vaccine card. The 6 could be a G.
Pt received MMRV vaccine in his Lt thigh on the 14th of May 2019. MOP reported the Pt's Lt thigh had redness in the size of a quarter on the 16th of May, the area was warm to the touch with small red bums in the area. Pt reported itchiness. No fever or pain.. Pt was seen on the 16th by his PCM and was treated with Benadryl and Steroids.  Pt followed up with PCM on the 17th of May and the redness, itchiness, and warmth  decreased.
Unable to lift arm day after vaccine. 12/31/21 developed sneezing.  1/1/21 developed fever & cough in am that progressed during the day to chest tightness/heaviness.  Developed stuffy nose, headache, bone aches, lethargy.  Continues with increasing cough.
pt devel 3 episodes of shaking arms & legs lasting approx 10sec w/o LOC & no fever;
I started to feel extremely fatigued and I had really bad dizzy spells too. The fatigue was very bad. I had a couple of dizzy spells before I received the vaccine so I am not sure they are related. I am still dealing with this at this time.
the previous dose was 4 years prior.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received the previous dose of Twinrix 4 years prior at the time of reporting).   On an unknown date, the patient did not receive Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 08-NOV-2022 Reporter's Comment: The reporter called in to inquire about the vaccination schedule of Twinrix, as the patient that, wished to receive the vaccine had gotten the previous dose 4 years prior at the time of reporting.  The reporter did not have information other than the patient's date of birth and gender. The Vaccine Administration Facility was the same as Primary Reporter. The VAERS details were updated for the previously administered Twinrix dose. The reporter asked to be contacted through e-mail. Additional Supportive Information: Till the time of reporting, the patient did not completed the Twinrix vaccine immunization, which led to incomplete course of vaccination. As it was not clear which dose was pending, therefore in worst approach case was kept valid with incomplete course of vaccination considering the Twinrix vaccine immunization was pending and meanwhile follow-up request was raised for the same.
This spontaneous report received from a consumer concerned a 19 year old male of an unspecified race and ethnicity. 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 administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in NOV-2021 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 hypertrophic cardiomyopathy. On 19-DEC-2021, the patient died from hypertrophic cardiomyopathy. An autopsy was performed on an unspecified date. The consumer reported, the grandson died suddenly on 19-DEC-2021. His autopsy said he died from hypertrophic cardiomyopathy (HCM) and genetic testing should be done on the other kids in the family. The hospital that did the testing called and said, his gene test did not show HCM as the cause. The patient had received the vaccine a month prior to his death and should it be assume as cause? The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender's Comments: V0- 20220454599 -COVID-19 VACCINE AD26.COV2.S- Hypertrophic cardiomyopathy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: HYPERTROPHIC CARDIOMYOPATHY; Autopsy-determined Cause(s) of Death: HYPERTROPHIC CARDIOMYOPATHY.
Rash erythematous; Rash pruritic; skin warm; Myalgia; heart racing; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), DIZZINESS (Dizziness), RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PALPITATIONS (heart racing). 17-Jul-2021, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Myalgia). On 18-Jul-2021, the patient experienced RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form; HYDROCORTISONE for Rash, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. On 17-Jul-2021, PALPITATIONS (heart racing), DIZZINESS (Dizziness) and MYALGIA (Myalgia) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
This spontaneous report as received from a consumer's wife refers to an 86 years old male patient. The patient's medical history included polycythemia vera, pulmonary fibrosis and prostate cancer. On 18-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant medications included: unspecified blood pressure medication and various unspecified medications. The patient had no drug allergies or reactions. It was reported that on 18-JAN-2014 (also reported as a day after the vaccination) the patient broke out in a rash on the front of his body and his back. The rash blistered and then scabbed. At the time of this report the patient still had deep red blisters and most of the scabs were gone. It appeared that he would be scarred. The reporter felt that this medication was ineffective. The patient was given tramadol as a treatment. His outcome was reported as recovering. Lab diagnostic studies included blood work performed on an unknown date (results not provided). The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. The patient sought medical attention via a doctor visit. Additional information has been requested.
Approximately 7 hours after receiving my second dose of the Pfizer/BioNtech COVID-19 vaccine, I developed soreness in my right arm near the injection site. Around two hours later, I noticed mild aching in my back and legs accompanied with a low grade fever of 99.0 degrees, compared to my normal temperature of 97.8 degrees.
Patient broke out in a vesicular rash on 8/13/2015 in the am that was very itchy. Patient was seen by a provider on 8/17/2015 with a 103.4 temp and was diagnosed with Varicella.
Crohn's; Sick; Not feeling well; Headache; Sore throat; FACILITATED COLLECT  This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from (manufacturer control number: 21K-163-4121163-00) from a contactable consumer (patient)   This 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on 11Oct2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  Daily Dose: Citrate Free (as reported) for Moderate to severe ulcerative colitis.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced crohn's  on an unspecified date with outcome of recovering , sick) on Oct2021 with outcome of recovering , not feeling well on Oct2021 with outcome of recovering , headache on Oct2021 with outcome of recovering , sore throat on Oct2021 with outcome of recovering.  The action taken in response to the events for adalimumab was unknown.The clinical course was reported as follows: Solicited report from the by a consumer of a 38 year old male with events of non-serious Sick, Not feeling well, Headache, Sore throat and Crohn's with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Crohn's. In Oct2021, the patient experienced Sick, Not feeling well, Headache and Sore throat . Pfizer BioNTech COVID-19 Vaccine was also considered suspect. Additional information :It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Sick, Not feeling well, Headache, Sore throat and Crohn's was not provided.  Causality for  Pfizer BioNTech COVID-19 Vaccine  The reporter's causality for the event(s) of Sick, Not feeling well, Headache, Sore throat was possible for  Crohn's was not reported.         The reporter's assessment of the causal relationship of the event Crohn's with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.                                No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Crohn's disease, Illness, Malaise, Headache, Oropharyngeal pain cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Fatigue (onset: 10 hours post-dose; length of AE: 12 hours) Body Ache  (onset: 10 hours post-dose; length of AE: 12 hours) Headache, severe  (onset: 10 hours post-dose; length of AE: 12 hours, took 600mg ibuprofen which relieved the headache)
PASSED AWAY DUE TO THE JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient concerned a 4 decade old male. 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), 1 total 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 patient passed away due to the Johnson and Johnson vaccine and cause of death was unknown. It was unspecified if autopsy performed. Reporter just got off the phone with her cousin it was her best friend who passed away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210730562-covid-19 vaccine ad26.cov2.s-passed away due to the Johnson and Johnson vaccine. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Extremely fatigued, rash on torso day after second dose.  Patient denied any fever, chills, body aches. Rash resolved within 2 days.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified day in 2009, the patient was vaccinated with the first dose in the vaccination series of GARDASIL (dose, frequency, route of administration, LOT number, expiration date were not provided). On 16-MAY-2018, the patient received GARDASIL 9 intramuscularly, as the second dose in the vaccination series (dose, frequency, LOT number, expiration date were not provided), and on 11-JUN-2018, received GARDASIL 9 intramuscularly, lot # N023828/ exp. 25-JUN-2020 (dose, frequency and indication were not provided), for the third dose in the vaccination series. No adverse effects were reported. No further information was provided.
Immediate burning at shot site, within 15-20 minutes a pouding headache, chills, nasca, and lethargy. within the hour shoulder, neck & back tightness and pain. This lasted for about 24 hours. The following day the tightness moved from shoulder neck to elbows and knees; the following day it spread to my ankles toes and hands. On Saturday, June 8th, I started to feel better and but, I was not fully recovered until June 12th.
4/26 The patient was admitted to the hospital after presenting to the emergency department with the left inguinal hernia. Underwent hernia repair.
sneezing; stuffiness; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 15-Mar-2021, the patient experienced SNEEZING (sneezing) and NASAL CONGESTION (stuffiness). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt. received vaccine and had blood drawn. Sat in waiting room about 15 min. after administration. Left with mother and family. Fainted on street outside clinic. Family brought back in to clinic. Recovered quickly.
Extreme fatigue and lethargy.  Fever of 101.2.  Chills.  Inability to eat much or drink. Diarrhea.  Symptoms for more 2 days so far?
I seem to have had a reaction to my first booster shot and it was identified when I asked my pharmacist if he had ever seen the booster cause hives; huge lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "I seem to have had a reaction to my first booster shot and it was identified when I asked my pharmacist if he had ever seen the booster cause hives"; LIP SWELLING (non-serious), outcome "not recovered", described as "huge lip". The events "i seem to have had a reaction to my first booster shot and it was identified when i asked my pharmacist if he had ever seen the booster cause hives" and "huge lip" required physician office visit. Therapeutic measures were taken as a result of urticaria, lip swelling. Additional information: Patient reported that he seem to have had a reaction to his first booster shot and it was identified when he asked his pharmacist if he had ever seen the booster cause hives. He looked it up and the first picture that popped up on his database from site was a guy with a huge lip! That was him exactly! He have been fighting this for almost a year with an allergist and just started Xolair shots. Have been controlling it with Prednisone and Benadryl. He asked "Do you have any solutions or suggestions".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with an expired dose of M-M-R II lot # L032182 and expiration date 25-AUG-2017 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). No adverse effects were reported.
No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 4th patient out 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
feeling lightheaded; heart rate has been flactuating; diarrhea; clummy; fatigued; nausea; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy), FATIGUE (fatigued) and NAUSEA (nausea). At the time of the report, DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy), FATIGUE (fatigued) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Patient apparently suffered a minor stroke early morning of 4/11/2021. Patient had headache, leg pain, and left leg weakness (described 'left leg giving out').
Information has been received from a license practical nurse concerning a 52 year old female daycare provider with sulfa allergy and no medical history, who on 09-NOV-2005, at 16:45, was vaccinated intramuscular into the right deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 09-NOV-2005, the patient was vaccinated intramuscular with a third dose of influenza virus split virion 3v vaccine inactivated (FLUZONE). Concomitant therapy included levothyroxine Na (LEVOXYL).  There was no illness at the time of vaccination.  On 11-NOV-2005 the patient developed cellulitis, fever and body aches.  The patient's arm was swollen and redeemed.  The patient was treated with cephalexin (KEFLEX) 500 mg four times a day for 10 days, gatifloxacia (TEQUIN) 400 mg every day for 5 days and ceftriaxone sodium sodium (ROCEPHIN) 500 mg every day for 3 days.  The patient was reported as recovered.  Follow up information from a health professional indicted that the patient was seen on 11-NOV-2005 by a physician and complained of a red, raised, swollen area at the injection site that spread to the axilla.  It was noted that the patient said she had run a fever, but her temperature was normal in the physician's office.  The diagnosis was cellulitis and an abscess of the upper arm.  The patient was seen again on 12-NOV-2005 and received another injection of ceftriaxone sodium (ROCEPHIN), and the arm area looked improved.  The patient had not been seen since.  There was no product quality complaint involved.  Additional information is not expected.  This report is a consolidation of two reports concerning the same patient.