chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's first dose was the Janssen vaccine. This was her Moderna booster. She waited 20 minutes after vaccination at the pharmacy and was fine and left. She left and then shortly after started to experience lips swelling and tingling and facial flushing. She returned to pharmacy and was given 25mg of benadryl.  Her facial flushing decreased. Lips still felt swollen but were no longer tingling. Lips did not appear swollen in appearance but felt that way to her. She remained at pharmacy for 30 minutes and after symptoms started to resolve, she left. She was given benadryl capsules to take at bedtime and was counseled to go to the ER if she experienced hives, shortness of breath or if she felt that throat was closing.
No additional AEs/no PQCs; VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion.; This spontaneous report has been received from an office administrator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1892788 with expiration date: 02-DEC-2023) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (lot # U7255AA with expiration date: 03-DEC-2024; route unknown), both for prophylaxis after a temperature excursion. The dose and strength were nor reported for suspect vaccines. No additional adverse events (AEs)/no product quality complaints (PQCs).   Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) experienced the temperature excursion above 9 degree Celsius (C) (10.92C) for 1 hour 0 minutes 0 seconds. No previous temperature excursions reported.
Never recovered from Dose 1, continued to have additional issues after the fact including headache, tiredness extreme severe shaking uncontrollable, vomiting, muscle, and diarrhea. In addition, on a road trip began to feel unwell, excessively sweating head seizures and past out. Ambulance was called an taken to hospital locally, local hospital. Symptoms lasted 5 days was in hospital for 2 days.
Rash (Covid arm) appeared on the left side of the stomach  and in the underarm area of the left arm 1 day after the vaccine. The site of the shot is painful and it is difficult to lift the hand.
One week after injection experienced intense itching at injection site, which progressed to 2 inch diameter raised circle, which was red and hot. This progressed to diffuse red bumpy itchy rash about the size of a hand over L deltoid. At 3 weeks post injection, this rash remains.
development  of rash on arms,  itchy feeling on arms and torso;  feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded,  decreased itchiness
This is not an adverse event. This is an administration error. Patient was under dosed in error and received 0.25mL instead of the recommended 0.50mL. Patient did not have any AEs and has been asked to return to the clinic and receive a full dose of the Moderna bivalent booster (0.50mL).
diarrhea, watery diarrhea; shaking; no appetite; felt burning while going to the bathroom and like acid in that area; vomiting; felt cold, she could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea, watery diarrhea), TREMOR (shaking), DECREASED APPETITE (no appetite), BURNING SENSATION (felt burning while going to the bathroom and like acid in that area) and VOMITING (vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048AZNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (diarrhea, watery diarrhea), TREMOR (shaking), DECREASED APPETITE (no appetite), BURNING SENSATION (felt burning while going to the bathroom and like acid in that area), VOMITING (vomiting) and CHILLS (felt cold, she could not get warm). On 13-Mar-2021, TREMOR (shaking), DECREASED APPETITE (no appetite), BURNING SENSATION (felt burning while going to the bathroom and like acid in that area), VOMITING (vomiting) and CHILLS (felt cold, she could not get warm) had resolved. At the time of the report, DIARRHOEA (diarrhea, watery diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
A spontaneous report was received from a nurse concerning a patient who received COVID-19 Vaccine and the second vaccine dose was administered 9 weeks after the first (inappropriate schedule of vaccine administered).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter. On unknown date, the patient received their second dose for prophylaxis of COVID-19 infection. On unknown date, the patient received the second dose 9 weeks after the first dose. Treatment information was not provided. The patient received both scheduled doses of prior to the event; therefore, action taken with the drug in response to the events is not applicable. The outcome for the event, received the second vaccine dose was administered 9 weeks after the first (inappropriate schedule of vaccine administered), was recovered on an unknown date.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their second dose for prophylaxis of COVID-19 infection 9 weeks after the first dose. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of vaccine administered.
received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported.  It was reported that, the patient received the Moderna Monovalent Booster instead of the bivalent vaccine. The nurse stated that, this happened because the monovalent vaccine with purple border was labeled as booster dose. No adverse event noted.  No treatment medications were reported.
8/16/07 12pm Gardasil administered. Child felt light headed. 10 Minutes later while sitting, eyes rolled back, and turned pale/ (-) LOC. Duration 10-15 seconds.
REDNESS/SWELLING BELOW INJECTION SITE, WARM TO TOUCH WITH NO PAIN OR FEVER. NO RASH. DEVELOPED OVER COURSE OF 24 HOURS AFTER INJECTION.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient ws vaccinated with the first dose of GARDASIL intramuscularly (dose, lot number were not reported) in January 2013 (exact date unspecified). Subsequently the patient was vaccinated with the second dose of GARDASIL intramuscularly (dose, lot number were not reported) in March 2013 (exact date unspecified). It was reported that the patient would be vaccinated with the third dose of GARDASIL intramuscularly (dose, lot number were not reported) on 20-AUG-2014- at the time of the call. No adverse effect were reported. Additional information has been requested.
Two children contracted vaccinia from my small pox vaccination. Ages 6 (girl) and 9 (boy). First sign of it was noticed on 2Jul04. I was vaccinated on 13Jun04.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscularly at left arm on 15Jan2021 at single dose for COVID-19 vaccination. Medical history included her son having Covid-19. Concomitant medications were unknown. The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021. She believed this was related to her son having Covid-19. The patient didn't think she got the COVID from her shot, she thought she got it from her son who had it. She called to ask if it was okay if she received her second dose on 05Feb2021. The patient stated she already spoke with her doctor and he said it was okay as long as she was feeling better. Outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021.  Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection.   Further information like COVID infection date needed for meaningful medical assessment.
Information has been received from a nurse practitioner concerning a 16 year old female with a history of Hodgkin's disease (at the age of 12, patient was diagnosed with Hodgkin's disease and went thru Chemotherapy), who was vaccinated a few weeks ago with Gardasil. The patient developed localized reaction like shingles after getting vaccine. Unspecified medical attention was sought. No additional information was provided. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 16 year old white female patient with Hodgkin's disease (diagnosed at age 12 and went through Chemotherapy and illness at time of vaccination included dysmenorrhea) who on 15-JAN-2007 at 12:07, was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-JAN-2007, one week after receiving the vaccine, the patient developed painful vesicles which lasted for six weeks. The patient described them as a painful cluster of red bumps that enlarged, blisters erupted followed by crusting over. It was reported that the patient was not seen for eight weeks after the injection and the vesicles were not verified by the staff. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
her husband died 4 years ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), in 2019 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 2019, outcome "fatal", described as "her husband died 4 years ago". The patient date of death was 2019. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The caller mentioned that her husband died 4 years ago and might have taken the vaccine and possibly in clinical trials at the time.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: her husband died 4 years ago
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 months old patient who received expired FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U5912CA via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
54 year old male with mulitple medical issues sig for ESRD, HD MWF, HLD, HTN, HLD, CAD, PCI, LAD, CTO of RCA, DM, obesity, chronic back pain, asthma, chronic atrial fibrillation on xarelto, s/p colonoscopy recently, benign polyp found, hx of septic shock requiring intubation, 2019 at that time had acute cholecystitis and was too unstable at the time to have surgery so he had a percutanous drainage of the gallbladder, had recovered and tube was removed. He requred placement on HD and had an avfistula placed in 2020 and post op had another episode of respiratory failure requireing intubation again . He subsequently recoveresd from these episodes. So yesteday he presented from HD hypotensive and has had a cough and fever of 101 at home with a productive cough of clear sputum, denies SOB, or chest pain or nausea or vomiting. He feels week and was given a fluid bolus of a liter of fluids in the ED, cultured and started on empiric abx for right lower lobe pneumonia seen on chest xray. He denies sick contacts and is boosted with moderna vaccine x 3, he cant remember dates. He is a poor historian.
substantial and extensive swelling of male genital organs; left visible evidence of surface bruising and discoloration; left visible evidence of surface bruising and discoloration; swelling moved to upper right lip and adjacent area of face; swelling in lower right lip; lethargy; mild flu-like symptoms; chronic severe cough/ occasional light cough; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 10Oct2021 at 12:30 (Batch/Lot Number: FH8020, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was a pharmacy or drug store. Relevant medical history included back issues, peripheral neuropathy, and hypothyroid, all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications in two weeks included levothyroxine taken for an unspecified indication, start and stop date were not reported and unspecified supplements and homeopathic therapy. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in the left arm on 05Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: EN6198, Expiration date: unknown) as dose 1, single and administered in the left arm on 26Mar2021 at 02:00 PM at the age of 69 years old (Batch/Lot number: ER8727, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On day 2, on 11Oct2021 at 10:00, the patient experienced adverse events (AEs), which included mild flu-like symptoms and beginning of chronic severe cough. On day 3, on 12Oct2021, the patient continued with severe cough and also experienced lethargy. In the morning (a.m.) of day 4, on 13Oct2021, the patient had swelling in lower right lip with occasional light cough. In the a.m. of day 5, on 14Oct2021, the patient's swelling moved to upper right lip and adjacent area of face; then in the afternoon, there was reduced swelling in the upper right and increased swelling in the lower right lip and adjacent area of face. Beginning on the evening of day 6, on 15Oct2021 at 21:00, the patient began to have substantial and extensive swelling of male genital organs, which persisted for approximately 36 hours before normalizing and left visible evidence of surface bruising and discoloration. The patient did not receive any treatment for the adverse events. At the time of the report, the patient was recovering from the substantial and extensive swelling of male genital organs, which left visible evidence of surface bruising and discoloration, while he was not recovered from the rest of the events.  Follow-up attempts are completed. No further information is expected.
shingle shot (2) in 2019 and now / shingles/ suspected vaccination failure; shingles on right side of back; under right breast; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingles shot and experienced shingles on right side of his/her back and under the right breast. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Vaccine given beyond 30 days of refrigeration period; Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cefdinir).   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-313106 (Patient Link).
vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vial was not initially stored in the refrigerator. Vial did not undergo any temperature excursions. No treatment information was provided.
pt inadvertently recv 5th dose of Acel-Immune & devel swelling @ the inj site which progressed to involve the entire leg;pt mom stated that leg was twice the size of nl;taken to ER;
SOME CHILLS; 100.4 FEVER; VERY LOW ENERGY; LITTLE TIRED; This spontaneous report received from a patient concerned a 48 year 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 was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced little tired. On 25-MAY-2021, the subject experienced some chills. On 25-MAY-2021, the subject experienced 100.4 fever. On 25-MAY-2021, the subject experienced very low energy. Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 100.4 fever, some chills, and very low energy, and the outcome of little tired was not reported. This report was non-serious.