chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a 55-year-old patient who received the 1st dose of GARDASIL 9 on 12/08/2020 and developed a whelp; She got the 2nd dose on 01/09/2021 and became itchy all over; I have a 55-year-old patient who received the 1st dose of GARDASIL 9; This spontaneous report as received from a physician refers to a 55-year-old female patient.   The patient's concurrent conditions included Raynaud's phenomenon, allergy to metals (aluminium), and allergy to bacitracin ointment. Her medical history was not reported. Concomitant therapies included valacyclovir hydrochloride (VALTREX).     The physician called to inquire about the contraindications for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) if a patient has an aluminum allergy.   The physician stated "I have a 55-year-old (inappropriate age) patient who received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 08-DEC-2020, 0.5 milliliter, intramuscular in the arm (lot #1691180, expiration date 15-NOV-2022) for an abnormal pap smear which showed high risk (HPV) human papillomavirus and developed a welt (urticaria).   She got the second dose on 09-JAN-2021 and became itchy all over (pruritus). The physician needed guidance on whether she should receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No treatment was administered for the events. No laboratory tests were performed, and the patient did not seek medical attention. On an unspecified date, the patient recovered from the events. The patient did not die. No product to retrieve. No PQC was reported. No additional adverse events were reported.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 26-MAR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006191 and expiration date on 02-FEB-2015, dose 0.5 ml, intramuscular. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen, red, baseball sized lump with white/gray center about 3/4 inch diameter at site of injection.  Swollen lymph nodes-cervical-same side.
Fatigue Body aches Fever Headache Chills  Treated with Ibuprofen Ongoing
No additional AE reported.; HCP calling to report that a patient was administered an expired vaccine of VAQTA.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 15-MAR-2023, the patient was vaccinated an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 ml/ 1x (once), lot #U036184, expiration date: 02-MAR-2023, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). No previous temperature excursion. No additional adverse event was reported (no adverse event).
within 10 minutes of shot burning pain in chest and a tightening of chest.  Shortness of breath.   shortness of breath and chest pain sporadic since the shot.
This spontaneous report was received from an administrator referring to a 2 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unspecified date, the patient received GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). No adverse effect was reported.
Patient called the pharmacy around 9:30 am of 10/3/18 to inquire if severe uncontrollable shaking was a side effect of the SHINGRIX vaccine. She stated that she was very cold and could not stop shaking uncontrollably. I informed her that shaking is a possible side effect, however severe shaking should be evaluated. She was seen and per pt around 5pm on 10/3/18 she had a fever of 102 degrees F and had a heart rate close to 200bpm. Per pt, the possible Dx of febrile seizures resulting from the SHINGRIX vaccine was discussed. The patient came into the pharmacy on 10/5/18 and stated that she was feeling better. We discussed taking precautions prior to the subsequent vaccine in attempt to avoid the high fever.
This spontaneous report as received from a nurse and refers to a 15 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in December 2017, reporrted as "at the 12 month old visit", the patient was vaccinated with PROQUAD (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 08-MAR-2018, reported as "at the 15 month old visit", the patient was vaccinated againg in error with PROQUAD lot number N019250 with expiration date on 20-DEC-2018 for prophylaxi (dose, route of administration and anatomical location were not reported). On the same date, the patient also was vaccinated with an unspecified GSK Hepatitis A vaccine. There was no adverse effect reported.
About 1 minute after injection, patient began to experience swelling of tongue. Swelling moved to throat. Epinephrine  was administered and paramedics were called. Patient took home supply of Benadryl (2 capsules of 50mg dose) . Patient refused care from paramedics and husband picked her up and she went home. Patient was alert, not experiencing difficulty breathing, and ambulating well under own power.
Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022; Patient received expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vials were set to expire on 12-Feb-2022 and based on the stickers they were putting. On 13-Jan-2022, Vaccines placed in refrigerator.  There was no product complaint associated. No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035456 with expiration date 01-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA008700: US-009507513-1707USA002177: US-009507513-1707USA008699:
Right arm swollen, hot to touch, pain when touched. Red spots on deltoid. Took Benadryl and Cortisone.
Patient received the 1st dose in 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2020).   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 stated that the patient received the first dose of the Shingrix vaccine in 2020 and wanted to know how to proceed. The patient had not received the 2nd dose of the Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter stated she did not have additional information about the patient. The reporter did not consent to follow-up.
At 1018, Pt c/o tingling and numbness in Left arm (injection arm). VS BP 141/89, HR 81, OxSat 97, RR 18. @ 1026 pt states numbness and tingling is starting to go away. Medics on site observed pt. 1041 Pt instructed to contact PCP if tingling /numbness continues. Pt. D/C .
Woke up nauseous at 7:00 am. At 8:30 was called by school nurse that she was in the nurse's office with a 100.3 fever and had puked. I took her home, she still had 100.3 fever, gave 12.5 ml of Children's Tylenol at 09:00. She drank a small glass of water and slept for 2 hours. Woke up, fever still 100.0. She slept for another 4 hours, woke up fever was 99.3. By 20:00 temperature was 98.3, she felt fine and hasn't had any problems since.
Anesthesia of right arm and right leg with gradual improvement starting in right arm and then to right leg.
rash on his/her face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of RASH (rash on his/her face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on his/her face). At the time of the report, RASH (rash on his/her face) outcome was unknown.        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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist and refers to a 72-year-old female patient with penicillin, cephalosporin, COMPAZINE and iodine allergy. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M042851, 0.65 ml, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent lot# L034399. In July 2017, the patient experienced injection site mass, injection site erythema, mass, pruritus, injection site pruritus and injection site urticaria. The outcome of the events was reported as recovering/resolving. The relatedness between the events and ZOSTAVAX and sterile diluent was not reported.
Received a phone call from mother stating "my child arm is red, swollen and hot." "He has a welt that's 8 inches in size." Public health nurse advised parent to follow-up with the Pediatrician as soon as possible. Follow-up phone call was made by Public Health Nurse. Parent states Pediatrician examined the child on 10-23-03 states child had a bad reaction to the TD/adult put child on medication: Augmentin 60 mg twice a day, Benadryl every 6-8 hours and Prednisone 20 mg every day. 2-5-04 per doctor hospital will not administer to again before 10 years lapse, if needs for injury after 5 years lapse must be evaluated by private provider first.
mom noticed rash in AM, it may have been there during the noc;rash covers stomach, chest, neck, cheeks;t103.4 was relieved w/APAP;high pitch scream lasting approx 2 hr;restless & dec appetite;in AM called MD said no more pertussis
He stopped talking, avoided eye contact and started rocking. We didn't realize that it meant anything until he was 4 and we got him tested for ADHD. We were told that he couldn't be diagnosed until the age of 5. We just got him tested and diagnosed with ADHD and Autism 3 months ago. We are working to get started with therapy and getting an IEP for him in school.
pt recvd flu vax 30SEP93 & was noted to be acting out of character by family including some hallucinations & belligerence toward family; pt also noted to be very sedate @ times; adm to hosp 4OCT(3 w/low grade fever;
Patient came in for her second dose and upon filling out the checklist reported her prior reaction to her first dose of vaccine 4 weeks earlier. She reported hives that was treated with diphenhydramine at home, but she did not require treatment from a healthcare provider. The hives appeared within 6 hours of vaccination, but no other details were provided. I informed the patient she should contact her doctor about the reaction and that we aren't able to provide her second dose at our store.
Patient had mild fever and chills and aching in the arm of injection.  Called pharmacy to report and it was recommended to take Tylenol as directed on package and let us know if worsening occurred.
This spontaneous report has been received from the patient's mother referring to a 4 year old male patient. The patient did not have medical history, drug reactions or allergies or concomitant medications. Information regarding the patient's concurrent conditions was not reported. On 30-AUG-2017, the patient was vaccinated with PROQUAD lot # N008825 and expiration date 30-AUG-2019, by subcutaneous route (strength, dose and anatomical location were not provided) for prophylaxis. On 31-AUG-2017, the patient developed red swelling, "hot to the touch" at injection site (Vaccination site erythema, swelling and warmth) which size was an inch in diameter also a "mound" swelling the size of a tennis ball developed on the patient's thigh (was not specified if was left or rigth thigh)(Local swelling) . It was also mentioned that in September 2017 (reported as the following days) the swelling at injection site and the thigh area subsided, but both became very itchy (vaccination site pruritus and pruritus) and as result the patient has scratches and scars in those areas. At the reporting time the outcome of Vaccination site pruritus, Pruritus,Scratch, Vaccination site scar , scar, vaccination site erythema and vaccination site warmth was reported as recovering. The causality assessment between the PROQUAD and the events was not reported. The patient sought medical attention and unspecified treatment was given for the adverse events, none laboratories were performed. Additionally, the reporter requested the lot check.
Information has been received from a registered nurse concerning a 5 year old male who on 08/13/1997 was vaccinated with varicella vaccine. Subsequently the pt experienced an itchy rash at the groin area and developed a low grade fever. On approximately 11/14/2001, the pt was diagnosed with strep throat. The nurse reported that there was a chicken pox break out in the school. The registered nurse also reported that another child developed a rash after therapy with varicella vaccine was administered. Additional info has been requested.
Moderna COVID-19 Vaccine EUA  severe chills followed by sweats and increased heart rate overnight for 3 nights.  Flu-like symptoms (aches & fatigue) during the day for 3 days.  Headache on day 3.
Off and Ongoing fever and chills for over a week (about 10 days total) at nights, would go back to regular temp in AM
Psoriasis on his elbows actually improved for a few days; Fatigue; Total body soreness; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness). On 08-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness) had resolved.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-366494, MOD-2021-366526 (Patient Link).
Mild symptoms of runny nose; Blister in my groin area and it's black and about the size of a dime in diameter; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter). At the time of the report, RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Patient noticed a blister in the groin area which is black and about the size of a dime in diameter. Concomitant medication information not provided.  Treatment information not provided.
dose of Infanrix was given today after it was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received DTPa (Infanrix) (batch number 7km94, expiry date 10-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received Infanrix. On 20-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: dose of Infanrix was given today after it was expired). The outcome of the expired vaccine used 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: 20-JUN-2023 The reporter was a medical assistant. The reporter did not consent to follow-up. The reporter stated that Infanrix was given after it was expired, which led to expired vaccine used.
Sore and swollen right arm, fever 101, chills, shaking, headache, muscle aches, nausea, no appetite, neck stiffness, no energy.
Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19 INFECTION/GOT COVID AGAIN; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 43 years old. No concomitant medications were reported. On 2022, the patient experienced covid-19 infection/got covid again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection/got covid again was not reported. This report was non-serious.