chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to a 23 year old female patient. The patient had no pertinent medical history nor drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL (dose3, dosage, route and lot number unknown). Concomitant medication included Levothyroxine (manufacturer unknown). The medical assistant reported that a patient may have been administered 3 doses of GARDASIL at an unspecified physician's office, on unspecified dates. The medical assistant stated that patient was seen in their office on 27-NOV-2013 for a "well woman" visit. At that time the patient had a routine PAP Smear completed. The medical assistant reported that the PAP Smear results were received, on an unspecified date, and showed that HPV-16 and "HPV high risk non 16/18" were "detected". The patient received no treatment. The outcome of the events was unknown. Additional information has been requested.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, dose and route of administration were not provided), which had temperature excursions between 8.5C and 12.4C for time frames between 9 minutes and 53 minutes. The vaccine did not have previous temperature excursions and no additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007425: US-009507513-2112USA007426: US-009507513-2112USA007427: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007436: US-009507513-2112USA007437: US-009507513-2112USA007438: US-009507513-2112USA007439: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007445: US-009507513-2112USA007446: US-009507513-2112USA007447:
Narrative:  per clinic and notes, patient experienced urticaria with influenza vaccine.  Vaccine was administered at a clinic on 11/11/2021 per notes (per clinic), this could not obtain adequate information on the reaction.
COVID-19; The site on her body where she was vaccinated broke out in a rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash). At the time of the report, COVID-19 (COVID-19) and VACCINATION SITE RASH (The site on her body where she was vaccinated broke out in a rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
The evening after obtaining  the  covid vaccine, I started experiencing  mild tingling and numbness to my left arm, left leg,  and left side of my mouth and cheek. The left side if where I received my injection.  The numbness and tingling resolved after the first day to my arm and leg, but has continues around the left side if my upper lip. The sensation is only intermittent and can last a few hours. No treatments have been tried.
Patient received the third dose of Moderna (as well as Flucelvax Quadrivalent/flu vaccine). Patient stated next day when he went to work he had a slight fever. Later in the day, he felt lightheaded and experienced vertigo. Co-workers called paramedic: BP was high. Patient kept overnight for having low potassium and magnesium levels.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 08-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 7 of several reports from same reporter. Additional information has been requested.
5 hours post inoculation - lethargy, lower extremity discomfort, skin hypersensitivity, fever.
Flushing of face; Adverse food reaction; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of face), ADVERSE FOOD REACTION (Adverse food reaction) and FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUSHING (Flushing of face), ADVERSE FOOD REACTION (Adverse food reaction) and FATIGUE (Fatigue). At the time of the report, FLUSHING (Flushing of face) and FATIGUE (Fatigue) had resolved and ADVERSE FOOD REACTION (Adverse food reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment Drug was Provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pain, induration, erythema at injection site pain with elevation of arm on 5/12/06. Better now.
This spontaneous report as received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown dates, the patient was intramuscularly vaccinated with 4 doses of LIQUID PEDVAXHIB (dose was not reported,lot # M045206 with expiration date: 27-APR-2019). Concomitant medications were not reported. No side effects reported. Additional information has been requested.
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
TIRED; BRAIN FOG; ACHES; CHILLS; This spontaneous report received from a pharmacist concerned a 38 year old male. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no premedical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced brain fog. On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced chills. On 03-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from brain fog, chills, aches, and tired. This report was non-serious. This case, from the same reporter is linked to 20210456372.
Sore throat; Fatigue; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history included fibrosis pulmonary. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore throat and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat and fatigue was resolved on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccines administered at 2 PM.  At 2:20 PM reported intense itching right arm.  Vital signs stable.  BENADRYL liquid given at 2:25 PM orally.  At 2:35 reports itching redness right upper thigh.
Mom called approx. 6 hours, post vax, and stated pt awoke from sleep with reddened raised whelps starting on sides. Denied any SOB, choking sensation or trouble breathing. Pt started on Zyrtec. The next day, pt doing better with a rash.
Dose # 2 given < 6 months after dose #1 Dose #1 received 8/18/2021
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Patient signed up for appointment and choose first dose as appointment reason. We let him and wife know they would need to come back in 28 days for second dose. Technician administered shot and when she gave pt card he told her it's his second. The technician called me to evaluate the situation. I asked wife if she wanted to schedule her second shot on 20th. They replied no, that they knew their second appt was elsewhere and they wanted to get it sooner so they could fly in the airplane to see grandson.  I called Doctor and left voicemail that patient had received second dose on 22nd day as opposed to 28th day like he was supposed. to. I have not heard back yet and will try again tomorrow.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: I tested negative for covid; (09Mar2023) Positive, notes: tested positive for covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022; Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 001B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-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. The patient received booster 2 dose. It was reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. The vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than 30 days after 11-Jan-2022 was not in accordance with the university. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
It was started with itchy throat, runny nose, shortness of breath and sneezing. Then I got muscle pain. On Sunday I noticed that I got rashes all over my chest. On Monday it got worse, more prominent.
Rash face, mouth, eyes, and back + itch. Rash on back starts at injection site and continues to spread.
Patient lost consciousness (fainted) and was helped to the floor. Regained consciousness within 1 minute and was monitored for 45 minutes
Rash on back and L upper arm, no pain/itching, no vesicles, lasted about 1 month, no fever.
Accidentally administered a third dose; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose of Menveo received on an unknown date). Concomitant products included MENVEO.   On 28th March 2022, the patient received the 3rd dose of Menveo. On 28th March 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received his second dose of Menveo in January 2022.  It was unknown if the patient experienced any adverse reactions from the accidental third dose of Menveo. Additional Supportive Information:the patient returned to the office for a well-child visit and was accidentally administered a third dose of Menveo,which led to extra dose administered.
Diarrhea, Dyspnea, Cough, Shortness of Breath, Nausea and Swelling of right upper arm
After pt received immunizations while mother was holding pt pt went in and out of consciousness in mother's arms. Regained complete consciousness after 20 min.
24 hours post vaccination site with redness & elongated lump. Temp to 101 degrees. Upper arm swollen from shoulder to elbow. On 8/15/12 (in Dr's office for a different issue) no redness. Afebrile but palpable elongated lump remains.
fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter had a patient that reported a high grade fever with the dose of the Shingrix vaccine. The reporter would like to know if it was safe for the patient to administer the 2nd dose. Also, the reporter had some specific questions about Shingrix vaccine. The reporter was a pharmacist and had a patient that received the rabies vaccine in the past and was told to always inform that he got this vaccine rabies before getting any other vaccine because for some vaccines he could be at risk of a serious reaction.  The reporter would like to know if it was safe for the patient to administer the Shingrix vaccine.      Lab Comments: lab test performed on unknown date
Myalgia, Arthralgia, Fatigue, Swelling at Injection site Narrative:
16APR92 devel rash over entire body; lasted 2 days t103.4; fussy; seen by MD 17APR92 MD felt rash was rxn Bactrim, fever was from DTP;
Discharge summary "the patient is a 74 YO male who presented to the emergency department for lower extremity weakness and lightheadedness.  He is a dialysis patient was scheduled for dialysis today however did not go secondary to his symptoms.  History of kyphoplast.  MRI was performed and showed no acute abnormalities.  He underwent dialysis secondary to hyperkalemia.  When he returned he had no improvement of his weakness and had difficulty ambulating.  Physical therapy recommended admission/placement.  Hospitalist team agreed to admission"
Swelling at injection site. Pain Redness Itching. Treating with TYLENOL/Ibuprofen/BENADRYL.
2 days after receiving the vaccine, I noticed that the area around the injection site became very red and slightly swollen.  For several days afterwards it  was very itchy and tender.  Exactly 2 weeks after the injection, my left arm developed neuropathy from my wrist to my elbow.  This is still ongoing (3rd day of neuropathy)  The area around the injection site is still tender to the touch, although the redness and itchiness have gone away.
soreness on left arm all the way up to my shoulder, Itching on random parts of my body and body aches
When changing clothes, I noticed injection shot area bright red & hot to the touch (approx. 3-1/2 in. x 3-1/2 in size). I rubbed the area, & it started to welt & itch. The site today (approx. 15 hrs. later) is still red & hot to the touch.  Yesterday would have been 10 days since the injection.
Pt did not respond to Engerix-B vax series; 16AUG92 HBSAB titer neg; 2 booster injects given; refused further injections;
Received COVID-19 Moderna vaccine 03/17/2021. Called on 03/18/2021 to  report a rash the next day and a small lump at the vaccine site, left arm. Reported that rash persisted for about 2 weeks. Pt took benadryl and used topical cortisone cream. Resolved without incident.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 22.12 for dose administered on 28-Apr-2021. No concomitant medications were reported. On 19-Apr-2021, the vaccine with batch number 007C21A was moved to fridge. On 28-Apr-2021 at 9 a.m, vials underwent temperature excursion with temperature of 33 degrees Fahrenheit. On 28-Apr-2021, 4 vials were moved to the clinic. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.  This case was linked to MOD-2022-566976 (Patient Link).