chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 14-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports reported from same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Received Yellow Fever vaccine 4/21/06. Felt ill. 4/22/06. Nausea, vomiting, diarrhea, weakness, SOB and dizziness; advised to go to ER - declined. Given IV fluids. Had U/A and blood work drawn.
Redness at injection site, swelling, itching, hot, hurts to touch, swelling is egg-shaped (about 7 cm per pt). Treated with children's BENADRYL three times a day.
Hives after initial dose 3 days after being administered. Provider, believed it was not related and advised pt to get her second vaccine. After 2nd dose pt had a response mildly the same day and it progressed over the next week. Hives were far more severe than after initial vaccination affecting the periorbital tissue, arms, abdomen, and legs. Exacerbated pt's plaque psoriasis. Pt was prescribed a topical clobetasol 0.05% BID. pt to follow-up next week. No changes to respiration or irritation or oropharynx.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 16:00 as dose 1, single (Lot number: Er8727), in left arm, on 18Apr2021 at 16:00 as dose 2, single (Lot number: Ew961), in left arm and on 29Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 57 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 included Paxlovid (Lot number: FX2740) from 18Apr2022 to 23Apr2022. Clinical course was reported as, Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient had a relapse of covid (symptoms and + antigen) 12 days after beginning Paxlovid after testing negative on 27Apr2022 at 15:00 (and no treatment Received for the symptoms). Patient had no Hospitalization Prolonged.
Received 2nd dose of ROTATEQ on 6/17/14. Had severe belly pain and blood per rectum on 6/27/14. Had X-Ray and ultrasound one hospital showed possible intussusception. Sent to another hospital had rectal procedure to resolve successfully. F/U here in clinic 7/1/14 - all back to normal.
Headache swelling and pain at injection site, reports can not seem to  get rid of the headache even with medication, fatigue  Narrative:
Missed menstrual cycle-was supposed to begin cycle 9/14/21. It is now 9/21/21 and still have not started cycle. Took 3 different pregnancy tests- all negative. My cycle is regular and occurs ever 5 weeks. I have never skipped a monthly cycle.
sudden chills with almost incontrollable shaking, headache, temp to 100.8, aches and joint pain
Patient received flu and pneumonia vaccine in left deltoid on 10/1/13. Redness and swelling noted at injection site and left arm on 10/3/13. Advised to use cool compresses and MOTRIN PRN.
Adverse reaction after firs dose of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 57-year-old female 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient developed an adverse reaction after the administration of the first dose of Shingrix and she mentioned it as an allergic reaction. The physician asked if the patient should receive the second dose. The follow up consent was granted.
Missed the dosing window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window) had resolved. Not Provided          Concomitant information was not reported.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR received updated Second dose details, Events onset date Added.
Pt given 0.5ml SC of Zostavax vaccine instead of Varicella vaccine. No immediate adverse effect was noted.
FULLNESS IN THROAT  PERI ORIAL NUMBNESS  CHEST TIGHTNESS  PRESSURE IN CHEST   PATIENT WAS GIVEN EPI PEN , TRANSPORTED TO ED DEPARTMENT IMMEDIATELY
Syncope, Seizure, Convulsions, Fainting, Fever, Sore throat
Pt. started breaking out yesterday - trunk & all extremities - red pustules. Low grade temp x 2 days. Normal appetite. Complains of "itching".
Information has been received from a healthcare worker concerning a 23 year old female who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) IM into the left deltoid and had a syncopal episode.  The patient felt dizzy while sitting down (the room was spinning) immediately after receiving vaccination.  It was unclear if the patient lost consciousness, but smelling salts were used and the patient was observed for 15 minutes and then was "fine".  There was no concomitant medication.  It was unknown if the patient sought medical attention.  Follow up information was received who reported that the female subject patient with no known pre-existing allergies, and no illness at time of vaccination, was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) at the physician's office at 11:00 am.  On 23-OCT-2008, immediately after receiving vaccination the patient experienced a syncope.  The patient did not fall.  The patient layed down for 15 minutes, and smelling salts and cold compresses were used.  On the same day, the patient recovered 15 minutes later after the vaccination.  No further information is available.
Numbness and Tingling of hands progressed to bilateral legs, unable to ambulate. Treatment was provided at Hospital details unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. Concurrent medical conditions included drug allergy (sulfa allergy). Concomitant products included Atorvastatin, Losartan, omeprazole, verapamil and hydrochlorothiazide. On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 4th June 2018, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The symptoms started the evening of the day of vaccination, according to the reporting pharmacist. The reporting pharmacist stated that the patient had denied any symptoms of allergy after vaccination.
Patient was admitted to the ED with left deep peroneal vein thrombosis on Feb. 9 2021 after patient noticed prolonged  edema in both ankles. Patient started talking 10 mg of Eliquis twice a day on Feb. 11, 2021. And on Feb. 17 2021, 2 more blood clots were found in the patient's peripheral veins within the limbs. Patient descreased dose of Eliquis to 5mg twice a day on Feb. 18 2021. Patient continues to take 5mg of Eliquis twice a day.
1/27/22 EMS called to pt's home due to not responding; pt had expired and was cold; taken to Hospital, Tn; post-mortem COVID test was positive; there are no other records on this patient
20 hours post vax, the vaccinee had a psychotic break. No other precipatiting conditions. The pt got better within 2 months with short course of Zyprexa. A follow up report received 8/1/2000 adds: (5/17/00) Pt was hospitalized for a weekend and is now fully recovered.
This is a spontaneous report from a contactable physician through a Pfizer Sales representative. A 6-months old patient of unknown gender and race received the third dose of PREVNAR 13 on an unknown date for immunization. The patient had previously received the first dose of PREVNAR 13 on unknown date at the age of two months and the second dose of PREVNAR 13 on unknown date at the age of five months. Relevant medical history and concomitant medications were unknown. After the third dose of PREVNAR 13 the patient developed fever of 106 degrees Fahrenheit on unknown date. Therapeutic measures taken for the event included acetaminophen (dose and frequency unknown). The outcome of the reported event was unknown at the time of the report. Follow-up (05SEP2012): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no drug reactions/allergies. The patient's current condition included diabetes. On 07-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J002693, expiry date 07-JUN-2014, route and dose were not reported) Vial 19400 PFU. Concomitant therapies included tramadol hydrochloride, atenolol, losartan potassium and aspirin. On 08-SEP-2013, the patient developed redness in her arm, restless leg syndrome in both legs, insomnia, "flashing" in her eye and a tear in her retina following the administration of ZOSTAVAX. The patient sought medical attention (saw the pharmacist). The outcome of the reported events developed redness in her am, tear in her retina, flashing in her eye, insomnia and restless leg syndrome in both legs was reported as not recovered/not resolved. Additional information has been requested.
within one hour of administration, severe burning pain developed from shoulder to elbow, then progressed down to wrist. Pain persisted and shoulder movement became restricted.
12 month old / received the adult dose; 12 month old / received the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The 12 month old patient received the adult dose of the Havrix vaccine inadvertently,which led to adult product administered to the child and accidental overdose. The reporter consented to follow up. This case was linked with US2021129066 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129066:same reporter
Placed in a mental institution; Will miss second dose and for 30 days she will be in mental institution; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution). At the time of the report, MENTAL DISORDER (Placed in a mental institution) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will miss second dose and for 30 days she will be in mental institution) 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.   Concomitant product was not provided by the reporter.  Treatment information was not provided
Trouble raising left arm; Sore left arm injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 003121-2A, 048B21A and 025B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site) was resolving.    No concomitant medication were reported.  Patient told her doctor, but the doctor does not think it is related to the vaccine. The doctor did not diagnose and did not prescribe any medications to her.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 4:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 4:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
MOSQUITO LIKE BITES / BUMP; SLEPT A LOT; TIRED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced slept a lot. On 12-APR-2021, the subject experienced tired. On 15-APR-2021, the subject experienced mosquito like bites / bump.  Treatment medications (dates unspecified) included: cortisone, and ethanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mosquito like bites / bump, tired and slept a lot was not reported. This report was non-serious.
4 weeks+ of: - chest pressure  - random sharp pains in chest - heart pounding  - increase heart rate and blood pressure - difficulty breathing and swallowing  - shortness of breath - throat pressure - dry throat and tongue - head pressure (back of head through my ears to my nose and down my throat) - lethargy - loss of appetite  - difficulty sleeping
Information has been received from a health professional concerning a 64 year old male physician who on 11-APR-2007 was vaccinated intramuscularly, into the right deltoid, with 0.5 ml dose of Pneumovax 23 (lot #655592/1175F).  On 11-APR-2007 the patient developed an injection site reaction described as cellulitis.  Medical attention was sought and the patient was treated with KEFLEX.  On 19-APR-2007 the patient recovered.  The healthcare worker requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Extreme swelling of his right upper leg (more than double regular size); below the shot area including the knee and above the knee. Area is warm and red. Mild fever.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2022 at 9:40 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2022 at 9:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours). On 08-Feb-2022 at 9:40 AM, EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date of vial was initially stored in refrigerator was 22-Jan-2022 and vial was stored in fridge post puncture. Date of vial was first punctured was 07-Feb-2022 at 10:15 AM. Vial did not undergo any temperature excursions. No concomitant medication was provided. No treatment information was provided.
This spontaneous report was received from a register nurse concerning an unspecified number of patients of an unknown age and gender that were vaccinated with a dose of ZOSTAVAX dose, dose number, lot number, expiration date and route were not reported), that were improperly stored. Medical history and concurrent conditions of the patients were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Shingles vaccination. This is my second shot. I had a milder reaction with the first shot, but it is more severe with the second shot. Chills, aches and pains, 101 degree fever.  I am reporting these symptoms 36 hours following vaccination.