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 12-JAN-2023, 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 received from the one reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This spontaneous report was received from a registered nurse refers to 9 months old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 15-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot# N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
Redness, swelling, warmth to touch of left arm, 101 fever, weak, pain occurred at 1am the next day. Pt took TYLENOL, applied heat, elevated arm.
Improperly stored and administered vaccine; no adverse event; This spontaneous report was received from the medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-DEC-2022, there was a temperature excursion of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) vaccine, with a measured temperature of 49 degrees Fahrenheit, during 10 hours 0 minutes and 0 seconds. Moreover, it was stated that there were no previous temperature excursions.  On 27-JAN-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, with a valid lot #W009104, and a expiration date of 04-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (Improperly stored and administered vaccine). The patient did no experienced any adverse event.
Hives; Rash; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3302) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:30, the patient experienced hives and rash. 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.  The clinical outcome of the events hives and rash were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse (R.N.) concerning herself who in late June 2008 vaccinated her husband with a dose of ZOSTAVAX (Merck). About a week later, her husband developed a mild, red, "heat" rash (WAES# 0809USA02419). On 01-SEP-2008 she started to develop shingles lesions on the left side of her face. On 05-SEP-2008 she was diagnosed with shingles by her family physician. She was treated with ZOVIRAX ointment and TYLENOL WITH CODEINE #3. She was already on therapy with hydrochlorothiazide, atenolol, aspirin and CRESTOR. She developed about 12 vesicular lesions. At the time of this report, the patient was recovering. Follow up information was received from the R.N. who reported that at 9AM on 12-JUL-2008 she vaccinated her husband with a first dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously in his right arm. She had no pre-existing allergies, birth defects and medical conditions. In the morning of 01-SEP-2008, she experienced blisters with fluid filled, lesion on left side of lung, painful line broke out on left lower jaw tracking to left lower lip and pain left ear. On 06-SEP-2008 she visited a physician and was diagnosed with shingles. At the time of this report, she recovered. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source.
When I left, I immediately needed to go home and sleep and developed a headache.   As the week continued my normal nausea intensified as well as having a headache and began to have episodes of becoming extremely warm with sweat and then was cold. I did not eat this week except very minimal crackers or toast.  Thursday I vomited, Friday I stayed home from work and vomited again. Saturday- Sunday I did not work but slept all day. Monday, I had a work appointment that I went to.  It lasted about 2 hours when I vomited some more. Tuesday-Wednesday while I wanted to go to work, did not feel at all confident in my ability to not vomit as well as hot and cold spells. My abdomen has been distended throughout this with several days of not being comfortable touching this area  I have not seen a physician, however health department said I should report this and I did email   my gastroenterologist at the university  about what I have been experiencing
Fever, severe body aches; headache;  injection location rash, swelling, pain
headaches for a week; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the left arm, on 05Jan2021 14:00, at single dose, for covid-19 immunization. Medical history included chronic back pain, blood pressure, and pain. Unspecified concomitant medications were taken for blood pressure and pain. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first injection, the patient had headaches for a week on Jan2021. No treatment was received for the headaches and the patient recovered from it on Jan2021. The patient has not been COVID-tested post-vaccination.
Injection site became swollen and tender; Injection site became swollen; lymph nodes on side of his neck (same side as injection) were swollen and tender; lymph nodes on side of his neck (same side as injection) were swollen and tender; Light headed; Arm Hurt; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender) and VACCINATION SITE SWELLING (Injection site became swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen), LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender). At the time of the report, DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender) outcome was unknown and LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
1 hr later crying up every hr during noc; t102 ax; mo states APAP did not lower temp; Pt crying constantly; lt leg has a knot & is swollen;  hosp 6APR92 dx croup;
The patient started feeling very dizzy and losing his vision within minutes of receiving the vaccine.  The patient was conscious and slowly responded to questions. Memory intact. Patient recovered quickly after EMS arrived and didn't require any medical assistance.
"Beginning on day 2 after first dose, extreme tiredness no matter how much sleep I get".; Always nauseated; No appetite whatsoever; "Vomiting occurred on one day only"; Vivid dreams every night; Nightmarish dreams every night; Dizziness only for the first week.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19, shellfish allergy that caused severe nausea, blood pressure abnormal and ankle bloating caused due to ace inhibitors which were tried previously for BP (blood pressure) control. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (HCTZ) and carvedilol (MANUFACTURER UNKNOWN); both for unknown indications from unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021, beginning on the second day after the first dose, the patient experienced extreme tiredness no matter how much sleep she got, she was always nauseated, she had no appetite whatsoever, she had vomiting which occurred on one day only, she had vivid nightmarish dreams every night which was not normal for her and dizziness only for the first week. Since the vaccination, the patient had not been tested for COVID-19.  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 these events. The clinical outcome of the event's extreme tiredness, nauseated, no appetite, vivid nightmarish dreams was not resolved at the time of the report. The clinical outcome of the event vomiting was resolved on 22May2021. The clinical outcome of the event dizziness was resolved on an unspecified date in May2021, after the duration of a week at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
8 hours next day after vaccination; have severe headache and feeling of nausea for 24 hours.
Medium strength lightheadedness, then about 45 minutes later, headache with severity of 7 on a 10 scale.  3 hours later both symptoms gone.
Patient states they began to get a red pimple-like rash across different sections of the body, starting with the chest. He stated it looked like shingles compare to what he had seen online, but was not localized to a single area like shingles. He was unsure if the reaction was due to the shot or something else. He plans on following up at his next regular dermatology appointment.
7 days after I received the vaccination I developed a raised rash under the area where I received the injection. Over the course of the day it got worse and my hand started to tingle. I called our Occupational Health Director and was instructed to take Benadryl and Advil and use a cold compress . I went home and did all those things in addition I took a 100mg Doxycycline that night and the next morning. The next day the rash area was not raised but the redness and itching was going down toward the elbow. By the second day on the same treatment my rash area was almost resolved.
dizziness, lightheadedness and sensation of throat swelling.  occurred within 10 minutes of vaccine administration.   given Benadryl 50mg IM observed for 30 mins; felt better and sent home
Information has been received from a person working in a physician's office concerning a 9 year old white female who on 22-JUN-1998 was vaccinated with a first subcutaneous dose of Varivax (Lot# "0062"). On 11-JUL-2006 the patient was diagnosed with chickenpox. Subsequently, the patient recovered. Medical attention was not sought. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) in own words reported that the Shingrix was given in arm. The reporter was requested by another patient for getting the vaccine in the gluteal region. The reporter was asking was there any reason why it could not be given in the gluteal region. The patient's deltoid region was extremely sore and therefore several patients were wanting to avoid the sore arm. The reporter would relay that on when the issue arises. The HCP disconnected chat right after that so unable to get any follow up questions to HCP.
allergies jumped up over the weekend; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 25Feb2021, as dose 1, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included methylprednisolone. The patient experienced allergies and it jumped up over the weekend and reported as that could've been a side effect from the vaccine. The patient started taking Methylprednisone 4mg dspk on an unspecified date (reported as Monday). The patient asked if this would lessen the efficacy of the vaccine. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports tingling, discomfort, and numbness down left arm. Most of the numbness is located on the end of his thumb on the left hand. These symptoms have not improved or worsened in the past 3 weeks.
not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) 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 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 MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Body ache; Fever; Difficulty to move the arm; Pulsating pain moving down to my finger tip and then to my neck; Injection site muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck), INJECTION SITE PAIN (Injection site muscle pain), MYALGIA (Body ache) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck) and INJECTION SITE PAIN (Injection site muscle pain). On 12-Mar-2021, the patient experienced MYALGIA (Body ache) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck), INJECTION SITE PAIN (Injection site muscle pain), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-044110 (Patient Link).
first dose on 10/18/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th October 2018).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up
Patient said that 2 hours after administration of vaccine had itchiness at area of injection (left arm). Took Allegra Monday night. Tuesday a.m. itchiness was now starting on right arm as well, and more profound, as well as "small round pimple-like dermatitis" from wrist to shoulder apparent on BOTH arms. Took Allegra again. By Wed a.m. itchiness partially had gone down, but rash was there.
Patient reported feeling "sick", and stated he did not sleep well that night. Patient reported feeling dizzy and had a temperature of 100.1.
Pt exp sore throat & joint pain 2 wks p/receiving Typhoid vax during military duty; treating MD felt the sx were due to strep infect rather than the vax;
adverse reaction; Reaction; Contraindicated drug administered; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included egg allergy (patient had an egg allergy or some other type of vaccine in the past).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction, documented hypersensitivity to administered product and contraindicated drug administered. On an unknown date, the outcome of the adverse reaction, documented hypersensitivity to administered product and contraindicated drug administered were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient with an egg allergy had a reaction to a flu vaccine or some other type of vaccine in the past.  The reporter did not consent to follow up.  The caller has no further information regarding reaction or involved vaccine. Declined to provide patient identifiers.  The reporter stated the testing was done after the patient had the reaction and it was determined it was due to the egg content in the unknown vaccine.
Technician stabbed me with the needle using 2 thrusting motions with enough force to move my shoulder and arm forward 3-4 inches. Extreme pain during the 3-4 seconds to administer the shot. Nerves, tendons and bone were hit with the needle. Shooting and stabbing pain along with weakness still persist in the upper arm mostly when the arm is being used to drive a car; performing household chores, etc.
requested medical records, but they were never received; pt had a positive COVID TEST on 10/9/21; per death certificate, pt passed away in the hospital with the causes of death being Multi-system organ failure and COVID 19