chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have shingles / had the shingle shots about 2 years ago/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and covid-19 vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and covid-19 vaccine at an unknown dose and frequency. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had last Covid vaccine about 5 weeks before the date of reporting, and had shingles in the week of reporting.  The patient did not know if there was any connection or not. The patient had the shingle shots about 2 years before the date of reporting, and they were only 51% effective. This case was considered as suspected vaccination failure as laboratory confirmation for target disease was unknown at the time of reporting.; Reporter's Comments: .
Case number PHEH2014US020518, is an initial spontaneous report from a medical assistant received on 09 OCT 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 012031A) intramuscularly on 01 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Fine PM of vax; @130AM mom noted "wiggling & shaking" as pt slept; mom thought pt was "swallowing tongue" & inserted finger in mouth; pt unresponsive x/to painful stimuli; temp in ER 103; p/arrival pt played; admitted & played through day;
Information has been received from a 24 year old female with an unremarkable medical history and no known allergies or adverse drug reactions reported. In November 2006, the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of Gardasil. concomitant therapy included influenza virus vaccine (unspecified) and hormonal contraceptives (unspecified). In November 2006, right after she received her first injection of Gardasil, the patient vomited and the passed out. The patient developed burning at injection site. The patient sought unspecified medical attention. It was reported that the patient was alright after about 20 minutes after the injection. The patient plans to receive her second shot on 17-JAN-2007. In November 2006, the same day that the first dose of the vaccine was administered, the patient had recovered from the events. Additional information has been requested.
anxious, c/o a tightness of throat, and itching. She took oral loratadine followed by oral  Benadryl. She verbalized improvement in symptoms but requested assistance to go the Emergency department.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 78-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced rash and injection site reaction. On an unknown date, the outcome of the rash and injection site reaction were recovering/resolving. It was unknown if the reporter considered the rash and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX at 16.55 hours. The patient developed a rash or injection site reaction approximately one day after vaccination. (It was not specified if the rash occurred at injection site).
Heart race; Fever; Chills; Shaking; Throat sore; Trouble breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient did not receive any concomitant medications. On 08Sep2021 at 03:00, the patient experienced heart race, fever, chills, shaking, throat sore and trouble breathing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart race, fever, chills, shaking, throat sore and trouble breathing were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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 "unknown" and all described as "The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The patient, asking if he requires any additional booster doses at this time of the Pfizer COVID-19 vaccine. The patient having the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. The caller reports also having had COVID exactly a year ago yesterday. The patient said this occurred after his third and then his fourth dose. All of the doses have been the Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; diarrhea; nausea; lethargy; This is a spontaneous report from a contactable other healthcare professional (hcp reported for self). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot EK9231, expiry date not reported), via an unspecified route of administration on 16Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included known allergies to poultry and egg. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included ethinylestradiol, norethisterone (CYCLAFEM 0.5/35), riboflavin (VIT B2), colecalciferol (D3), magnesium, and bifidobacterium lactis (PROBIOTIC); all reported as other medications in two weeks. Patient had no other vaccine in four weeks. On an unspecified date in Jan2021 (also reported as 03Jan2021; pending clarification), the patient experienced headache, diarrhea, nausea, and lethargy continued after 4 days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events headache, diarrhea, nausea, and lethargy were not recovered.
Moderna COVID-19 Vaccine EUA Temperature 103.7; shaking, chills and lethargy Injection site red, hard, swollen, painful, approximately 2.5-3 inches diameter Tylenol, fluids, rest & ice pack to site
p/vax pt w/diffuse rash on both arm & upper chest;c/o itching;no diff breathing or other s/s resp distress;rash slowly subsided over over several days time;
This spontaneous report as received from a medical assistant refers to multiple 1 to 4 year old patients. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. Multiple unidentified patients received (Oka/Merck) VARIVAX doses (0.5 ml, intramuscular) (unspecified in series) between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects reported. The lots affected include "private stock and VFC stock" with lots and expiration dates: private: Lot J006695 expiry 30-MAY-2015 and Lot J012210 expiry 28-SEP-2015. No outcome reported. Additional information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1008 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
patient developed full body itching evening of 2/23 following vaccination on 2/19. on 2/24 developed tingling in fingertips
I had my first shot 1/14/2021, my second shot 2/8/2021, and my third shot 10/5/2021.  My first two doses were through my employer at the Medical Center.  My third dose was through a Health Department vaccination clinic.  On December 13, 2021, I had pain in the teeth of my left lower jaw.  Within the next two days, I had weeping blisters on the left side of my chin and cheek.  I had ear pain and my face hurt.  I tested negative for COVID 19 on December 15, 2021.  I went to urgent care on December 16, 2021.  The provider said it looked like it could be Shingles and gave me the antiviral medication, Valtrex.  I began the antiviral.  Over the next few days, I had ear pain, burning on the left side of my tongue, pain in my lower left teeth, and intermittent tingles in my left cheek.  I went to my PCP on Monday, December 20, 2021.  At that point, I had had almost no new blisters and the existing ones were drying up.  I still had intense ear pain.  She gave me gabapentin for the pain and told me to finish the antiviral medication.  Over the next week, the pain declined in severity and frequency.  I have some evidence of the blisters on my face (discoloration), but it is all healing.   I anticipate no long term health concerns from having Shingles.   My PCP is planning to give me a Shingles vaccine in June 2022.
Tenderness at site and after 3 or 4 days I noticed a round, slightly swollen, red discoloration at injection site.   Then after a day or two I noticed it began to itch.
Patient had severe soreness and pain at the right shoulder joint, it kept on worsening during the first 2 weeks after getting the shot. On the third week, she couldn't mover her right arm, She saw her orthopedist on 1/24/19, and she was diagnosed with Bursitis of the right shoulder joint. She received a cortisone shot and was prescribed Voltaren topical  gel 1%.
Am in menopause, and after having not menstruated for over a year, had  an extremely heavy period after receiving vaccine. Was taking soy protein isoflavins for hot flashes, which had completely subdued them. About a week after vaccine hot flashes started again, and soy no longer works, at all. I now have very severe hot flashes, between 20-30 a day, and recently at night began experiencing hot flashes that last between 1 and 2 HOURS.
Reactions within 1-2 days; 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 VACCINATION COMPLICATION (Reactions within 1-2 days) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions within 1-2 days). At the time of the report, VACCINATION COMPLICATION (Reactions within 1-2 days) 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 and treatment medications were reported.
Patient was administered from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on 04-Nov-2021.  The dates of administration of vaccines were some patients had on 05-Nov-2021 and the other had doses on 12-Nov-2021.  The vial had not undergone any temperature excursions. HCP (health care professional) stated that no adverse event as a result of the misadministration, and patient was monitored.  No treatment medications were reported.
10/20/04 4:30PM administered Td, Varicella and Hep B vaccines. He immediately broke out in Hives and began itching with wheals on face, red eyes/scratching, red hands and feet, swollen lips, heart rate increased from 80 to 140, Pt given Dyter, Zyrtex, Unapred, continued itching, given 2 mg with Pulmicort 0.5mg symptoms resolved. Heart rate decreased to 88. Pt recovered without complications.
Patient reports that he began to experience welts to the inside of the right arm on 05/24/2023 and was also experiencing the same red welts to the groin areas bilaterally..
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored VARIVAX (Merck). No adverse effects were reported. The outcome of events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Rash, red & itchy, noted on R/arm between elbow & shoulder on 1/27/00. Today, 1/28/00, rash has faded & not bothering him. No swelling or blisters noted.
Swelling around injection site, headache. Told to apply cold compress 15min on 15min off. Next day the swelling around the sight doubled. Dr said take 1 Benadryl every 6 hrs.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 16 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
RECEIVED Tdap 10/26/06, BEGAN WITH FEVER, CHILLS  EVENING OF VISIT, SEEN 10/27/06 TEMP 102.3AX AT HOME, MOM GAVE MOTRIN, TEMP IN OFFICE 98.5 (TYMPANIC), VOMITED ONCE, ABD PAIN WHEN WALKING. NO OBVIOUS FINDINGS ON EXAM 10/27/06. REST AND FLUIDS. PT BETTER IN 2-3 DAYS.
Pt woke up the next morning and his lips were very swollen. He had a small patch of itch rash on his leg but not all over his body. He did not complain of difficulty breathing.  His swelling has diminished with allergy medication. His physicians office offered no advice.
Headache; Sore Throat; Arm Pain; Fatigue; Body Aches; This is a spontaneous report received from a non-contactable consumer (Patient). A 25-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at left arm on 13Feb2021 02:45 (at the age of 25-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at left arm on 23Jan2021 02:45 (at the age of 25-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within four weeks time and patient did not take any other medications in two weeks. Patient was not had COVID prior to vaccination and patient did not tested COVID positive post vaccination. Patient was not pregnant at the time vaccination. The patient experienced headache, sore throat, arm pain, fatigue and body aches on 13Feb2021 at 20:00. Patient was not received treatment. Outcome of events was recovering.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
itchy skin, hives IM Diphenhydramine (25mg) admin x 1 VS obtained x 3 Itching subsides
pt recv vax; approx noon went to pizza hut, pt starting shaking & chilling; to er; eyes rolled back, unresponsive; T 105.3; discharged from er about 5pm; in good condition; no more immun;
a patient who is immunocompromised received only 0.25mL as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster). In October 2021, ACCIDENTAL UNDERDOSE (a patient who is immunocompromised received only 0.25mL as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter did not allow further contact
Pain in back of head at base of skull for 10 days.  Had to take motrin and tylenol to relieve the pain.  Ended after 10 days.
confirmed COVID infection; confirmed COVID infection; This is a spontaneous report from a non-contactable consumer. An 83-year-old male consumer received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # unknown) via an unspecified route of administration on 02Feb2021 (at the age of 83-year-old) at single dose for COVID-19 immunisation. First dose (Lot # unknown) was received via an unspecified route of administration and on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had not COVID-19 prior vaccination. The patient had confirmed COVID -19 infection on 01Mar2021. Date of COVID test positive was reported as 03Mar2021. The patient was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received the vaccine and waited 15 minutes at which point she was feeling dizzy and nauseous.  She applied a cold pack to her neck.  She did not feel any better by  approximately 30 minutes following  the vaccine so she requested we call an ambulance.
Patient was given only the adjuvant portion; Patient was given only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 9th June 2021, the patient received Shingrix (unknown). On 9th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. The patient was given only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter had no patient information at hand at time of the call. The reporter consented to follow up but agreed to follow-up via postal mail. The reported batch number pertains to Shingrix adjuvant.
Onset of a rash: raised bumps and itchy in left shoulder and left upper back. Then started feeling some tingling nerve sensation shooting down the same left arm as well as severe headaches and throbbing in left ear. Self diagnosed w/ shingles and confirmed it family medicine practice visit. Was prescribed antiviral shingles 7-day course: valacyclovir 1000 mg tablet
Patient received vaccine that had been prepared from the previous evening but stored in refrigeration, so it was outside the 6 hour expiration window per package insert.  I spoke to Pfizer and the vaccine has been studied and is stable for 24 hours at temperatures 2 to 20 degrees C so revaccination was not indicated since the vaccine she was given fell within those constraints.