chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she tested positive for COVID-19; she tested positive for COVID-19; This is a spontaneous report from a contactable consumer via a medical information team. A female consumer (patient) of an unspecified age received first dose BNT162B2 (Solution for injection, lot/batch number has been requested) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was reported that, received first dose of Pfizer-BioNTech COVID-19 Vaccine, after that she tested positive for COVID-19 on Monday 22Feb2021. She was scheduled for second dose 06Mar2021, however after a conversation with her Physician, she was told "cannot get it right now". Also stated that her husband got tested on Sunday, and came back negative for COVID-19 yesterday, she asked: "can he still get his second dose, because she tested positive and we live in the same house?". Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
since 2 am on the day after, I have been experiencing a lot of body pain and chills -- as though I have the flu.  I am able to retain fluids, but it is terribly hard to urinate.   I am extremely tired and lethargic.  I am sweating and going between being hot and then cold.
Approx. 1/2 hour after injection my right arm became numb with intermittent pins and needle sensation from shoulder to fingers. This lasted until the following morning. On Wednesday, I had swelling on the right side of my body-face,neck,arm,leg, and foot. I had no respiratory difficulties. I did take Benadryl 75mg which helped resolve the swelling by Thursday morning.
Irritation in small areas of medical left arm deltoid; Irritation in small areas of left calf; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site irritation in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site irritation (Verbatim: Irritation in small areas of medical left arm deltoid) and skin irritation (Verbatim: Irritation in small areas of left calf). The outcome of the injection site irritation and skin irritation were not resolved.   It was unknown if the reporter considered the injection site irritation and skin irritation to be related to Shingrix.     It was unknown if the company considered the injection site irritation and skin irritation to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter stated that she was at a health fair day before reporting giving education on the Shingrix vaccination and a patient came up to her afterwards describing the irritation she had. The patient stated that she received the Shingrix vaccine 3 weeks ago (unsure of date) and had now developed irritation in 2 small areas in the medical left arm deltoid ( this is the area the patient received her vaccination) and her left calf.  This irritation is described as no peeling, no pain, no itching, no ill effects.  The patient was unsure if events related to the vaccine or not. The reporter did not consent to follow up.
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES.  ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS.  THE NEXT DAY HAD A VERY BAD HEADACHE.  ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS.  HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION.  ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
Left health clinic about 3 minutes, post vax, and returned about 1 minute later complaining of "dizzy and room spinning." Assisted to supine position with feet elevated and stated no longer felt dizzy. Light red blotches noted on forehead, neck and upper trunk, denies itching, denies respiratory difficulty and states feels "fine". Assisted to seated position and within about 5 minutes was given juice to drink. Rash subsided on trunk and appeared at scapula area. Scapula rash subsided, within 5 minutes. Additional treatment included Benadryl and notify PCP if any further problems.
Redness at injection site that started as a small red dot, which progressed to a spot the size of a hand. Tingling on & off in hands and body. Red dots on front of legs.
Nausea - Immediately.  Itchy skin - 24 hours.  Hives - both legs 48 hrs.
Sinus infection headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SINUSITIS (Sinus infection headache). At the time of the report, SINUSITIS (Sinus infection headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Contact information provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
3 hours after the booster vaccination I experienced extreme fatigue and lightheadedness.  I laid down for several hours and felt a little better. The next 4 days I had a fever of about 101°. This was accompanied by severe headache, muscle pain, and weakness. After the four days the headache was gone, as well as the fever. However, the severe fatigue lasted for another five weeks. And as of today, I am still experiencing unusual muscle pain and weakness.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer, took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Reported "tingling feeling" on bottom lip and "heart-racing" for approximately 24 hours post vaccine.
hives on her face and neck / broke into hives this morning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her face and neck / broke into hives this morning) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021 at 8:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on her face and neck / broke into hives this morning). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her face and neck / broke into hives this morning) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090576 (Patient Link).
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that " My friends dad died shortly after taking the jab. I am scared to take the shot". On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220213070-JANSSEN COVID-19 VACCINE Ad26.COV2.S- DEATH. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Rashes with 1- 2 hours on both arms , leg , stomach. Non itchy After 5 days the rashes are still there
Second dose: Spotted next morning after the second vaccine; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration on 08Jun2021 at 17:30 (at the age of 33-years-old) in left arm, as 2nd dose, single for COVID-19 immunization. Medical history included ongoing thyroid, it was discovered about 2 years ago when she had blood work done. Concomitant medications included levothyroxine taken for thyroiditis from an unspecified start date and ongoing and ethinylestradiol, norgestimate (TRI FEMYNOR) taken for birth control from an unspecified start date and ongoing. The historical vaccine of the patient included first dose of BNT162B2 (BNT162B2; Solution for injection; Lot number: EW0177) via an unspecified route of administration on 18May2021 at 17:00 on left arm, 1st dose, single  for COVID-19 immunization and experienced Really bad pain in the lymph node area of the armpit and breast area 2 days after the first shot. It was mentioned that the patient did not require emergency room and physician office visit. The prior vaccinations (within 4 weeks) and events following prior vaccinations were reported as none. On 09Jun2021, the patient experienced that she spotted the next morning after the second vaccine. Two of her coworkers spotted as well. Caller stated the spotting stopped the same day that it started which was on 09Jun2021, and it stopped later in the evening. The outcome of event recovered on 9Jun2021.
Severe headache and vomiting in the middle of the night.  Also pain at injection site.  Flu like symptoms the day after the injection.
Started getting redness and swelling at injection site with blistering that peeled.  When seen 10/243/14 at 4:30p, arm was swollen, red, hot from shoulder to elbow w/ 2 peeled areas.
Information has been from a health professional concerning a 21 year old female who on 16-MAR-2007 was vaccinated with GARDASIL (yeast, lot # 653736/0014U). Concomitant therapy included birth control pills (unspecified). On approximately 20-MAR-2007 the patient experienced hair loss in circular patches on her head. It continued to occur even after the second dose  (lot # 657872/0515U0. When the patient brushed her hair a lot of hair would fall out, which made her almost bald. She received steroid injections in her head and 2 prescriptions (unknown). The patient was almost back to normal until she received her third dose of (yeast, lot # 657872/0515U) on 28-NOV-2007. The patient started losing hair again and had to get the injections of steroids and use the prescriptions again. Labs performed included CMP, thyroid, Iron and CBC (results not specified). As of 12-FEB-2008, the patient was almost fully recovered. Additional information has been requested.  03/25/2008 MR received for multiple OV beginning 7/12/2007-3/12/2008 with DX:  Alopecia Areata and likely telogen effluria. Eczematous patches on legs. Pt presented with c/o hair loss x 2 months and rash on legs. Diffuse thinning on scalp with areas of total alopecia on crown. Dematitis on legs. OVs 10 & 11/2007 with hair growing well in response to tx. Two new areas noted 12/18/2007. No bald spots noted 3/12/08
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2013, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) at the Health Department for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Pt recvd 3 doses of Hep B vax 8DEC90, 12DEC90, & 21MAR91 & on 14MAY91 pt devell t101, macular rash, swollen joints, & exp malaise & myalgia; lab eval 14MAY91 revealed elevated liver enzyme levels; On 15MAY91 pt tested neg for Hep A IgM;
Severe pain in injection site,  swelling, redness, Muscle pain, diarrhea
Fever to 102, night of GARDASIL #2, Varicella #2, and MENACTRA - reduced with TYLENOL, no other symptoms.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Redness and swelling to left upper arm, developed 4 days after vaccination, hard lump to injection site, persistent redness swelling and pain present at day 10
Patient c/o pain to his right hand from the wrist down that he said started around 11am and worsened around 12:30pm or 1pm. Patient denied having any swelling, pain, numbness, tingling or discoloration at the injection site or to his right hand. Patient denied pain up his right arm and no chest pain, Patient said that it was only his right hand that felt pain when he tried to close his hand to make a fist.
I was in the health center for my booster COVID shot but empty syringe was conducted to me at first time. The nurse noticed the syringe was empty after she injected it. And then she gave me another shot with vaccine. Obviously, there was a serious human error/misconduct there as there should not be any empty syringe at all at the to-be-injected area. I was not sure whether it was saline or air or something else that was injected to me, or the syringe was totally empty which means the plunger was at the bottom of the syringe (but there would be a very obvious difference as soon as the nurse picked up the syringe in this case)  So far, there is no serious adverse symptom except itch in the injection area but the possible consequences that may occur in the future remain unknown. I request an incident report from the health center including what exactly happened and risk evaluation. In addition, I reserve the right to be held accountable in the future.  I hope more strict procedures are imposed in the COVID vaccine preparation and injection process to prevent those incidents from happening again in the future.
Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Vomiting-Medium
This spontaneous report was received from a health professional refers to an unspecified number of patient of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. On unspecified dates, the patients were administered with doses of ROTATEQ (lot # K016314, expiry date: 05-JUN-2016; lot # K023532, expiry date: 21-JUN-2016; lot # L000571, expiry date: 26-JUL-2016; L000434, expiry date: 10-JUL-2016) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA014024, 1506USA014025, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Red rashes on upper extremities, and left shoulder with generalize itching. Took allergy medication Xyzal 25mg PO.
30-month-old child was given a booster injection of IPOL with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 08-Jun-2022.  This case involves a 30-month-old male child was given a booster injection of IPV (VERO) [IPOL] with no adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR B) for Immunization; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Immunization.  On 31-May-2022, the 30-month-old child received a second Booster dose of suspect IPV (VERO) at dose 0.5ml once (lot: V1A121M, expiry date:15-Feb-2024) via intramuscular route in the right arm for immunization (product use issue, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Recovered on 31-May-2022 for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He had a 3 seconds seizure within 15 minutes of Pfizer covid19 vaccine administration.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. The patient was treated with antibiotics. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was provided as follows: The reporting nurse was the patient. The age at vaccination was not reported. The patient received dose of SHINGRIX a few weeks before the reporting date and had a bad reaction. The patient said that the area where the injection was given got very red and swollen so much that she needed to be given an antibiotic. The reporter did not consent to follow up.
Heart palpitations, they lasted from 3 hours after vaccine until the following afternoon, around 26 hours.
This case was considered medically important (OMIC). Information regarding influenza virus vaccine was received from a healthcare professional regarding a male patient who experienced GBS. The patient received a dose on an unspecified date in 1985. The patient has a past history of poliomyelitis. Indication for influenza virus vaccine was immunization. Product was administered in on an unspecified date in 1985. Dose regimen was 1 dose. Concomitant medications were not reported. The patient was diagnosed with GBS after receiving a flu vaccine in 1985. The reporter stated that the patient does not have any continued problems associated with the event. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested. No additional information was available at the date of this report.
10/13/12 - evening and overnight, general tired feeling, chills, mild fever that would break and resume over and over.  Tylenol taken 10/14/12 to help with fever.  Extremely tired, chills continue, lack of appetite, sore arm at injection site.  Evening of 10/14, diarrhea sudden and urgent.  Fever decreases slightly.  Monday, 10/15, headache, possible dehydration, diarrhea mostly gone but still continues.  Appetite non-existent.
Severe upper back pain for 3 days. Worse on left side which was injection side. I'm a nurse, I've never had a pain like this before and nothing else in my life is different.
Per patient's mother, about 15 minutes after vaccine, he started screaming in car, pulling at his face. Came into office screaming, consoled after exam with stickers and Gatorade.
This spontaneous report as received from a pharmacist via center, concerns to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2015, the patient was vaccinated with an expired dose of VARIVAX, (expiration date: 24-MAR-2015), (dose, route, lot number and indication were not reported). Conocomitant therapies and relevant laboratories test of the patient were not reported. Additional information is not expected since the pharmacist declined to provide further information of the report.
Post vax the patient's right upper arm was swollen within hours after vaccination. The swelling and redness increased extending up to the right earlobe. The patient was treated with Atarax, Orapred and Tylenol with codeine.
Flu shot given in shoulder joint. Ruptured bursa and probably tendons. Required physical therapy and appt. upcoming with orthopedic surgeon.