chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse (also reported as a medical student) concerning a female with no medical history and no drug reactions or allergies who on 15-FEB-2010 was vaccinated IM with GARDASIL (lot # 662299/1099Y, expiration date 17-APR-2011). There was no concomitant medication. The nurse reported that the patient became nauseous and a rash appeared shortly after GARDASIL was administered (also reported as "within a week of vaccination"). No lab diagnostics studies were performed. The events went away on approximately 22-FEB-2010 ("within a week of the vaccination"). The patient sought unspecified medical attention. Additional information has been requested.
Administered vaccine within 3 minutes of receiving vaccine, patient came back to the clinic with several bumps and redness above the injection site and complaining about itching and soreness.
Patient developed a vesicular rash and associated pain on left upper chest, under arm, and onto patient's back. Symptoms started on 5/19/18 in the evening.
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # M002053 with expiration date 11-JUL-2017, lot # L050910 with expiration date 14-JUN-2017, lot # M003436 with expiration date 19-JUL-2017 and lot # M001152 with expiration date 05-JUL-2017; dose and route not provided), which were exposed to temperatures of 7 Celsius degree (C) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 1 hour post vaccination, child notices a baseball size lump at the injection site. She went to her school nurse, who administered some Benadryl. Child then started to experience trouble breathing and shortness of breath, so school nurse notified the parents who then took her to Hospital Emergency Room. Child's mother states that her son has a known allergy to Benadryl. In EMR physician's note states the following: "Patient is given oral dexamethasone and observed.  She has had no worsening of her symptoms.  No problems breathing.  The swelling in her deltoid is improving."
I always get sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she already been vaccinated with Shingles vaccine. The patient stated that after receiving Shingles vaccine he/she always get sick. The patient stated that how could a vaccine do you any good. Additional supportive information: Follow-up would not possible as no contact details were available.
The patient was sitting on the medical exam chair and couple minutes after receiving the shot he told his mom that he feels light headed and moment after he blacked out and fell from the chair to the floor.  He was out for couple seconds then opened his eyes but not responding much.  We provided Epipen since we noticed he was kind of shaking.  We called 911 and EMT showed up at our lab and took his vitals.  His blood sugar was at 90, and blood pressure at 100/80.  They recommended taking him to the ER to be evaluated for any possible head or neck injury from the fall.  The mother said he had blacked out before at sight of blood.
joint pain; red rash on chest; swelling under breasts; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Swelling, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain), RASH ERYTHEMATOUS (red rash on chest) and BREAST SWELLING (swelling under breasts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication 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 events, a causal relationship cannot be excluded.
Information has been received from a licensed practical nurse concerning a 16 year old male with no pertinent medical history and no drug allergies, who on 25-FEB-2011 was vaccinated with the first dose of GARDASIL (lot #1560Z). There was no concomitant therapy. On 25-FEB-2011 immediately after the first dose, the patient developed dizziness and light headiness for 3-5 minutes. The patient was very anxious about the GARDASIL and had low blood pressure prior to and following the vaccination. There were no labs or diagnostic tests performed. The patient sought unspecified medical attention. The patient was given glass of water and laid down for 15 minutes. Subsequently, the patient recovered from dizziness and light headiness on 25-FEB-2011. Additional information has been requested.
Developed rash on torso and inner thighs. Extremely itchy and red. Reported to doctor but told not from vaccine. Persisted until day of second shot but was calming down. Once second shot administered, rash flared right back up. Still have rash and it?s a month and a half.
12/14/11- Patient was seen this am for immunization review. No record of hep B and patient wished to recieve it so administered first dose in series. Patient stated had an asthma attack after receiving pneumococcal vaccine in past. No contraindications noted on questionnaire. Had patient wait in waiting room after immunization due to history of asthma attack induced by prior vaccination. Minutes after vaccination patient stated that breathing was becoming more difficult. Lungs noted to have expiratory wheeze. Had patient take two puffs of inhaler and escorted to ER. Evaluated and treated with no lasting adverse effects per MD note. VAERS completed.
8 days after vaccination after developed fever and irritability lasting 3 days followed by rash on abdomen on day 4.
I developed a non stop under eye twitch on my left eye 2 days post vaccine.  Today is 6 days later and it's still twitching.  I also feel extra fatigue.
Possible Myocarditis - In September of 2021, I rejoined my kickboxing class, which is something that I have been doing for 15 years.  Immediately following a particularly strenuous training session (heart at peak rate), my heart suddenly went into a rapid heart pattern, forcing me to immediately stop what I was doing and drop to the ground. I was startled  as I had never experienced anything like that in my life.  It happened again one week pater, but not as bad.  For the next few months I reduced my training so not to reach high intensity and did not have that experience again.  It has now been a year and I have not experienced any more symptoms and have had high intensity training, so it appears to have resolved itself.
Red rash, hot, abscess, given prescription for antibiotics (KEFLEX), itchy.
Case previously recorded as MA2009-4285. Initial case report received from a pediatrician via agency on 04 NOV 2009. A 1-year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 100813) i.m. on 30 OCT 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Reference no: NA09-007607.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Information has been received from a nurse practitioner via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 03-AUG-2017 the patient was vaccinated with the third dose of GARDASIL 9 (lot # was reported as M015087, expiration date 20-OCT-2019; dose and route were unknown) for prophylaxis (inappropriate schedule of drug administration). On 29-MAR-2017 and 17-MAY-2017, the patient was respectively vaccinated with the first and second dose of GARDASIL 9 (dose and route were unknown) for prophylaxis. No adverse effects were reported.
Given TDAP & VARIVAX 3/3 0900 AM. 3/3/09 2330 To ER via ambulance with high temp muscle tremor, arm pain. 3/5 seen in office with cellulitis (R) deltoid 4x5 cm (+) erythema (+) warmth (+) tender.  4/28/09 Received ER medical records of 3/4/2009. FINAL DX: acute fever s/p immunizations; muscle spasms Records reveal patient experienced abrupt onset that awakened her from sleep of fever, HA, tremors & muscle cramps, anxiety, crying.  Improved w/hydration & Tylenol & d/c to home to f/u w/PCP.
Post vax, 2 month old male, became fussy and cranky and not himself. Advised to continue on Tylenol. T-98.7
pt recvd vax 11AM on 23AUG94;230AM 24AUG95 pt had episode of rhythmic movements of extremities, w/ 5-10mins of limpness, pallor, unresponsiveness;ER/ f/u exam 12 hrs later WNL;CBC nl;x/for initial WBC 24,400-9100 12hrs;tonic clonic szs
Fever, chills,  nausea, vomiting, diarrhea, headache, extreme pain at injection site, blurred vision, confusion, exhaustion, night sweats, hard lump at injection site/muscle knot two weeks later. Took anti-nausea medication, ibuprofen, acetaminophen, used ice packs. 48 hours later fever broke.
1 of 8 pts (4-6 yr age range) seen /win the past wk /w severe local rxns, pt had 3 X 3 inch area of redness, tenderness & warmth, also low fever
1200 - patient began having facial itching, swelling of cheeks, and skin tone became pale. 1340 - patient in pediatrician office, began having small amount of redness of skin around face and mild swelling.
itching of scalp; forehead had slight swelling; cold sore; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old male patient received second dose for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN5318), via an unspecified route of administration, on the left arm, on 29Jan2021 at 12:00 at a single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL), chronic acid reflux, and Caisson's sickness. The patient has no known allergies. The patient has other unspecified medications taken in two weeks. The patient previously took his first dose of bnt162b2 (lot no. EN3246) on 08Jan2021 at 12:00 PM, on the left arm for Covid-19 immunization. The patient has not taken other vaccine in four weeks. On 02Feb2021 at 21:00, several days after vaccine had strong itching of scalp, lasting several hours prior to bedtime. Noticed that his forehead had slight swelling at bedtime. Overnight this cleared up, patient had taken valcyclovir the prior day for a cold sore. He was reporting this, but may be a red herring. The patient has no Covid prior vaccination and not Covid tested post vaccination. Outcome of the events was recovered on an unspecified date in 2021.
Papular rash at injection sites. Mom states similar rash occurred after same set of injections on 3/7/11 but no other information available. Lot numbers different.
1 cm tender shotty nodule with slight erythema, just 1 cm medical to vaccination site fever 103 degrees F irritability
7x8 cm area erythema and warmth with central 3x4 cm area of vesicles at sight of injection w/i 24 hrs of vaccination. Also with fever.
Pt was given Hep B rather than Hep A ordred. Provider, staff and mom were notifed. No harm. Hep A appt was scheduled with parent.  Hep A and Hep B packaging almost identical. Labeled and organized vaccines, in hopes error doesn't happen again.  Staff notified of similarity in packaging.
Baseball size knot where injection given, red, swollen, hot to touch, chills, body aches. Patient went to hospital on 1/20/17 since physician could not see her. Patient was told having an allergic reaction to the vaccine and was told had pneumonia. Was given a MEDROL Dosepak, Oxycodone and LEVAQUIN by hospital doctor.
Pain; Redness; chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), CHILLS (chills) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Pain), ERYTHEMA (Redness), CHILLS (chills) and FATIGUE (Tiredness). On 27-Mar-2021, PAIN (Pain) and ERYTHEMA (Redness) had resolved. On 28-Mar-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported. There was no relevant treatment medication reported.    It took about two and a half weeks for the reactions to settle down especially the tiredness. Had the 2nd dose without any issues.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 07-JUL-2021 - updated event outcome.
Bloody nose. Lasted 5 minutes. This usually only happens when I take acetaminophen.
Right away: Swelling, redness, numbness of side the vaccine was administered on. Within a few hours: severe pain, weakness, extremely high fever. Next day: high fever, dizziness, patient fainted and had to be taken to the emergency room. Fever persisted several days, patient made full recovery.
Patient with persistent increased pain at injection site with palpable spasm of deltoid ipsilateral trapezius and ipsibilateral latissimus. No erythema or signs of infection. Large local reaction. Motrin/ Benadryl.
Reported to the emergency room 10/7/2021 with several hours of right facial droop. Diagnosed with Bell's palsy. Treated with Prednisone and Valtrex. Seen in the office 10/13/21 with near 100% complete resolution of symptoms
Pain in left arm, Vaccination site pain; Fever; Pain in lymph node; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], PARACETAMOL (TYLENOL) and CAFFEINE for Migraine.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 100.7 (High) body temperature: 100.7 F.         Action taken with mRNA-1273 in response to the event was not applicable. Patient mentioned that doctor prescribed Maxalt but that doesn't work properly so patient does not administer it.
PT CALLED AT 08:54 TODAY (8-9-19) C/O BAD REACTiON TO 2ND GARDASiL. SHOT (GiVEN AT 08:30-8-8-19) & PT STATES APPX 16-17:00 JOiNTS HURTING, HAiR HURT, NAUSEA, SWEATY, BAD HADACHE. MUCH BETTER TODAY
Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190).  Stent put in.
ACUTE IRITIS LEFT EYE. TREATED WITH PREDNISOLONE 1% EYEDROPS. PT IS CURRENTLY ASYMPTOMATIC
Prior to vaccine, periods were 3 months apart for 3 or 4 days  due to birth control.  After receiving 1st vaccine, periods have been every 2 weeks and each one lasts 6 or 7 days. Cramps have also gotten more severe since the vaccine. These new period symptoms have continued after 2nd vaccine.
The pt received his 1st 2 injections of Lymerix on 3/15/99 and 4/16/99. He received his 3rd Lymerix and 3/17/00 and approximately 2 months post vax the pt experienced severe tiredness and developed a moderately unbalanced gait with some paresthesia.  Pt gradually worsened over time and was referred to a neurologist. The neurologist made a diagnosis of "spastic motor skills". An MRI of the brain and neck was interpreted as normal. The vax provider considered the tiredness, unbalanced gait and paresthsia to be possibly related to Lymerix administration. The neurologist stated that the "spastic motor skills" were possibly related to Lymerix administration. The tiredness, unbalanced gait, paresthesia, and spastic motor skills persisted as of 12/19/2000.
Tenderness at the injection site; Redness at the injection site; irritation; physical weakness; Fatigue/when exerting himself like going shopping; Low fever; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (from 2016). Previously administered products included Immunosupressive drugs (were stopped a couple of years prior to getting the Shingrix vaccine).   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2019, 9 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation and weakness. On an unknown date, the outcome of the injection site tenderness, injection site erythema, low grade fever and muscle weakness were recovered/resolved and the outcome of the skin irritation, fatigue and weakness were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix intramuscularly and experienced a low fever and then the symptom resolved. The fatigue started and dissipated. Muscle weakness started to occur two weeks. The muscle weakness lasted for about two months and basically put him on the couch because of the physical, muscular weakness and fatigue when exerting himself like going shopping. He experienced tenderness and redness at the injection site. The patient was a bone morrow transplant survivor. He also had a series of transplant vaccinations after his transplant and the Shingrix was the last vaccination on the schedule. All other vaccinations were completed 6 months prior to getting the Shingrix vaccine. The patient refused to provide his DOB.  The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020AMR009634.
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 08-APR-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Erythema 5x7cm with central indurated area 3x 1.5cm.
almost two weeks later my arm is still very sore at injection site. the next morning after the vaccine when i was at work i had to leave my classroom because i felt sick.  i felt nauseated, sweaty, light headed, short of breath and my heart was pounding like i had been running a marathon.  i thought i was gonna have a heart attack.  i HAD to go outside for fresh cool air and sit down. i was also applying a cold compress, drinking cool water and taking very deep breaths i was able to return to work in about 15 minutes.  i continued to feel nauseated for the rest of that day and the next.
On 1/30/01, had local reaction at injection site; lump and pink color. Recommended warm compress, Tylenol and observation.
Monovalent, Moderna COVID-19 vaccine administered to patient as a booster dose. Patient was due for bivalent, Moderna COVID-19 vaccine booster dose.
A report was received from a health care professional on 07 November 2003, concerning several vaccinees who experienced soreness, redness, swelling and itching at the site of injection after an unspecified length of time after receiving Fluvirin on unspecified dates in October and November 2003. On unspecified dates in October and November 2003 the vaccinees experienced soreness, redness, swelling and itching at the injection site. The swelling was described as the size of a small orange, raised, red and hard. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.