chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGLES VACCINE (received 4 years ago) and Pneumonia vaccine (received couple of years ago). Concomitant products included PNEUMOCOCCAL VACCINE and Aspirin (Baby). On 31st May 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, 11 days after receiving SHINGRIX, the patient experienced shingles, skin swelling and blister. In June 2018, the patient experienced pain in arm, pruritus and erythema of extremities. On an unknown date, the outcome of the shingles, pruritus, skin swelling and blister were not recovered/not resolved and the outcome of the pain in arm and erythema of extremities were recovered/resolved. The reporter considered the shingles, pain in arm, pruritus, erythema of extremities, skin swelling and blister to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported that he had the shingles vaccine four years ago but he could not recall the name of the vaccine. Concomitant product included Vitamin D. At 1:42 PM, the patient received SHINGRIX. The patient was experienced sore and red on his arm for three days later. The patient experienced a red circle the size of a baseball after injection with soreness that resolved after four days. This past weekend the patient experienced itchiness and this morning he had shingles. The patient claimed that on one side he had an inch long streak and then another streak that was about 4 to 5 inches in length with swelling and blisters on his right side of his body.
Kawasaki's syndrome. Received IVIG and ASA.  5/26/09 Received H&P w/report. FINAL DX: Kawasaki syndrome Records reveal patient experienced fever, erythematous rash all over, swelling of hands/feet, injected eyes, perioral erythema, dry lips, red throat, toe skin peeling  x 8 days.  Seen in outlying ER day before admit & defervesced.  Cardio & ID consults done.  Tx w/IVIG & high dose ASA.    6/15/09 Received hospital medical records for 2/8-3/10/2009 for outpatient IVIG infusions.  Was not admitted. FINAL DX: Kawasaki syndrome Records consisted of d/c summary & H&P already received.  D/C summary indicates patient to have repeat echo & labs s/p d/c & continue on ASA.
Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 08Apr2021 at 16:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. 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 COVID vaccine. The patient did not take any concomitant medications. On 14Apr2021 at 15:00, the patient experienced joint pain. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Location of vaccine administration became red, warm to the touch, and raised. Within 5 minutes of administration.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient with allergy to codeine, ULTRAM, sulfa drugs and pneumonia. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007822, expiry date: 15-AUG-2015, in the left arm, dose and route of administration was unknown). Other suspect therapies included influenza virus vaccine (unspecified) (vaccinated on 29-SEP-2014 in the left arm, dose and route of administration was unknown). The reporter stated that the patient received an unspecified pneumococcal vaccine (manufacturer unknown) previously on an unspecified date but did not experience a reaction from that administration. On 01-OCT-2014, the patient experienced 5 inches of redness near the injection sites which was very painful and itchy. The reporter also stated that the patient's scalp was also very itchy. Patient had called pharmacy and sought medical attention. BENADRYL and MOTRIN (dose and frequency unknown) was given as a treatment for the event. No lab tests were conducted. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
This spontaneous report was received from a veterinarian regarding an approximately 19 year old male patient who is her son. No medical history or drug allergies were reported. On an unknown date in September 2013 or October 2013, the patient was vaccinated with dose 1 of GARDASIL (Lot #, expiry not reported). No concomitant medications were reported. On an unknown date in 2013, the patient experienced diarrhea after he received his first dose of GARDASIL. He had not received a second dose of GARDASIL. The veterinarian also mentioned that her son started his first year of college at about the same time that the diarrhea began. The reporter stated that she believed the diarrhea may not be a bad now as when it first started. No treatment was given. No laboratory tests were performed. The outcome of diarrhea was unknown. The relatedness of the event to GARDASIL was unknown. No PQC involved. Additional information has been requested.
large area of swelling, arm was heavy and painful which went down her arm to her wrist; significant local reaction at the injection site; large area of swelling, arm was heavy and painful which went down her arm to her wrist; large area of swelling, arm was heavy and painful which went down her arm to her wrist; This spontaneous report as received from an office manager, and refers to a 15 year old female patient. Information regarding the patient's pertinent medical history, drug reactions/ allergies and concomitant medications was not provided.  On 18-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot number and expiration date were not reported for vaccination.         On the same day, as soon after received the vaccine, the patient had a significant local reaction at the injection site, describe as a large area of swelling, arm was heavy and painful which went down her arm to her wrist. It was reported this lasted several days, the patient was seen in the physician office on 16-JUL-2019 with some residual pain, but was improving almost back to normal. It was unknown if a treatment was given or if the laboratory tests were performed.  The relatedness between the adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Info has been received from a licensed practical nurse concerning a 45 year old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). On 12/02/2002 at 19:00 concomitant therapy included an intramuscular dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch #U0925AA). There were no other concomitant medications. Both doses were "given with a 25 guage, 1" needle". There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2002 at 21:00, the pt developed extremity stiffness, pain and "induration from elbow to shoulder". The duration was 24 hours and he did not require medical care as a result of this. It was also noted that the nurse had suspected the "activity played a major role in their reactions". The pt recovered on 12/05/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02079 and 0304USA02081. No further info is expected.
Pneumovax administration left deltoid several hours later developed pain, swelling redness expanded to involve entire upper left arm.
pt recvd vax 23MAy95 & on 19NOV95 pt devel varicella w/approx 50 lesions & a temp of approx 102.9;pt's mom noted failure of the vaccine;@ time of the report pt was fine;
patient states increased hear pain after immunization per patient his medical provider could not find a medical issue. pt states had heart pain before immunization but increased
Fever of 105 F for 15 days and white blood cell count was as high as a Leukemia patients.
Long Covid, including persistent brain fog and extreme fatigue and anxiety and  hives. The symptoms have been present every day since onset and have significantly impacted patients ability to carry out daily activities. She has not experienced any other symptoms associated with Covid-19 such as fever or cough
I woke up with a headache and a sore throat. That evening I got body aches. The next morning I has no taste or smell. I had an appointment with a doctor the next day, 10/15, and I reported that I had the symptoms. The doctor advised to go get tested. Was sent to the partner clinic for a PCR COVID-19 test. 10/16 the clinic called and notified me I was positive. Person from the clinic advised to treat symptomatically. 10 days later, I still had body aches, headaches, fatigue, and shortness of breath. I went in to see my Nurse Practitioner who asked for some blood work and sent me home. I received a call advising that the blood work was normal. I sought out my cariologies who had an Echocardiogram, an EKG, a bubble study, a trans thoracic ultrasound, and a nuclear stress test. All of these were normal and so the cardiologist advised this was likely Long COVID. Since then, some days are better than others, the fatigue comes and goes, as does the sense of taste.
Pain, swelling, itching, hardness in the right arm. Tingling in the back. Pain and tingling in the face, on the right side. Head and neck pain. The discomfort in the arm has lessened a bit, but the discomfort in the head, face and back continues.
I experienced a breakthrough case of COVID-19 with vomiting, headache, foggy memory, coughing and my voice is scratchy.
hot legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 89 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "hot legs".  Additional information: she lives with an 89 year old woman who had hot legs or problem with her legs after receiving the 1st dose of the Pfizer BioNTech Covid 19 Vaccine. She wants to know if she should still receive the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm throbbing pain and swelling that continues to come and go. I have been taking Ibuprofen to relieve the discomfort with relief for some hours.
Patient received the incorrect bivalent booster based on age.  CDC Poison Control Center was contacted for guidance.  Mother of client made aware to monitor for 3-4 days for symptoms and go to the emergency department for severe allergic reactions.
Patient said vaccine dribbled back out of injection site; he later had a case of influenza starting in February 2013 and believes an inadequate vaccine admin is to blame.
body aches; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (chills) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds (mold), Allergy (mildew), Dust allergy (dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 27-Mar-2021, PAIN (body aches), CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Patient did nit seek medical care (office visit, Urgent care, ER, hospitalized). Patient did not experienced a similar event in the past. She felt like she had more traveling joint pains, muscle pain, and exhaustion lately.   This case was linked to MOD-2022-668645, MOD-2022-668643 (Patient Link).
41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) in a 41-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) (seriousness criterion medically significant). At the time of the report, HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant products reported. No treatment products reported.  Company Comment: This spontaneous case concerns a 41-year-old, female patient with no medical history information reported who experienced the unexpected, serious (medically significant) event of Hepatitis which occurred on unknown interval after receiving the first dose of mRNA-1273. The clinical course, risk factors, diagnostic evaluation including hepatitis profile, liver biopsy, liver enzymes and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old, female patient with no medical history information reported who experienced the unexpected, serious (medically significant) event of Hepatitis which occurred on unknown interval after receiving the first dose of mRNA-1273. The clinical course, risk factors, diagnostic evaluation including hepatitis profile, liver biopsy, liver enzymes and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chest pain; Elevated Blood Pressure; This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19. Concurrent medical conditions included atrial fibrillation.   On 13th August 2021 10:00, the patient received the 1st dose of Shingrix. On 13th August 2021, less than a day after receiving Shingrix, the patient experienced chest pain (serious criteria hospitalization). On an unknown date, the patient experienced increased blood pressure. On an unknown date, the outcome of the chest pain was recovered/resolved and the outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the chest pain and increased blood pressure to be related to Shingrix.  Additional details provided were as follows: The patient self-reported this case. The patient stated that she had a terrible/bad reaction from her first dose of Shingrix and asked if she should get 2nd shot. The patient received 1st dose and experienced chest pain at that mid night. She was sent to the emergency room and was hospitalized. Less than 2 months after vaccination, the patient also experienced elevation in the blood pressure and had electrocardiogram (EKGs) performed during this time. Provided Medical Information number for customer to provide to health care professional. The patient did not have further information regarding lot and expiration of the Shingrix. The reporter consented to follow-up.
pt recvd vax & exp burning/stingling upon vax @ inject site; therapy dates were DEC93 to JAN94;
Pt dx'd with varicella today. Approx. 20 vesicles trunk, abdomen. Advised to take Benadryl and Aveeno baths prn.
DEVELOPED COVID19 WITH SYMPTOM ONSET 8/19 (MUSLCE ACHES, WEAKNESS, SORE THROAT, CHEST PAIN) AND DIED
Patient complains of small red bumps, rash and tightness of skin mostly on the left side (non-vaccinated) arm and some bumps on the right side. Started to see symptoms a couple of days after the vaccination, tends to worsen with sweating or heat.  Not worsening but taking benadryl and will continue to monitor.
Patient c/o feeling hot, nauseous, and like he was going to faint while in waiting area, after receiving H1N1, brought to cot in clinic area, pt pale, EMT called, message left for mother. Evaluated by EMT, refused transport.
I had the shot and today I have shingles/Suspected vaccination failure; I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 5th September 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and on the day of reporting he/she had shingles so it was not a shul. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt recv vax 1986 & 13APR96 pt was hosp w/probable pneumococcal infect;On 14APR96 pt died;COD was pneumococcal sepsis;
First dose in February, no side effects other thank slightly sore R arm.  2nd dose in March I noticed achiness in my upper right chest and middle right rib cage.  Area in upper right chest is where scarring from lung cancer radiation is located.  Middle rib cage is where possibly gall bladder removal scar is.  The pain has progressively gotten worse since March.  The best I can describe the pain is like a deep muscle tissue bruise or tear.  Very painful when I cough, sometimes just a quick sharp pain, other times when I just move.  Two CT scans (June 2021 & Sept 2021) show no signs of cancer  and mammogram (June 2021) was also clear.  July 30, 2021 I experienced a-fib & am on medication to control it.  No previous a-fib symptoms that I am aware.
Allergic reaction. Cold sweat, hives, flushing, swelling itching.
pt with hx of DMT2, heart and liver transplant; previous CMV viremia; previously tested positive for COVID, placed on antibiotic for pneumonia; presented to ED due to O2 sats at home in the 70s; Optiflow 50L and 70% FiO2; pt's O2 sats worsened; intubated; transitioned to comfort care measures; pt expired in the hospital
leukocytosis--March May--pneumonia July--nausea, headache, SOB, CP, elevated D-Dimer.
pt recvd 2nd dose of vax & exp more severe flu-like sx such as extreme fatigue, polyarthralgias, abdo discomfort, nausea, anorexia, & malaise; MD did not administer the 3rd dose; No further details were provided;
20 minutes after receiving had a hot flash, nausea, ached all up her neck and ear and fingers were tingling and numb. Took Tyl and hot bath, felt better, by next AM was fine.
PATIENT LEFT ARM TURNED VERY RED AND SWOLLEN. WAS TOLD TO TAKE BENADRYL TO HELP THIS REACTION. ALSO REPORTED HAVING CHILLS AND LOW-GRADE FEVER THE NIGHT OF THE VACCINATION. UPON OBSERVATION, AREA STILL RED AND SWOLLEN/PUFFY 3 DAYS LATER.
Information has been received from a 66 year old female with high blood pressure, high cholesterol and a thyroid problem who on 07-NOV-2007 was vaccinated in the right arm with ZOSTAVAX. Concomitant medication included LIPITOR and THYROXYINE. It was reported by the patient that on the same day (07-NOV-2007), after her blood pressure was taken her physician gave her a prescription for quinapril hydrochloride, 20 mg, once a day because her bottom number was high (values not specified). She reported that on 11-NOV-2007, she started to feel fatigue and thinks it may have been caused by her blood pressure medicine. It was reported that at the time of this report she has not recovered, had called her pharmacist, and will contact her physician in follow up. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
large lump in left armpit; chills; fever; runny nose; sore throat; body ache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache), VACCINATION SITE MASS (large lump in left armpit) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065FZ1A or 065FZIA, 003B21A and 041BZ1A or 041BZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache), CHILLS (chills) and PYREXIA (fever). On 06-Dec-2021, the patient experienced VACCINATION SITE MASS (large lump in left armpit). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache), CHILLS (chills) and PYREXIA (fever) had resolved and VACCINATION SITE MASS (large lump in left armpit) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.