chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning his 76 year old wife with Crohn's disease and a history of pancreatitis with the use of PURINETHOL who on 07-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included prednisolone (5mg every other day). It was reported that 14 days after receiving the vaccine, on 23-JUL-2009, the patient had a flare of her Crohn's disease. She had had mild diarrhea and the physician was treating her with PEPTO BISMOL. Upon rechallenge with PURINETHOL, the patient again experienced pancreatitis. At the time of reporting, the patient had not recovered from flare of her Crohn's disease. The outcome of the pancreatitis was not reported. Upon internal review, pancreatitis was considered to be an other important medical event. Additional information has been requested.
On way back to school, vision became blurry.  Started sweating.  Felt light and tense.  Felt hot.  Lasted few minutes.  Once she got air ok.  Didn't eat breakfast.
Patient reports that during the immunization on 5/10/21 she felt it was painful and ever since her left arm has been aching.  It aches and is painful to use.  She saw her provider today and she had some imaging done.
This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies, and concomitant medications were unknown at the reporting time. On an unknown date (reported as couple of years ago), the patient was vaccinated with M-M-R II (dosage, route, anatomical location, lot number and expiration date were not reported), which was reconstitute with sterile diluent (dosage, lot number and expiration date were not reported), for prophylaxis. On an unknown date, the patient developed rash. No treatment was given for the event. At the reporting time, the patient recovered from rash on an unspecified date. The casual assessment between M-M-R II, sterile diluent and the aforementioned event was not provided.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-FEB-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a medial group for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
a "minimal soreness" in her arm; she has been vaccinated with our PNEUMOV AX 23 three previous times/physician wants to give her a 4th booster shot of PNEUMOVAX 23 again; Information has been received from a 56 years old female patient referring to herself. On an unknown date when the patient was "6 years old", she had her spleen removed because she had a "hereditary genetic" disorder called "hemo-spherocytosis", which she explained was an abnormality with the way her blood was shaped causing her spleen to "sometimes reject" or even "attack" her own blood, hence why she had her spleen taken out when she was a child.     On an unknown date in her 20's, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml for pneumonia prevention (prophylaxis) (strength, route, lot# and expiration date were not provided). On an unknown date in her 30's, the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). In approximately 2010 (reported as about "10 years ago" when she was in her 40's), the patient was administered the third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (incorrect dose administered).   In approximately 2010 (reported as "after she got her 3rd re-vaccination shot about 10 years ago"), the patient experienced a "minimal soreness" in her arm but she said she recovered fairly quickly from the soreness (she thought the day after the vaccine was given she was fully recovered). The patient also stated her current physician wanted to give her a 4th booster shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again for pneumonia prevention out of an "abundance of caution" because her doctor said she "could have a higher risk of infection" as a result of not having a spleen. No product quality complaint (PQC) was involved. The causality assessment was not reported.
rapid heart beat; cough; fever 102F; ACHINESS; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102F), TACHYCARDIA (rapid heart beat), PAIN (ACHINESS), CHILLS (CHILLS) and COUGH (cough) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever 102F), PAIN (ACHINESS) and CHILLS (CHILLS). On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat) and COUGH (cough). At the time of the report, PYREXIA (fever 102F), TACHYCARDIA (rapid heart beat), PAIN (ACHINESS), CHILLS (CHILLS) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment provided and concomitant medication given
Rash began to be appear on Left arm at site of vaccination 10/24/12 evening, then rash continued past elbow the next morning with itching.
experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.; Left arm was hot; had to much swelling on their left arm, it was very hot, lasting 2-3 days; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK UNK, q4h. At the time of the report, DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) outcome was unknown.            Concomitant medications included medication to replace thyroid.  Treatment for the events included ice.   This case was linked to MOD-2021-318648, MOD-2021-318654, MOD-2021-318659 (Patient Link).
Dose 1 Pfizer 2/26/2021  lot # EN6205  Pt had a cardiac arrest at home 9/7/2021, died in the Emergency Room on 9/7/2021. Not a Covid related death.
I had the Chickenpox as a child. During pre-employment blood screening it was determined I did not have immunity to chickenpox and I was instructed to receive a vaccine. I received this vaccine on 10/26/2017. 11/11/2017 I started with headache, low grade fever, cough and body aches. 11/12/2017 I began to break out on my scalp and arms. Approximately 10 spots were counted. 11/13/2017 I began to break out on my back and abdomen. Approximately 30 spots were counted. 11/14/2017 spots are breaking out all over my body, 50 or so at present. Some now have small blisters. Itching is becoming intense. Moderate headache, body aches, cough.
About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feeling very warm. Taste was off- many foods just did not taste good. General body aches, ambulation unsteady, blood sugar went up to over 700. This lasted  until about 11 the next morning.
Severe Back Pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included open heart surgery. Previously administered products included Flu vaccine with an associated reaction of malaise (received flu vaccine in 1976 and reaction ill ). Concurrent medical conditions included allergy to antibiotic (allergic to neomycin) and penicillin allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, several years after receiving Flu vaccine, the patient experienced back pain. On an unknown date, the outcome of the back pain was resolved with sequelae.   It was unknown if the reporter considered the back pain to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that approximately 10 years before the reporting date, she received a flu vaccine and experienced severe back pain that lasted 48 hours. The patient did not consent to follow up. The patient did not provide any additional details.
Patient was vaccinated at 11:56am and 5 minutes into the observation period (at12:01pm) the patient informed the nurse he was feeling flush. The nurse checked on him, and noticed he was pale. The patient then fainted. The nurse examined the patient with her stethoscope and saw that his pulse was very slow.  The nurse then called 911. After the nurse called 911, the patient awoke. When the EMS arrived, the patient fainted again. The EMS and the nurse observed that the patient's heart rate was erratic. The patient's blood pressure started slightly high at 118/90 and was steadily dropping to about 90/50. The EMS advised the patient receive an IV and the patient refused. The EMS advised the patient go to the hospital for an IV and the patient refused. The patient also refused a finger stick. The EMS stayed on site to observe the patient, until his heart rate was back to normal and he was able to walk again. The EMS advised the patient to go to his doctor. The patient's wife came and picked him up. The patient informed the nurse he has a history of fainting from needles.
Broke out into hives/rash on my face and face started to swell up on left side.
adult patient who had a titer performed, and the patient needs a dose of MMRII; This spontaneous report was received by customer who refers to an adult patient (exact age was not provided).   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown.  The causality assessment was not provided.
pt recv vax & 8 days p/vax pt was found to have elevated liver enzymes;pt feels well, & has no sx;elevated lab values cont;
This is a spontaneous report from a non-contactable other HCP (patient). A non-pregnant 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via unspecified route, administered in left arm on 10Feb2021 (Lot number: EN6201) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), penicillin (known allergies: penicillin) from an unknown date and unknown if ongoing. She received other medications in two weeks: Birth control- antidepressant. The patient did not receive other vaccination in four weeks. Patient had been diagnosed with COVID-19 prior to vaccination and not tested post vaccination. On 26Mar2021, the patient experienced Menstral cycle disruption- consistent period for 2 months straight. Heavier than normal flow. She had physician office visit for the events. No treatment received for the events. The clinical outcome of events was not recovered.No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmD, and a health professional concerning a 20 year old female with an allergy to erythromycin ethylsuccinate who on 08/14/2001 was vaccinated with a first dose of varicella IM in the left arm. The pt developed localized erythema and swelling 12 to 24 hrs post vaccination. The pt developed a 4cm diameter site reaction. The pt subsequently recovered. No further info is available.
Janssen COVID-19 Vaccine EUA  My skin (on top and going deeper) felt tingly, prickly, sensitive all over my abdomen. This began the day after the vaccine (4/9). By the afternoon of 4/12, it was feeling more intense. That's when I realized I had a skin irritation on my lower back and stomach. I went to my doctor and it was diagnosed as shingles.   My doctor said it was not caused by the vaccine but a stress reaction to the vaccine + normal stress in my life.
After the client received vaccines, she complained of dizziness and shortly after passed out and appeared to seize for approximately 30 seconds. When the client became conscious and alert again, she complained of shortness of breath. Client was helped into recovery position and vitals were taken (BP: 81/46, HR:46). Called 911 due to shortness of breath and symptoms. Took vitals again after 3 minutes, BP was 97/64, HR was 56. Ambulance arrived within 4 minutes and assessed patient. Per Medics, client was within normal limits however they advised the patient be assessed at the Hospital and parent agreed. Parent came by later to collect paperwork and stated that the patient was doing fine and was released from the hospital with no issues.
Patient had received a Moderna vaccine.  His company is offering a chance to win money for getting your first vaccine. Client denied receiving previous vaccine so he could enter the drawing for the money.
Information has been received from a consumer (patient's mother) referring to her daughter, a 19 year old female patient. Information about patient's concurrent conditions and medical history was not reported. "Last year", in 2014 the patient was vaccinated with three doses of GARDASIL (lot#, dose, route not reported). On an unspecified date the patient was given a dose of GARDASIL 9 (lot#, dose not reported, intramuscular injection) by accident (extra dose administered). No adverse event was being reported. Additional information has been requested.
cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; sneezing; itchy eyes; itchy throat; cough developed with some myalgias so I prepared the test in the evening and it was positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant), COUGH (non-serious), MYALGIA (non-serious) all with onset 22May2022, outcome "unknown" and all described as "cough developed with some myalgias so I prepared the test in the evening and it was positive."; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "not recovered", described as "itchy throat"; EYE PRURITUS (non-serious) with onset 21May2022, outcome "unknown", described as "itchy eyes"; SNEEZING (non-serious) with onset 21May2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Negative, notes: I did a COVID home test that same morning which was negative; (22May2022) Positive, notes: On Sunday 22May, cough developed with some myalgias so I prepared the test in the evening and it was positive.
Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.). At the time of the report, COVID-19 (Patient had long COVID, symptoms were more severe. Lost sense of smell and taste, fatigue, coughing, body ache, sore throat, congestion, felt like fever, chills.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Body temperature: 98.5 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       No concomitant medication was reported.  Patient believed she received the pediatrics vaccine instead of the adult vaccine. The reason was because she entered the lot number in a system it stated pediatrics and they also got COVID-19. Patient believed the strength of the pediatrics was lower so that might have cause her to have COVID-19. Patient had an O2 sensor at home and it came back normal for her and her husband. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750412 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750412:Husband case
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 029K20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2  test: (Positive) might have tested positive. None allergies were reported. It was reported that after the second dose and booster dose, patient was knocked out for an entire day and was out of it. Patient felt fine after that day of sleeping. Patient was going to see rheumatologist. No treatment details were provided. Company Comment: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. On an unknown date event Covid-19 occurred. Patient tested for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. This case was linked to MOD-2022-637954, MOD-2022-638295 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. On an unknown date event Covid-19 occurred. Patient tested for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Lost vision and almost fainted, "very low" blood pressure occurring off and on for a week. Emergency room said it was a migraine but it was not.