chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CARDIAC SYMPTOMS, CHEST PAINS, FEELS NOT GOOD, HR IS FAST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, one total, administered on 17-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included glyceryl trinitrate. On 18-MAR-2021, the patient experienced chest pain and called emergency services. On 24-MAR-2021, the patient reported to have heart attack, confirmed and experienced the following symptoms including cardiac symptoms, chest pains, feels not good, heart rate is fast, and was hospitalized. The patient stated that the ambulance came on 24-MAR-2021 and was admitted to hospital on 24-MAR-2021 and was discharged on 26-MAR-2021. The patient was hospitalized for 3 days. The patient reported that she have cardiac concerns prior to injection with the Janssen covid-19 vaccine and reported to have past medical history as 2007- by pass, 2008- single by pass, 2015 double by pass. The patient stated that she is going to have a stents by consulting Dr. The patient also reported that she is now on 8 more medications. (medications not reported). Laboratory data included: Troponin T (NR: not provided) 5.9 to 12.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardiac symptoms, chest pains, feels not good, hr is fast. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received from patient on 28-MAR-2021. The following information was updated and incorporated into the case. The patient's past medical history included bypass (2007), single bypass (2008), and double bypass (2015). The patient reported additional events as heart attack, heart rate is fast,  and feels not good. The seriousness criteria of 'chest pain' was updated to serious. The patient had visit to emergency room. The patient was hospitalized on 24-MAR-2021 and discharged on 26-MAR-2021. The number of days hospitalized is 3 days.; Sender's Comments: V1 Additional information received in this version is regarding medical history (bypass (2007), single bypass (2008), and double bypass (2015)), events (heart attack, heart rate is fast and feeling not good), seriousness criteria and hospitalization details.  20210340970- Covid-19 vaccine ad26.cov2.s -Heart attack. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
No issues with eyes other than needing glasses; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (No issues with eyes other than needing glasses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L204) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EYE DISORDER (No issues with eyes other than needing glasses). At the time of the report, EYE DISORDER (No issues with eyes other than needing glasses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication were reported.  No treatment medication were reported.  It was reported that on 25 Feb 2021 patient went to optomiticist for first eye exam.   This case was linked to MOD-2022-475104 (Patient Link).
This is a spontaneous report from a nurse referring to a 44 year old male pt who on 5/27/99, received his 1st Lymerix, with no ill effects. On 6/24/1999, he received the 2nd dose and 1 day later, experienced nausea, dizziness, headache, aching joints, flu-like symptoms and a tingling left arm at injection site. The pt was advised to take Tylenol or ibuprofen as treatment, and the pt has not decided to receive the 3rd Lymerix injection. The most recent information received on 8/5/99, reports the symptoms resolved, 3 days later on 6/28/1999.
did not dilute pediatric pfizer, before inject 0.20ml to patient, call and talk with parent, they said the kids are seem ok, will call back tomorrow to check again.
headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.
ConstNt itching all over the body. I called my doctor and she advise cream over the counter. Now is not that bad, but I still itchy but not like before.
Difficulty breathing taken to hospital SAO2 level 75 put on 15 liters O2 sent home on the 01/22/2015.
Pediatric vaccine was diluted with 0.13ml instead of 1.3 ml so the  patient got a more concentrated dosage. Patient ppresented only mild redness at administration site.
Pt. states that after receiving the 1st dose of Phizer 09/11/2021, started experiencing symptoms 09/27/2021 of chest pain, rapid heart beat, swelling in the injection site, and soreness. Soreness still continuing, other symptoms lasting 24hrs. No noted Primary visit/communications.
This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On 13-MAR-2019, the patient was vaccinated with M-M-R II,  lot # R028523, expiration date 04-OCT-2019, intramuscularly (strength, dose, frequency, and anatomical site of administration were not provided) for prophylaxis ( incorrect route of product administration). Sterile diluent lot number R002058 was mentioned. No adverse events were reported. The outcome of the event was unknown.
terrible diarrhea; indigestion; She did not feel good; she can not remember, she had symptoms from her stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset May2021, outcome "unknown", described as "terrible diarrhea"; DYSPEPSIA (non-serious) with onset May2021, outcome "unknown", described as "indigestion"; MALAISE (non-serious) with onset May2021, outcome "unknown", described as "She did not feel good"; ABDOMINAL DISCOMFORT (non-serious) with onset May2021, outcome "unknown", described as "she can not remember, she had symptoms from her stomach".  Additional information: She stated she had a really important question. She got the second dose this past Saturday, 01May2021. The next day or on Monday, she cannot remember, she had symptoms from her stomach.  She did not eat anything out of the way because she knows how she was. She did not feel good. Tuesday went by. She was not feeling good again. She had indigestion and did not eat enough to warrant it. It dawned on her that it could be the vaccine, but she was not sure. She had terrible diarrhea, like the runs and dysentery, the other day. She could see if she ate something that does this, like food.  She was not saying it was the vaccine, but she is wondering if this has ever been reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Persistent pain at site Constant  pervasive weakness, joint pain Chills Diminished sense of taste Malaise Inability to think clearly
Came into office for recheck of CBC, found to be neutropenic, WBC-1.3; followed up with repeat CBC, day 3 WBC-3.4 with continued increase, thereafter. Temperature 102F from 9/11/99 to 9/12/99. On 9/13/99 temperature decreased to 98.5. On 9/28/99, WBC-5.0.
Diarrhea stared Monday 3pm and is still here Wednesday 7 am.
tinnitus; achy; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm on 08Feb2021 09:30 (Batch/Lot Number: EN5318) as dose 2, single for covid-19 immunization. Medical history included bronchitis from 29Nov2019 to 05Jan2020 (After the illness and believe it could of been Covid), breast cancer from Jun1999 to an unknown date (Radiation ended in Jul), thyroid cancer from Feb1986 to an unknown date (Cancer free), radiation from an unknown date and unknown if ongoing (Radiation ended in Jul). There were no concomitant medications. The patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm on 18Jan2021 08:00 (Batch/Lot Number: EL1283) as dose 1, single for covid-19 immunization and experienced feeling unwell, fever, sore throat, flu like symptoms. The patient experienced tinnitus in Mar2021 with outcome of not recovered, achy in 2021 with outcome of recovered on an unspecified date in 2021. Second dose had minimal side effects achy for 6 hrs. The event tinnitus was reported as serious per medically significant. The adverse event required visit to physician office. No treatment received. Vaccination facility type was hospital. No prior vaccinations (within 4 weeks). No relevant test.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112933 Same reporter/ patient, different dose/AEs.
This is a spontaneous report from a contactable pharmacist. A 66-years-old female patient received PREVNAR 13 (Lot # M56416, Expiry Date Jun2017, NDC number 0005197102), intramuscular at 0.5 ml single in the right deltoid on 24Oct2016 for immunisation. Medical history included ongoing allergy to Sulfa, ongoing to latex. There were no concomitant medications. The patient experienced rash at the injection site, pretty big on 25Oct2016 with outcome of not recovered.
Noticed Pustular rash on chest and back 12 days after receiving smallpox vaccine. Discussed with HC and pictures sent. No fever, no itching, Dx Non-viral pustulous.
left axillary LAD swelling    Narrative: Left axillary LAD swelling occurring one day after  2nd dose of covid vaccine, leading to ED visit. No Treatment  given.
STERILE WATER FOR INJECTION MIXED IN AS DILUENT. NO ADVERSE REACTION REPORTED TO PHARMACY AT TIME OF THIS REPORT
This spontaneous report as received from a 67 years old male consumer reporting on himself with no drug reaction or allergies who on 09-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (Dose and lot number not reported). No other co-suspects were reported. Concomitant medications included lisinopril (manufacturer unknown), clopidogrel, carvedilol, omeprazole, CRESTOR and aspirin. The consumer stated that on 10-JUL-2012 in the morning, he woke up to a large amount of blood on his pillow. He stated that it looked like blood mixed with water and that the bleeding was coming from his mouth and arm. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for patient awoke up to a large amount of blood on his pillow, the bleeding was coming from his mouth and his arm was unknown for ZOSTAVAX. Additional information has been requested.
On 11-15-16 approximately 10PM chills, shivering, muscle aches, nausea, fever 100 + (sick and miserable all night). Next day those symptoms gone, but very sore left arm where injected-with large red patch (approx. 4" x 6") + itching and stinging/throbbing pain. Redness faded after about 2 weeks. My arm still hurts and it is very painful to raise and use arm.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent (MERCK). On 02-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021318 with expiration date: 07-AUG-2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. No adverse effects reported. The reporter stated that the temperature excursion occurred between 6° F and 14° F (13.7° F), with a time frame of 964 minutes. The call was given by data logger. There were not previous temperature excursions reported.
First symptom was coughing that worsened quickly.  Used inhaler with no improvement. Then swelling of lips which progressed to full facial swelling and throat swelling. Drove to Hospital Emergency Dept. Treated with  benadryl, epi, steroids and ivfs. Monitored for 4 hours and discharged home.  Rash then  developed to vaccine administration site (left arm) 24 hours later.
headache like migraine; tenderness; neck started hurting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (headache like migraine), TENDERNESS (tenderness), NECK PAIN (neck started hurting) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MIGRAINE (headache like migraine), TENDERNESS (tenderness), NECK PAIN (neck started hurting) and CHILLS (Chills). At the time of the report, MIGRAINE (headache like migraine), TENDERNESS (tenderness), NECK PAIN (neck started hurting) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called to say that she went to md because her up arm was red and warm from the shot. This did not happen with the previous dose. MD prescribed Medrol dose pak and recommended benadryl
headache; stomachache; slight fever; fairly significant muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2020239759).   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th November 2020, 2 days after receiving Shingrix, the patient experienced fever (serious criteria other: serious per reporter). On an unknown date, the patient experienced muscle pain (serious criteria other: serious per reporter), headache (serious criteria other: serious per reporter) and stomach pain (serious criteria other: serious per reporter). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, headache, stomach pain and fever were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, stomach pain and fever to be related to Shingrix.  Additional details were reported as follows: The vaccine was given in his upper left arm. The patient experienced fairly significant muscle pain, headache, stomachache and a slight fever. The muscle pain and headache lasted for one day, his stomachache never caused him to throw up and the slight fever started on Monday after injection.  He stated these all lasted up until a day before date of reporting.  The symptoms started to go away on Monday and were reducing each day.  On the day of reporting patient stated that this was the 1st day he was feeling well.  He also experienced the same reactions from the 1st dose of the Shingrix vaccine, but they were not as serious and only lasted one day.  His doctor was aware of the reactions from the 1st dose, but not the 2nd.  The reporter did not consent to follow-up.
patient received her initial dose of VARN AX 6 daysprior to her 1st birthday.; no adverse event; This spontaneous report was received from a medical assistant and refers to an 11 month old female patient, that at the time of this report was 16 years old. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.      On an unknown date (reported as " 6 days prior to her 1st birthday"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). No additional adverse events were reported.
Patient received his 5 yr immunizations on 8/28/17. Mom had called the clinic on 8/29/17 stating that his upper left thigh (subcutaneous area) is red, swollen and warm to the touch. She reported that there was a lump the size of a plum as well. He was afebrile but there was tenderness at the injection site. After consulting with Dr. parent was informed that it is safe to continue monitoring patient at that time. Mom was advised to apply ice or heat and give Tylenol as needed for pain. If patient develops a high fever (> or equal to 103), swelling continues to increase at 48 and 72 hours, or he overall worsens, mom advised to call back. Mom then called back on 8/30/17 at 5:17 pm and stated that the swelling was about the size of a cucumber and he was having more severe pain. He was still afebrile. Given significant worsening of pain and size of erythema, Dr. was concerned that patient has a local cellulitis from the vaccine. It was advised that he be seen at ED that night. Mom agreed and ended up taking him to the ED. At the ED, they did an ultrasound per mom and there was no abscess, just cellulitis. Patient was put on a course of Cephalexin and sent home.
Patient was here at the pharmacy to describe about the adverse reaction. She says next day after the vaccine her arm was swollen up to the point she could not move. Went to care now on Wednesday (oct 18), gave them 2 shot on her hip  clindamycin and also a epipen. Care now recommended to go to other doctor, went to quest (on Thursday). Doctor marked a line on her arms/ Friday it was diagnosed as cellulitis.  She  was given clindamycin and probiotic (not sure whether it was  from vaccine or from somewhere else).
Symptoms began 10/23 with scratchy throat. Tested positive for COVID-19 10/24. Had one day of sevre symptoms and 9 days of mild to no symptoms. On day 10 of COVID-19 I had a Grand Mal seizure.  Went to the ER and was hospitalised for observation. I had no more seizures and have lost all memories of that day. Was placed on anti seizure medication but doctors don't believe it will happen again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) positive; (10Jan2023) negative; (10Jan2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 05Jan2023 to 10Jan2023.
Patient received PPSV23 at 12:09pm on 4/6/22.  0.5mL, left upper arm, IM.  Developed swelling of left upper arm at ~2100 that evening.  Also reported sore arm.  No fevers, swollen lips, difficulty breathing, vomiting, or chills.  She felt a little dizzy briefly.  Still had left upper arm swelling at 0200 on 4/7/22 and so went to emergency department for evaluation.  She says they gave her tylenol, recommended cold compresses, and told her it would improve with time.  I checked in 4/7/22 and 4/8/22 (today).  Continued improvement of swelling of left upper arm and soreness.
Member reported swelling and redness to Left deltoid 2 days s/p anthrax administration. Denies f/c but has soreness. Exam: the entire left deltoid and lateral/supsension biceps is indurated and there is errythemia and the same location. There is no wound present. Recommend rest, ice/heat, OTC anti inflammatories. (Dr.)
approx 16 days p/vax pt exp local react w/2-3 pustules at inject site & fever
No adverse effect.  Patient was given Pfizer Covid Vaccine Booster dose and patient did not meet the required age for booster at time and date of administration.
I was vaccinated. With both types and still had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. A little overly optimistic. The patient was vaccinated with both types and still had shingles twice. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.