chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute Pulmonary Embolism; bronchitis; Blood clot; Passed out 5 times that night; Couldn't breathe; Heart pain; Cough; Fever; Muscle sore; Super sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Acute Pulmonary Embolism), LOSS OF CONSCIOUSNESS (Passed out 5 times that night) and THROMBOSIS (Blood clot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emergency care (got X-ray and was told she possibly had bronchitis.) on 06-Jun-2021 and Emergency care (was hospitalized for 2 days with a diagnosis of Acute Pulmonary Embolism.) on 08-Jul-2021. Concurrent medical conditions included Drug allergy (Allergy to Hydrocodone) and Drug allergy (Allergy to Codeine). Concomitant products included VIT D [VITAMIN D NOS] for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore). On 15-May-2021, the patient experienced COUGH (Cough). On 06-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) and CHEST PAIN (Heart pain). On 06-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 5 times that night) (seriousness criterion medically significant). On 08-Jul-2021, the patient experienced PULMONARY EMBOLISM (Acute Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). 08-Jul-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced BRONCHITIS (bronchitis). The patient was treated with RIVAROXABAN (XARELTO VASCULAR) at a dose of 15mg. On 16-May-2021, SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore) had resolved. On 10-Jul-2021, PULMONARY EMBOLISM (Acute Pulmonary Embolism) and THROMBOSIS (Blood clot) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 5 times that night), DYSPNOEA (Couldn't breathe), CHEST PAIN (Heart pain), BRONCHITIS (bronchitis) and COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, X-ray: inconclusive (Inconclusive) possibly had bronchitis as reported by patient.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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. Further information has been requested.; Sender'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. Further information has been requested.
I'm wondering if I suffered an allergic reaction; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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 Immunisation, reaction(s): "nausea", "Vomiting"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "nausea", "Vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I'm wondering if I suffered an allergic reaction".  Additional information: The patient experienced nausea and vomiting for all three doses and really took about three days to recover from each shot. The patient tried the Moderna shot last week and still got sick but not quite as badly. The patient was wondering whether the patient is suffering from an allergic reaction. The patient did not know anyone else who gets hit from the shots in that way.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; Cancer; FEEL SICK; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to Severe).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant) and MALAISE (FEEL SICK). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, NEOPLASM MALIGNANT (Cancer), MALAISE (FEEL SICK) and HEADACHE (Headache) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of CANCER, FEEL SICK and HEADACHE with HUMIRA (ADALIMUMAB) was a reasonable possibility.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 53-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Neoplasm malignant, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease can be a contributory factor for neoplasm malignant. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 53-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Neoplasm malignant, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease can be a contributory factor for neoplasm malignant. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Neck rash (red large and burning sensation) Bump and redness at injection site (right arm) Itching and hives on legs and thighs
It did itch; 2 weeks later developed a round circle rash   ,1/3 of a dime around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It did itch) and VACCINATION SITE RASH (2 weeks later developed a round circle rash   ,1/3 of a dime around) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (It did itch) and VACCINATION SITE RASH (2 weeks later developed a round circle rash   ,1/3 of a dime around). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (It did itch) and VACCINATION SITE RASH (2 weeks later developed a round circle rash   ,1/3 of a dime around) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details was included generic blood pressure medicine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2015, the patient was treated by a family medicine physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
flu-like:  low grade fever, headache, chills/sweats, myalgias, fatigue, sensitive skin - all lasted about 24 hrs  Sore arm at injection site lasted 3 days
Moderna COVID-19 vaccine EUA headache, chills, joint pain, nausea, body aches during the early morning of March 4 and throughout the rest of the day.  Then symptoms eased and gradually went away throughout night of March 4 but then just tired for two more days.
Vaccine  (2nd dose) was give around 11:00 am on 2/11/2021.  Around 9:30 that night I started to feel achy all over.  Around 2:30 am I woke up with the severe chills and could not stop shaking.  Fever of 100.7.  I had severe headache, dizziness, n/v, severe joint and muscle pain.  I had severe ear aches, my jaw and teeth even hurt.  I started having left chest pain.  My husband took me to ER (Billings, Montana).  Chest x-Rays, EKG, and blood work were done.  Everything checked out normal.  I was released to go home.  The symptoms were much worse than from the first covid shot and I thought the reaction from the first shot were horrible.  I slept most of the day.  Around 10 am on 2/13/2021 I felt better.  I will never have that vaccine again!!
Firmness, redness, heat, itching in 3 inch diameter circle around injection site
Dermatographic Urticaria developed 10 days following injection; onset as full body hives and itching, with some facial angioedema - urticaria has persisted for 3 weeks.
Right arm soreness for 36 hours,  Headache, fatigue, inability to concentrate beginning 24 hours after vaccination and lasting for approximately 4 hours.
HEAVY MENSTRUAL BLEEDING; CHILLS; HEADACHE; FEVER; URINARY TRACT INFECTION SYMPTOM/BLADDER PAIN; This spontaneous report received from a parent concerned a female of unspecified age. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced urinary tract infection symptom/bladder pain. On 09-APR-2021, the subject experienced heavy menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and urinary tract infection symptom/bladder pain on APR-2021, and had not recovered from heavy menstrual bleeding. This report was non-serious.
Got the vaccine too and I got shingles/Suspected vaccination failure; I got shingles; Nerve pain; 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 an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and got shingles and nerve pain really bad. The patient still suffers from nerve pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2022AMR139977, as tag in same interactive digital media post.; Sender's Comments:  US-GSK-US2022AMR139977:tag at post
sick; bad cough; lack of appetite; high fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Back injury. Concomitant products included LORATADINE for Allergy, DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been to the ER her HCP  twice.  Concomitant medications included a Muscle relaxant.
vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms; 49-year old female patient received fluzone hd qiv; vaccine came out of the crack in the barrel and sprayed into the patient's eyes; Initial information received on 05-Oct-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 49 years old female patient to whom when the nurse administered the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2023, the 49 years old female patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: standard/0.7 ml, frequency: once, expiry date: not reported and lot number: U8132BA) via unknown route in unknown administration site as immunization (product administered to patient of inappropriate age), vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms (eye irritation) and (accidental exposure to product) (same day latency).  Action taken: not applicable.  An unknown corrective treatment was received for the event (eye irritation). It was not reported if the patient received a corrective treatment for other events.  At time of reporting, the outcome was Unknown for other events and was Recovering / Resolving for the event eye irritation.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  A Product Technical Complaint (PTC) was initiated on 05-Oct-2023 for FLUZONE HD QIV (lot/batch number: unknown) (Expiration date: unknown).  The sample status of the PTC was Not Applicable and the complaint was set in process.  Additional information was received on 05-OCT-2023 from quality department: Batch number and  PTC details added, text amended accordingly.
red area top (L) leg: itchy and hot 14cm x 14 cm; treated with OTC Benadryl , Duricef and cold compresses
In the morning of June 30th, her daycare sent us a message and noted that both of her feet were very red, sweaty, and looked swollen to the ankles. They told us they would let us know if there were any changes. Because she's a baby learning to walk and trying to stand a lot, we had them hold her so she wasn't putting as much pressure on her feet to see if the swelling would go down. It did a little. She took a nap and ate lunch. After that, her feet swelled up a lot again and became so sweaty it looked like she had stepped in water. They did change her out of pants in case it was a blood flow restriction. It was a very warm day, but she was in air conditioning. At that point, I picked her up and took her to the doctor where I didn't notice any swelling or redness at that time. Her daycare did tell me that her feet looked a lot better than they did earlier. At the doctor, all of her vitals were perfect and there was no other issue that we could identify. The doctor told us to keep an eye on her to see if it happened again and to make note of it. Since we got her home from the doctor, we have not seen her feet be really swollen or red.
patient received improperly stored ROTATEQ on an unspecified date; No adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) one vial/ once,(lot # R033251 with an expiration date in 29-JUN-2020), orally, for prophylaxis (strength was not provided), that underwent an unspecified temperature excursion, during a time frame of 60 hours. There was no previous temperature excursion, but digital data logger was involved. No adverse effects were reported.
Cold chills, body aches, sweats, headache. Did not seek treatment. Took Mucinex and Tylenol.
No adverse effects; A patient was administered improperly stored PROQUAD; This spontaneous report was received from a pharmacist referring to a 4-year-old patient of unknown gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency and route of administration were not provided) (lot # S009759 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 27-SEP-2020). A sterile diluent properly stored was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).   The temperature of storage and time frame of the excursion were 15°F (Fahrenheit) to 46°F (17.6°F) and 56 hours and 40 minutes respectively, a previous temperature excursion was at 6°F to 14°F (6.2°F) for 10 minutes. A datta logger was not used. No adverse effect was reported
Within 2 hour, allergic reaction started: swollen, puffy  and red eyes, airway irritated, voice hoarse, tremors and fever.  Took 2 Motrin and eventually fell sleep around 1am.   Today, throat is not as irritate, eyes are still puffy and red, and voice hoarse.   Contacted the pharmacy and they confirmed that the vaccine was Thimerosol-free and that it was possible that she reacted to vaccine. Per patient she was not asked which vaccine she wanted; she would have chosen the regular as she has never had a problem with that one. It would be helpful if patients are given the choice.
fever (wasn't sure of the temp number), itching and redness at the injection site, swelling. Patient used hydrocortisone and alcohol for the bruised area
Pain immediately with injection followed by pain down top of arm from shoulder to finger tips (left arm) for several days, with pain then extending into lower part of left arm, back left to center of back) and left breast into center of chest.  Rash developed under left breast and extended around into back 8/27/19, went to urgent care 8/29/19 diagnosis - Shingles. Prescribed Tylenol 3 for pain and Valacyclovir 1000 3x day.
pt recv vax 22NOV98 & 24NOV98 pt devel diarrhea (watery stools 3x daily & generalized itching;
My 81-year-old father, and my brother received the first dose of the Pfizer covid vaccine at the  Hospital  on Wednesday January 13, 2021. Within a couple of minutes of them returning home, my father collapsed. As it turns out, he'd had a silent heart attack. He is still in the medical center area Hospital this morning. A cardiologist who was filling in for my father's primary cardiologist thought maybe my father had a blockage and might have needed a stent. But when Dr. performed a cardiac catheterization,  he only found a little plaque. Medical personnel are not too sure what caused the heart attack. My was very dehydrated when he was admitted, and he has underlying health conditions including diabetes, high blood pressure, dementia and a history of blood clots. Those are just a few of his health issues. His primary cardiologist, Dr is back in town. He plans to see if my father has AFib before they release him. I believe Dr. an internist at Hospital,  said my father's INR on admitting was 1.2. My father's hematologist, Dr.,  had told us to let the person administering the vaccine know that my father is on blood thinners. I was not present when my father and brother received the vaccine, but I assume my brother passed that information on to them.
Left arm - deltoid area: Hot to the touch, red and purple color, hard, swollen, itchy