chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a currently 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012554: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066:
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some tingling in her extremities. EMS evaluated patient on-site. Patient was instructed to remove her mask and take deep breaths to settle her anxiety. Patient was hypertensive (175/104), SPO2 97%, and a FSBG of 95mg/dl. Several minutes later, the patient reported a return of dizziness and tingling. EMS obtained a 12-lead EKG that was unremarkable. Patient refused transport to the hospital.
NO ADVERSE EVENT REPORTED- PATIENT RECIEVED 2 DOSES OF THE HIGH DOSE VACCINE- ONE IN SEPT, ONE IN OCT
Information has been received from a physician a 39 year old male with no drug reactions or allergies who on 20-Nov-2008 was vaccinated subcutaneously with a 0.5ml first dose of VARIVAX (Oka/Merck). Concomitant therapy included some unspecified medications. "About 2-3 days ago", on approximately 01-Dec-2008 the patient developed a rash with 6-8 pox on his leg which "looked like chicken pox". The patient went to the office. No laboratory or diagnostic tests were performed. At the time of this report. 03-Dec-2008, the outcome was unknown. Additional information has been requested.
I became warm and flushed  all over a few minutes after shot , then foggy feeling with congestion in sinus. I waited about 20 minutes and left  I spoke to my allergist and he said that I had experienced mild anaphylaxis and should not take dose 2 of the vaccine
Around 5:30 PM I began experiencing normal symptoms like headache and muscle ache. At 8:15 PM I began to feel light headed, nauseous, and short of breath. Around 8:20 I needed to lay on the floor to prevent myself from fainting. My eyes were rolling back because I was borderline unconscious. I felt like I had no control of my body and had to go to the bathroom. For around 15 minutes I was on the floor convulsing, shaking as if I had chills and my muscles were involuntarily tensing. My pulse was extremely low. After the convulsions stopped I remained on the floor an additional 15 minutes.  Around 8:45 PM I was able to return into my bed with assistance. My nauseous remained and I began experiencing chills. I slept on an off the entire night. At about 1 AM what I suspect was a fever began to break and I was extremely sweaty. For the following day I experienced exhaustion and muscle soreness. I am still experiencing exhaustion. I recognize a bulk of my symptoms were normal but the convulsions, losing consciousness, and inability to control my body seemed worth reporting.
Pt says he fainted while driving an hour or so after receiving the vaccination. Denies feeling dizzy or anxious prior to syncopal event. When asked about anxiety levels he responded "no more than from any other vaccine" and denies any history of fainting in the past from vaccines. Spoke to patient the next day and he says otherwise he doesn't feel great but no worse than he expected to feel. Specific symptoms were not evaluated.
19 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: TCR form was attached. email ID was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sore throat, light sensitivity with  my eyes, always tired (sleeping 10 hr nights and several naps a day), Headache, tongue and mouth sore
Fatigue and injection site soreness. Narrative:  Patient awakened this AM with injection site soreness and fatigue. She did not come to work today stating she felt too tired
Fever, Tachypnea, Diarrhea, fatigue, site pain redness swelling Narrative:
Shortness of breath; Feeling pretty off and Generally feeling sick; Zero energy; Coughing; Queasy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and MALAISE (Feeling pretty off and Generally feeling sick) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath) and MALAISE (Feeling pretty off and Generally feeling sick). At the time of the report, DYSPNOEA (Shortness of breath) and MALAISE (Feeling pretty off and Generally feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
serious issues after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious issues after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (serious issues after second shot). At the time of the report, VACCINATION COMPLICATION (serious issues after second shot) outcome was unknown.            Reporter did not allow further contact
Family reported that the patient experienced deteriorating health after each covid vaccine. Patient was seen in PCP office on 11/18/2022 and the visit was reported to be uneventful. Patient died on 11/19/2022. Listed on the death record as one of the suspected causes of death is COVID Moderna Bbv Vaccine
one day Friday only - chills, migraine, aches in both legs, cough (only for one day -Friday), sinus (cheekbones), thirst, slept about all day Friday, woke up Saturday morning felt fine  no fever (did not feel warm - was chilly all day) - felt like old time flu
1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of vaccine given 10Feb2021 and has not been given the 2nd dose to date (19Apr2021)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
morning he felt sleepy; lost appetite; felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out; little irritability; overnight fever; chills; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability) and PYREXIA (overnight fever) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no allergies. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Hypothyroidism, Blood pressure abnormal, Heart disease, unspecified, Cardiac fibrillation (heart rate), Hemochromatosis and Heart rate abnormal. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure management and Heart rate abnormal, VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and DOXYCYCLINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) was resolving.            Concomitant medication included Thyroid medication for Hypothyroidism. It was reported that patient did not any seek medical care.   This case was linked to MOD-2022-656368 (Patient Link).
nurse administered dose of Tenivac on 01NOV2022 and it had expired 08OCT2022 with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 24 years old female patient whose nurse administered dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) on 01nov2022 and it had expired 08oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none   On 01-Nov-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022, via intramuscular route in the right arm as Immunization  On 01-NOV-2022 the nurse administered dose of tenivac on 01nov2022 and it had expired 08oct2022 with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Caller wanted to know if it will cause any effects for the patient. Should the re-administer with non expired TENIVAC?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event     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.
The adverse events were fever and sharp chest pain.  Took him to the Emergency Room after continued chest pain for 2 hours.  After 3-4 hours of chest pain, the sharp chest pain subsided while in the E.R.  The E.R. nurse gave him Motrin.   He was released after 4 hours in the E.R.
155PM 17FEB95 mom calls in w/ c/o crying on & off since approx 930AM; high pitched cry; sleep-awakens w/cry; urged to call MD or to go to ER; mom reports pt is fine; saw MD pt cried until 230-245PM that same day; cried when leg touched;
Could not straighten my right leg for 24 hours. Serious pain if I tried to straighten it. I had to walk with a cane or crutches. Felt like a sever pulled muscle. Woke up the next morning and all was well. This lasted 24 hours.
Myalgia, Arthralgia, Diarrhea, Fatigue/ swollen glands; tingling in fingers; swelling in legs Narrative:
Swelling (bruising (L) deltoid beginning same day as vaccine (given 4/24) in evening, lessened by next day. Vomiting - 2x evening after vaccine, C/O nausea today with no vomiting. (Child reported she started yesterday after vaccine given-but vaccine actually given 2 days ago).
TYPE 2 MI PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 2/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient was here to receive 2nd dose pfizer for primary series.  Patient received the bivalent pfizer dose instead.  Patient is not experiencing any adverse effects and was told to contact us if that changed.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old male patient who experienced papular rash on his inner thigh, and it spread to the rest of his side, while he received vaccines PREVNAR 13 and PENTACEL. The patient's past medical history included Rash with At 7 weeks old, a generalized rash on his face and neck then arms, legs, and chest and back. It was itchy, and had finer papules than this rash. Pinpoint size papules, they changed the mother's diet and it got better over the course of few days.. The patient's past vaccination(s) included PENTACEL at 2 months, rotavirus vaccine at 2 months, PREVNAR 13 at 3 months with first dose of the PREVNAR 13 vaccine and PENTACEL at 4 months with 2nd PENTACEL dose, 1mm to 2mm size papules, with white heads. The patient's past medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 14-Jun-2018, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot T94430 in the right thigh. On 17-May-2018, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5439AA. The patient developed a non-serious papular rash on his inner thigh, and it spread to the rest of his side (rash papular) <<Unknown latency>> following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and <<Unknown latency>> following the administration of PREVNAR 13. Final diagnosis was papular rash on his inner thigh, and it spread to the rest of his side. The patient was treated with PHENETICILLIN POTASSIUM (PENICILLIN B) for Immunisation. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for papular rash on his inner thigh, and it spread to the rest of his side.
This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL (Lot # J013324 Expiration date: 12-FEB-2016, Lot # K010574 Expiration date: 08-APR-2017 and Lot # K006960 Expiration date: 19-FEB-2017) (doses, routes and anatomical location of administration were not reported). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
She got her vaccine, it hurt when she got the shot which was unusual for her, possibly the placement was sensitive on her arm.  She ran some errands, got home and was tired believed due to her errands, got something to eat.  She was extremely tired that by 6:00 PM she took her medications and went to sleep.  She felt chilled, checked her temp and it was a little elevated, but went back to sleep.  Around 8:00 PM her temp was 100._, and took it again and it was 100.4 to 100.6 and then up to 101, and went to 101.9 and got concerned.  Then she decided to make sure she got plenty of fluids and drank diluted coca cola and has distilled water which she added to the frozen coke and gave her cold coca cola non-fizzy and has been drinking that.  Her temp still kept going up but not higher than 101.9 and now this morning she woke up and it has started to go down and it was 97.6 which is her normal for her, and now it went up again to 98.6, and now 98.7.  She did not take anything for the fever as she is allergic to Tylenol and also highly allergic to aspirin.  She was hardly able to make it to the bathroom this morning, and now this morning she has severe dizziness and feels like she traded the temp for the vertigo.   She is so dizzy she cannot get to the kitchen to take it.   She did call her doctor but was not able to get through yet.
Headache; loss of appetite; Lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Lot number: EWD172) at the age of 54 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 (Vaccine Name: Pfizer COVID-19 vaccine 1st dose , Lot Number / Expiry Date: 1Aug2021/unknown, Route, Anatomical Location: Left arm, No. of Previous Doses: n/a, Date: 01Aug2021, Age at Immunization if date not available: 54), administration date: 01Aug2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Caller reports when she had COVID-19, she was diagnosed with pneumonia after the 2nd COVID-19 vaccine. so she had them give it in her left. Caller states she was extremely ill, lethargic, had loss of appetite, and a headache that was really bad even after Tylenol and Motrin. She reports usually she tries to avoid the Tylenol and Motrin because Tylenol and Motrin is not good for the liver. Caller states she drinks tons of water and tries to stay hydrated. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
2nd vaccine  Moderna lot # 026l20A, administration 1/22/21  In March of 2021 noticed tinnitus getting worse, called PCP for referral since I had local evaluation including hearing test and MRI. I did return to local ENT and had repeat hearing test which was reported as little change  and currently have hearing aids that I am trialing , have had no relief with hearing aids
Severe trigéminal neuralgia flare that began about 36 hours after receiving the vaccination
Information has been received from a physician concerning a 12-month-old  male who on 15-OCT-2007 was vaccinated intramuscular with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U) and a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 657244/0527U). On 27-OCT-2007 (previously reported as 25-OCT-2007) the patient broke out on small papular lesions with red base itchy varicella but all equal size and shape spread all over the face, neck, arm, body and leg. It was reported the patient had "no fever and the child was otherwise fine". The patient sought medical attention through their physician and was treated with diphenhydramine oral (BENADRYL). No diagnostic labs were performed. On 29-OCT-2007 the patient recovered. A product quality complaint was no involved. Additional information is not expected.
Fever of 102.8 in the evening after seeing doctor. Seen at hospital emergency room for fever.
I just had my acupuncturist clear signs of the return of my long-dormant Systemic Lupus nephritis (in my kidneys) in February. After every Moderna shot, including the half-dose booster (received at a different pharmacy), there have been multiple signs of it re-flaring again. I refuse to go on stronger immunosuppressants during the pandemic and these flares have costed me in health and acupuncturist/TCM herbal bills not covered by my insurance.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  receiving second vaccine on 1/20/21. She reported fever 103, body aches, chills, nausea and headache
. Patient had been monitored for 30 minutes with fleeting headache that patient did not report, then left and went to car, and drove for a few minutes. Then noticed that she had R eyelid swelling and facial swelling. Did have some sore throat and nausea. Then got diarrhea later that same day. No hives, wheezing, SOB, chest tightness, lightheadedness Patient went back to clinic and was treated with IM benadryl 50mg with improvement of symptoms. Then took oral benadryl for the next 2 days.