chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 13 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-APR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
This spontaneous report as received from a pharmacist (Pharm. D.) refers to a patient of unknown age and gender. On 25-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular, lot# H009826, expiry date 11-FEB-2014. The patient was inadvertently administered the expired dose of PNEUMOVAX 23. No adverse effects reported. Additional information is not expected.
Projectile vomiting X 8 in 6 hours, fever, hurt all over.  Vomiting continued for 12 more hours.  Patient missed work X 1 day.
heart palpitations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
21Aug91, 21Sep90, 21Feb91 pt vax;  Titers revealed pt did not serconvert
Hard knot in the right deltoid muscle and spotty dark red rash over the injection site, both lasting a month. Treated rash with triamcinolone cream.
Feverish, discomfort at injection site. Next morning she was fatigued, slept excessively, very fussy. Poor appetite.
Initial misuse report received from a healthcare professional on 28 October 2013. The cases were received on 21 March 2014. A patient (younger than 65 years) had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (I had Covid). At the time of the report, COVID-19 (I had Covid) outcome was unknown. No concomitant medications were reported. No treatment drugs were reported. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 8 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 8 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
BODY ACHE; DID NOT SLEEP WELL; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. 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: UNKNOWN) dose was not reported, administered on //2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On //2021, the subject experienced body ache. On //2021, the subject experienced did not sleep well. On //2021, the subject experienced chills. On //2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, did not sleep well, chills, and fatigue on //2021. This report was non-serious.
promethazin (Allergy); fever seizure; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 15 months old patient who experienced promethazin (allergy) and fever seizure, while he/she received vaccines MMR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and while treated with PROMETHAZINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot "C5544AA" via unknown route in unknown administration site.  On an unknown date, the patient started taking PROMETHAZINE dosage unknown (with an unknown batch number).  On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot R008031 via unknown route in unknown administration site.  On an unknown date, the patient developed promethazin (Allergy) (drug hypersensitivity) and fever seizure (Febrile convulsion) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, MMR and PROMETHAZINE.  Final diagnosis was fever seizure and promethazin (allergy).  Action taken with promethazin was unknown  It was not reported if the patient received a corrective treatment.  The outcome is reported as Unknown for promethazin (allergy) and patient was Recovering from fever seizure.  Follow-up information was received on 08-Jul-2019 from a Physician.  Age of patient, suspect vaccine, event updated in field and narrative.  Documents held by sender: none.
Hives/wheals developed 10 days post booster. Have faded to dermatographia.
Whole upper arm became inflamed - reddened to extreme. Pain and heat and indurated. Lt. arm.
All three vaccines administered 7/20/04. Low grade fever (palpable) within 2 hours. Then, high fever 105 degrees F on 7/21/04 documented in hospital. Child also very irritable. No infection found. Pt seen 7/21 and 7/22/04: Prescriptions given.
Patient started getting hot flashes and chills around midnight the night the vaccine was administered. He had a fever of about 101*F on 9/7/2013 at 4pm.
Neck muscle soreness; Soreness radiated through entire skull; Pyrexia; felt enormously fatigued; myalgia; Arm soreness; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), INJECTION SITE ERYTHEMA (Redness at injection site), NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site). On 20-Feb-2021, the patient experienced NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull), PYREXIA (Pyrexia), FATIGUE (Felt enormously fatigue) and MYALGIA (myalgia). On 15-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved. On 23-Feb-2021, PYREXIA (Pyrexia) had resolved. On 25-Feb-2021, MYALGIA (myalgia) had resolved. At the time of the report, NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and FATIGUE (Felt enormously fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101.0 (High) 101.0 degree F low grade fever stayed for 3days. On 20-Feb-2021, COVID-19:. On 22-Feb-2021, COVID-19: Negative.         Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient Demographics added. New event added. Information of 2nd dose of vaccine added.
1. Right-side whole body numbness: sudden onset of complete numbness on right third (approx) of body, from head to foot.. with complete self-resolution in about 30 minutes. Four such incidents in 11/2021 through 12/2021. No incidents since, and only a minor and very partial numbness remains in fingertips and right side of mouth.   2. Pneumonitis: right lung mass of 4cm x 4cm x 4cm causing constant and extreme coughing. Briefly life-threatening.  Resolved with treatment.   3. Various inflammations (ear, left knee)   4. Generally feeling tired all the time, starting Nov/Dec 2021. Initially debilitating but now is 90% or more resolved.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
diarrhea worsened dramatically; bloating; discomfort; Currently still occurs 5x daily; weight loss; fatigue; dehydration; loss of muscle mass; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 7533), via Intramuscular route of administration, administrated in Left arm on 10Apr2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP 6995), via Intramuscular route of administration, administrated in Left arm on 20Mar2021 13:30 (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization and experienced diarrhea. The patient's medical history included Pre-diabetes/glucose intolerance, peripheral neuropathy, PACs (Premature atrial contractions), PVCs (Premature ventricular contractions), and osteopenia. The patient's concomitant medications included Metformin, Januvia, atorvastatin, valacyclovir HCL, famotidine, calcium citrate, multivitamin, and vitamin D3. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. Patient did covid tested post vaccination. On an unspecified date, the patient experienced diarrhea worsened dramatically, bloating, discomfort, currently still occurs 5x daily, weight loss, fatigue, dehydration, and loss of muscle mass. On 29Apr2021, the patient underwent lab tests and procedures which included (polymerase chain reaction) Nasal Swab, SARS-CoV-2 test: Negative, Nasal Swab. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received treatment as a result of adverse events which included Antibiotic therapy, symptomatic treatment, and FODMAP diet. The outcome for all the events was not recovered.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650278 same patient/reporter/product, different event
In pm, pt started shaking, fever, pallor, vomiting; To MPD dx stomach virus; Administered supp, Amoxil, & cont APAP;
4 days after receiving the 2nd Shingrix, I noted pronounced rash and edema at the injection site (2x2") and halfway between my shoulder and elbow (2x5"). The area also itches. No other symptoms, and the rash and edema did not impede my in my work and home tasks.
female patient was administered the first dose, in a three-dose series, of GARDASIL 9 6 years ago, the patient missed all following subsequent doses; No adverse effects reported; This spontaneous report was received from a pharmacy student refering to a female patient of currently 24 years old. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 06-JUN-2013 (reported as 6 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the patient missed all following subsequent doses. No adverse effects reported.
per patient, roughly 3 hours after vaccine administration she experienced, chest tightness, coughing, and Itching/runny Eyes. she noted that approximately 2.5 hours after start of symptoms she took a Benadryl OTC, and about 2.5 hours after that she was still having symptoms. She went to sleep and woke up with no symptoms.
EMS called due to pt being unresponsive; O2 sats in the 80s on RA; hypotensive; in ED pt dx with septic shock from UTI, positive COVID test; COVID pneumonia; O2 supplementation; DNR/DNI but family wanted IVFs and ABX to see if pt improved; renal failure; severe thrombocytopenia; acute anemia with heme positive stool requiring transfusion; given IV Decadron; family made family comfort care; hospice where pt passed away
This case was reported by other health professional via call center representative and described the occurrence of injection site redness in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number H3S5D, expiry date 31st May 2017). Concurrent medical conditions included bicuspid aortic valve (The patient reported that he had this all his life), overweight and back disorder. Concomitant products included nutritional supplement (Probiotics), MICARDIS, fish oil, whey protein (Immunocal), LESCOL, calcium and Testosterone cream. On 25th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 26th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation. On an unknown date, the outcome of the injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation were not recovered/not resolved. The reporter considered the injection site redness and injection site irritation to be probably related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the generalized rash, tiredness, generalized urticaria, wheezing and throat tightness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that he was a retired paramedic. The patient received Multivitamin as a concomitant medication. The patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. The patient experienced rash, welts and hives on body. The patient planned to continue follow up with his physician on an unknown date. The patient sent pictures of the welts he experienced on his right arm on the date of reporting (pictures provided were 30 minutes a part, before and after).
Past lot that had also been expired that was administered to Patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients).    NDCID number was reported.  Patient age was reported as 52 years 11 months.  No concomitant medications were reported. It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A this was administered to patient in between 08-Apr-2022 and 15-Dec-2022. No treatment medications were reported.
2 days following vaccines, developed red, tender and warm local reaction today 10 x 6 cm, no longer tender, no systemic symptoms.
2nd immunization 8/6/21, Pfizer brand COVID vaccine,  LOT EW0183, IM R arm
Initial report was received 08 July 2009 from a health care professional. A 38-year-old female patient with an unknown medical history, had received an injection of DECAVAC, lot number U2590CA on 06 July 2009 and within 24 hours, she developed flu like symptoms, fever and injection site redness which measured 8 - 12 inches in diameter. The event required a doctor's visit. It was unknown if the patient had any concurrent illness at the time of vaccination and her recovery status was reported as unknown. The reporter for this case is the same as for case number 2009-03018. Documents held by sender: None
Chills, fever, muscle aches, joint pain. Patient went to emergency room and primary care doctor.
Sharp pain near under breast took breath away Consult in office with PAC Had Blood Work, Xray, Ct Scan
Site: Itching at Injection Site-Mild, Systemic: Patient came in on 5/20/2021 reporting that she got a bad shot on 04/22/2021. Pharmacist on duty asked patient what reaction did the patient get. Patient refused to answer and left the pharmacy. Pharmacist tried to follow up with the patient but phone num-Mild, Additional Details: Patient came in on 5/20/2021 reporting that she got a bad shot on 04/22/2021. Pharmacist on duty asked patient what reaction did the patient get. Patient refused to answer and left the pharmacy. Pharmacist tried to follow up with the patient but phone number is invalid.
Vaccine injected 8:52 am. Client returned at 9:13 saying she felt dizzy, light headed, if she closed her eyes she would pass out. 9:15 B/P 154/100, P 129, 9:20 126/78 P 124. 9:47 143/103 P 100, no change. Mothers MD office called client refused, 911 called client taken to ER.
Fussiness, low-grade fever 101.5F X 24 hours; when pt seen in office, pt was over bundled and flushed with temperature of 101F; once pt unbundled, without Tylenol, temperature went down to 99.7F and pt not fussy.
I developed severe symptoms similar to COVID but worse.  After 3 weeks of myalgia, fatigue, joint pain and swelling  I went to my PCP.  I have a positive ANA and CRP for the first time in my life.
Death on 12/16/2021; need to report vaccine info if death occurs within two weeks of injection.
Very fatigued; Nausea; woke up with rapid heartbeat and continued for several hours; headache; Could not sleep much due to rapid heartbeat; Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM; Arm was very sore; Slight chills; 99.5 temp that went away quickly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 12:00 (Lot number: EN9809, Expiration Date: Jun2021) at the age of 57 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, Lot no: EL-1283, EXP: Apr2021, Vaccination time: 12:00), administration date: 29Jan2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "About 3 am woke up with chills", "headache", "Arm was very sore", "Saturday, was very tired/lethargic/Felt blah all day, tired", "out of breath". The following information was reported: CHILLS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Slight chills"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Feb2021, outcome "recovered", described as "99.5 temp that went away quickly"; HEART RATE INCREASED (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "woke up with rapid heartbeat and continued for several hours"; HEADACHE (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "headache"; INSOMNIA (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Could not sleep much due to rapid heartbeat"; SLEEP DISORDER (non-serious) with onset 20Feb2021 03:00, outcome "recovered", described as "Woke up at 3AM. Finally fell asleep at 7AM, awoke at 2PM then slept again from 5-7PM"; FATIGUE (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 20Feb2021 14:00, outcome "recovered", described as "Nausea"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "recovered", described as "Arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, body temperature increased, heart rate increased, headache, insomnia, sleep disorder, fatigue, nausea, pain in extremity.  Additional Information: The vaccine was given at a workplace clinic. It was reported that the patient generally have a very good immune system and rarely get sick and when she did, it usually only last a few days. It was further reported that after about a total of 16-17 hours, the patient suddenly felt fine. The patient was still experiencing some fatigue up to 2 weeks after each shot. Events did not result to emergency room nor physician office visit.  No follow-up attempts are possible. No further information is expected.