chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pertinent background; serious recreational cyclist, 5000+ miles/yr, 20 rides 100 miles or more previous yr, 850 mile this year before incident, avg ride 50+ miles. Went for bicycle ride the day following 2nd shot.  At 22 miles I apparently blacked out and crashed. Ambulance was called as I was rising from crash and I was taken to ER. No memory of crash. Symptoms: alert and lucid; amnesia, could not remember morning activity, day, or date; trembling; unsteady to walk; crying for no reason; abrasions to hip and knee; muscle soreness developed; no serious injury. ER performed CT head w/o contrast; PO chest; ECG x 2; CBC & Diff Comp Metab Pn Troponin 1 x 2. All test results were VG normal. 2 1/2 hours after the crash I returned to a normal state while getting my CT scan. Sent home after all test results cleared.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema and tenderness. On 2nd June 2018, the patient experienced general body pain and chills. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the general body pain, chills and tenderness were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. The reporter considered the pain in arm, general body pain, chills and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness close to the injection site after receiving the SHINGRIX vaccine on left deltoid at 2:00 to 2:30 in the afternoon that was larger than a quarter, approximately the size of a baseball. The patient also had soreness that hurts when touching. The redness peaked yesterday and seems to get worse when he was moving at work. On Saturday he experienced chills and a body ache.
Caller is reporting that an improperly stored vaccine was administered on 25JAN202 l.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013205, expiration date reported on 02-DEC-2021, but upon internal validation established as 03-DEC-2021 (anatomical location and administration route were not reported) and with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S004119 expiration date reported on 10-FEB-2021, but upon internal validation established as 11-FEB-2021 (anatomical location and administration route were not reported) both vaccines as prophylaxis. The vaccines had a temperature excursion of above 9 Celsius (°C) (13.4 °C), during 2 hours and 9 minutes. It was confirm that a digital data logger was involved.     combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Crack in the back/ severe back problems; Severe back problems; was hospitalized for back problems that she was having prior to receiving the vaccine; has missed her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems), BACK DISORDER (Severe back problems) and CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Back discomfort (was hospitalized for back problems and had crack back.).  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems) (seriousness criterion hospitalization), BACK DISORDER (Severe back problems) (seriousness criterion hospitalization), CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (has missed her 2nd dose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems), BACK DISORDER (Severe back problems), CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) and INCOMPLETE COURSE OF VACCINATION (has missed her 2nd dose) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were provided by the reporter.  The patient was recently discharged from the hospital and had missed 2nd dose  No treatment information was provided by the reporter.  Company Comment: Very limited information regarding hospitalization has been provided. Yet, consumer states that patient was hospitalized due to back problems that she was having prior to receiving the vaccine. Consumer states that her back problems were not caused by vaccine as it was already ongoing. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Very limited information regarding hospitalization has been provided. Yet, consumer states that patient was hospitalized due to back problems that she was having prior to receiving the vaccine. Consumer states that her back problems were not caused by vaccine as it was already ongoing. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.
Information was received from the physician concerning a 17 week old pt with upper respiratory infection, post vaccine in the left thigh. Pt was irritability and prolonged crying. Pt experienced injection site erythema (10x10) cm, pt was treated with Tylenol pt was monitored by physician. Pt was sleeping and the symptoms resolved. Mother also reported that pt has similar reaction at 2 months of age with redness on both legs. The pt also experienced red irritated site with another vaccine.
Moderna COVID-19 Vaccine Mild chills started the night of the day injection received (approximately 11 hours after injection). Next morning got up with major chills, low grade fever, muscle  and body aches, severe headache, fatigue Took Ibuprophen and Tylenol Shot was received on a Thursday and Saturday night I finally started feeling better and by Sunday symptoms were gone.
Headache, Myalgia, Arthralgia Fever, chills fatigue, injection site pain Narrative:
This spontaneous report was received from a nurse referring to an unspecified number of female patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with ROTATEQ per oral, lot # N010709 with expiration date 05-DEC-2018; GARDASIL 9 (route of administration was not reported) lot # N017686 with expiration date 02-DEC-2020, lot # M031557 with expiration date 07-APR-2019, lot # reported as M021407 with expiration date 30-APR-2018, and lot # M024261 with expiration date 30-JUL-2018; PNEUMOVAX 23 (route of administration was not reported) lot # N014946 with expiration date 01-FEB-2019 and lot # N011491 with expiration date 04-NOV-2018; and VAQTA (route of administration was not reported) lot # N026997 with expiration date 10-NOV-2018 and lot # N017094 with expiration date 31-AUG-2018; all for prophylaxis. It was also reported that the patients were administered with improperly stored NUVARING vaginally, lot # N024432 with expiration date 30-SEP-2020 and lot # 0000690070 with expiration date 31-JUN-2020 (dose, frequency and indication were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 78 Fahrenheit degrees or warmer and the NUVARING to a temperature of 79.1 Fahrenheit degrees; all products for 6 hours and 31 minutes. A previous temperature excursion was reported for all vaccines with a temperature between 47 to 77 Fahrenheit degrees for 15 hours and 34 minutes. Additionally, a previous excursion for NUVARING was reported with a temperature of 75.2 Fahrenheit degrees for 5 hours and 34 minutes. Lot number M021407 is an invalid lot number for GARDASIL 9.
About 30 seconds after receiving vaccine, patient felt heart palpitations, felt hot and nauseous/dizzy. Patient's skin became very flushed. Redness lasted around two minutes. Patient felt back to normal after about 6 minutes.
Pain and tenderness of the lymph nodes in left armpit; Fatigue; Muscle pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included ALPRENOLOL, AMLODIPINE BESYLATE and THIAMINE HYDROCHLORIDE (B1 VITAMIN) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 28-Mar-2021, LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included none.
pain at injection site on the day of injection; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site on the day of injection on unspecified date. Both he and his wife experienced pain at injection site on the day of injection. On the second day after the vaccine, she started suffering from joint pain, muscle pain and inflammation (swelling in hands and wrist) and has been ongoing since and had not noticeably resolved. States her pain seems to subside during day but comes back at night. Also reports that the pain seems to travel throughout her body from one shoulder to the next shoulder. She had consulted her hcp who has prescribed anti inflammatory which helps the pain. The outcome of the event was unknown.  Information about lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Right arm, red, swollen and tender to palpatation, 24 hours, post vax. Advised parent in home care with significant improvement in 24 hours.
I administered 1 ml.  The correct dose is 0.5 ml.  Patient has no adverse event.
This case was reported by a medical technologist and described the occurrence fo fatal Guillain-Barre syndrome in an adult male subject who was vaccinated with hepatitis B vaccine (manufactured unspecified) for prophylaxis. On an unspecified date before August 14 2005, the subject received a dose of hepatitis B vaccine (dose number not provided). At an unspecified time after vaccination with hepatitis B vaccine, before August 14 2005, the subject experienced Guillain-Barre syndrome. The subject subsequently expired as a result of the Guillain-Barre syndrome.
p/vax recvd several hrs later mom reported pt became limp, & pale which lasted for several minutes then pt was adm to hos for observation; t101.8;
I had a sore throat, stuffy and runny nose, cough, & fever of 99.8. I took ibuprofen. I called a clinic with the doctor who advised me to initiate ZYRTEC with the ibuprofen. She also prescribed PAXLOVID but I did not take it. I had completed an at home COVID 19 test on September 13, 2022 and it was possible. The medicines I was taking over the counter cleared up the runny nose and the fever. The symptoms got worse 2 days after. The sore throat felt like I had a breathing tube. It just burned at the back of my throat and down my chest and the cough got worse. My fever continued but did not get higher. I had an extreme unbearable headache which ibuprofen did help with. I slept for almost 2 days. I was still testing positive on the 3rd day but the stuffy nose got better, the cough was not as bad and I no longer had a fever. I currently feel that I have completely recovered but I am still testing positive as recent as today.
Adacel administered to a patient intravenously instead of intramuscularly, with no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53-year-old male patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] administered intravenously instead of intramuscularly, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jan-2023, the patient was administered 0.5ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Strength: standard (formulation, lot number and expiry date: not reported) via intravenously (iv) not otherwise specified (nos) route in unknown administration site for Immunization, instead of intramuscularly, with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, caller asking for guidance moving forward and does not have additional information to provide since the patient is waiting at their clinic. Patient is being observed for 2 hours and is 30 minutes in at time of call. Product no longer available. Escalated for further assistance due to there not being an alternate route. Vial discarded, unknown by caller.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown.  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.
TEMP 99.7 TO 100.8 FOR 2 DAYS, INCREASE ON SLEEP, INCREASE SPIT UP, RUNNY DIARRHEA/STOOL
Beginning spring 0f 2021 I began tp experience periods of escalating fatigue, head pressure and instability.  These occurred randomly and lasted 2-3 days.   Sometimes on day 3, I found it difficult to motivate myself to get out of bed.   Blood tests were run but no causal results were found.  30 days after my second booster I was admitted to the hospital for a suspected MI.  The symptoms were minor chest pressure lasting over 30 minutes followed up with the discovery of elevated Troponin.
Vaccine given ?beyond use date? of 6/19/23 Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complications for patient.
Started vomiting 12/10/09 from 6pm-3am for a total of 16 times. Diarrhea x 1 on 12/11/09 at 10am.
a rash on her arm/rash was about 4 inches long/the rash is resolving on its own; her left arm was warm and fairly red; doesn't itch too much; still feels a little sensation; her left arm was warm and fairly red/the color is already reducing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing). At the time of the report, VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Abdominal cramping within one hour of receiving the first dose of the vaccine lasting for up to 12 hours.  Felt better next day.
expired dose of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA580A, expiry date 31-AUG-2022) for prophylaxis.   On 07-SEP-2022, the patient received Menveo. On 07-SEP-2022, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter was a Clinical Supervisor. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 6 years old male patient who experienced stomach/gastrointestinal problems, nauseous a lot and throws up, doesn't finish his meal and does not feel good after eating, approach to appetite has changed and vomited with milk, while he received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. In April 2018, the patient received a dose of suspect DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE (lot number: C5116AA and expiry date: 05-Jan-2019). On an unknown date, the patient developed a non-serious stomach/gastrointestinal problems, nauseous a lot and throws up,  doesn't finish his meal and does not feel good after eating approach to appetite has changed and vomited with milk following the administration of DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE. No Lab data was reported. Final diagnosis was vomited with milk, approach to appetite has changed, doesn't finish his meal and does not feel good after eating, nauseous a lot and throws up and stomach/gastrointestinal problems. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. Documents held by the sender: none.
A non-serious report of administration of expired FluMist was received from a non-commissioned officer and a health care professional concerning a 37-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient received FluMist via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administration FluMist (expiration date 24-Mar-2008) was different from the lot# of the other supply of FluMist with expiration date of 25-Dec-2008. The expired lot of FluMist was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FluMist was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error at the time of the initial report, nor at the time that follow-up was obtained, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
Burning in hands, hands falling asleep. Brain fog,   Feeling of falling, loss of balance, Leg and arm weakness, joint pain, muscle pain, stabbing pains in abdomen and back shortness of breath headache diarrhea. On the 6th day after receiving vaccine I woke up with a rash and extreme itching all over