chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART RACING; HEAVY HEAD; VERY TIRED; This spontaneous report received from a patient 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) dose was not reported, administered on 03-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced heart racing. On 03-APR-2021, the subject experienced heavy head. On 03-APR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy head, and very tired, and the outcome of heart racing was not reported. This report was non-serious.
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
had side effects; had to take off work; 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 VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work). At the time of the report, VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-060935, US-MODERNATX, INC.-MOD-2021-060922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060935:Reporter 2 Dose case US-MODERNATX, INC.-MOD-2021-060922:Reporter 1 Dose case
My heart was racing; Felt really weird in my body; Right leg got kind of numb and my body was so weird after that; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration on 14Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After taking the vaccine, patient's heart was racing and patient felt really weird in body and right leg when patient was driving in the evening on the highway, patient's right leg got kind of numb and body was weird after that. So, the patient was resisting taking the second shot. Patient asked what if he/she take the second shot after this time as it is more than two months. The patient had not decided yet and he/she want to know what is the maximum period after the first one and if so, what is the is the effect. The outcome of the reactions was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021377639 same drug, different patient/AE
Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/28/2023 Discharge Date: Feb 9, 2023  PRESENTING PROBLEM: UTI (urinary tract infection) [N39.0] Acute cystitis with hematuria [N30.01] Complicated UTI (urinary tract infection) [N39.0]   HOSPITAL COURSE: Patient is a 76 y.o. female with a past medical history of dementia, CKD, essential hypertension, among other comorbid conditions who presented to the Hospital Emergency Department on 01/28/2023 from a local long-term care facility via EMS with complaints of vomiting and tremors onset 1 day prior to presentation. The patient was diagnosed with an acute urinary tract and COVID-19 infection and admitted to the hospitalist service for ongoing management and coordination. She was started on Rocephin for urinary tract infection medication. COVID was treated with prophylactic remdesivir to prevent progression for 3 days. Given the patient's vomiting and a brownish color to the emesis the gastroenterology team was asked to evaluate the patient for potential upper gastrointestinal bleed. EGD showed hemorrhagic gastritis, likely from PO iron. IV Iron supplementation was started instead. Her biopsy from EGD was positive for HSV esophagitis and she was started on treatment with acyclovir. HIV testing was negative. ID was consulted who agreed with management and recommended 10 days of therapy.   Patient clinically improved with no further concerns. Discussed with patient and DPOA to obtain outpatient labs in 1 week. She was prescribed Acyclovir to complete a total of 10 days of therapy and Protonix twice daily for her Esophagitis.
ROTARIX was reconstituted with sterile water and was given as a injection to the Lt arm.
received the 1st dose / developed shingles 3 weeks later; rash on abdomen to her back; 1st dose of Shingrix on 30Mar2019 / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details provided were as follows: The age at vaccination for 1st dose was not provided but it could be 79 or 80 years and it was not applicable for this report. The patient received the 1st dose of Shingrix and experienced shingles 3 weeks later, no pain but rash was on abdomen to her back. The patient was late for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
redness; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced a little redness after getting first Shingrix vaccination, but did not experience anything after getting second vaccination. The reporter consented to follow up. The case has been linked with the case US2020172512.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172512:Same reporter
Sore arm Headache Chills Fever Body aches Teeth sensitivity Neck pain Fatigue
Patient in office for routine well child check and immunizations on 12/6/04. Sudden infant death 12/9/04.
Nausea; headache; dizzy; warm hand; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 20-year-old male patient. A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201 and expiration dates were not reported), via intramuscular route of administration on 11Feb2021as first dose, single for COVID-19 immunisation. The patient medical history included known allergies from risperidone. Concomitant medication included citalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was tested for covid post vaccination. On 11Feb2021 the patient experienced nausea, headache, dizzy and warm hand. Adverse Event treatment included juice and observation. Therapeutic measures were taken as a result of nausea, headache, dizzy and warm hand. The outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Positive tested for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive tested for COVID-19) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.      Medical history was not provided.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive tested for COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive tested for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with vitamins. Concomitant medications were not reported.   This case was linked to MOD-2021-090196 (Patient Link).
Pt had swelling  and soreness at the vaccine site starting about 3-4 hours after the vaccine was administered.  24 hours later the redness spread down to her elbow and was sore. She also stated that her legs felt stiff but there was no rash in that area. 48 hours later the area is still red but it is dissipating.
first dose 15Oct2021, has not received another; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 15th October 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not want to give out patients details beside gender. The reporter consented to follow up.
Patient received Pfizer 0.3mL booster vaccination on 1/13/2022, at 17:19, in the left arm. It was discovered the beyond-use-date was 1/9/2022. Patient denied symptoms/concerns or reactions in clinic during the office visit. It is recommended the patient receive another dose since this one was beyond its use-by date.
? Ears ringing ? Dizziness ? Could not stand up ? Started 2 minutes after receiving vaccination ? Going on 4 minutes ? Will call 911 if does not resolve by 10 min total ? Ambulance offered to patient ? refused for now ? Pt reports never having had a reaction to a vaccine in the past ? Mother is shopping, will drive patient home ? At 10 min, patient reports that she is feeling better while remaining sitting, and that ringing in ears is still noticeable, but markedly decreased in volume ? Pt is able to stand up and reports that she is no longer dizzy and able to walk ? Driven home by Mother
Information has been received from a nurse referring to a child patient between the age of 2 years and 5 years old (gender unknown). No relevant medical history or concurrent conditions were reported. On 26-MAY-2015, a single-dose vial of PROQUAD (Merck) underwent temperature excursions at 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015 the patient was vaccinated with above mentioned PROQUAD (Merck) (lot # K014798, expiration date 12-MAR-2016, injection; dose not reported). Concomitant medications were unknown. The reporting nurse stated that the patient had not experienced any adverse events. This is one of several reports received from the same reporter. Additional information has been requested.
Latent onset shingles outbreak in female patient that has never had chicken pox, but has had the varicella vaccine .  Was reported in the journal as well.  Extreme shooting pain, 10/10, with herpetic sores outbreak on left leg . Managing symptoms with PO valacylovir, gabapentin and po NSAIDS .  Note: covid vaccine did not cause the shingles outbreak, rather the immune response caused the antibodies to varicella (vaccine) to cause a shingles outbreak
INCORRECT VACCINE ADMINISTRATION TECHNIQUE (WRONG SIZE NEEDLE USE); NERVE WAS HIT DURING INJECTION; HEADACHE, HEAD PAIN; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight was less than 90 pounds and height was 154.94 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced headache and head pain (Dose number in series 1). The patient felt that wrong size needle was used and the health care professional was standing while doing the injection and a nerve was hit during injection. The patient said that any side effect she had experienced was due to the administration technique (wrong size needle, incorrect vaccine administration technique). She also states that she felt like that the wrong technique might have led to less absorption of the vaccine. The patient had a SARS-C0V-2 IGG antibody (severe acute respiratory syndrome coronavirus 2 immunoglobulin G) test and the results were 0.93 and the range value should not be less than 1.00. She stated that this test was just to verify and also she did not have covid-19 infection within that time period (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, head pain, nerve was hit during injection and wrong size needle, incorrect vaccine administration technique was not reported (Dose number in series 1). The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was non-serious.
Completely out/eyes were closed; looked like he wasn't breathing; Began to shake, patient's head and arm shocked; Weak; little confused; A spontaneous report  was received from a consumer concerning a 69 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced began to shake (MedDRA PT: tremor), head and arm shocked (MedDRA PT: tremor), completely out/eyes were closed (MedDRA PT: loss of consciousness), looked like he wasn't breathing (MedDRA PT: respiratory arrest), weak (MedDRA PT: asthenia), and little confused (MedDRA PT: confusional state).  The patient's medical history included stroke. Concomitant product use included unspecified blood pressure pills, cholesterol pills, vitamins, and a drug for the patient's brain due to the stroke.    On 17 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, ten minutes after receiving the vaccination, the patient began to shake, patient's head and arm shocked and patient was completely out with eyes closed. The reporter stated it looked like the patient wasn't breathing. Seven minutes later, the patient was given an epi shot and oxygen. The patient was transported via ambulance to the emergency room (ER). At that time, a scan was performed - nothing was detected in patient's brain. Patient remained in ER from 0830 to 1500. Patient subsequently left ER very weak and a little confused. It was recommended for patient not to receive second vaccination dose.    Treatment information included epi shot and oxygen.  Action taken with mRNA-1273 in response to the events was not reported.    The events began to shake, head and arm shocked, completely out/eyes were closed, and looked like he wasn't breathing were considered resolved on 17 Feb 2021.  The events very weak and little confused were not resolved.; Reporter'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.
RASH 6.5 X 4 CM IRREGULAR, SLIGHTLY RAISE, RED PLAQUE ON LEFT THIGH 2 PUNCTUATE LESIONS NO FLUCTUANCE MIDDLE PART OF PLAQUE WITH MORE REDNESS THAN PERIPHERY. PER NOTE FROM DR. FROM EXAM
Hoarseness developed 2 hours after immunizations given and continued the next day. No fever or rash appeared.
Fatigue,  almost 3 weeks of  exhaustion, fever, continued long-term fevers up to 101.5° requiring bed rest. Fevers only decreased after two weeks.
The evening of the injection I was tired and nauseous, and my ears were ringing. The next day, 2/5/2021, my ears kept ringing. I was dizzy. I had fever and chills, and physical fatigue. It was difficult for me to stand up. I stayed on the couch. It was three solid days that I did not go anywhere. I was too dizzy to drive. I had lots of water. I used PEDIALYTE. I did not take any ADVIL or aspirin, or any over-the counter medication. With The Moderna Dose 2 and Dose 3 I had similar reactions with all 3 vaccines. What continued for like more 3 weeks was the loud ringing in the ears and the dizziness, until it kind of subsided. The ringing in the ear was a high frequency. The ringing in the ears and the dizziness that lasted 3 weeks and the fever, nausea, chills and fatigue occurred after each Moderna Dose 1, and Moderna Dose 2, and Moderna Dose 3. I received the Pfizer Dose 4 on 10/31/2022, the ringing in the ears occurred again, but it was over after 3 days. I did not have the other symptoms.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        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.   no concomitant was provided no treatment drug was provided
Sepsis (fever, tachycardia, acute viral pneumonia) secondary to acute COVID-19 viral pneumonia:   -supportive care   -IV fluid hydration with normal saline 75 cc/hour  -antipyretic therapy ordered p.r.n.  -empiric coverage with ceftriaxone
Six months after vaccination, I am experiencing intermittent chest pains and shortness of breath for the first time in my life.
Information has been received from a health professional concerning multiple females who were vaccinated with Gardasil (lot# not reported) and experienced heavy menstrual flow.  Subsequently, the patients recovered from heavy menstrual flow.  Additional information is trying to be obtained to determine how many patients.  Additional information has been requested.
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-JUL-2015, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 1 Celsius Degrees for 48 hours, at 0 Celsius Degrees for 48 hours, at -1 Celsius Degrees for 24 hours and at 9 Celsius Degrees for 72 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/3/2023 BILAT AGE RELATED CATARACT RIGHT FACIAL MUSCLE WEAKNESS 4/3/2023 BILAT AGE RELATED CATARACT ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/3/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY RIGHT FACIAL MUSCLE WEAKNESS 4/3/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY