chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk; tired; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a 65-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm on 12Mar2021, dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, fish oil and vitamins (unspecified). The patient did not have prior vaccinations within 4 weeks from the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 on 19Feb2021 AT 16:00 in the right arm. The patient experienced a stroke on 17May2021. It was after his second dose of the Covid vaccine. The reporter said that the most worrying thing is through all of the tests they can't find anything that attributed to the stroke. The patient plays tennis one level below pro and played 4 times that week, he played golf that Saturday, cut the grass on Sunday and there is nothing to attribute to the stroke. The patient has hemiparalysis on the left side and a long road back. The patient can talk but his left arm and left foot are paralyzed and he can't walk, he is in a wheel chair and undergoing intense Physical Therapy. The patient was also tired and he had a sore arm. The patient was hospitalized from 17May2021 to 04Jun2021 due to the events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk. The patient visited the physician's office on 08Jun2021. The events stroke and hemiparalysis on the left side and a long road back/left arm and left foot are paralyzed and he can't walk were recovering while the events tired and sore arm have recovered on an unknown date.  Information on the lot/batch number has been requested.
MOTHER OF PATIENT STATES SHE HAD HER SECOND DOSE OF COVID VACCINE YESTERDAY AND SHE PASSED OUT THIS MORNING.  MOTHER STATES PATIENT HAS A HEADACHE AND SPRAINED HER LEFT MIDDLE FINGER AND CANT REALLY PUT WEIGHT ON HER LEGS.  MOTHER OF PATIENT STATES HER STOMACH IS UPSET AND FEELS NAUSEATED. AFTER EXAMINATION ASSOCIATED SYMPTOMS INCLUDE FATIGUE, HEADACHES, AND NAUSEA.  PERTINANT NEGATIVES INCLUDE NO ABDOMINAL PAIN, CHANGE IN BOWEL HABIT, CHEST PAIN, CONGESTION, COUGHING, DIAPHORESIS, FEVER, RASH, VERTIGO, OR VOMITING.  THE SYMPTOMS ARE AGGRAVATED BY WALKING.  SHE HAS TRIED NOTHING FOR THE SYMPTOMS.  THE TREATMENT PROVIDED NO RELIEF.
Tonic-clonic seizure. Eyes and head deviated to right, jerking of bilateral arms and legs. EMS called VALIUM given. Seizure approx. 15 min.
Information has been received from a consumer concerning her 6 year old daughter who on approximately 11/26/03 was vaccinated with a dose of hep A virus vaccine inactivated. On approximately 12/12/03, the pt developed diarrhea, malaise, fatigue, stomach upset, a temp of 103 deg, mononucleosis and unilateral pneumonia. The pt was taken to the hospital and given two antibiotic injections and placed on asthma medication administered through a nebulizer. It was unknown if the pt was hospitalized. At the time of the report a few days later, the reporter stated that the pt was getting better, but was not fully recovered. The outcome was noted to be recovering with sequelaea. A product quality complaint was not involved. Upon internal review, unilateral pneumonia was considered to be an other important medical event (OMIC). Additional info is not expected.
Partial dose administrated; Pain at injection site; A spontaneous report  was received from a consumer, concerning a 73-year-old male patient, who received Moderna's COVID-19 vaccine and experienced pain at injection site and also informed about partial dose administrated.  The patient medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of event, the patient received their first of two planned dose of mRNA-1273 (Batch Number 205L20A ) for prophylaxis of COVID-19 infectious route intramuscular and experienced pain at injection site from 12 Jan 2021 to 16 Jan 2021. Patient was informed to self-administer acetaminophen.  On 05 Feb 2021, the patient reported his second dose of two planned dose of mRna- 1273 (Batch Number 043L20A) for prophylaxis of COVID-19 infectious route intramuscular. During the second dose he reportedly only received a partial dose.  Action taken with mRNA-1273 in response to the event pain at injection site was no change in dose. Action taken with mRNA-1273 in response to the event partial dose administrated was not reported.  The outcome of event, pain at injection site was considered unknown at the time of this report. The outcome of event partial dose administrated was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site pain, a causal relationship cannot be excluded.
polyarthritis; joint pain three hours after the vaccine; Diffuse pain; This serious case was reported by a physician via call center representative and described the occurrence of polyarthritis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (rheumatoid-like arthritis).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced polyarthritis (Verbatim: polyarthritis) (serious criteria GSK medically significant), joint pain (Verbatim: joint pain three hours after the vaccine) and diffuse pain (Verbatim: Diffuse pain).The outcome of the polyarthritis, joint pain and diffuse pain were not reported.   It was unknown if the reporter considered the polyarthritis, joint pain and diffuse pain to be related to Shingrix.   It was unknown if the company considered the polyarthritis, joint pain and diffuse pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The patient experienced joint pain three hours after the Shingrix vaccine, 24 hours after administration and she started to experience diffuse pain (she had to be taken to the emergency room by ambulance) and then developed polyarthritis (mainly in the hands).
Mother observed crying spell, stiffness, rolling eyes back, episode lasted about 1-2 min, episode happened approximately 3 days after Immunization, no fever. Seen by neurology - normal exam.
very sleepy; and then was asleep; wake up with fever of 101.2 to 102; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol allergy, Allergy to chemicals and Allergy to chemicals. Concomitant products included BISOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), LEVOTHYROXINE SODIUM (SYNTHYROID), AMITRIPTYLINE and METHOCARBAMOL (ROBAXIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102). At the time of the report, SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-009280 (Patient Link).   Reporter did not allow further contact
Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Confusion-Severe, Systemic: transglobal amnesia-Severe
Inflammation of lymph nodes size of baseball under left arm pit. Tender to touch.; Inflammation of lymph nodes size of baseball under left arm pit. Tender to touch.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 1301358A), dose 3 intramuscular, administered in Arm Left on 02Oct2021 15:00 (age at vaccination: 55-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included anxiety. Concomitant medication(s) included alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP6955), via Intramuscular in the left arm on 14Mar2021 (at the age of 55-years-old) and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: ER8735), via Intramuscular in the left arm on 04Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 04Oct2021, patient experienced inflammation of lymph nodes size of baseball under left arm pit. tender to touch. specific relevant test for thromboembolic events with thrombocytopenia was none. The outcome was recovered on Oct2021.   Follow-up attempts are completed. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT EXPERIENCED SYNCOPE (FAINTING) BUT REGAINED CONSCIOUSNESS WITHIN A FEW SECONDS.  HE WAS CONFIRMED THAT HE IS GOOD TO GO HOME BY HIMSELF.
received vaccine 19 hours after the vaccine was reconstituted /  was placed back into the refrigerator after it was reconstituted; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA636A, expiry date 31st May 2023) for prophylaxis.   On 8th October 2021, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The health care professional called that a pediatric age patient inadvertently received the Menveo 19 hours after the vaccine was reconstituted received in the left arm which led to incorrect storage of drug.  The office manager stated that Menveo was reconstituted and drawn up into a syringe yesterday around 4:45 pm from the day of reporting and was not administered until this morning at 10:40.  It was placed back into the refrigerator after it was reconstituted. The reporter consented to follow up viz email. The case US2021209451 identified as duplicate of US2021209460, so the case US2021209451 will be delete and all the information from the case will be merged into the case US2021209460, the case US2021209460 will be the case of record.
Patient notified administering pharmacist that she has a history of fainting after receiving flu shots. Two other pharmacists came in preparation to assist if needed. After the pharmacist administered the covid vaccine, the patient fainted for 1 second, regained consciousness.She refused medical treatment. Patient was breathing so Epinephrine was not administered. Patient was sweating and ice packs, water, and crackers were provided to her. She sat in a chair with her legs elevated for 1 hour with pharmacists closely monitoring her.
Increased heart PVC's within a week after second shot 4/8/21  and still continuing. Taking Metoprolol to manage but still ongoing. Not resolving. Sudden Sensoneural hearing loss 6/2/21 went to ENT and he prescribed high dose prednisone for 5 weeks, hearing returning to as it was but still have constant ringing in both ears (tinnitus)
shortness of breath, tested covid + weeks ago and dx with PNA.  Admitted on 4/3/2021. Pt had only 1 dose of vaccine, and thought the symptoms were r/t the side effects of the vaccine.  Pt d/c'd 4/7/2021
Chills, fever (103.5F), nausea, vomiting for 2 days treated with Advil 400mg every 8 hrs.
I have had a headache that I am unable to get rid of. The injection site reaction I had for a few days and then it resolved.
No adverse Reaction In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
Fever, sore throat, nausea & cough, headache, sneezing & hives.
Fever, chills, fatigue, muscle aches, headache, a little sore at injection point on arm.   No medication taken.  Took approximately 36 hours for adverse effects to subside.
Doses were administered from a vial that was punctured more than 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Mother reported labile fever commencing one week after vaccination, rash noted to upper torso (chest and back); lasted one week. Physical completed today, exactly two weeks after vaccination - rash is mostly resolved, noted to abdomen only.
Intussusception. First began with bloody diarrhea 1-10-09. Resolved 1-11-09. Recurred 1-14-09. US 1-15-09. Intussusception at cecum.  1/29/09 Received ER medical records of 1/15/2009. FINAL DX: cecal intussusception Records reveal patient experienced bloody stools.  Transferred to higher level of care by flight.  2/2/2009 Received hospital medical records of 1/15-1/16/2009. FINAL DX: ileocecal intussusception Records reveal patient experienced watery diarrhea & was dx w/rotavirus infection 8 days prior to presentation; 4 days prior to admit had bloody stools that resolved.  Day of admit had bloody mucous stool & taken to outlying ER where air enema only partially reduced IS & was transfered to higher level of care by flight.  Repeat air enema showed resolution of IS.  Surg consult done.  Admitted for overnight observation.  Did well & d/c to home.
Child had 2 vaccines in AM Hep B & PREVNAR - Both legs became very reddened shortly after given. No SOB noted at this time. Cold compresses given and observed for 20 min. Child sent home. Called at 125 pm and child was doing ok and sleeping. Called at 425 pm and mom said child was having trouble catching breath. Told to go to ER and F/U. Mom called in am child was ok. No more redness on legs & no SOB.
This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores around his lip and nose), VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 08-Mar-2021, the patient experienced ORAL HERPES (Cold sores around his lip and nose). At the time of the report, ORAL HERPES (Cold sores around his lip and nose), VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Concomitant medication included blood pressure and diabetic medications. The patient stated he had his second dose since then with no adverse events. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Event outcomes were updated to recovered/resolved and second dose taken added in I narrative.
No adverse event; Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Administration error 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to adult patient from pediatric vials of Moderna COVID-19 Vaccine).    No concomitant medications were reported.  HCP stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. HCP was not aware of any adverse events after the vaccines were given.  No treatment medications were reported.  Out of 26 patients this case contains details of patient 22.
pt recv vax 15AUG95 & 29AUG95 pt devel a rash all over body, but according to mom was not very sick;
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported. It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.
Pt. presented to nurse with complaints of dizziness and scratchy throat. Nurse contacted on-site medics immediately. On-site medics assessed patient. Per patient's request, pt. was transferred to the ER via ambulance.
4DEC90 PM - low grade fever to 101; Lt leg mildly red, warm, sore. 10DEC90 lt leg became very swollen "baseball size" purple-red w/ inc warmth & tenderness no inc systemic fever- dx cellulitis & hematoma.
24 hours later: fever achy muscles fatigue chills  it all went away after 24 hours
02/05/2021 PM onset of chills, extra tired, no fever; 02/06 - nausea, low grade fever, and extra tired , moderate not severe; 02/07- generalized crimson body rash, did not itch; 02/08 Improved