chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinic nurse reports that at about 11:40 pt reported she was dizzy, couldn't feel her hands and feet, pt reported her "throat felt numb"; tachypneic, tachycardic; BP was 140/90  Clinic nurse had patient lie down, continued monitoring while EMS was called. Pt never had respiratory distress or difficulty breathing- but breathing was faster than normal.  EMS arrived; pt remained stable and transported to Hospital.  Per Hospital ER visit notes: Upon arrival to ER, pt reported she began to feel short of breath after the vaccine was given; states she started to cough; felt as if she could not move her arms; she was dizzy and wheezing.  EMS started a Duoneb. No fevers or chills Progress Notes:  There does appear to be a cough.  There is some rapid breathing.  The Duoneb was stopped.  She was tachycardic.  We will give oral Benadryl.  Benadryl 50mg capsule given. Re-evaluation at 12:50pm she states she feels much improved.  She does continue to have bilateral upper extremity tremors.  She continues to have a mild scratchy voice.  At 1:45 the patient states she is back to her baseline; states she is no loner shaking, her cough has stopped; states that she still feels mild soreness to her throat that she believes is from a cough.  Eager for discharge.  Diagnosis per Hospital:  Moderna vaccine allergic reaction
she experienced pain on the right arm after the first dose.; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, she experienced pain on the right arm after the first dose. (pain in extremity). The Caller is scheduled for her second dose on the 22Feb and asking if it's safe to take Tylenol for the fever. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Post 2nd Dose: Stiff neck accompanied with pressure spreading down to bilateral shoulders. Pressure absent the next day, stiff neck lasting approximately 24-32 hours from onset.
little headache; stomach pain; constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), CONSTIPATION (constipated) and HEADACHE (little headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), CARVEDILOL, ENALAPRIL, AMITRIPTYLINE, LISINOPRIL, MEMANTINE, DILTIAZEM, ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN and CHLORTHALIDONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced CONSTIPATION (constipated). On 29-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced HEADACHE (little headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) had not resolved and HEADACHE (little headache) outcome was unknown.            Treatment included:  laxative medication ,patient  ate grains with vinegar for constipation and no improvement according to the patient.  Action taken with mRNA-1273 in response to the event was Not Applicable.  Upon internal review on 04-AUG-2021, the age was corrected to 65 years.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-MAY-2021 and contain now new information. The consumer does not have an email id
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-NOV-2017 and 18-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 30-JUN-2019; lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
no adverse event; PNEUMOVAX 23 that underwent a temperature excursion was administered; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-JUL-2021 the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe (lot number T036820, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 01-JUL-2022) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion above 9°C (22.0C) for 44 hours 0 minutes and 0 seconds, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
LARGE RED HARH HOT PAINFUL AREA ON LEFT UPPER ARM TO ELBOW. ALSO HAS A PAINFUL RED AREA UNDER LEFT ARM PIT. RIGHT ARE SORE AND PAINFUL WITH SOME SWELLING.
Delayed injection site reaction: redness, hot to touch, itching, slight swelling. This is the second day of the delayed reaction so it persists although itching has stopped.
severe myalgias, weakness, mild headache  01/04/10 MR and DC summary received for DOS 10/13/09-10/15/09.  DX: myositis, influenza virus, vaccine adverse reaction. Pt c/o muscle pain and weakness. Pt had progressive achy muscle in arms and legs, HA, runny nose, dry throat. On examination: Pt A Ox3 and no nuchal rigidity. Tx: Vit D, acetaminophen. Pt discharged home in good condition.
Shingles on stomach for 5 days then changed in to what seemed like chicken pox.  Currently still battling the symptoms of this shot.
Information has been received from a physician assistant concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  The patient recovered before leaving the office.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information have been received from a physician's assistant and a physician concerning a 15 year old female with scoliosis and a history of chondromalacia patellae who on 30-JUL-2007 was vaccinated with the first dose of GARDASIL (lot #658282/0929U), IM. Concomitant medication was not reported. On 30-JUL-2007 within 60 seconds of receiving the vaccination, the patient experienced a vasovagal syncope episode with systolic blood pressure in the 80's. The patient was resuscitated with juice and placed in the Trendelenburg position. Subsequently on 30-JUL-2007, the patient recovered from the vasovagal syncope episode before leaving the office. Additional information is not expected.
Severe generalized hives, itching, burning sensation, 48 degree after Tdap admin. Tx with PO steroids and injection.
Patient was given 0.5mL for a booster that should have been 0.25mL, incorrect dosage indicated.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided. Date the vial was initially stored in the refrigerator 24Sept 2021 Date of administration of vaccine 24Oct2021 - 27Oct 2021
Medication Error occurred when new Pfizer vial mixed with 0.3cc NS , 0.3cc of vaccine was drawn from mixed vial, and administered to patient. Pt was given increased dosage than the recommended dosage with incorrect reconstitution with NS. This was the patient's booster dose. She denied any significant immune response to her first or second dose on 1/14/21 and 2/04/21. Pt tolerated administration of incorrect dosage of vaccine without symptoms or difficulties.
pt recvd vax; mom reported high pitched crying x 3 hrs p/ 1st dose of vax;MD recommended infant have only DT;
Patient experienced syncope after receiving Hep A, influenza, MenACWY, Tdap, and varicella vaccines. Briefly unresponsive, pale complexion. Recovered quickly; monitored for almost 1 hour.
This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 14-MAY-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 9°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
I had an extreme hypoglycemic episode within 48-hours of receiving the COVID-19 vaccine which resulted in my being transported to the hospital by ambulance.
5/15/9 - MMR given with Hep A, Hib, DTaP, PCV-7, VZV - 5/28/09 - Rash after fever - 6/02/09 - Vaccine reaction noted with rash, fever.
Pain at injection site with increased pain around the deltoid region starting 24 hours after injection and lasting for 48 hours. The deltoid was hot to the touch during the increased pain period described above.  The pain and heat resolved approximately 84 hours after the injection.  Tenderness and mild pain to the touch in the area under the armpit of the same arm where the vaccine was injected. This tenderness and mild pain started approximately six days after injection.  This has not resolved yet.
Right arm-deltoid injection site: erythema, warm to touch, induration, pruritis, c/o pain.
ADMINISTERED VACCINE OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The reporter stated that, on 22-MAR-2021, they administered 2 doses of product to the 2 patients at their facility, However these 2 doses was exposed at the room temperature for more than 2 hours recommended (10-15 mins past the recommended 2 hours) (administered vaccine out of temperature range).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine out of temperature range was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343668-covid-19 vaccine ad26.cov2.s-administered vaccine out of temp range. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
"Moderna Covid-19 Vaccine EUA" Red injection site about 3 x 2 inches with a fever in arm.  Low grade fever, tired, all of my muscles ached and became tight.  Symptoms lasted 24 hours.  Tiredness lasted 48 hours.  All good after that.  Arm stayed red and warm for 3-4 days
Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts  at injection site. Very tired.  slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.
Erythematic, morbilliform rashes. Face, legs and hands (palms and dorsal surface of hands). Itching-mild itching. Developed 24 hours after Recombivax HB vaccination. Prednisone 20mg two times a day for 5 days given.
administered an expired Daptacel to a patient,with no reported adverse event; Initial information received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old male patient who was administered an expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an expired unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot C5893AA and expiry: 21-Jun-2023 via unknown route in unknown administration site as prophylactic vaccination (immunization), with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired daptacel to a patient,with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tinnutis,  About 29 hours after my first dose, it began to sound like water running in my right ear.  Then on the 6th day after my first vaccine, the same sound began in my left ear.  This is the 7th day after my first dose and the sound continues continuously in both ears.   Hearing was reduced
Administration of the vaccine to a 15 years old patient; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of the vaccine to a 15 years old patient) in a 15-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of the vaccine to a 15 years old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of the vaccine to a 15 years old patient) had resolved.          No Concomitant medications were reported. No Treatment information was reported.; Sender's Comments: This report refers to a case of product administration to a patient of an inappropriate age (15 year-old) for mRNA-1273, lot # unknown, with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
BRAIN FOG; VERY HEAVY FEELING; FEELING GRUMPY; LOTS OF ACHES AND PAINS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 brain fog, very heavy feeling, feeling grumpy, lots of aches and pains, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain fog, lots of aches and pains, fever, very heavy feeling and feeling grumpy was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization.     The patient's past medical history included Vertigo (She usually had mild vertigo from Meniere's) and Meniere's disease (she had for 6-7 years). Previously administered products included for Drug use for unknown indication: Pfizer (patient was affected for months with side effects from the boosters she received (one Pfizer)). Past adverse reactions to the above products included Adverse event NOS with Pfizer.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall). At the time of the report, VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall) was resolving.              Treatment drug was not reported.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Information has been received from a physician concerning a 9 year old patient with asthma who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Two days later the patient was hospitalized with a large local reaction with a fever and was diagnosed by another physician with cellulitis. It was reported that the patient had a WBC of 22,600 and an increased C-reactive protein of 8.06. It was also reported that after antibiotic therapy, the white blood cell count dropped to 7800 and the C-reactive protein to 2.33. Additional information has been requested. The follow up received on 3/12/03 states it was reported that the child was admitted for a few days and that the exact day of discharge is unknown. On 2/24/03 the child had another visit to the physician's office and it was documented in the chart that at the injection site there was mild erythema, some tenderness and the swelling was completely resolved. The physician did report that the multidose vial of the vaccine that was used was cultured and the culture was negative; the remainder of the vial was discarded. Additional info has been requested.  Reported on 04/04/2003: "Follow up information received from a registered nurse indicated that on 02/14/2003 the patient developed a temperature of 102 degrees.  The reported indicated that the patient was hospitalized for 5 days.  CT scan revealed cellulitis.  It was noted that the patient recovered.  No further information is expected.
Patient received vaccine on 11/28/17. Patient came into the pharmacy on 12/1/17 to complain about the reaction. He said the reaction started the night of 11/28. He has a softball size ring near the injection site. The ring is hot, red, and sensitive to the touch. He said it has not gotten worse or better since 11/28. The patient also experienced chills and nausea throughout the last couple of days. I called his primary care physician to explain the reaction and we set up an appointment today at 2:15pm for him.
Patient tested positive for COVID 2/8/2021. URI symptoms started before or around the time she received the vaccine.
Pt had redness of irregular shape with irregular borders on right arm  where shot was given.  Red area is warm to the touch and slightly raised.  Area is approximately 143X140 mm in size.  Pt says she ran a fever on Saturday but temp today is 98.8 degrees Fahrenheit taken tympanically.
A COUPLE OF DAYS AFTER TAKING THE MODERNA VACCINE, I BROKE OUT IN HIVES.
Half dollar size cellulitis left deltoid. Black and blue-day of injection large red, hot area-now a half dollar sized cellulitis.
90 yr old female developed redness from DTAP injection site 12" x 12" down (L) arm from deltoid - appeared like scalded skin, non tender with some swelling - placed on KEFLEX for cellulitis with f/u on 11/15/13.