chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician and a medical assistant for the pregnancy registry for GARDASIL concerning a 19 year old female with no drug reactions or allergies and with a history of papanicolaou smear abnormal and vaginosis bacterial, who on 15-SEP-2008, was seen in the office for symptoms of painful vaginal discharge. During her appointment she was vaccinated with her first dose of GARDASIL (lot#661046/0381x), 0.5 ml, IM. On the same date, she was placed on therapy with amoxicillin 500 mg, three times a day, for urinary tract infection. It was later found prenatal forte. On 22-SEP-2008, ultrasound was performed and results were normal with comments that estimated delivery date was 03-APR-2009 and the patient had been pregnant for 12 weeks and 3 days. The patient sought medical attention in the office. Additional information is not expected. Follow-up information was received from a pediatrician via Pregnancy Questionnaire for GARDASIL. On 25-JUL-2008 the patient was treated 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. On 15-SEP-2008 the patient was treated with AMOXICILLIN 500 mg three times a day for urinary tract infection. On 15-SEP-2008 the patient was vaccinated with GARDASIL (lot # 661046/0381K) and started prenatal Forte tablet one daily. It was noted the patient had no previous pregnancies and date of LMP was unknown. Infections or illnesses during pregnancy inlcuded +group B strep vaginal culture and + bacterial vaginosis. On 01-OCT-2008 the patient was treated for 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. There was no complication during pregnancy. Diagnostic test during pregnancy also included ultrasound for fetal survey with normal results on 21-JAN-2009 and ultrasound for biophysical profile with normal results on 06-APR-2009. On 10-APR-2009 the patient had a low tranverse C-section due to failure to progress and delivered a normal female baby with no congenital anomalies, weight 8 lbs and 4 ozs, length 21 inches. Apgar score 9/9 and head circumference 13 3/4 inches. It was reported that the baby has failed right ear on hearing screen test and the test would be repeated at two months of age. Upon internal review, C-section due to failure to progress was determined to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
6PM COUGH BEGAN. VERY DEEP COUGH. COUGHING EVENTUALLY BECAME UNCONTROLLABLE BY 8PM, TROUBLE BREATHING, CHEST TIGHTNESS, AND WHEEZING AT THAT HOUR. WENT TO EMERGENCY ROOM AND WAS ADMINISTERED ALBUTEROL (INHALED). AFTER 1.5 HRS OR SO, BREATHING PROBLEMS AND COUGH SUBSIDED. INTENSE BODY ACHES FOLLOWED WITH NAUSEA AND HEADACHE.
headache and feeling of nausea. patient laid down for 30, drank water, had spouse pick him up but still dizzy
Itchy eyes, itchy gums, runny nose and sore throat started at approximately 4:30pm 3/19/21  Nosebleed (no prior nosebleed in life) at approximately 7pm 3/19/21 Treatment: allergy medicine, benadryl, at 2pm 3/21/21
Myalgia, Rash, UticariaPruritus, warmth at injection site Narrative:  The patient reported experiencing the following reaction. Nine days after receiving the first dose of the vaccine, she reported a rash at her injection site which was itchy, warm to the touch and sore. She took one dose of loratadine 10mg and applied desonide 0.05% cream to the area.
Blood pressure have been high,can't walk far ,hard to breed,,light headed,A-fib,and the hospital E.R. done scans ,Blood tests, and everything came back negative,,,
On March 14, 2022, which was  day 16 days after receiving the vaccine my son woke up with an extreme allergic reaction. He had pox-like eruptions on his chest, back, forearms and calves. His eyelids and under-eye area were swollen and red. He had red swellings on his neck. He was taken to the same office where he had received the vaccine. They prescribed him a five day pack of prednisone to counter the allergic inflammation.
Pt was given 0.3mL of undiluted Pfizer 5-11 vaccine. Pt and his family were contacted as soon as mistake was noticed and were advised to monitor pt for any concerning symptoms. Per supervisor, pt was fine when contacted on 5/31/2022. Had sore arm and no other symptoms.
On third day after injection I had an achy head and ringing  in my ears for two full days.  On fifth day I felt normal myself.  No after affects since. Have full hearing capabilities.
per mom pt screamed from 830PM or 2FEB thru 930AM on 3FEB t up to 102, fever 3FEB in office 10AM 98.9 R;
immunocompromised had a 0.25 instead of 0.50 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Immunocompromised.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 01-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml). On 01-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml) had resolved.            No concomitant informations were reported. No treatment informations were reported.
flu like sx very severe sore arm-advised APAP & antihistamine every 4 hrs for 3 days;
Rubber core found in vial used for injection. Patient reported no signs/symptoms unusual post vaccination.
11cm X 10cm erythema; 4 1/2cm X 4cm induration on left arm.
1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.; Really Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) and PAIN IN EXTREMITY (Really Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AOL) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medial history reported). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) and PAIN IN EXTREMITY (Really Sore arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) outcome was unknown and PAIN IN EXTREMITY (Really Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Medication regularly taken: Blood pressure medication, Lipitor, fluid pill, thyroid medication. No Treatment information provided
Arm, shoulder sore, impaired perception, joint muscle pain which kept her awake. Pain in her upper back & ribs (approx 3 days).
screaming cry began 3-31/2hr p/vax given lasting 4-5hr;phoned MD to report that evening & was advised to give APAP & watch carefully;was  irritable next day;t101 ax for about 12hr p/vax;
Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 020F21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 10:45 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Mar-2022 at 10:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.  The vaccines were initially placed in the refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions.    This case was linked to MOD-2022-503838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received and contains non significant information.
little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 03-Jul-2010 and Graves' disease since May 2016. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCT) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 17-Feb-2021, the patient experienced RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy). The patient was treated with PREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated laboratory data, added dose 2 details for suspect product, treatment medications and event details was added. On 07-May-2021: fallow up in patient tab  patient race height weight and medical history was added in product tab concomitant drug dose route of administration and one new drug allagra  was added On 10-May-2021: no newinformation
Her incident report "states patient had a" racing heart and tightness in throat and chest area, VSS, taken WNL.  RN gave her epinephrine, 911 called, S/S's resolved, patient not transported, patient returned to work.
On 10/26/2000, the patient's mother was concerned that the patient might have chicken pox. On 10/27/2000 the child was diagnosed with chicken pox. The child was seen by the physician who indicated that the child "most likely" had chicken pox with well over 100 lesions. It was reported that the patient subsequently recovered. No further information is available.
Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours following vaccination; This is a spontaneous report from a contactable consumer (patient reported for herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration at the left arm on 20Jan2021 at 16:00 (04:00 PM) at single dose for Covid-19 immunization, administered in a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included prior malignancy s/p chemo and targeted therapy (last dose approximately 3 years ago). The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe vomiting and diarrhea 2 hours following vaccination on 20Jan2021 at 18:30 (06:30 PM). Therapeutic measures were taken as a result of the events which included ondansetron, oral fluids, and lorazepam. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
By that night, patient started feeling very achy.  Injection site was very swollen, red, and warm.  Patient had muscle and joint aches.  That night, patient felt a bit nauseous and woke up around 3am to read vaccine information.   Patient took Advil, which helped through the night.  Next day, patient still felt bad, face swollen and eyes were puffy.   Patient contacted the pharmacy for follow-up and directed to doctor. Doctor saw patient on Tuesday but no guidance/treatment given; told not to get the second dose.  Patient was flat out in bed and could not function.  Patient had fever of 99.   Body aches and arm symptoms show a bit improvement but then cough started.   Patient continues to take the Advil and now Mucinex for cough.   Patient is at 30% recovery.  Per patient, patient's vaccine information should specify how bad adverse events could be; only soreness and fever was mentioned--there needs to be more education.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 2 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced flu like symptoms and was wondering how long they would last. The representative answered to the patient that symptoms typically last 2-3 days but might vary from person to person. The representative advised the patient to follow up with their physician
Patient received second Pneumovax-23 Vaccine in the same 24 hour period. 201409301540 RUA-site of second penumonia vaccine. Slight redness and induration. 201409301740 RUQ Arm remains slightly pink at the vaccine site with no swelling.
Nephrotic syndrome with AKI. Kidney biopsy showed interstitial nephritis and podocyte foot process effacement. He was treated with pulse steroids and plasmapheresis with improvement.
Injection site pain, swelling, redness. Headache. Fever. Lower back pain. Extremely tender and painful left armpit
This spontaneous report was received a nurse director concerning about a 1-year-old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was vaccinated with PROQUAD and M-M-R II both administered concomitantly as prophylaxis (strength, dose, frequency, route of administration, site of administration, therapy type, lot number and expiration date of both vaccines were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm sore). At the time of the report, LIMB DISCOMFORT (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.  Treatment actions was unknown.
WITHIN 24 HOURS OF A TETANUS SHOT I HAD EXTREME HEADACHE, MUSCLE PAIN, FEVER OF 101, INJECTED ARM WAS VERY PAINFUL TO MOVE AND UNDER ARM WAS SWOLLEN. I STAYED IN BED FOR 2 1/2 DAYS UNTIL I FELT BETTER.  I HAD ASKED THE NURSE TO SEE IF THERE WAS A PRESERVATIVE IN THE SHOT. SHE SAID IT WAS PRESERVATIVE FREE. I HAVE HAD SIMILAR REACTIONS TO FLU SHOTS AND NO LONGER GET THEM.
Had itching of face and hands apprx. 7 days after receiving immunization. Pt states took Benadryl symptoms subsided in apprx. 30 minutes.
Patient presented w/ mother to receive meningitis vaccination series and flu vaccination. Menveo vaccination was provided. Upon further conversation it was noted an clarified with the patient and mother that they desired the Men B vaccination series. They were informed wrong vaccine had been provided and reported no symptoms at that time.
No adverse event; child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series).    No concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No current conditions and medical history were provided. The reporter stated that on 24-MAR-2015, 30-MAR-2015, 09-APR-2015, 20-APR-2015, 23-APR-2015, 26-APR-2015, 05-MAY-2015, and 07-MAY-2015, an unspecified number of patients were vaccinated with doses that were exposed to temperatures outside of the recommended range of ROTATEQ, lot # J011340, expiration date 14-MAY-2015, oral. No concomitant medication therapy was provided. No adverse effects has been reported. This is one of two reports received from the same reporter. Additional information has been requested.
active mononucleosis; A fever for 10 days and aches and chills developed 10 days after vaccination; A fever for 10 days and aches and chills developed 10 days after vaccination; A fever for 10 days and aches and chills developed 10 days after vaccination; This is a spontaneous report from a contactable other health care professional (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, administered in arm left on an unknown date in 2021 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) within two weeks included escitalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. On 19Jan2021 at 12:00, the patient experienced active mononucleosis, a fever for 10 days and aches and chills developed 10 days after vaccination. It was determined to be a reactivated EBV, so active mononucleosis. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-1 test (Nasal Swab): negative on 22Jan2021 and sars-cov-1 test (Nasal Swab): negative on 27Jan2021. Therapeutic measures were taken as a result of the events and patient was given Vitamins and Ibuprofen. The outcome of event was resolving.  Follow-up (19MAY2021): Follow-up attempts completed. No further information expected.
By report from mother: day after vaccines, pt developed a red area around left arm vaccine site and also a blistery ring of lesions around injection site. Went to different medical facility who gave her Keflex and Valtrex for "infection and shingles."
Patient had episode of intense right eye pain as well as hypertension 170'2/110's with no previous history of HTN.
Arm is red, warm to the touch, getting more swollen over the past few days and painful
About 6:00 pm parents noticed he was more fussy then usual and he wasn't feeding normally. A few hours later (about 3) noticed his legs were almost double in size so took him to ER. They didn't do any treatment and it slowly went away the next day. Also other note, the nurse that dose his vaccines. Started using a longer needles and he has not had problems since.
REDNESS, ITCHINESS, AND BUMPS ON LEFT ARM AND HASN'T GONE AWAY SINCE I GOT THE SHOT.