chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23jan90 pt vax hepta B .pt ex pain and tenderness at inject site.  w/i 24hrs pt ex stomach cramps, muscle and joint pain, fatigue, h/a, dizziness, fever, and diarrhea. sx continued for 12 days. pt seen by physician and treated for sx.
Information has been received from a physician referring to a 9 and a half months old infant patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ orally (lot#, expiration date, dose and strength were not reported). On an unknown date the patient received their third dose of ROTATEQ at "9 and a half months" of age (considered as inappropriate schedule of drug administration). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter did not want to be contacted.
Patient was admitted as inpatient on 11/25/21 due to acute respiratory disease due to COVID-19 virus. Patient was tested for COVID-19 and was positive on 11/24/21.
pt recvd vax, taken to er at 6:30pm w/ t 99.4; was vomiting & screaming; crying; high pitch cry lasted from 6:30pm to 10:30pm; tx w/ gatorade, apap; recommend infant dt #3;
I became lethargic and achy by 4 PM of Friday (the day I received the vaccine).  Early Saturday morning I became feverish, aching all over and had shivering that I could not seem to subside.  I slept the bulk of the day on Saturday and all night into Sunday morning about 6:00 AM.  Most of the symptoms had subsided by that time.
I had a headache at the top of my head, and a tingling sensation down my left leg from my buttocks to my calf. The tingling lasted until the next morning then went away. On 1/3/2021 I experienced a strong headache followed by facial numbness and tingling. This lasted for an hour or so and slowly subsided. The headache lingered for 3 days.
Abnormal heartbeat the day following vaccination.The highest bpm was 130+; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the day following vaccination, the patient experienced abnormal heartbeat. The highest bpm was 130+ and for no reason(was not excising, only sitting on a chair listening to zoom lecture), calmed down after laying down but had a few more consecutive abnormal heartbeat occurrences. No longer experience such side effect now. On an unknown date ,patient underwent heartrate measurement and the result was 130+ bpm. The clinical outcome of the event abnormal heartbeat the day following vaccination was recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Update the event verbatim to "Abnormal heartbeat the day following vaccination. The highest bpm was 130+ "and recoded it to heart rate increased. Treatment received ticked No. Remove the wording "Unit: {DF}" from lab data results field.  No follow-up attempts are needed. No further information is expected.
Swollen feet and ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet and ankles) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen feet and ankles). At the time of the report, PERIPHERAL SWELLING (Swollen feet and ankles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines include  levothyroxin.  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was unknown
Pfizer Booster shot (#3). Fever, chills, swollen armpit on injection arm, aches and pains from jaw to toes
Injection site has been sore but after 9 days it is a round swollen area that is still sore
No additional AE reported; Temp excursion of 47.9 F for 47 min on 01-DEC-2022; third dose of LIQUID PEDVAXHIB at 19 months old (reported as 18); This spontaneous report was received from a health care professional and referring to a 19-month-old (also reported as 18-month-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (lot #W006596, expiration date: 11-OCT-2024; dose and strength were not provided) administered intramuscularly in left thigh for prophylaxis and the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (lot #W023937, expiration date: 06-DEC-2023; dose and strength were not provided) administered intramuscularly in left thigh intramuscularly for prophylaxis (product use issue).  The administered doses of the vaccines experienced a temperature excursion since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes (product storage error). Digital data logger was involved. No additionally adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA001021:
1/21 vaccination Ten minutes after vaccine, felt like something crawling all over my. SOB, went to the ER they gave steroid injections and Benadryl.  Woke up that evening and I had SOB. I took EPI pen, transferred to ER and administered another EPI pen with steroid pack.  Third visit was to the Urgent care; administered steroid pack.  Fourth visit with PCM
Started with what I thought was a sinus infection- pain on one side of my face and congestion.  Had serious chills and fatigue on Day 1 Fatigue, diarrhea, sinus pressure/congestion Days 2-4 Mild Chest tightening in addition to the symptoms mentioned above  on days 4-9 (O2 saturation remained above 97), but ultimately went away and did not require intervention  Mild Fatigue continued for ~2 weeks to to the point that I could not maintain my regular work out schedule
Soreness at injection site; Diarrhea; Nausea; Low fever; Dose 1 on 03Aug2021 and Dose 2 on 08Oct2021; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 08Oct2021 at 13:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, stress processing disorder, central auditory processing disorder, penicillin allergy and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and drospirenone/ethinylestradiol (DROSPIRENONE; ETHINYLESTRADIOL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 09Oct2021 at 08:00, the patient experienced soreness at injection site, diarrhea, nausea and low fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at injection site, diarrhea, nausea, low fever were resolved on an unknown date in Oct2021.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 12-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the right arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Erythema of 7cmx9cm to left deltoid. Complaints of tenderness and heat to area beginning 5/12/05 at 17:00. Motrin PO given and ice pack applied.
Diagnosed with Bell's Palsy.  Drooping right side of face, unable to close right eye.  Lasted approximately 3+ weeks
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L029615 with expiry date 15-MAY-2017 and lot # M019706 with expiry date 24-OCT-2017 (dose was not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014444: US-009507513-1612USA014601: US-009507513-1612USA014599:
the Bivalent booster made her vertigo off the charts like fuel in a fire/has ringing in her ears, vertigo issues; almost passed out at the office when her vertigo got way out of control; fatigue; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient in her 50's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "vertigo" (ongoing), notes: COVID as a disease made her vertigo worse. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "got COVID a while later". The following information was reported: VERTIGO (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "the Bivalent booster made her vertigo off the charts like fuel in a fire/has ringing in her ears, vertigo issues"; PRESYNCOPE (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "almost passed out at the office when her vertigo got way out of control"; FATIGUE (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown". Clinical information: She was explaining that she did fine with the original vaccines for COVID 19 but then got COVID a while later. COVID as a disease made her vertigo worse. The following year she received a Bivalent booster (Pfizer BioNTech Bivalent Booster) and about a week later almost passed out at the office when her vertigo got way out of control. She said the disease made her vertigo worse, but the Bivalent booster made her vertigo off the charts like fuel in a fire. She still, today has ringing in her ears, vertigo issues, fatigue and a cough but didn't want to be contacted. She just explained she has vertigo and that was all known. The event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix and had little bit of pain at the injection site that lasted for maybe a day or 2 days. The reporter did not consent to follow up. The pharmacist was retired, no information was available for vaccine used
PATIENT NOTICED THAT AN APPROXIMATELY 4 INCH DIAMETER AREA AT THE PREVNAR 13 INJECTION SITE WAS PAINFUL, RED AND WARM TO THE TOUCH ON 9/21/16. SHE NOTIFIED THE PHARMACY ON 9/25/16. SHE APPLIED ICE.
About an hour later, slight headache. Around 2am on 1/12, woke up with hip joint pain. On 1/13 slight injection site pain and continued hip pain, and around 11am had slight nausea that went away. 1/14 still have hip pain.
my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.). At the time of the report, PAIN IN EXTREMITY (my right upper arm is tender and in pain. It hurts to raise my arm. I sleep with a pillow under it at night because it hurts to lie on it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment information was received by the patient.
Significant nerve pain without a typical cause. A full day of recovery from that pain. Slight fever and chills, with fatigue. Since then, my period has been heavier and inconsistent in arrival (was predictable and light before).
PATIENT RECIEVED 7TH DOSE OF COVID-19 VACCINE TODAY (MODERNA). PREVIOUSLY RECEIVED ON 02/13/21 (PFIZER), 03/06/21 (PFIZER), 07/31/21 (MODERNA), 08/28/21 (MODERNA), 09/25/21 (PFIZER), AND 10/29/21 (J&J).
One day after Moderna Covid 19  vaccine   eua my wife noticed a blister on my forehead.  I initially dismissed it as one of those things.  Over the next couple of days the blisters spread in a line on my forehead.  Soon after the blisters were around my ear.  I went to an urgent care and was diagnosed with shingles.  Currently the blisters on my forehead are receding, but the blisters behind my ear are still painful. I received valtrex for the treatment of shingles
Information has been received from a registered nurse concerning an adult female patient who on 03-Sep-2003 received a "primary vaccination" with a dose of MMR vaccine live (Lot #645265/0097N). Two weeks post vaccination the patient developed a rash and slight fever. Unspecified medical attention was sought. The registered nurse also reported that an adult male patient experienced rash and slight fever following vaccination with a dose of MMR vaccine live (WAES 0309USA01604). Additional information has been requested.
SORE/TENDERNESS AT INJECTION SITE.  DIFFICULT TO RAISE ARM.  LASTED ABOUT 36 HOURS ABOUT 6 - 10 HOURS AFTER INJECTION I NOTICED I WAS HAVING "TREMORS" AS MY HANDS WERE SHAKING AS I WOULD HOLD A PAPER OR SOMETHING IN MY HANDS.  THIS IS NOT TYPICAL.  ONLY HAPPENED EVENING OF INJECTION. CONGESTION EVENING OF INJECTION (RUNNY NOSE/SNEEZING WAS MY 1ST SYMPTOM WHEN I HAD COVID19) FELT TIRED FOR ABOUT 36 HOURS AFTER INJECTION. SEEMED TO BE BACK TO "NORMAL" WITHIN 36 HOURS.
01/01/2022/Present: Sharp but variable pain, right side above waist, accompanied by excessive gas, Simethecone, Sucralfate (1g), X-Ray, not yet resolved. 3/29/2021: Difficulty urinating; Urolift Procedure,  8/30/2022: Continued difficulty urinating, Office visit with Dr. prescribed Oxybuynin Chloride ER 10 Mg.; ongoing evaluation with follow-up appointment 11/1/2022. 9/10/2022: Vertigo (dizziness, nausea), has lasted 3 1/2 weeks, but seems to be resolved by 10/6/2022 following 2 visits with, FNP, and dosing with Preednisone and Sucralfate.
pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet; left leg is heavy when she walks; muscle spasms; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks), MUSCLE SPASMS (muscle spasms), MYALGIA (muscle aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Mar-2021, the patient experienced PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks) and MUSCLE SPASMS (muscle spasms). 15-Mar-2021, the patient experienced MYALGIA (muscle aches). On 14-Mar-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks), MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle aches) outcome was unknown.            No relevant concomitant medications were provided. Patient took a muscle cramp pill for her pain. The action taken for mRNA-1273 was not applicable.
Initial and follow-up information has been received through the Merck pregnancy registry from a 23 year old female, with no pertinent medical history, who on 19-APR-2007 was vaccinated IM with a third dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient became pregnant.  Date of conception was reported as 31-MAY-2007.  The patient reported a beta-human chorionic gonadotropin test (unspecified) was performed.  There were no adverse reactions.  At the time of the report the outcome of the patient was unknown.  On 29-FEB-2008 the patient gave birth to a liveborn infant via cesarean section.  The indication for the cesarean section was not provided.  The infant was healthy, normal, and delivered at full term.  Additional information is not expected.
COVID breakthrough. The first 2 weeks of infection I had runny nose, headache, cough, tiredness. The following 3-4 weeks I developed long COVID symptoms which included, extreme fatigue, nausea, shortness of breath, and increased heartbeat. I am still experiencing some of the symptoms until this day.
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.   It was reported that vaccines were stored in freezer and took out one to two vials and placed in fridge each day as .needed
Pt received PNEUMOVAX and FLUZONE HD in left arm on 10-11-16, pt reported severe pain beginning evening after injection, reported to pharmacy on 10-13-16 with pain and inflammation/redness covering about 80% of upper left arm.  Pt was referred to physician for evaluation.