chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed severe headache above eyes and ear stuffiness on 7/12/08.  Headache eased on 7/16.  On 7/14/08, in the evening, developed chills, shaking, and fever.  Fevers >102 degrees Farenheit continued on and off from Monday 7/14/2008 through 7/17/2008, evening.  On 7/14/2008 during the evening, developed body aches, dizziness, weakness and increased tiredness.  Visited Primary Physician on 7/15/08, who could not identify any bacterial or viral cause.  He had suggested this could be related to adacel administration.  On 7/17/08, fever seemed less in the evening, but developed another headache with frequent jolts of pain shooting down my Left Temple area.  Body aches continued especially in lower back, and have began feeling hypersensitive on the skin on my scalp, axilla, back, abdomen, groin, and thighs.  Dizziness continued, lethargic and sleeping frequently. Currently, 7/21/08, the headaches have diminished, no noted fever, but still having skin hypersensitivity, dizziness when moving eyes and milder body aches.
Information has been received from a licensed practical nurse concerning a 6 year old female pt with a Cefzil allergy who on 05/01/1996 at 10:30am was vaccinated with the first dose of varicella vaccine in the left thigh. There was no illness at the time of vaccination and no concomitant medication. On 04/21/2001, the pt developed chicken pox with 20-30 vesicular lesions. The pt sought unspecified medical attention. The pt recovered on 04/27/2001. No further info is expected.
Hyperthyroidism after 2nd dose; Subacute thyroiditis after 2nd dose; Inflammation after 2nd dose; Nodules in the thyroid after 2nd dose; dysregulated thyroid hormones after 2nd dose; This is a spontaneous report from a non-contactable consumer. A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via unspecified route on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via unspecified route on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced subacute thyroiditis, hyperthyroidism and Inflammation. The patient underwent an Ultrasound thyroid that showed nodules in the thyroid with dysregulated thyroid hormones, hyperinflammation and Severe hyperthyroidism three weeks after second vaccination. The time to onset was 1 month. The patient was treated with prednisone for his Severe hyperthyroidism. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
General sadness; She just feels really emotional; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported for herself that who received first dose of BNT162B2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER2613; Expiration Date: 30Jul2021) (at the age of 56-year-old) as SINGLE for covid-19 immunization. Medical history included breast cancer survivor from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) One tablet once a day and triamcinolone acetonide (NASACORT) Once a day in nose taken for an unspecified indication, start and stop date were not reported. On 31Mar2021, the caller was having what she thinks was a side effect from the vaccine but she was not sure, she did not see it listed on the paperwork. Its odd but the side effect was general sadness. The caller wants to know if this can be from the vaccine. The caller was not a sad person, she just feels really emotional (In Mar2021). The outcome events was unknown.  No follow-up attempts are possible. No further information is expected.
Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions. Total number of vials/doses was 28. No treatment medication was reported.
Severe headache; nausea; dizziness; joint pain; injection site swelling and redness; injection site swelling and redness; fatigue; fever; This is a spontaneous report received from contactable consumer (patient) reported for herself. A 44-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: ER8729), via an unspecified route on 08Apr2021 at 09:45 (age at vaccination: 44-year-old), as a single dose for covid-19 immunization. Medical history mentioned as none. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No allergies were reported. Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 09Apr2021 at 05:00, patient experienced severe headache, nausea, dizziness, joint pain, injection site swelling and redness, fatigue and fever. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Received vaccine 12/14/21 at about 3:30pm, felt run down and flu-like that evening.  Woke 12/15/21 felt flu-like,  achy, weak, and short of breath.   By 10:00am, it was difficualt to breath and had rapid heart beat.   Went to Urgent Care at  Health Care.   Was admitted to Hospital 12/15/21 for shortness of breath, fever, rapid heart beat, and low o2 sat.   Discharge after fever broke 12/16/21.  Condition worsened all week.   The morning of 12/26/21 had Grand Mal Seizure and was taken to Hospital by 911 call abulance.  Stopped breathing during Seizure and spiked 102.5 fever.   Continued page 2.  Was treated for Seizure and PRES syndrome brought on by complications exacerbated by the Moderna vaccine.  Was admitted to the hospital to treat neurologic, cardiac, coranary heart disease, emphezema, respiratory stress post seizure, and renal failure.  12/29/21 was released from hospital with follow up appointment in orthopedics, cardiology, respiratory, nephrology, dialysis, and infectious disease.   At home condition: weak, short of breath, using oxygen, racing heart rate, high blood pressure, ruptured rotator cuff and tricep from seizure.    Have NOT been able to work consistent since the adminstration of vaccine on 12/14/21.
During soccer practice exhibited erratic behavior. Crying, unaware of surrounding or people, saying random statements, wide eyes and staring, also closed eyes and motionless.
following day p/vax 24 hrs later while pt in bath, pt started breaking out in hives; 1st on legs, then arms & back, raised red hives @ inject site; seen in ER given DPH & referred to allergist; rash itchy;
Headache, Arthralgia, Fever, Fatigue, chills, injection site pain and swelling  Narrative:
Pt recvd 1 dose of Engerix-B & 10 days following exp paresthesias & bell's palsy on face;
Redness, inflammation, and warmth at injection site (L) deltoid) mom states it presented on 6/21/14. Pt complains of soreness. Pt is a febrile. Mom has been using cold compress and elevating pt's arm.
Headache, fatigue, body aches, chills, fever of 100, large red bullseye mark at injection site that is severely itchy and burns. All symptoms with the exception of the bullseye mark were moderately managed by Advil.
Morbilliform rash on trunk, diaper area, face, nape of neck 10 days after administration of MMR 2 #1; low grade fever, cervical LAD.
Developed shingles within 30 days. No direct proof of causation but the timing is suspect: young, otherwise healthy. I thought that you may be interested in this in case others report the same.
I had muscle pain and joint pain that has just resolved on about April 2nd. It involved my whole body.  I was able to take a little ibuprofen even though I have IBD and that helped.
Patient is 12 years old and given pediatric dose(5-11yrs) pfizer vaccine as booster dose.
lot is of the powder the lot for the diluent suspension is 4ZM93 Patient had a large red wheal on left arm and hives on chest and neck
had been fatigue the day after getting the first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (had been fatigue the day after getting the first and second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (had been fatigue the day after getting the first and second dose). At the time of the report, FATIGUE (had been fatigue the day after getting the first and second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-417520, MOD-2021-058152 (Patient Link).
Patient had Pfizer booster. 1st dose was Johnson & Johnson. Reaction occurred after dose of Pfizer: swollen lymph nodes in left axillar.
Information has been received from a physician concerning a 16 year old female who on approximately 24-AUG-2007 was vaccinated with her first dose of Gardasil in her right arm.  Concomitant therapy included MENACTRA and BOOSTRIX in the left arm.  On 31-AUG-2007 the patient came into the office reporting a sinus infection and the physician identified swollen lymph nodes in her neck and right axillary area.  As of 31-AUG-2007, the patient's sinus infection and swollen lymph nodes in her neck and right axillary area persisted.  Patient Quality Complaints (PQC) was not involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Information has been received from a physician concerning a 16 year old female who on approximately 24-AUG-2007 was vaccinated with her first dose of GARDASIL in her right arm.  Concomitant therapy included MENACTRA and BOOSTRIX in the left arm.  On 31-AUG-2007 the patient came into the office reporting a sinus infection and the physician identified swollen lymph nodes in her neck and right axillary are (also reported as axillary lymph nodes on the right arm 3-4 days after vaccination).  AS of 31-AUG-2007, the patient's sinus infection and swollen lymph nodes in her neck and right axillary area persisted.  Patient Quality Complaints (PQC) was not involved.  Additional information has been requested.
TESTED POSITIVE FOR COVID 19, AFTER BEING FULLY VACCINTTAED.
Tinnitus and hearing loss evaluated 01/13/2022 after many months of symptoms of ringing and tones in ears.
Reports pain and persistent swelling at injection site since injection. Advised ice topically for 10 minutes/hr while awake and ALEVE tabs 2 PO Q 12 hr x 5 days. Also reported numbness/tingling of fingers. to see PCP if sx persist after treatment above.
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIARRHEA (Diarrhea). At the time of the report, DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication were not provided.
Approx 0-5min p/inject pt exp h/a, dizziness, nausea, abdominal cramps, inc pulse & respiration upon exam;
received shot in left arm, the next day my left arm, neck and upper back were sore, the next day I had aching pain radiating through my right shoulder and down my right arm. and getting worse. Seems my neck/upper back pain may have pinched nerve and is causing this.
Not sure if this is a coincidence or not as mental health issues run in the family. Since receiving the Pfizer first dose, the patient has had a case of psychosis and has been admitted to inpatient as of 5/25/21  for psychological evaluation.  First symptoms I personally noticed were about 24 hours after she received the shot. Speaking and getting stuck in loops,  making up stories that never occurred, forgetting what ?reality? she is in, paranoia, not able to sleep are symptoms she is exhibiting.
COVID arm/hurting/it is a reaction/COVID shoulder; little pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included METFORMIN, HCTZ, ICOSAPENT ETHYL and FLUTICASONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant product included spectrum and is used as Multivitamin Men's Health  It was reported that there was a little pain prior to the second shot that was a level 1 out of 10 usually when patient was doing things like mowing the grass or putting up lights. He would take ibuprofen to help.   This case was linked to MOD-2021-357899.
L Deltoid Swollen for 2 days. Red circle around injection site 5 mm. diameter. Red streak ventral deltoid, down to axilla for 1 day. Painful axillary lymph node for 2 days.
Red splotch about 2 inches in diameter appeared immediately following injection (which was expected), and has not yet gone away. 2 days after the injection, the splotch became incredibly itchy and very hot to touch, like it was burning from the inside. This subsided a bit by day 4. It still is occasionally itchy and warm to the touch, but not unbearably so, though the red spot on my arm is still very noticeable.
dizzy; nauseas; discomfort; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort), VACCINATION SITE PAIN (injection site pain), DIZZINESS (dizzy) and NAUSEA (nauseas) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031AZ1A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DISCOMFORT (discomfort) and VACCINATION SITE PAIN (injection site pain). On 14-Apr-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseas). At the time of the report, DISCOMFORT (discomfort), VACCINATION SITE PAIN (injection site pain), DIZZINESS (dizzy) and NAUSEA (nauseas) outcome was unknown.            This case was linked to MOD-2021-076506 (Patient Link).
No additional AE details or PQC; 6 months old was administered a dose of ROTATEQ after 2 doses of Rotatrix series; This spontaneous report as received from a consumer refers to a 6 month old patient (gender unknown).   The patient's concurrent conditions, medical history or concomitant medications were not provided.     On unspecified dates, the patient received the first and second dose of rotavirus vaccine live oral 1v(ROTARIX) (dose regimen details, lot #, expiration date and indication were not provided).  On 22-MAR-2022 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral for prophylaxis (interchange of vaccine products).  No additional adverse events were reported.
DIARRHEA, HEADACHE, FEVER, MUSCLE PAIN, COUGH
4" x 4" area of erythema, warmth, tenderness. Prescribed with cool compresses and Benadryl.
buzzing ears; weakness; feel headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches) in a 59-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches). At the time of the report, TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported some side effects after the Moderna vaccine (both doses) 4 or 6 months ago. Patient stated that She does not remember exact date. Since the 1st dose she started to feel headaches, buzzing ears and weakness.  Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2021-381184 (Patient Link).
p/vax pt devel 8-10 scattered pinpoint lesions;reporting MD noted that the lesions did not look like typical varicella;two of the lesions had pinpoint scabbing;
On 1/10/2022, patient did not receive COVID-19 Moderna booster as requested and injected with empty syringe in error. Follow-up done with patient. Received correct COVID-19 Moderna vaccine booster on date entered.
no adverse events; improperly stored Proquad; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 19-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R028531, expiration date 02-APR-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion from -14 to -10 degrees Celsius (-13.3 degrees Celsius) for 30 minutes and from 9 to 25 degrees Celsius (17.8 degrees Celsius, multiple) for 32 minutes. The data logger was involved. There were no previous excursions reported.     The outcome of product storage error was unknown.   This report is cross-referenced with MARRS # 1906USA008121 and MARRS #1906USA008290 (same reporter).; Sender's Comments:  US-009507513-1906USA008121: US-009507513-1906USA008290:
Three children received a dose of the VARIVAX that was stored out of recommended temperature range.; Information has been received from the office manager and refers to a child patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported), for prophylaxis, which were stored in the range of 57.9 Fahrenheit degrees for 49 hours. No previous temperature excursion was reported. Unable to retreive the vial as it was disposed of after administration of vaccine.  Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA001387: US-009507513-2009USA002056:
Myalgia; intense headache; high fever; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 (Lot number: EL3248) at single dose (dose number 2, left arm) for COVID-19 immunization. The patient medical history included COVID-19 (Prior to vaccination, patient was diagnosed with COVID-19). The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization, on 19Dec2020 07:30 (Lot number: EJ1685) at single dose (dose number 1, left leg) which was administered intramuscularly at left leg. The patient is not pregnant. No other vaccine was given in four weeks and no other medication was given in two weeks.  Patient has no known allergies. Vaccine was administered at hospital. It was unknown if patient tested for COVID-19 after vaccination. Concomitant medications were not reported. The patient experienced Myalgia, intense headache, and high fever on 07Jan2021 17:00. Treatment was not received. Outcome of the events was recovered on an unspecified date in Jan2021. The reporter assessed the events as non-serious.
At 2 mo of age-child had reactions to immunization, pin bumps around site, no bandages used at 4mo and 6mo same reactions occurred on upper thighs. At 1yr and 15 month shots (few days later) the pin point bumps all over the body. Now at 2yr shots (few days later) pin point rash all over, and face very hot and swollen. Mother states child around 27lb. Instructed mother 3/4 tsp of BENADRYL and call if no improvement. Also instructed mother to visit with Dr about this issue.
Pt states on 7/25/07 she developed hives/rash all over body. On 7/26/07 it worsened all over body. Referred to Primary MD for treatment.