chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3RD DOSE MODERNA COVID VACCINE GIVEN 2/25/21, #031L20A; 4TH DOSE MODERNA GIVEN 11/5/2021, #012F21A; 5TH DOSE MODERNA GIVEN 5/17/22, #038A22A; 8/16/22 Pt brought to Medical Center with fever, hypotension, increasing SOB; O2 supplementation; IV ABX; positive for COVID; 8/23/22 admitted to Healthcare Center; hospice; terminal dx of aspiration  pneumonia; COVID; progressed quickly through terminal process and passed away in the center
Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old).; Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old).; This spontaneous safety report, with reference number 02312186 (Interaction # 02312170), was received by the partner on 04-JAN-2023 and forwarded on 05-JAN-2023, from a physician.  The case was considered off label use due to Product use in unapproved population (40 days old infant).   Due to the nature of the event, the causality between the event "Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old)." and Vaxelis was not applicable.  Further information is expected.
Administered a dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 50 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 2 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097898:Same Reporter US-GLAXOSMITHKLINE-US2022097904:Same Reporter US-GLAXOSMITHKLINE-US2022097905:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter
the patient had trigeminal neuralgia real fast, like the reporter, and got worse with the second dose; This is a spontaneous report from a contactable consumer (patient's daughter). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: unknown and Expiration date: unknown) via an unspecified route of administration on an unspecified date in Jan2021 (reported as near the middle or end of January) (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. The patient also received BNT162B2 (Lot number: unknown and Expiration date: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (reported as the middle or end of February) (at the age of 61 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included thyroid condition (patient had her thyroid removed on an unspecified date or when the reporter was like 8, about 20 years ago), and COVID-19 on an unspecified date in 2020 (patient had COVID before the end of Thanksgiving). Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid condition. The patient previously received shingles shot on an unspecified date in 2020 (the patient got the first shingles shot last year, at least over 8 months ago, but the patient didn't get the second dose) and flu shot (patient got the flu shot around the same time with the reporter) for immunisation. On an unspecified date in Jan2021, the patient had trigeminal neuralgia real fast, like the reporter, and got worse with the second dose. It wasn't known if it was shingles or what until they diagnosed that. The reporter claims that her mother never had symptoms before, and they started with the first dose and got worse with the second dose and claims that it became chronic neuralgia. It was reported that the symptoms happened the same day as the first dose, and then symptoms for the second immediately got worse. The reported events lead to a physician office visit. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment. The patient was previously on naproxen sodium (ALEVE) but it gave her an upset stomach so she switched to paracetamol (the strong dose, the 8 hour one). The patient's doctor prescribed her a pain reliever. The reporter thinks it was possibly gabapentin and doesn't know if that was to help the patient cope with the pain. The patient started taking it a week ago but was not helping. The reporter's seriousness criteria for COVID-19 vaccination and trigeminal neuralgia was not specified. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus  Facial swelling  Eye irritation  Lip and mouth irritation  Throat irritation Canchre sores Tounge sore  Ongoing - some improvement w Benadryl and nose steroid spray
Patient complains of severe soreness in the right arm, from shoulder to elbow, where PNEUMOVAX was administered on 9 Oct 2011. She also complains of inability to raise arm over head. Her primary care doctor advised alternating hot/cold compresses.
fever, blistery rash-Seen in ED. Admitted to ICU c/o Staph skin infection vs. Steven-Johnson syndrome 4/22/08-ER records received for DOS 4/5/08-DX: seborrheic dermatitis. Facial dry scaling skin. Low grade fever. 5/7/07-records received for DOS 4/6-4/9/08-DC DX: Staphylococcus scalded skin syndrome. Diaper rash. Presented with 2 day history of fever and 1 day of rash. Night of vaccination developed fever up to 101. Rash developed in middle portion of face orally and over anterior aspect of both ears. Mild erythema on chest and diaper area. Irritable. Two small vesicles on left check and neck area have ruptured. Rash appears hyperkeratotic with some cracks and bleeding. Two 1cm denuded areas on left check and neck.  Follow-up: On 4/15/08 noted in chart that pt followed up with doctor and was determined that rash was not related to vaccine administration.
pain in the underarm the same night she got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization.  The following information was reported: AXILLARY PAIN (non-serious) with onset 14Dec2021, outcome "unknown", described as "pain in the underarm the same night she got the shot".  Additional Information: Clinical Trials Experience Local and Systemic Adverse Reactions Solicited in the Study In participants 16 through 55 years of age after receiving Dose 2, the mean duration of pain at the injection site was 2.5 days and for swelling 2.1 days.  Booster Dose In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose included lymphadenopathy. Revised: 09Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Tdap immunization on 7/1/09.  Returned to our clinic on 7/8/09 c/o redness & itching around injection site.  Large reddened, hot area on (L) upper arm/deltoid are.  Pt denies pain but does c/o extreme itching in the area.  As of today (7/10/09) pt states the area is "still red but improving".  Taking CLARINEX 5mg daily/Hydrocortisone cream.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after 20-JUL-2016), the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L029615, expiration date 15-MAY-2017; dose was not reported). The vaccines had a temperature excursion to 26 F for 90 minutes on 20-JUL-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
3 days after the vaccine I got red bumps or hives around the injection shot, not in the shot itself. Very red blotches and itches very bad and getting bigger larger than a softball.
Patient was admitted to Hospital on 1/10/2022 due to tachycardia and shortness of breath. Patient discharged initially on 1/8/2022 from Hospital after being treated for COV ID-19 infection. Patient presented in severe respiratory distress. Patient had right sided pneumothorax and chest tube placement in the emergency department. CT surgery was consulted. Patient was monitored. Patient's tachycardia persisted. Steroids were continued for hypoxic respiratory failure secondary to his recent COVID-19 infection. BiPAP was administered given profound hypoxia. Patient was transferred to heart care unit due to the refractory tachycardia. Improvement in pneumothorax and subsequent removal of chest tube. Patient remained with poor respiratory function. Tachycardia persisted. Cardiology and electrophysiology were consulted. Patient was treated with amiodarone and was placed on diuretic therapy. Patient remained tachycardic despite adequate medication administration. Antibiotics were administered due to presence of UTI. Cardioversion was performed on 1/21/22 with good results in his heart rates. Patient rapidly decompensated on 1/22/22 with hypotension and increasing air hunger. Comfort measures were discussed with family regarding status and poor outcome potential. Patient was provided comfort medications, and able to pass with family at bedside. Patient expired on 01/22/22 at 1700 from Acute hypoxemic respiratory failure Acute combined Heart failure.
4 hours after the vaccine shot on my left arm, my left eye started twitching.  It happened a lot at first, and happened multiple times a day for 10-20 minutes at a time.  After a couple weeks it slowed down to the point where it only happens every couple days.  This absolutely did not happen before that exact day so I am relatively sure it was caused by the vaccine.
mom recv vax & child devel pain in joints, a rash & a swollen knee & hands 2wk p/mom immun-has had resolution of sx;child had been immunized
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route unknown, lot# M022556, expiration date: 26-MAY-2017; lot# reported as L048848, expiration date: 09-AUG-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Lot number L048848 is not valid for VAQTA. Additional information has been requested.
Tinnitus; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient arrives today for update of immunizations. Per note - "Behind on shots, will come back in 1-2 weeks for next set. Prefer to do 2 shots at a time."   Spoke with father asking which vaccinations patient is to have today with delayed schedule, father unsure. Patient has not received any 6 month immunizations yet. Discussed which 6 month vaccinations are typically due (pediarix, prevnar 13, and rotateq). Father states they only do two vaccinations at a time, prefers to do one injection and the oral.    Rotateq (oral) & pediarix (IM injection) discussed with father prior to administration. Administered to patient, he tolerated well.    4-month Rotateq immunization was administered at office visit on 7/13/22. Per Merck's guidelines, Rotateq immunizations are to be given at least 4 weeks apart. 6 month Rotateq given two weeks early.    PCP out of office, Dr. informed in office, he states to inform patient's mother/father that patient may experience mild abdominal discomfort/diarrhea. If symptoms persist or worsen, go to ER. This nurse called mother at 4:45pm 7/27/22 and left message to call back.    Spoke with mother this morning 7/28/22, relayed message. Mother voiced understanding. Asked for condition update on patient, she states patient has been acting his normal self, no concerns at this time. No adverse reaction. Instructed mother to call back at office if she has any concerns or questions.
Patient received the incorrect dose of 0.5mL versus the correct dose of 0.25mL. No adverse event.
Rash all over body.  Reported to Primary Care Physician, prescribed a Antihistamine & topical Hydrocortisone Cream. Treatment for 5 days.
late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. No patient's identifiers provided. No lot number and expiration date provided. The vaccine was administrated on another facility. No vaccination date provided. The reporter consented to follow up.
Acute diastolic heart failure - Pt was admitted and started on diuresis. cardiology consulted via telephone and recommended to continue metoprolol and diltiazem. Pt continued with diuresis and was able to be weaned to 1 LPM oxygen. Discharged. ED visit and hospital admission within 6 weeks of Receiving the COVID vaccine. Patient passed away 2 months later on 3/2/2-22 of congestive hearth failure.
Improperly stored vaccine administered; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 18-JAN-2021, 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)(lot # S031287, expiration date 08-APR-2022; dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 46.7 degrees Fahrenheit for 5 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. No product quality complaint (PQC) was reported. 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: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Woke up 4 am 8/31 severe headache and dizziness.  Fever and neck ache.  Vomiting occurred around 7 am blood pressure and heart rate stable.  Headache lasted for a couple of days.
Varivax given to patient 10/21/99. No documented case of varicella. Patient seen in our office 2/20/06-diagnosed shingles/ Herpes Zoster.
I felt dizzy; Headache; A spontaneous report was received from a nurse concerning herself, a 34-year-old, female patient who received Moderna's COVID-19 vaccine and felt dizzy and had a headache.  There were no medical history and concomitant medications reported.  On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 037K208) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 29-Dec-2020, 15 minutes following the injection, while she walked to the parking lot, she began to feel dizzy and had a headache.  Action taken with mRNA-1273 in response to the events of dizziness and headache was not provided.   The outcome of the events dizziness and headache was unknown.; Reporter's Comments: This case concerns a 34-year-old, female, patient, who experienced an unexpected non-serious event of Dizziness and an expected non-serious event of Headache. The events occurred one day (same day) after receiving the first dose of mRNA-1273, lot # 037K208. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Pain at injection site not relieved with every 4 hour OTC meds or ice. Pain described as severe and continuous. Reports slight swelling of fingers and tingling on affected side for one hour while at MD office today. Was prescribed Vicodin and NSAID.
5 hours later.  Terrible Headache, so bad could not sleep the entire night.  Chills, aches, small fever.  10 Days later.  Rash and bumps all over both arms, neck and upper back
Patient collapsed while walking to bed at 11 pm 6/17/23. .  Seemed OK when he got into bed.  Wife couldn't rouse him in AM, seemed to be sleeping peacefully.  By afternoon 6/18/23, he was admitted to Hospital.  Immediate Dx was "Sepsis, pneumonia with fluid around the lungs, urinary tract infection" and patient remained comatose for several days..  Tramsferred tp The Nursing Home, t continue to recover.  On day 25 of illness (7/12//23), patient still cannot walk. Has been hallucinating since regaining consciousness, some days worse than others, Seems to be improving.  Memory and cognition otherwise .normal. I reported the Covid #6 shot to ER Dr, cardiologist Dr. and house Dr. .  He was in the hosp. 9 days.
pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: 4.         Concomitant medications were not reported. Treatment medications were not reported.  Reporter stated that patient is prone to bronchitis and pneumonia as she is a smoker.  Company Comment  This case concerns a female patient of an unknown age with a reported medical history of smoking, who experienced the serious unexpected event of Pneumonia. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The medical history of smoking is a confounder. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received as patient demographics, lab data, medical history, dose details updated.; Sender's Comments: This case concerns a female patient of an unknown age with a reported medical history of smoking, who experienced the serious unexpected event of Pneumonia. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The medical history of smoking is a confounder. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.
Tinnitus-right ear / Constant, buzz pulsating sound; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2021 (Lot number: EL1284) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Known allergies: OA. Concomitant medication(s) included: CELEBREX; MYRBETRIQ; VITAMIN D 3; VITAMIN B 12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EJ1685, Anatomical site: Left arm), for COVID-19 immunisation, reaction(s): "Headache", "tinnitus - right ear, constant, buzzpulsating sound". The following information was reported: TINNITUS (non-serious) with onset 11Jan2021, outcome "not recovered", described as "Tinnitus-right ear / Constant, buzz pulsating sound". The event "tinnitus-right ear / constant, buzz pulsating sound" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: The patient had no known allergies. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021 after the dose 2, the patient experienced tinnitus-right ear, constant, buzz pulsating sound. Therapeutic measures were taken as a result of events and included treatment with audiotory exam and CT scan.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441560 Same patient/Vaccine, different event, different vaccine shot
20JUL92 mom reports that pt had a temp 103 p/several doses of APAP; vax given 15JUL92; vomiting lasted from THursday AM to PM; pt was fussing & crying; pt seen by MD 17JUL92;
Left sided shoulder and chest pain, muscle spasms, intermittent since incident, occurring every other day on average.
Paleness, dizziness, fainting, ache, pains, chills, fever, aching arm where shot administered, weakness 4 days bed rest.
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100.  Increased difficulty breathing.