chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of burning throat in a 46-year-old male patient who received TWINRIX Adult (batch number 7C4Z3, expiry date 6th May 2018). Co-suspect products included TWINRIX Adult (batch number 7C4Z3, expiry date 6th May 2018). On 15 September 2016, the patient received the 1st dose of TWINRIX Adult. On 15th February 2017, the patient received the 2nd dose of TWINRIX Adult. On 15th September 2016, less than a day after receiving TWINRIX Adult and not applicable after receiving TWINRIX Adult, the patient experienced burning in throat. On 15th February 2017, the patient experienced burning in throat. On an unknown date, the outcome of the burning in throat and burning in throat were unknown. It was unknown if the reporter considered the burning in throat to be related to TWINRIX Adult. It was unknown if the reporter considered the burning in throat to be related to TWINRIX Adult. Additional details were provided as follows: The nurse reported a patient who reported that he experienced burning sensation in his right throat after receiving his 3rd dose of TWINRIX Adult, on the day of reporting. The patient had not previously reported to the reporter's office, but when this happened after the 3rd dose the patient told them that the same thing also happened after his 2nd dose (less than a day after receiving the vaccine). The patient did not have any breathing difficulty. The patient stayed in the office for at least 1 hour waiting to see the doctor for a routine appointment and did not report any further effects. It was unclear if the reported lot number (7C4Z3) corresponds to the 1st dose of the vaccine or the 2nd dose or both the doses of the vaccine.
6/01/23 Shringrix Vaccination.  Very sore right arm headache.  6/03/23 Injection site bruised blackened. 6/07/23 Nerve pain in feet & ankles, knees 6/16/23 Numbness started in hands, arms while in bed sleeping.  6/19/23 Nerve pain & pain in joints of hands, knees, ankles, fingers, wrists. 6/20/23 Felt like a electrical current going through my legs, arms, feet.6/22/23 Stinging burning tingling in hands & ankles  6/26/23 Contacted DO's office.  Informed Dr's Assistant of adverse reaction to Shingrix vaccination & I was going to file report with VAERS.  Informed her taking Vitamin B12, B Complex Vitamins.  She going to talk to Dr. Outcome: Some stinging pain in knees, feet, ankles.
NECK PAIN; ACUTE HEADACHE OR POUNDING HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUL-2021 15:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUL-2021, the subject experienced injection site pain. On 03-JUL-2021, the subject experienced neck pain. On 03-JUL-2021, the subject experienced acute headache or pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 03-JUL-2021, and had not recovered from acute headache or pounding headache, and neck pain. This report was non-serious.
Patient has had 10+ Gout flare ups this year after receiving his vaccines.  He has increased intensity of flare ups after each of his vaccinations and his booster. He initially did not require medication but now he requires allopurinol  at max dose and still requires colchicine for acute flare ups. Prior to his vaccines, he had a flare up every other year that resolved spontaneously.
left eye spasm; developed a rash; it is itchy; an increased in her heart rate; headache; extremely tired; a fever of 100.6,; sore arm; sweating; upset stomach; feeling off; her balance is off; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2019 and experienced events, refer case US2020028114).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder. On 18th February 2020, the patient experienced itchy rash, red rash and heart rate increased. On 19th February 2020, the patient experienced blepharospasm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash, red rash and blepharospasm were not recovered/not resolved and the outcome of the heart rate increased, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder were recovered/resolved.   It was unknown if the reporter considered the itchy rash, red rash, heart rate increased, blepharospasm, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient developed a rash as one bump below the injection site as a red streak and it is itchy after vaccination. The patient also experienced a left eye spasm. The other side effects she reported included a headache, extremely tired, sore arm, sweating, a fever of 100.6, upset stomach, feeling off, and her balance was off. The patient also experienced increased in heart rate after vaccination. The patient consented to follow up.
A 66-year-old male patient, with an allergy to dyes, and Celebrex; and who has reflux disease, had received a right deltoid, intra-muscular injection of FLUZONE SV "2006-2007" USP, lot number U2187AA, on 30 October 2006. Within one hour post-immunization, the patient experienced a strong metallic taste in his mouth. The next day, the metallic taste continued and he complained of a headache. He had no other complaints. Per the reporter, a 23 gauge, 1 inch needle was used for the injection. The patient did not seek medical attention, and no diagnostic tests or laboratory work were performed. At the time of this report, the patient had not recovered. Follow-up information received on 06 December 2006 from a health care professional. The patient recovered.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated; Liver disorder; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious), BLOOD BILIRUBIN INCREASED (non-serious), TRANSAMINASES INCREASED (non-serious), outcome "unknown" and all described as "Pfizer COVID vaccine causing elevated alkaline phosphatase, bilirubin , and transaminases Mine were incidentally found to be elevated"; LIVER DISORDER (non-serious), outcome "unknown", described as "Liver disorder". The patient underwent the following laboratory tests and procedures: biopsy liver: unknown result; blood alkaline phosphatase: elevated, notes: after my initial series; then trended down; blood bilirubin: elevated, notes: after my initial series; then trended down; transaminases: elevated, notes: after my initial series; then trended down  Additional information: Facility type for vaccine noted as school or student health clinic. The patient was incidentally found to be elevated alkaline phosphatase, bilirubin and transaminases 5 months after his initial series, then trended down until August. The patient got the booster on 01Oct2021 (after which he had significant myalgias, fatigue, and some nausea) and they went even higher and now were not coming down. All other causes/etiologies had been ruled out with a complete workup. Next step was liver biopsy which was on Monday.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101587485 similar report from same reporter
slight muscle ache; headache; chills; severe body aches (all); sore throat; tired; watery eyes; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6200) via an unspecified route of administration, administered in Arm Left on 22Feb2021 07:30 (at the age of 54-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included Kidney donor. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, on 01Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On 22Feb2021, the patient experienced slight muscle ache, headache, chills within 2 hours. 12 hours post vaccine, severe body aches (all), chills, sore throat, tired and watery eyes. These lasted 24 hours. Some relief after 24 hours, some lingering effects 36 hours after. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201478 same patient, different drug/AE
flu; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious social media case via social media from a consumer (patient).  This case involves a patient of unknown demographics, who got the flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, condition medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received an unspecified dose of INFLUENZA VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after administration of INFLUENZA VACCINE, the patient had flu (influenza) the only time he/she had the shot.  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown.  There will be no information available on the batch number for this case.
Hospitalized;  COVID-19 positive (9.5.21);  fully vaccinated  Admission Date: 9/5/2021 Discharge Date: 09/10/2021  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is an 82 yo female with PMH of severe COPD, bronchiectasis, PE who was hospitalized on 9/5 with COVID19 pneumonia.   Onset of her symptoms were on 9/2. Patient had been vaccinated with Moderna earlier this year. Laboratory workup revealing for hyponatremia of 128 and positive COVID19 test. Hypoxic with ambulation in ED. CT Thorax showed post operative changes secondary to left lower lobectomy and extensive chronic lung changes with no notable acute process.   She was started on Decadron and Remdesivir and continued on home bronchodilators. We held home neb treatments secondary to COVID19 status. Her breathing and cough improved. PT/OT recommend Home with Home Care.   She was weaned to room air. Clinically stable for discharge on 9/8 but felt fatigued so monitored for 1 more night. On 9/10 - pt felt strong, back to baseline and ready to discharge home. She is discharged home in stable condition.   We discussed the following: - completion of Decadron for 4 more days (total of 10 days), THEN resuming home dose Prednisone - self quarantine through 9/1 - patient was recommended to monitor their oxygen levels at home with pulse oximeter and contact his PCP or call 911 if oxygen levels drop below 92%. Patient will need close follow up with PCP with additional outpatient testing/labs.  - Patient was provided COVID discharge instructions and to self monitor for any signs/symptoms of blood clots. We reviewed COVID self-isolation instructions.
Subsequent to receiving one dose of varicella virus vaccine live, on 2/5/96, the pt experienced approximately 30 skin lesions on 4/12/99. His lesions were mostly from the waist up and no other symptoms were reported.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021 at 11:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.40.  Concomitant products were not reported. On 03-Mar-2021, Excursion time was 09AM,10AM,1PM temperature was 51, 34,35 total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:51, 10 AM: 34, 11 AM: 44, 12 AM:46, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36 and 5 PM: Not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Vaccine exp: use by date = 10/7/22 8 wk after defrost Exp Dae 10/31/2024
Received the vaccine at 10:55 on 2/15/21.  While sitting for observation at 11:05 started to feel tachycardia and dizziness.  11:20 - got in the car to drive home swallowing became difficult when trying to drink water, dizziness got worse, felt extreme and nausea.  During that time (according to Watch) heart rate went from 82 bpm to 130 bpm and stayed elevated above 120 until 11:43.   Drank electrolytes and took Pepcid at 12:00 PM.  4:00 PM Fatigue and Chill, normal heart rate.  Next day, 2/16/20 Extreme Stomach pains overnight, diarrhea and tachycardia with HR at 138, very clammy and warm.  Tachycardia continues through 2/18/20.
administered IPOL post excursion with no reported adverse event; temperature excursion at 47 Fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event; Initial information received from  on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA422655(CLUSTER), 2022SA422419(CLUSTER) and 2022SA422653(CLUSTER).  This case involves a 4 years old female patient who was administered ipol post temperature excursion at 47 fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2022, the suspect IPV (VERO) was exposed to a temperature excursion at 47 fahrenheit for 20 minutes due to the refrigerator door being left opened with no reported adverse event (product storage error).  On 23-Sep-2022, the patient received 0.5 mL toatl dose of suspect IPV (VERO) once (lot V1A022M and expiry date: 17-Feb-2024) via intramuscular route in the left thigh for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt received Moderna vaccines on 02/08/21 and 03/08/21. Pt presented to the ED on 10/29/21 with complaints of cough, weakness, and fatigue. Pt was found to be COVID positive.
nausea; Inappetence; fatigue; headache; brief chills; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications in two weeks prior to the vaccination included atorvastatin (LIPITOR), sertraline hydrochloride (ZOLOFT), fish oil, multi-vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 27Jan2021 at 06:30PM patient experienced nausea, inappetance, fatigue, headache, brief chills. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from the events on unknown date.
Pfizer / BioNTech/ Tested positive/ Covid symptoms; Pfizer / BioNTech/ Tested positive/ Covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Lot number: EL9267) and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "recovering", and all described as "Pfizer / BioNTech/ Tested positive/ Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) positive, notes: Tested positive on antigen on 06Jul; (12Jul2022) positive, notes: on 12Jul Positive antigen; (15Jul2022) Negative, notes: on 15Jul Negative antigen; (16Jul2022) positive, notes: on 16Jul Tested positive on antigen 16Jul p.m. (5 days after completing Paxlovid and 36 hours after negative antigen). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid symptoms began on 05Jul Tested positive on antigen on 06Jul Began Paxlovid on 07Jul Completed Paxlovid on 11Jul Positive antigen on 12Jul Negative antigen on 15Jul in a.m. No symptoms Sore throat began 15Jul in p.m. Followed by minor cold symptoms. Sore throat, cough, sneezing, on 16Jul Tested positive on antigen 16Jul p.m. (5 days after completing Paxlovid and 36 hours after negative antigen)  Additional information: Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=07Jul2022, treatment stop date=11Jul2022, indication=Treatment of COVID-19. other medication in 2weeks product=L-Thyroxine (Synthroid)
ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 ACUTE POSTHEMORRHAGIC ANEMIA. ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 ANEMIA
Began itching below site of injection 8/28/07 during school.  School nurse noted rash (faint red, raised) below site, down left arm to wrist.  Last night (8/28) rash spread to left side of neck, chest & under arm.  Has applied Benadryl cream with minimal relief in itching.  No rash on rest of body.  No SOB . No hives.  (Left messages but no return calls for follow-up)