chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Inbound call from HCP who stated MMR-II was inadvertently administered after being improperly stored during a supported temp excursion. No additional AE details or PQC.         ?    Names of vaccines involved (including lot/exp) MMR-II W001598 01/1; This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. Concomitant medication included sterile diluent (manufacturer unknown). The patient's concurrent conditions, pertinent medical history and drug reactions/ allergies were not provided.  On 31-JAN-2023, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was improperly stored during a supported temp excursion (product storage error). Temperature was 8.6 Celsius degree. Time frame was 10 minutes. Previous temperature excursion did not occur. On an unknown date in 2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # W001598 has been verified to be a valid lot number, expiration date was reported as 14-JAN-2024, dose, route and anatomical location were not provided) for prophylaxis. No additional adverse event (AE) details (No adverse event).
Autoimmune disease; Bruises on her arms "like an old lady"; Low B12; Platelet count that went up, then down; Platelet count that went up, then down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: The only medications she takes is one for her blood pressure and one for her thyroid; "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot (Verbatim:Crazy spike in blood pressure), administration date: 2020, for Immunization, reaction(s): "Crazy spike in blood pressure"; Flu shot (Verbatim:Cortisol spike), administration date: 2020, for Immunization, reaction(s): "Cortisol spike". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease"; CONTUSION (non-serious), outcome "unknown", described as "Bruises on her arms "like an old lady""; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "Low B12"; PLATELET COUNT INCREASED (non-serious), PLATELET COUNT DECREASED (non-serious), outcome "unknown" and all described as "Platelet count that went up, then down". The patient underwent the following laboratory tests and procedures: Blood cortisol: (2020) Spike; Blood pressure measurement: (2020) crazy spike; Evaluated: (unspecified date) Unknown results, notes: HCPs evaluated for a thyroid tumor; Platelet count: (unspecified date) that went up; (unspecified date) It went Down; Vitamin B12: (unspecified date) Low. Clinical course included patient is asking if there is a variation in the recommendations for timing of dose 2 of the COVID vaccine in light of her autoimmune disease. Patient also mentions that she gets the flu shot every year, but in 2020, shortly after she got it, she had a "crazy spike in blood pressure", as well as a cortisol spike, so much so that her HCPs evaluated for a thyroid tumor. She also mentions that, seemingly unrelated to a medication, she has noticed bruises on her arms "like an old lady", but was found to have low B12 and a platelet count that went up, then down. She states the only medications she takes is one for her blood pressure and one for her thyroid. E-transmitted to Agency for AE information for a non-Pfizer product, as did not realize until call had ended.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
mom called to report pt had t103.4 R 15AUG94 830PM; mom gave partial dose of APAP @ 1015PM; mom called MD; c/o elevated fever & soreness of LE's;
Muscle twitches; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Muscle twitches) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced MUSCLE TWITCHING (Muscle twitches). At the time of the report, MUSCLE TWITCHING (Muscle twitches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medication information was reported. Patient developed muscle twitches and other symptoms similar to Syndrome. They did blood work and treated her.   Reporter did not allow further contact
Extremely sore Arm, fatigue, migraine and cloudy mind starting 12 hours after injection
Tinnitus; This is a spontaneous report from a contactable pharmacist, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 28Jan2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the right arm on 07Jan2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 the patient experienced tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event tinnitus was not resolved.  No follow-up attempts are needed. No further information is expected.
Necking swelling; Neck tightness; Rash on Neck; Rash on Chest; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 24-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 SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest). At the time of the report, SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
swollen and today it remains a tiny bit swollen; cheek was a little bit swollen; This is a spontaneous report from a non-contactable consumer. This female consumer (patient) reported herself that a female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 02Feb2021 (Tuesday) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She did not have a reaction on 02Feb2021. The next day, which was yesterday, her cheek was a little bit swollen and today it remains a tiny bit swollen. She was asking what to do and if this was normal. Will it go away on its own? Can I still get the second dose? She declined consent to contact. She declined to provide mailing address and email. The outcome of the events was unknown.  Follow-up (04Feb2021): This is a follow-up spontaneous report from a non-contactable consumer.   No follow-up attempts are possible; information about batch number cannot be obtained.
woke up with a headache and sore throat the morning after vaccine was given later in the day school nurse called my daughter still had headache and low grade fever it all lasted 2 days from the time shot given.
Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 10/2/2022 Discharge Date: 10/14/2022  PRESENTING PROBLEM: Weakness [R53.1] Fatigue, unspecified type [R53.83]   HOSPITAL COURSE:   Patient is a 66 y.o. male who presented with generalized weakness and fatigue.  Past medical history significant for CKD, recently had fistula placed in anticipation for future dialysis. Patient reported that his girlfriend passed away three weeks ago. She assisted in ADL's and food preparation. Patient reported being depressed, weak and fatigued. Patient also has low oral intake over this time period. Due to increased unsteadiness and weakness he presented to ED. Found to be incidentally COVID-19 positive. Being admitted for therapy evaluation. 500cc bolus was ordered in the ED due to low oral intake and creatinine elevated above baseline.  Nephrology was consulted and renal function was closely monitored.  Renal function remained stable.   Patient had drop hemoglobin of unknown etiology.  Received 1 unit of blood.  Gastroenterology was consulted and recommended no further as patient does a clear source of bleeding.  Patient will continue on Epogen given his significant underlying kidney disease.   Therapy was consulted who subacute rehab placement.  Currently awaiting patient to be out of isolation prior to subacute rehab placement.  Medically stable discharge.   Patient at discharge has a creatinine of 3.75, BUN of 112. No evidence of uremia.  Seen in consultation with Nephrology recall that he was medically stable for discharge, will arrange for weekly renal panel as an outpatient.  Once his fistula is functioning, he is likely starting hemodialysis as an outpatient.
Pt. comes to LH vaccine clinic for second dose of Moderna. Pt. had known reaction to first dose and had seen an allergist prior to second vaccination. Pt. was informed to pre-medicate with Zyrtec which she did the night before and the morning of. Patient informed of emergency protocol prior to vaccination if she were to have reaction. Pt. agreed to accept vaccine. Pt. was injected at 10:25. Started to have itchy throat but no hives or respiratory distress and was given 25mg of Benadryl at 10:31 per protocol. Patient at 11:00 throat itchiness was not improving, but not worse and was then directed she needed to go to ER. 911 activated. By 11:11 patient developed facial swelling and con't throat itchiness. 0.3mg of epi delivered to right thigh. No respiratory distress at the time, but patient immediately state she felt better. Medics then took patient to ER.  Patient admitted. Admission overnight to monitor respiratory status given recurrent symptoms and multiple Epi doses required.  Currently has received  Epi 0.3 x4, IV Benadryl, IV Famotidine, Methylpred 125 mg
Body aches, awakened with shivering. Tiredess persisting into the day.
whole body aches, chills, fainting, vomiting, headache, weakness 12 hours after vaccine Weakness and headache continued for 4 days
This spontaneous report as received from a consumer, as part of a marketing research program conducted by agency, refers to consumer's older daughter (patient's age, pertinent medical history and drug reactions/allergies were not provided). On an unknown date, the patient received a first dose of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, it was reported that after the first shot in the GARDASIL series, the patient had a very painful, severe complication. At the time of the report, the patient's outcome and the relatedness between the events and suspect therapy were not provided. Additional information has been requested.
Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Hypertension and Anxiety.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat). At the time of the report, COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 on a home test.         It was reported that patient received either first or second booster dose. Concomitant medications include blood pressure medication, anxiety medications. Patient didn't experience fever. No treatment details were reported. Company comment-This Spontaneous case concerns a 76-year-old, female patient with relevant medical history of immunocompromised status reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 7 days after receiving a dose of mRNA-1273 Vaccine.  It was reported that patient was very sick with cough and sore throat a week after vaccination. No further details on clinical course, other lab test results and treatment received were reported. No details provided regarding the initial vaccination schedule. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19, elderly age and relevant medical history could be confounding factors for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 76-year-old, female patient with relevant medical history of immunocompromised status reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 7 days after receiving a dose of mRNA-1273 Vaccine.  It was reported that patient was very sick with cough and sore throat a week after vaccination. No further details on clinical course, other lab test results and treatment received were reported. No details provided regarding the initial vaccination schedule. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19, elderly age and relevant medical history could be confounding factors for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This is a 66 y/o female presenting to office for f/u reaction pneumovax injection. Patient reports she started experiencing some circular redness around the injection site starting Friday night. It has now grown to a softball sized circular region on left shoulder region.  1. Vaccine reaction, initial encounter (Primary) Assessment & Plan: Doxycycline 100mg BID x 7 days.  Medrol pack as ordered.  Pepcid 40mg daily.  Advised if this worsens, to notify provider.      Orders: -     doxycycline (VIBRAMYCIN) 100 MG capsule; Take 1 capsule by mouth 2 (Two) Times a Day for 7 days.  Dispense: 14 capsule; Refill: 0 -     methylPREDNISolone (MEDROL) 4 MG dose pack; Take as directed on package instructions.  Dispense: 21 each; Refill: 0
This spontaneous report as received from a registered nurse refers to an approximately 84 year old female patient. The patient's concurrent conditions included diabetes mellitus. The patient's concomitant medications included unspecified diabetes medications. She did not have any known drug reactions or allergies. In approximately 2012 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported). In approximately 2015 (reported as "recently"), the patient experienced shingles on her face. The nurse reported that shingles resolved on an unknown date in approximately 2015, but the patient was left with only a little redness at the site of where rash was, which was going away slowly. The patient did not receive any treatment. There were unknown laboratory tests performed, but the results were not provided. The patient sought unspecified medical attention. The outcome of the little redness was reported as recovering/resolving by the time of the report. The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Fatigue, shortness of breath, thirsty, joint pain, lower left back pain, nausea and chills. All symptoms have been going on for 5 days now
This patient received her second vaccine 13 days too soon. I have contacted GSK, the patient and the physician Per the CDC, the second dose is only considered invalid if it is given at less than 1 weeks after the first. This was 6-7 weeks after the first so the dose will not be repeated.
felt like got run over by a mac truck; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt like got run over by a mac truck) and ABDOMINAL DISCOMFORT (upset stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe rheumatoid arthritis).   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (felt like got run over by a mac truck) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, MALAISE (felt like got run over by a mac truck) had resolved and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.            Concomitant medication and treatment information were not reported. No treatment information provided.  Action taken with mRNA-1273 in response to the event was Not Applicable
Caller states the mom mentioned that the patient experienced body itching after the first dose of the Covid-19 vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 28Jan2022 (Lot number: 33130BA, Expiration Date: 31May2022) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Caller states the mom mentioned that the patient experienced body itching after the first dose of the Covid-19 vaccine.".   Follow-up attempts are completed. No further information is expected.
almost lost right eye; This case was reported by a consumer via interactive digital media and described the occurrence of visual impairment in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced visual impairment. On an unknown date, the outcome of the visual impairment was unknown.   It was unknown if the reporter considered the visual impairment to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got new and improved shot and reported that almost lost his/her right eye. Additional Supportive Information: Follow-up would not possible as no contact details were available.
ringing in ears, pain in left inner ear and left jaw. Swelling in both ears confirmed at urgent care and began course of decongestants, Allegra, flonase. Pain and inflammation progressed in left jaw and localized to molar tooth (#18). Upon dental visit, it was determined there was extreme inflammation surrounding tooth #18 and underwent emergency root canal on 5/21/21. Persistent inflammation post-root canal with 3200mg Ibuprofen daily, pain and swelling in left lymph node under chin.
On 10/18/00, became febrile and had generalized clonic seizure, lasting less than 5 minutes. Seen in ER and evaluation negative. Seen in office on 10/19/00 and dx'd with febrile seizure. Still having fevers.
Booster; received positive COVID tests. Symptoms are mild and resolving; received positive COVID tests. Symptoms are mild and resolving; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative.  An adult female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive, had received positive COVID tests.  Reporter is patient's husband. Patient's age was reported as approximately 45 and had no underlying conditions. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
EPILEPSY, UNSPECIFIED 10/2/2022 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.              For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant Medication use information was not provided by reporter.