chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRAIN FOG; INSOMNIA; INJECTION SITE TENDER / SORE ARM; TIRED; HEADACHE; SORE AND ACHEY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced sore and achey. On MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced injection site tender / sore arm. On 13-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 14-MAR-2021, was recovering from insomnia, and had not recovered from sore and achey, headache, brain fog, and injection site tender / sore arm. This report was non-serious.
HYPOXIA 4/13/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
Indigestion lasting more than 2 weeks. I have never had indigestion or stomach-related illness before. I was able to get in to see my doctor and he prescribed Prilosec. I took this for 7 days and was able to get some relief. Still not back to baseline over 1 month later.
Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours; No adverse event; Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours), PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022 at 1:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours), PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours) and PRODUCT STORAGE ERROR (Dose administered after more than 12 hours post puncture/Dose administered after exposure to room temperature for more than 24 hours).    No concomitant medications were reported.  The vial size was reported as 2.5 mL and was an individual vial.  The vial was first punctured on 15-Sep-2022 at an unknown time.  The vial was initially stored in refrigerator post puncture on 15-Sep-2022.  The vial did not undergo any temperature excursions.  The total amount of time during the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 27 days.  No treatment medications were reported.   Reporter did not allow further contact
pt noted arm that inj was given in was becoming very sore;lt arm became red & hot from shoulder to elbow which extended to underside of arm;a lump the size of a baseball devel just below the inj site;called ER advised to use ice & advil;
Experienced a stroke on the morning of 11 April 2021. Symptoms resolved on their own after medication in the Emergency Room, but I was hospitalized for a week.
Elevated temp, pain in bilateral lower extremities. Employee took Ibuprofen for her symptoms drank water and rested. Employee reports pain/pressure around eyes upon awaking this morning with decrease in pain to bilateral lower extremities, temperature is normal.
Feeling faint; tingling of tongue; numbness left side face; heart racing; red blotchy rash on chest; unusual high blood pressure; headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 11Mar2021 08:30 as single dose for COVID-19 immunization in an unspecified facility. Medical history included Shingles from Aug2020, mild lymphedemia legs, mild arthritis, and history of stroke from an unknown date. The patient had no known allergies, no COVID prior to vaccination, and has not been tested for COVID post vaccination. The patient has not received other vaccine in four weeks. The patient's concomitant medication includes an unspecified medication taken in two weeks. On 11Mar2021 8:45 am, immediately following injection, the patient experienced feeling faint, tingling of tongue, numbness left side face, heart racing, red blotchy rash on chest, unusual high blood pressure, and a 5-day headache. No treatment was given. The outcome of the events was reported as recovered.
Swollen lymph nodes on/near collarbone area and in neck. Pain in neck and collarbone. Told to take Ibuprofen 400mg.
Later on in the day of receiving vax, pt's whole arm began to ache. One hour later, the arm began to itch below the injection site. The next day, pt felt like a cold was starting, she had a nonproductive cough which lasted 5 days. Pt saw MD on Friday 11/16 and MD said she had an allergic reaction to PPV. MD treated pt with Iophen DM liquid cough medicine and Avelox.
This spontaneous report as received from a physician referred to a patient of unknown age. Physician reported that patient of another unspecified physician received the 1st dose in the GARDASIL series on 14-JUN-2011 ((Lot#, dose/frequency, route were unspecified) and the 2nd dose on 19-DEC-2012 (Lot#, dose/frequency, route were unspecified). No adverse effect reported. It was unspecified whether patient had sought medical attention. The outcome was unknown. Additional information is not expected.
Child was brought in by mom one week after getting immunization at Dr office with a rash on face, arms and legs x 2 days. No meds were given and told to return 1 week to date all rash had faded.
Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient; Amount of vaccine that the patient actually received  is less than half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Diagnosed by Rapid test) on 25-Dec-2020. Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021 at 6:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 6:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose). On 12-Mar-2021, DEVICE CONNECTION ISSUE (Syringe and needle not properly connected, Vaccination was leaking down the arm of the patient) and ACCIDENTAL UNDERDOSE (Amount of vaccine that the patient actually received  is less than half dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was revaccinated. No Concomitant medications were provided. No Treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up was received on 25-Jun-2021 and patient demographics were updated, new medical history was added, New dosing regimen was added for Suspect vaccine.
Allergic reaction - pruritis over entire body; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 39-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 04Mar2021 15:30 (at the age of 39-years-old) as DOSE 1, SINGLE for covid-19 immunization. (Vaccination facility: other). Medical history included hypertension, Hashimoto, depression all from an unknown date and unknown if ongoing. Concomitant medication (other medications in two weeks) included lisinopril (LISINOPRIL), fluoxetine hydrochloride (PROZAC), levothyroxine (LEVOTHYROXINE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug hypersensitivity (known allergies to doxycycline). Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. It was reported that on 04Mar2021 15:30 patient experienced Allergic reaction Pruritus over entire body. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result event with Self medicated Benadryl. The outcome for the event was reported as unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.  .
This spontaneous report was received from a nurse practitioner regarding to an unspecified patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot #L016428, expiration date 30-JUL-2017, dose was not provided). No adverse effects were reported. Additional information has been requested.
Pt woke up on 2/18/00 with flat red spots all over body, slightly itchy when touched. Pt was nauseous, cough, slight runny nose noted. On 2/17/00, rash remains, no other symptoms.
Lesions on lt arm, papule on lt cheeks and rt hip with sm. vesicular component. Excoriations on her abd.
Within 24 hours of the vaccine, Patient had a rash that broke out over her legs, arms, vaginal and gluteal areas, and her stomach.
Grandmother states the girl was vaccinates on 10/20/2016. Right arm swelling and red. Arm is warm to touch and redness.
Severe chills, shaking, severe headache, slight nausea.  Fairly sore arm at injection sight.  Began around 2am  2/4/2021 and lessened somewhat the next day.  Reactions finally were gone on 2/6/2021
fever x 2 days tx w/APAP effectively @ 2000;6MAY had brief gen sz in bath tub lasted 3-4 min-911 called brought to hosp ER:initially postictal;t105.8;short gen sz;prolonged sz required valium, dilantin, phenobarb;resp arrest-intubation
Lethargy; Body ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 06Feb2021 08:50 (Lot number: EL3248) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diuretic therapy" (ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for diuretic therapy, start date: 2012 (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EK9231) intramuscularly at 08:10 AM, in left upper arm), administration date: 16Jan2021, when the patient was 68 years old, for COVID-19 immunisation, reaction(s): "Minimal soreness at injection site", "headache", "some lethargy". The following information was reported: LETHARGY (non-serious) with onset 06Feb2021 15:00, outcome "recovered" (Feb2021), described as "Lethargy"; PAIN (non-serious) with onset 06Feb2021 15:00, outcome "recovered" (Feb2021), described as "Body ache". Therapeutic measures were not taken as a result of lethargy, pain.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patient were vaccinated with an improperly stored dose of VAQTA (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Thought it was allegic reaction; Experience a lot of tiredness; Experience / a sore / throat / she thought / was an allergic reaction; Experience / itchy throat / she thought / was an allergic reaction; Experience a stiff arm; Headache; First Shingrix dose in Sep-2020 / Second dose / on 6-Apr-2021; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient stated that she had shingles 35 years ago.). Previously administered products included Shingrix (1st of dose Shingrix received in September 2021, no problems.).   On 6th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th April 2021, 12 hrs after receiving Shingrix, the patient experienced allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness, headache and drug dose administration interval too long. On an unknown date, the outcome of the allergic reaction and drug dose administration interval too long were unknown and the outcome of the tiredness, sore throat, itchy throat, limbs stiffness and headache were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, tiredness, sore throat, itchy throat, limbs stiffness and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient was late for 2nd dose because she was in another state for three months which led to drug dose administration interval too long. In the morning or afternoon time, the patient received 2nd dose in the left deltoid. The patient stated that she was not feeling well and was pretty sick. The patient further described this by describing the symptoms she had. Twelve hours after vaccination, she started to experience a lot of tiredness and a sore and itchy throat that same day in the middle of the night.  The patient stated that she thought the sore and itchy throat was an allergic reaction to the Shingrix vaccine she had just received.  She started to experience a stiff arm and a headache that same day after she received the Shingrix. She stated that nothing she took helps her headache. She stated that this tired feeling, stiff arm, headache, as well as the sore and itchy throat was still present. The reporter did not consent to follow-up.
Very bad headaches; nausea; chills; no strength: could hardly get up out of bed; ached. I believe I had fever but did not take my temperature. However, I broke out in sweat the second day after vaccination. Took TUMS and ADVIL. I am concerned as to if I should take the 2nd shot!
-Chills -Feeling faint -Heart Palpitations -Headache -Disrupted vision
not feeling good; upper respiratory infection; high blood pressure; a 101.1 fever.; feel spaced out/light headed; slight cough; hot; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 06Oct2021 17:45 (Lot Number: FF8839, expiry date: unknown) as dose 1, single (age at vaccination:40-Year-old) for COVID-19 immunisation from Pharmacy or Drug Store. Medical history included hypertension, Gout, and Acid reflux (gastrooesophageal reflex). Concomitant medications included irbesartan (IRBESARTAN), amlodipine besylate (AMLODIPINE BESYLATE), and omeprazole (OMEPRAZOLE). No known allergies. All were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Irbesartan, Amlodipine Besy, Omeprazole. The patient was not diagnosed with covid-19 before vaccination, and tested post vaccination. On 07Oct2021 10:00 the patient experienced not feeling good, upper respiratory infection, high blood pressure, a 101.1 fever, feel spaced out/light headed, slight cough, and hot (feeling hot). The events resulted in emergency room visit. Event was not resulted in prolonged hospitalization. On 08Oct2021 the patient underwent lab tests and procedures which included blood pressure measurement: 176/117 (units unspecified), sars-cov-2 test nasal swab: negative and body temperature: 101.1 (units unspecified). On 11Oct2021 blood pressure measurement: 167/114 (units unspecified) and body temperature: 101.1 (units unspecified). The patient had not received treatment for all the events. The device date was 11Oct2021.The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Body aches, no treatment, 8-10hrs malaise, no treatment, 12-24hrs
About 20 minutes after receiving the first dose, patient developed dry mouth and it felt hard to swallow. She stated the episode of symptoms lasted about 15 minutes. She denied feeling any shortness of breath.
Fever increased 104.9 on Friday Oct 16, 2009. Body aches, cough.
migraines, muscle aches, chills, fever, extreme fatigue to the point can?t sit up for extended period of time,  eye pain, loss of apetite, nausea and vomiting, redness in eyes, insomnia
We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients). At the time of the report, PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients) had resolved.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received with non significant information.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
No additional AE; Patient received a dose of the VAQTA vaccine that was improperly stored.; This spontaneous report was received from an other healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 23-MAY-2023, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (formulation pre-filled syringe, lot #X004813, expiration date 28-JUL-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2306USA003052:
Episode of shortness of breath, unable to take a deep breath during a basketball game. I took her to the emergency room at Medical Center, they did ekg, vitals, lab work which included a troponin, CT scan of her chest.  Her troponin was 639, then repeated and was 616, ekg normal. CT scan negative. Was diagnosed with myocarditis.  Referred to a pediatric cardiologist.  Went to see him 1/3/22 Dr. He repeated labs, ekg and did an echocardiogram.  Troponin had dropped to 7, wbc 5,000 ( which had been 18,000) ekg normal, echo normal and put a heart monitor on her for 2 weeks.  Going to do stress test 4/15/22.