chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2021-390578 (Patient Link).
Headache; Nauseous; He threw up; This is a spontaneous report from a contactable consumer (parent). A 12-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731) via an unspecified route of administration in left arm on 17Jul2021 at 12:00 (at the age of 12-year-old) as single dose for COVID-19 immunization. Patient had no medical history and was very healthy. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration as single dose for COVID-19 immunization and nothing happened [no adverse event]. On 17Jul2021, after second dose of vaccination when patient got home, he experienced headache and then he was nauseous and then once he threw up. Corrective treatment included Tylenol. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Nurse gave wrong dose of bivalent covid-19 vaccine booster. doctor immediately notified and spoke with family. Supervisor also notified immediately of event.
On April 2, 2023, I woke up and the right, big toe was very sore and new it was the beginning of a GOUT attack. I was taking ADVIL 3 times a day. It had been several years since I had an attack. I went to urgent care of the 26th of April and got a prescription for indomethacin and prednisone colchicine. After about 3 days I was able to walk. As of today, I am not able to wear dress shoes, but I am able to wear my running shoes to keep pressure off of my toe.
- After the first dose: just a sore shoulder; nothing major. - After the second dose: about 10 hours after, I felt chills, lower back pain, pain on the back of the lower legs, fatigue, increasing fever reaching 101 , exhaustion and a bit of diarrhea, and dry cough. The symptoms lasted about 12 hours, but decreasing gradually after 8 hours. - Eleven days after the second dose: While the dry cough has not gone away, in the evening of this 11th day, I began to experience 100.9 degree fever, extreme lower back and back-of-the leg pain, mild diarrhea, mild headaches, a red rash that started on the left torso and, over the course of 12 hours, kept spreading, eventually covering the entire body from head to toe.
24 yr old female Hep  B #1 6/20/2002- little reaction. Hep B #2 09/16/2002 (same lot #) given in arm. By that afternoon started to have muscle and joint pain in arms and legs, became worse. Resolved little over 10 days
@ approx 630PM pt began to c/o h/a which grad became more severe; t100 mom gave APAP h/a becam excruciating w/pt holding head & crying due to pain; pt went to bed 830PM awoke 130AM 29MAY92 vomited, t103;
This spontaneous report as received from a medical assistant refers to a 12 year old female patient with none drug reactions or allergies. Pertinent medical history was not reported. On 03-MAR-2015 and on 05-MAY-2015, the patient was vaccinated with the first dose and second dose, respectively, of GARDASIL (Lot number, expiration date, route and dose were not provided). On 08-SEP-2015, the patient was vaccinated with the first dose (reported as the third dose) of GARDASIL 9 (Lot number, expiration date, route and dose were not provided). Concomitant medications were not reported. The reporter stated that within minutes after being vaccinated with GARDASIL 9, the patient developed blurred vision and a sharp headache. The patient was instructed to lie down in the office "for a few minutes" and to had a few sips of water to drink. No laboratory diagnostic studies were performed. The patient recovered of sharp headache and blurred vision on 08-SEP-2015. The reporter did not assess the relatedness of GARDASIL and GARDASIL 9 and GARDASIL to sharp headache and blurred vision. Additional information has been requested.
fever, diffuse macular papular rash & irritability, not hives 7-10 days p/vax
lip swelling and tongue swelling 24 hours after vaccine was administered . patient was sent to the hospital
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 74-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to SHINGRIX. Additional details were reported as follows: In 2018 after vaccination, the patient experienced a really red upper arm and that was hot to the touch. The events were lasted for a few days.
Lethargy, impaired cognitive function began on 3/29.  By the morning of 3/30, the lethargy and cognitive function is back to normal. Slight headache, low fever and slight chest pain began. Felt better by the afternoon of 3/30 once I took ibuprofen. That evening at approximately 7 pm, I noticed my heart rate was high. My resting HR is about 70, but my HR was at 125 - 130 and I was not exerting myself and was sitting. My HR remained high after I went to bed, and chest pain became worse. By 12:30 am on 3/31, chest pain was getting severe and had pain in both arms. Went to ER at around 3 am on 3/31. Later learning I had a mild heart attack. Had EKG, Blood work, ECG, and Heart Catheritazion. No blockage and normal results except blood work. Blood work showed elevated enzymes.  While in the ER, I was given blood thinner and glycerin tablets, aspirin. Since 4/2, my heart rate and blood pressure have returned to their norm without medication.  I once again have perfect blood pressure readings and perfect HR.  I have returned to normal daily activities as of 4/4.
Neck pain at 2:30 on may 21, 2021 Soreness where the pain occurred on may 21,2021. Possibly lymph nodes. Headache on and off  Arm soreness
PATIENT COMPLAINED OF RASH ON CHEST AND FOREHEAD. SHE WAS GIVEN STEROIDS FOR 5 DAYS. AN ADDITIONAL RASH WAS SEEN UNDER THE ARM THAT DID NOT RECEIVE THE VACCINATION
Patient developed hives 6-6-08, and took BENADRYL Q 6 hours.  On 6-7-08, pt still had hives, then developed fever, and joint pain.  Dr. recommended pt. go to ER, where she received prednisone, ZANTAC, and DECADRON inj.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 05-MAR-2015, the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received TRUMENBA, (Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 27Jun2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient had pain at the injection site for 3 days. She had a headache behind her eyes and her eyes are watering. The outcome of the event pain at the injection site was recovered on unspecified date. The outcome of other reported events was unknown. Information on the batch/lot number has been requested.
Please know that this point there is no emergency, but I am furious at the enormous side effects I've endured on the 1st and 2nd vaccine My 1st vaccine was March 5th at 10:30 am .  Next day I had a slight fever and was exhausted all day long. I had to keep laying down after being up for an hour.  5 days passed and I was in the grocery store and my legs were on fire and I had huge Welts -hives all up-and-down my legs .  I started to faint and the woman in the bakery sat me down until it passed.  I had a headache and a slight fever after that . I also had a enormous sneezing fits, of which there was no apparent trigger.  At the time I just chalked it all up to allergies or something un related to the vaccine because so many days had passed.   I received my 2nd vaccine on March 26th at 8:00 p.m. at the  Farm stadium. The next day my arm was a little sore,  nothing unusual. The following day I was a little tired again nothing unusual. The 3rd day ( Mar 29) all hell broke loose.   I got the hives all over the place, I could not stop sneezing . I've got a massive headache, and I can barely stay awake over an hour without taking a nap. I am absolutely miserable! I wish I had never taken the 2nd vaccine.  This may not be life-or-death, but it sure as hell sucks. I wouldn't recommend the vaccine after this experience . And if it's anything like my 1st vaccine, I've got a week of this to endure
Information has been received from a pharmacist regarding a 63 year old female patient. There was no medical history, drug reactions or allergies. On 10-JAN-2014, the patient was vaccinated with a single dose of ZOSTAVAX (subcutaneous in the left arm) (lot # J001700, expiration date 08-MAY-2014). On 11-JAN-2014, the patient developed redness and itching at the injection site. The area of reaction involved the whole back of the left arm. The patient did not receive treatment for the adverse events. The patient sought medical attention, called the pharmacy. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.; Next day, he started with full body aches.; It is puffing and sore.; It is puffing and sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, METFORMIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PRAVASTATIN for an unknown indication.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.). The patient was treated with ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Spikevax) (Unknown) was not applicable
Tingling, arm feels "heavy" and "weak", arm that was vaccinated. Patient called PHN over, described that arm where she received vaccine felt heavy and weak. Patient states she felt tingling in arm, down to hand immediately following vaccine administration. Patient states her arm feels sore, soreness radiating into neck. Patient states she is feeling a little better after fifteen minutes. Recommended to follow up with PCP and seek care if symptoms persist or worsen. Pt. discharged from clinic.
MISCARRIAGE 11/30 and 12/1 Medical records received for DOS 11/16- 12/4 LMP 10/23/09.  C/O odor, pain and discharge on 11/16.  HCG +  on 11/25.  11/30 c/o cramping, bleeding, passing mucous tissue. Miscarriage.  HCG level decreased from 11 to 4.
shingles lower back - 12/11 Muscle soreness, 1/3 Lower extremity myopathy, 1/8 ataxic gait/wheelchair, areflexia ongoing to date
Patient became positive for Covid after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient became positive for Covid after 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-May-2021, the patient experienced COVID-19 (Patient became positive for Covid after 1st dose). At the time of the report, COVID-19 (Patient became positive for Covid after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
BACK PAIN; GENERAL BODY ACHES; This spontaneous report received from a patient via a company representative concerned a 50 year old female. 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, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced back pain. On 2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and general body aches on 2021. This report was non-serious.
100 degrees fever; Nausea; Chills; Diarrhea; Unusually strong headache; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 at 15:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 16Apr2021, at 09:00, the patient experienced 100 degrees fever, nausea, chills, diarrhea and unusually strong headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events 100 degrees fever, nausea, chills, diarrhea and unusually strong headache was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the vaccination approximately 3 hours later patient experienced severe leg pain that has since resolved. Patient had leg pain for one week.  Patient also experienced fever for 1 day after the vaccine
injection site tenderness; headache; Chills; nausea; Fever; This spontaneous report from a contactable Consumer (patient).   A 40-year-old female consumer reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6201), on 16Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (ADVIL 12 HOUR) for an unspecified indication.  The patient experienced injection site tenderness on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , nausea on an unspecified date with outcome of recovered on an unknown date and fever on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296244 Same patient, same drug, different dose
Patient described:   April 3rd, 2021:  Normal COVID19 vaccine symptoms including fever, headache, and body chills,  April 10th, 2021: Dizziness, unbearable headache on the left side of the head, constant/continuous headache (headache will not go away), complete hearing loss on the right side, and nose bleeds.  April 14th, 2021: Visited clinic with symptoms that initiated on April 10th, 2021. New symptoms include vision impairment including white lines, black and yellow spots, and blurred vision. Additional symptoms: constant headache, dizziness, vertigo. The clinic advised that they could not help with treatment due to a possible link with the vaccine. Receiptionist unable to refer the patient to a hospital no reason provided.  The clinic could not help. Gave patient the option to go to the hospital if the patient could not breathe.   After April 14th, kept attempting to make an appointment with a healthcare provider. No response from clinics. Symptoms described continued and did not get any better.   Received appointment at the Clinic for May 17th. Immediate referral to a specialist on May 18th. MRI scan gave on May 18th. Diagnosed on May 24th with a brain aneurysm. Brain aneurysm treatment will begin June 14th, a catheter will be inserted to identify the brain aneurysm location.   Permanent damage has not been outrulled.
This spontaneous report was received from a physician of unknown age regarding himself/herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient received a dose of PREVNAR 13 followed by PNEUMOVAX 23 (lot#, expiration date, strength, dosing details and route of administration were not reported) before the patient was 65 years old for prophylaxis. No adverse effects reported.
Sharp pain in left lower back.  Moving down left leg and left foot.  Numbness in leg and foot and slight swelling .  Dizziness, fainting 1 time, with rapid heart beat after fainting. Symptoms started 2 1/2 days after shot.   Taking Tylenol every 6 hours.  Lower back improved leg and foot still swore
Mild arm pain; Pfizer Bivalent/14-OCT-2023; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2023 at 15:45 as dose 5 (booster), single (Lot number: 4665) intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergies: Acetaminophen" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2023 at 15:45, outcome "unknown", described as "Pfizer Bivalent/14-OCT-2023"; PAIN IN EXTREMITY (non-serious) with onset 14Oct2023 at 19:00, outcome "not recovered", described as "Mild arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks. Patient received various Rx and OTC medications in two weeks. Patient did not had covid prior vaccination. Patient did not test for covid-19 post vaccination. The vaccine facility type was Pharmacy or Drug Store.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330651 same reporter/product/events; different patient;US-PFIZER INC-202300330662 same reporter/product; different patient;
Muscle and body aches - right hip and joint pain. I woke up with a sore throat and I had a sore arm the next morning. Thursday, I started getting a cough and that started getting worse and I was sick for about 6 weeks. I was short of breath, extremely tired and coughing. They started me on a Z-pack and Dx'd me with bronchitis at the time. After I finished the Z-pack I went back to Doctor and he put me on another antibiotic for 10 days twice a day  - maybe Augmentin 875. And put me on a dose of Prednisone at the same time. I still had a cough and couldn't get rid of it. Adver discus twice a day and a Prednisone Taper. I am still on it the Adver. I was out of work for two weeks and had to use my PTO and paid family leave. The symptoms have resolved - but it was 6 weeks. First doctor visits were drive through since I had a cough. I had a total of four doctor visits.
Pfizer COVID-19 Vaccine EUA  Approximately 5-10 minutes post vaccination patient experienced chest tightness, shortness of breath, and tongue swelling. Initially treated with epinephrine by EMS with some resolution, but symptoms returned. Patient transferred to emergency department and treated with epinephrine 0.3 mg, famotidine 20 mg, diphenhydramine 25 mg, and methylprednisonole 125 mg. Observed patient for over 2 hours, symptoms resolved with treatment,  and discharged home.
Itching skin, started in extremities then progressed inwards. I took benadryl and applied anti-itch cream to affected areas.
After receiving vaccines patient fainted for approx. 5-10 seconds. Client was assisted to lying position. Client quickly started talking and following at commands. Vital sign: B/P=112/71, HR=53, pulse ox 99%. Client given water and snack. Client stated he was nervous and was holding his breath. 2nd set of Vital signs taken 10 minutes after 1st set: B/P=10/68, HR=50, pulse ox=99%.  Mother present and child left with mother.