chrisvoncsefalvay/vaers-outcomes huggingface dataset:
late for second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (late for second vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (late for second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (late for second vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
J&J Covid one shot has made me so incredibly ill.  First my husband was so ill immediately after the shot for one week and he is still sick.  I haven't been sick in years and now I am dealing with pleurisy and pleural effusions in my lungs; pneumonia, and on many different medications and can't breathe.
Brought on water retention and heart failure symptoms 3 weeks after second dose. Death on August 5 2021
Starting on February 3 starting experiencing dizziness, nausea, headache, shakes like I had a bad stomach due.  The symptoms waxed and waned and have continued to this date. Background history I have a Covid test on November 4th and received a confirmation by telephone that it was positive on November 9th.  After 14 day quarantine I felt fine and proceeded with my life.   The symptoms now appear to me to be related to the vaccine.  Was this the result of having Covid or getting the vaccine within the 90 days of having supposed immunity or a result of the vaccine.  It does make me question getting the second injection
A day after getting the moderna vaccine shot dose #1 in my left arm, that arm hurt for a couple of days.  7 days after getting the Modena dose 1 (yesterday) - my arm developed a rash at the injection site.  So far, now 8 days after the vaccination, the rash is getting more swollen and incredibly itchy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergies: Allergic to walnuts" (unspecified if ongoing), notes: Known allergies: Allergic to walnuts; "Known allergies: Allergic to pecans" (unspecified if ongoing), notes: Known allergies: Allergic to pecans. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment I retested positive; (13Dec2022) positive, notes: I retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Gestational period was provided as 22. Other medication in 2weeks: No. The patient received Paxlovid treatment from 06Dec2022 to 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feverish; Achy; Headache; Stomach pains; Diarrhea; This case was reported by a consumer and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received Shingrix. On 30th October 2019, 1 days after receiving Shingrix, the patient experienced fever, pain, headache, stomach pain and diarrhea. On an unknown date, the outcome of the fever, pain, headache, stomach pain and diarrhea were unknown.   It was unknown if the reporter considered the fever, pain, headache, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was achy, feverish,  had a headache, stomach pain and diarrhea after reciving shingrix vaccine.
Fever Persistent injection site swelling, pain, and warmth for more than 6 weeks. Fever and chills for 2 days. Narrative: Persistent injection site swelling, pain, and warmth for more than 6 weeks. She saw her personal provider 2 times and was treated with physical therapy and steroid patches. Took muscle relaxer and Ibuprofen for pain.
This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency, route of administration and indication were not reported, lot# L021215 with expiration date 10-JUN-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Information has been received from an employee of a distributor concerning two patients who on unspecified dates were vaccinated with Pneumovax 23. Subsequently the patients were hospitalized. No further details were provided. No further information is expected.
PT sat down after the shot administration and very quickly lost conscience. His mother patted him and withing a couple of seconds he came to. He seemed very sleepy and unable to focus, but began feeling better soon.
Had vaccine Friday at 2:00 pm by 10:00 pm started aching then by midnight had fever about 102 with chills the remainder of the night. Next morning Saturday every muscle and bone in body hurting and had temperature until about 9:00pm which was day after injection. This is now Sunday morning, no fever but very tired and sore in neck and back.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning an eight-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 29-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, and concurrent condition was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, injection, lot # L018500, expiration date 13-APR-2017; lot # L033343, expiration date 16-JUN-2017, (dose, route of administration and concentration were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II, lot # J016235, expiration date: 19-DEC-2015 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. was given vaccine, walked to check out counter, fell back, hit head on floor. she was noted to be pale around lips and left hand was twitching. She also was incontinent with urine on the floor. Pt. came to in a few minutes and was transported to Emergency Room.
Arm is sore; dizzy; Leg is swollen; Leg starting to hurt; Knee cap is the size of her thigh; Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it; knee hurt; Chills; Fever; Diarrhea; Has been so sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore) and DIZZINESS (dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea) and ILLNESS (Has been so sick). On 06-Apr-2021, the patient experienced MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it) and ARTHRALGIA (knee hurt). At the time of the report, CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it), ILLNESS (Has been so sick) and ARTHRALGIA (knee hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient states she tested negative for covid..         Concomitant Product: Antibiotic No treatment details were added.
Developed redness at area of injection - warm to touch. Redness spreading down arm. Given antibiotic - cephalexin 250/5ml one tsp BID x 10 days. Given Antihistamine - cetirizine 5mg/5ml 1/2 tsp PRN BID.
I started getting symptoms of increases body warmth and chills. I had a mild sore throat and a dry cough, fever at 100.4 and increased fatigue. I took an at home COVID-19 test that was positive. I contacted my doctor and was prescribed a half dose of Paxlovid due to renal issues. My symptoms lasted strongly for 24 hours.
ACHE JOINT/MUSCLE, ACID REFLUX, MOOD ANXIETY, ARTHRALGIA, BRADYCARDIA, CONCENTRATION DIFFICULTY, CYST INCREASE SIZE, DEPRESSION, GASTRIC ULCER, GASTRITIS, HEADACHES, PAIN MUSCLES/JOINT, STIFFNESS, SKIN CONDITIONS, SLEEP PROBLEM, CONJUNCTIVITIS (MEDICAL INF. AVAILABLE).
Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am.  Was seen in the ED and found to be in sinus tachycardia; resolved without intervention.
tightness in chest, short of breath. elevated CK lab. elvaluated in ER at Medical Center. Treated with fluids. Followed up with PCP and cardiology at Medical Center.
HEAD SPINNING/WORLD SPINNING/ VERTIGO; SLIGHT DIZZY; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight was 165 pounds, and height was 175.26 centimeters. The patient's past medical history included drug allergy, and concurrent conditions included okra allergy, alcohol use, nonsmoker, essential hypertension, and seasonal allergic asthama, and other pre-existing medical conditions included the patient had no history of drug abuse. The patient experienced drug allergy when treated with hydrochlorothiazide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch was not reported and has been requested. Concomitant medications included amlodipine besilate for hypertension, and losartan for hypertension. On MAR-2021, the subject experienced slight dizzy. On 24-MAR-2021, the subject experienced head spinning/world spinning/ vertigo. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head spinning/world spinning/ vertigo on 24-MAR-2021, and the outcome of slight dizzy was not reported. This report was non-serious.
Pt had the same reaction as she did on 08/21/17. She fainted almost immediately after being given the HPV 9 and had a small seizure. The Hep A vaccine was given first. She was a little confused and upset when she came to. Pt was given a cool cloth for her forehead and a drink of water. RN enc mom to take child to PCP if she had any concerns or if pt had any other symptoms. RN called mom a few hours later to check in and mom reported that she was fine.
Information has been received from a pharmacist concerning a female in her "either late 40s or early 50s" who on 29-OCT-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23.  It was unknown if the patient had received PNEUMOVAX 23 in the past. On the same day the patient also received a dose of "flu shot" in the opposite arm.  On 29-OCT-2008 the patient experienced pain upon injection.  "Four hours later", her arm "froze" (the pharmacist unsure what the patient meant by this).  On 30-OCT-2008 the patient had pain but no visible symptoms and no swelling.  The patient also felt "out of it".  The patient called the pharmacist.  It was reported that the patient had been taking TYLENOL and ADVIL for her symptoms.  At the time of the report, the patient had not recovered from the events.  The pharmacist considered the patient's symptoms to be disabling.  Additional information has been requested.
marked local reaction w/fever, pain, & 8x8 cm erythema & induration nl PE other than local rxn & fever 101.3 (tympanic); treated w/DPH, APAP, cool compresses;
This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 09-JAN-2018, the patient was inadvertently vaccinated with PROQUAD, by intramuscular route for prophylaxis. No adverse effects were reported.
Right upper arm is swollen and redness and states it feels numb on 4/17/01 at 10:55 PM. Treated with Zithromax, Atarax and follow-up with MD.
A 47-year-old female patient with no known allergies or illnesses at the time of vaccination had received an administration (route and site not reported) of FLUZONE  SV '2005-'2006 USP on 04/Nov/2005  On 08/Nov/2005 she complained of feeling "unsteadiness She said she did not feel unsteady on her feet, she felt "unsteady in her head."  She was seen by a physician.  It is unknown if the patient recovered from this event at the time of this report.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (Lot No. J006850 Expiration date: 31-MAR-2016 this lot was not improperly stored). Then, on 16-SEP-2014, the patient received the second dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High Blood Pressure; This serious case was reported by a consumer and described the occurrence of blood pressure high in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number RS3A9, expiry date 08-OCT-2024) for prophylaxis.   On 22-SEP-2023, the patient received Shingrix 50 mg. On 23-SEP-2023, 1 days after receiving Shingrix, the patient experienced blood pressure high (Verbatim: High Blood Pressure) (serious criteria clinically significant/intervention required). The outcome of the blood pressure high was not resolved.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.     It was unknown if the company considered the blood pressure high to be related to Shingrix.   Additional Information: GSK receipt date: 20-OCT-2023 This report was submitted via the online direct entry reporting system.  The reporter gave permission to contact them..
herpes outbreak; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (herpes outbreak) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (herpes outbreak). At the time of the report, HERPES VIRUS INFECTION (herpes outbreak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. Treatment medications were not reported   Reporter did not allow further contact
Swelling and pain in right eye occurred within 10 minutes of getting shot. Eye swelled nearly shut overnight and over 24 hours later is still swollen with a burning pain.
Chills started first at 16:00 Fever was first detected at 22:00 on 4/7/2021 Fever lasted until 19:00 on 4/8/2021  highest fever detected was 102.5 Body aches started at 11:00 on 4/8/2021 and lasted until approx 16:00  Took 200mg Aleeve at 03:00 on 4/8/2021 and 80 mg aspirin at 08:00 on 4/8/2021 and 200 mg Aleeve at 15:00 on 4/8/2022
MUSCLE PAIN TOOK HER BREATH AWAY WHEN SHE NEEDED TO LAY DOWN AND GET UP; BAD MUSCLE PAIN IN UPPER BACK; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypothyroidism, post-traumatic stress disorder, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and expiry: 07-AUG-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination.  Concomitant medications included hydrochlorothiazide/spironolactone for high blood pressure, levothyroxine for hypothyroidism, and sertraline hydrochloride for ptsd.  On JUN-2021,the subject experienced muscle pain took her breath away when she needed to lay down and get up. On JUN-2021, the subject experienced bad muscle pain in upper back.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: meloxicam, cyclobenzaprine, and tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad muscle pain in upper back, and muscle pain took her breath away when she needed to lay down and get up. This report was non-serious.
5 Minutes post vaccination, pt experienced seizure like symptoms. Speech was slurred and patient went into a fetal position and was flailing his arms. He returned to the chair and we placed him on the floor while waiting for 911. The paramedics check him out and with advice from the mother he was not taken to the hospital. He was escorted to his parents car and driven home.
A report was recieved from a consumer on 02/26/2003, concerning a male vaccinee of unknown demography who received Fluvirin intramuscularly on 02/26/2003. On 02/26/2003, the vaccinee was supposed to receive another vaccine via the intradermal route but was inadvertently given Fluvirin instead. No adverse event had occurred at the time of the report.
no adverse event; a patient was administered with a properly stored expired MMR II; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 05-MAY-2020, the patient was vaccinated with properly stored dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R025335 with expiry date 06-APR-2020, therapy type: RHA; 1 dosage form) (strength was not reported) via subcutaneous route for prophylaxis (expired product administered). The expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. No additional adverse effect reported (no adverse event). No product quality complaint (PQC) was involved.
WAS ON  VENTILATOR; SUSPECTED COVID-19 INFECTION; DEATH; This spontaneous report received from a media article via a company representative concerned a 61 year old female of unspecified race and unspecified Ethnic origin. The patient's height, and weight were not reported.  The patient's concurrent conditions included exposure to covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.   A day later of vaccination patient traveled extensively and returned home nine days later. On an unspecified date in MAR-2021, the patient was not feeling well and had difficulty in breathing. Later, patient's sister drove her to the hospital where she had ups and downs but was eventually put on a ventilator. On an unknown date in APR-2021, the patient died due to unknown cause of death. It was unspecified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient died an APR-2021 and the outcome of was on ventilator and suspected covid-19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210514186-covid-19 vaccine ad26.cov2.s-Death, was on ventilator, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH