chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided.  Reporter stated that on 17-Dec-2021, the vial was initially stored in the refrigerator and the use by date was 16-Jan-2022. Also stated that the vial did not undergo any temperature excursions.
Day 1 Large red spot, stinging, fevered. Day 2 Soreness and knot. Day 3 More redness, soreness, larger red spot. Headache. Still have small red spot and itching.
Patient developed shingles approximately 3 weeks after immunization. Shingles outbreak located on same arm and included injection site. On 5/24/18, patient saw his dermatologist who said the shingles outbreak was probably caused by trauma from the immunization. He prescribed Valacyclovir 1000mg three times daily for 7 days, Tramadol 50mg three times daily, and Betamethasone valerate 0.1% cream once daily as needed. Patient also went to the emergency room on 5/27/18 to treat nausea assocaited from Valacyclovir and Tramadol.
pt says he started feeling nauseated. He started having severe abdominal cramps that came in waves and raised heart rate.  He went to Hospital ER in State.  He was admitted for observation.  He had blood test and had an EKG.  He was given regimen morphine shots.  He DX was severe abdominal cramps,  raised heart rate and Dehydration.  He was told to FU w/ PCP.  Pt feels like these symptoms were from taking the vax earlier that day.  He did not feel well for about 5 to 6 days.  He says he feels better today.
This spontaneous report as received from a registered nurse refers to a patient of approximately 64 year age. On 05-NOV-2013, the patient was vaccinated with VARIVAX (Merck) lot # J006109 and expiry date 21-MAY-2015. No concomitant medications were reported. ON 05-NOV-2013, the patient inadvertently received VARIVAX (Merck) instead of ZOSTAVAX and no adverse effect was reported. This case is linked to 1311USA002811 (same reporter). Additional information is not expected.
My symptoms began 5/14. I woke up the next morning feeling like I had a head cold. I had congestion, runny and stuffy nose, and a mild cough. No fever or lethargy and no loss of senses. My daughter tested positive two days earlier so I took a rapid covid test which came back positive almost instantaneously. I contacted my doctor the next day who prescribed Paxlovid. I began the 5 day regimen that evening and my symptoms began to dissipate by the following Wednesday.
Within 15-20 minutes: Dizzy and lightheaded. Hard to think clearly. Headache. High heart rate and heart arrhythmia. Pin prickly over whole body, then itchy. Heavy throat and chest, tight throat, hard to breathe, dry and phlegm feeling in throat (was very hydrated. 64 plus oz water that day). Low blood pressure, icy cold limbs. Face might have swelled slightly I was concentrating on breathing. Took 2 Benadryl per pharmacy directions, probably around 5:25. Symptoms stayed consistent for 2/3 hours and started subsiding.  Hour 6: Took a Benadryl and 2 Tylenol to and went to sleep. The itchiness has continued
Patient received flu + COVID bivalent booster on 11/19/23, dies on 11/22/22 from an unknown heart issue.  **I am a pharmacist, but not directly involved with this patient.  She is a friend I knew from yoga class.  I saw online she died suddenly from what her partner described as an unknown heart issue.  I saw she recently had vaccines administered and wanted to make sure it was reported to VAERS**
included 104 degree fever the next day; hives around the injection site; headache for 2-3 days
Pt received first two doses of sinopharm per daughter's request, to give pt pfizer booster shot (got okay from PCP). Notified allergist stated that sinopharm considered fully cavvinated by regulatory authority (non-MRNA). No data but go ahead and give one dose today.
FELT EXTREMELY HOT; BAD HEADACHE; 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, batch number: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced felt extremely hot. On APR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache, and felt extremely hot. This report was non-serious.
Started pink about 1cm first day post. 3cm second day post. Fifth day post was 8cm-10cm and 9n sixth day post was grayish with red ring around it. I have pictures.
greater than 3 hrs of crying reported by mom; unconsolable; exam=painful inject site;
swollen left eye; redness on right hand and wrist; itching of both eyes; rash underneath eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen left eye), ERYTHEMA (redness on right hand and wrist), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (tetracycline), Drug allergy (meloxicam (Mobic)) and Drug allergy (amitriptyline). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ALPRAZOLAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EYE SWELLING (swollen left eye), ERYTHEMA (redness on right hand and wrist), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye). The patient was treated with POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS) for Eye irritation, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swollen left eye), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye) had not resolved and ERYTHEMA (redness on right hand and wrist) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Slight temperature up to 100.4 began within a couple hours of shots and lasted until approx. a week and a half later; chills began a week later and lasted about a day; severe muscle/joint pains, particularly in the hips, began a week later and lasted a few days, chickenpox rash began a week later and lasted approx. 5 days.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient did not have any pertinent medical history and drug reactions or allergies. On 18-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as M001746, expiration date 17-APR-2017, dose and units were not reported) subcutaneously. Concomitant therapy included FLONASE. The patient experienced an unspecified adverse event approximately in July 2016. The pharmacist stated that she received an electronic prescription for the patient for prednisone (manufacturer unknown) (from an unknown provider) on the day of this report. The pharmacist stated she did not know why the patient was prescribed with prednisone (manufacturer unknown). It was reported that treatment (unspecified) was given for the event and there were no lab diagnostic studies performed. The outcome of the adverse event was unknown. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Patient recieved flu shot on 9/23/09.  Noted swelling of the arm day after flu shot given.  Was seen on 9/25/09 by Dr.  Dr. noted swelling and erythema in the area where the shot was given.  Patient was advised to utilize ice and over the counter medications and to follow up if no expected resolution of symptoms.
Sudden onset of wheezing, throat constriction, hoarse voice, trouble swallowing, dizziness.
Information has been received from a RN concerning a 10 year old white female who on 08/18/95 was vaccinated SC in the left arm with a first 0.5mL dose of varicella virus vaccine live (Lot # 608667/0426B).  Subsequently the pt developed breakthrough lesions, which were mild. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the RN which indicated that the pt was an office employee's family member. The chickenpox onset was a very mild case and was not reported to the office. An office visit was not made. It was noted that the case was "hear-say" between a company representative and an office employee. The date of the event was unknown. The reporter indicated that the pt recovered. Further information is not expected.
Tinnitus in both ears for the last week and a half or so. This adverse event is ongoing.  Swollen lymph nodes in neck, armpits, and groin immediately after vaccination, lasting around one week. Patient recovered from this adverse effect.
Site sore on 8/26/11, pain moved to underarm area into armpit. Redness about 4 inches around site appeared 8/28/11. Sent to urgent care. MD told her to put BENADRYL on it & take Doxycycline 100mg BID.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX (lot# M036292, expiry date 17-AUG-2018; lot# M041079, expiry date 06-OCT-2018; lot# M003440, expiry date 20-JAN-2018; lot# M049125, expiry date 15-DEC-2018; dose and route of administration not reported) for prophylaxis. The doses of vaccine underwent a temperature excursion of -14 degrees Celsius for 7 months. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004810.
A physician reported that a 24 year old female received her 1st dose of Typhoid Vaccine, USP, Heat Phenol Inactivated, as well as Hep-A (manufacturer unknown) vaccine on 3/31/1999. Within 24 hours, she developed an injection site reaction characterized by redness, warmth, pain and swelling "the size of a baseball" at the site of Typhoid Vaccine administration.
Delayed menstrual cycle by 17 days after 2 does of gardisil vaccine
had moderate menstrual bleeding which started shortly after receiving second dose/The bleeding continues daily; This is a spontaneous report from a contactable nurse (patient). This 44-year-old female nurse received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 03Feb2021 18:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included IUD from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 06Jan2021 at 06:00 PM on left arm. Patient did not have COVID-19 prior to vaccination.  Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) 40mg qd (once a day) taken for an unspecified indication, start and stop date were not reported.  The patient reported that she "had moderate menstrual bleeding which started shortly after receiving second dose" and "the bleeding continues daily" on 05Feb2021 18:00 with outcome of not recovered. Patient was not tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
2 large spot where the injection went in it almost looks like have 2; feet is wider; Right foot and calf is swollen; sweating; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (feet is wider), HYPERHIDROSIS (sweating), PERIPHERAL SWELLING (Right foot and calf is swollen), VACCINATION COMPLICATION (2 large spot where the injection went in it almost looks like have 2) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (UNITHROID), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OXYBUTYNIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], ATENOLOL, LISINOPRIL, MONTELUKAST, SIMVASTATIN and ZINC for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (Chills) and FATIGUE (fatigue). On 08-Feb-2021, the patient experienced OEDEMA PERIPHERAL (feet is wider) and PERIPHERAL SWELLING (Right foot and calf is swollen). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (2 large spot where the injection went in it almost looks like have 2). On 08-Feb-2021, HYPERHIDROSIS (sweating) and CHILLS (Chills) had resolved. On 10-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, OEDEMA PERIPHERAL (feet is wider), PERIPHERAL SWELLING (Right foot and calf is swollen) and VACCINATION COMPLICATION (2 large spot where the injection went in it almost looks like have 2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details include stockings.
The patient developed severe chest pain on the 4th day after the vaccine, he presented to the local emergency room and had the abnormal tests as described below. His symptoms improved rapidly but due to active myocarditis was given recommendations for limited activity to reduce risk of fatal arrhythmia
The patient reported being extremely dizzy to the point where she couldn't get out of bed for a day.
Worst redness and swelling ever, compared to all previous vaccines in my lifetime. Normal amount of pain.
On 05/19/2000 the patient developed a severe case of chicken pox from head to waist. The patient also developed a fever of 101F and had a skin infection which lasted approximately 5-7 days. The patient sought unspecified medical treatment. Additionally, it was noted that 2 other patients also developed similar reactions. Additional information has been requested.
Patient was accidentally given the second dose on the 14th day after the initial dose.  Administrative oversight.
Narrative: 61yo male with a history of squamous cell carcinoma of trachea, malignant tumor of trachea, congestive heart failure, esophagitis, HLD, schizophrenia, alcohol abuse, elevated liver enzymes, elevated PSA, and HTN. Patient died on 06/16/2021 in hospice. Patient received one dose of the covid vaccination on 03/23/2021. Appears patient died due to complications of the malignant tumor of the trachea and death is not related to the covid vaccinations.
She has been experiencing tingling and needles in all of her extremities; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities). At the time of the report, PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Moderna COVID-19 Vaccine EUA, About an hour after receiving the 1st dose of the vaccine, my right eye started twitching on and off . I reported it to the pharmacist. My throat is also hoarse.
pt recv vax  26NOV96 & 19DEC to ER weakness legs/dysarthria, facial droop;transferred to another hosp-d/c to rehab;readmitted 6JAn-7JAN d/c to rehab;readmitted 7FEB;d/c to rehab;dx GBS;
sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included TROSPIUM for Anxiety, PANTOPRAZOLE SODIUM, ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days). At the time of the report, PAIN IN EXTREMITY (sore arm for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-416948, MOD-2021-416968 (Patient Link).
Ever since the day after I got my first dosage I have had almost completely non stop menstruation; spotting; I am bleeding constantly either full flow or spotting with only maybe a day or so without each month.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Lot number: EW0179) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing); "only menstruated a few times a year" (unspecified if ongoing), notes: ever since puberty; usually one to three menstruation cycles a year my entire life . Concomitant medication(s) included: MIRENA taken for contraception. The following information was reported: HEAVY MENSTRUAL BLEEDING (disability) with onset 31Jul2021, outcome "not recovered", described as "Ever since the day after I got my first dosage I have had almost completely non stop menstruation"; INTERMENSTRUAL BLEEDING (disability) with onset 31Jul2021, outcome "not recovered", described as "spotting"; MENOMETRORRHAGIA (disability) with onset 31Jul2021, outcome "not recovered", described as "I am bleeding constantly either full flow or spotting with only maybe a day or so without each month.". The events "ever since the day after i got my first dosage i have had almost completely non stop menstruation", "spotting" and "i am bleeding constantly either full flow or spotting with only maybe a day or so without each month." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, intermenstrual bleeding, menometrorrhagia. Patient was an intersex person assigned female at birth, that lives as a male. The patient had no known allergies and had no other vaccine in four weeks. The patient reported that ever since the day after she got her first dosage, she have had almost completely nonstop menstruation. This has lasted 6 months now, of nonstop menstruation. Before this, ever since puberty she had only menstruated a few times a year, usually one to three menstruation cycles a year her entire life and she was 27 now. This was obviously a glaringly huge change, to go from not having menstruation to having it for 6 months straight. The patient stated that she will not be getting her second dosage until someone gives her some answers. She had tried talking to her general healthcare provider and she brushed it off saying it'll go away "eventually" and that usually it's in 2-3 months. When she had spoken to her it had already been happening for nearly 5 months and now it's 6. She was bleeding constantly either full flow or spotting with only maybe a day or so without each month. This was not a problem with my IUD or health and is directly connected to the vaccine. The patient had no Covid prior vaccination and was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Pt presented c/o numbness in (L) index finger approx 15 min after receiving vaccine. States pain radiated to other fingers and progressed to arm. c/o numbness with coldness to extremity and inability/difficulty grasping items. States she receive seasonal flu vaccine 2 days ago at center.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJS342) at the age of 68 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 at 09:00 as dose 1, single (Lot number: EL9267), in right arm, on 04Mar2021 at 09:30 as dose 2, single (Lot number: EN6198), in left arm and on 28Sep2021 at 12:15 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated HbgA1c" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Swollen lymph node at left clavicle.  Sudden redness at injection site, 9 days after injection
mom came in 29MAR94 PM stated pt was seen @ ER 24MAR93 w/stiff neck & paralized rt side of face; pt started w/slurred speech & difficulty drinking from cup; dx bell's palsy by ER MD;
Fever 103 lasting two days, still not wanting to eat, nausea and change in behavior, not cooperative and scared of more things.
Left leg 8cm x 5cm knot, large local reaction - cool compresses with Benadryl for symptom control.
AROUND 11PM STARTED GETING THE CHILLS, LEGS SHAKING AND HAD FEVER OF 104. AT 1:30AM, EYES HURT TO THE TOUCH. MOM ENDED TAKING TO ER AROUND 3AM. THEY GAVE HER TYLENOL AND IBUPROFEN. SHE GOT HOME AT 6AM AND SLEPT AND TOOK TYLENOL AND IBUPROFEN ON AND OFF. FEVER FLUCTUATED FROM 101 TO 104 AND BACK, TYLENOL TOOK FEVER DOWN TO 99.7. BUT UPTO TODAY, SHE STILL HAS BODY ACHES.
Patient jerked her arm and said ouch when the vaccine was injected (after the needle was in). Needle popped out of her arm and vaccine spewed. Questionable dose was actually administered.