chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching, red; itching, red; arm is swollen; Abdominal cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea) and VACCINATION SITE SWELLING (arm is swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching, red) and VACCINATION SITE ERYTHEMA (itching, red). At the time of the report, ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
SHARP PAIN AT SOLAR PLEXUS IN WAVES,  STARTED 45 HOURS AFTER VACCINATION. WENT TO EMERGENCY ROOM AT HOSPITAL. BATTERY OF TESTS WERE INCLONCLUSIVE.  PRIMARY CARE DR SUSPECTS SPASM OF ESOPHAGUS.
Developed ache/stiffness in left knee and left jaw joint.  Knee started first, jaw followed a few days later.  Jaw stopped aching late last week (around May 20), knee is still inflamed and stiff.  Treating with ibuprofen.
100.8 fever; body aches; Chills; This is a spontaneous report from a contactable Consumer. This 20-Year-old Female (non-pregnant) Consumer (patient) received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EN6205; Expiration date was not reported) via unspecified route of administration on 03Mar2021 at 09:00 AM, as DOSE 2, SINGLE for covid 19 immunization (age at vaccination:20-Year-old). The medical history and concomitant medications were not reported. Patient previously received BNT162B2 as dose 1, single on an unspecified date for covid 19 immunization. The patient had not received any other vaccine in four weeks, the patient was not tested positive either before or after vaccination. On an unspecified date the patient experienced 100.8 fever, body aches and chills. The patient's laboratorial value included body temperature 100.8 on an unspecified date. The outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Rotator cuff tear/injury in left arm/shoulder. Loss of range of motion along with severe pain in certain positions.  Has not healed in over 6 months.
At about 7:30 my son started to get a fever we treated it with Motrin and then at 10 pm he started to reach another high fever so we gave him Tylenol and put him to bed at 1:45 am I had a gut feeling to go and check on my son and I found him in his crib in the middle of a seizure. Every doctor I spoke to in the emergency room last night points to this as the reason for my sons seizure. He was transported via ambulance to the hospital last night.
9-24-11 developed mild lower back pain progressively got worse to numbness feet, thighs and pain to legs. 9-28-11 went to ER after four days of progressive pain in legs, back, arms, and numbness in thighs and feet and weakness. IVIG 5 day course completed. 10-5-11 sent to rehabilitation facility.
Strokes; Blood clots; Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died), CEREBROVASCULAR ACCIDENT (Strokes) and THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Aneurysm.    In January 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 CEREBROVASCULAR ACCIDENT (Strokes) (seriousness criteria death and medically significant) and THROMBOSIS (Blood clots) (seriousness criteria death and medically significant). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter  Patient had multiple medical issues , got vaccine after and aneurysm.   Very limited information regarding this events has been provided at this time.  Further information can't be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death
minor tenderness, swelling and reddness at the injection site; minor tenderness, swelling and reddness at the injection site; minor tenderness, swelling and reddness at the injection site; This spontaneous report was received from a pharmacist via company representative referred to an approximately 66-year-old male patient. The patient's pertinent medical history, and drug reactions/allergies were not reported. The concomitant medications included zoster rge vaccine (mammalian)(SHINGRIX) and flu vaccine (not specified). On an unknown date in August 2019 (reported as 3 or 4 weeks ago from the date of reporting), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # R033079 has been verified to be a valid lot number, expiration date reported as June 2020, but upon internal validation established as 06-JUN-2020) for prophylaxis (route, dose, were not reported). On 18-SEP-2019, the patient experienced minor tenderness, swelling and reddness at the injection site (vaccination site pain, vaccination site erythema and vaccination site swelling) after receiving suspect product along with concomitant medications. The patient saw the pharmacist. The patient did not receive any treatment for the events. The outcome of vaccination site pain, vaccination site erythema and vaccination site swelling was reported as recovered/resolved (on 18-SEP-2019). The reporter did not provide any causality assessment. Product quality complaint was not involved.
No other information given at this time.; Medical assistant calls to report a temperature excursion/ The product were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 14-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
Client reported that she felt a "Charlie horse" in the muscle near her wrist on left arm. Client stated she felt "something " run down her arm when she rec'd her vaccine. Vital signs BP= 102/70  HR 81  R: 24: No complaint  SOB or difficulty breathing. No visible injury to left arm or rash. Waited  75 6B 15 minute  in  parking lot.
This case was reported by a nurse and described the occurrence of hives in a 21 year old male patient who received hepatitis B vaccine recombinant Engerix B. The patient had no pre existing medical conditions. On 3/29/2005, the patient received the first dose of Engerix B (lot AHBVA059BA) in the right deltoid. Approximately six days following the first dose of Engerix B, on 4/4/2005, the patient experienced hives and itching. The hives and itching improved on 4/6/2005. The immunization series with Engerix B was discontinued. The nurse considered the hives and itching to  possibly be related to vaccination with Engerix B and that the hives were of questionable etiology.
chills  Narrative:  27 y/o male presents to clinic with body aches, headaches, chills after receiving second round of Moderna Covid-19 vaccine on 04FEB2021 at 1400. He has not tried any OTC medications to help with symptoms. Denies nausea, vomiting, diarrhea. No fever.
Information has been received from a registered pharmacist concerning an adult female who in 2002 was vaccinated with two dosed of varicella virus vaccine live. The pharmacist reports that the pt now has a negative titer. Unspecified medical attention was sought. No further information was reported. At the time of this report there was no product quality complaint. Additional information is not expected.
I started having a cough about a few weeks after the vaccine. I have been treating the cough myself but I want to go to the clinic to have a doctor. I have been taking cough syrup but this is not effective. I have a doctors appointment coming up on Monday 05/16/2022.
I have been experiencing some pretty significant stiffness within the joints of my hands, primarily my left hand.  Difficulty extending fingers to stretch hand out, without pain.  Tightness.  Occasionally I have to use my other hand to stretch my fingers or flatten my hand to get cramps to alleviate.
The covid vaccine that has caused severe abdominal pain/severe pains; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Batch/lot number: Unknown) on 03Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that the covid vaccine that has caused severe abdominal pain (hospitalization). I round up in hospital and yesterday was severe pains and they ruled any life threatening issue out, through a CAT scan, blood work and urine specimen, so I just basically wanted to know if anybody else had the problems with the abdominal pain. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received an extra, unintended 0.5 ml dose of ADACEL (lot U6141AB and Exp. Date 15-Dec-2020) via unknown route in the left arm on 21-Mar-2019 (15 months later) and first dose on 25-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 and MENACTRA for immunisation. It was an actual medication error case due to extra dose administered. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Ischemic stroke, right side of brain. It caused left-side paralysis, requiring acute inpatient stay until 10/9/21, and subacute inpatient stay until 11/23/21. It required physical therapy, first inpatient, then at home, and then outpatient into September 2022. It lead to loss of job.
6 Days after vaccines 10/22/08 awake with severe knee pain and swelling. Extreme difficulty ambulating- client saw an orthopedic MD and one week later infectious disease MD. Diagnosed with Lymes disease started Doxycycline
Tingling in left arm and hand (arm that received the vaccination) comes and goes.  This started a few minutes after the vaccination.  I assumed it was just temporary and didn't mention it.  But it has continued off and on since the time of my 2nd vaccination almost 2 weeks ago.  I feel it for a few seconds to perhaps a minute or so, then it's gone for a while.  This repeats multiple times throughout the day.   I have had no other side effects from the vaccination, no temperature of flu-like symptoms.
Large raised rash developed on arm. Area of redness and swelling (accompanied by itching) developed same day of vaccination and increased to approximately 4 inches in diameter by next day. Vaccination area continues to be painful with raised rash for approximately a week, when the rash/raised area began to subside. Itching symptom subsided in approximately 1 1/2 weeks and temporarily relieved when BENADRYL was taken.
administered from vaccines that experienced a temperature excursion; administered from vaccines that experienced a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the vial underwent an excursion on 10-Mar-2022 for 7 hours while stored in refrigerator. The maximum temperature reached was 64 F. The vial was returned to the refrigerator.  There were no visual inspection noting any vaccine state change. It was reported the vial was unpunctured at the time.  The patient had no adverse events post vaccination.  No treatment details were reported.
Felt like she was coming down with something; Left arm started shaking/significant tremor; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Left arm started shaking/significant tremor) and ILL-DEFINED DISORDER (Felt like she was coming down with something) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Left arm started shaking/significant tremor). On an unknown date, the patient experienced ILL-DEFINED DISORDER (Felt like she was coming down with something). At the time of the report, TREMOR (Left arm started shaking/significant tremor) outcome was unknown and ILL-DEFINED DISORDER (Felt like she was coming down with something) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.
changes in my periods/ starting a day or 2 earlier than usual; hormone imbalance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0161) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, prev dose lot number=EW0150, prev dose vaccine location=Left arm), administration date: 31Mar2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "changes in my periods/ starting a day or 2 earlier than usual"; HORMONE LEVEL ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "hormone imbalance". Therapeutic measures were not taken as a result of menstruation irregular, hormone level abnormal.  Additional information: No other vaccine in four weeks. The patient had noticed changes in her periods. They have been starting a day or 2 earlier than usual. Her periods were usually more predictable. The most current period a week after her 3rd booster has been a lot heavier than usual and started early as well. She had a nexplanon implant removed at the end of May and attributed the changes to hormone imbalance. She asked if this could still be an issue. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies. The patient received third dose on 03Nov2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to an 11 year old patient of unknown gender. On an unknown date the patient was vaccinated with GARDASIL lot # J007354. Route, dose and frequency were not reported. On an unknown date the patient experienced injection site reaction. The nurse stated that she could vaguely recall a patient reporting an injection site reaction, but this patient was "eleven years old," and multiple vaccines were administered during that same office visit (date not reported). At the time of this call, the nurse did not have access to the patient's information. The patient may have experienced an adverse effect to GARDASIL, lot # J007354. The nurse did not know for certain which vaccine the patient may have experienced an AE with. The outcome of injection site reaction was unknown. Additional information has been requested.
no adverse event; lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022).      Patient's age was reported as 63 Year 10 Month. No concomitant medications were reported. completion date was reported as 01-Aug-2022. The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022. No treatment medications were reported.
pain in  hand; Right elbowis swollen; Blood in urine; Right elbow hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts). At the time of the report, PAIN IN EXTREMITY (pain in  hand), JOINT SWELLING (Right elbowis swollen), HAEMATURIA (Blood in urine) and ARTHRALGIA (Right elbow hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine present: abnormal (abnormal) blood in urine.         Patient went to the hospital, they run some blood and urine tests and some x-rays and found they were fine.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-309210 (Patient Link).
Doses 18 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had two shingrix shots were 18 months apart. The patient asked that he/she was still protected. Additional supportive information: The patient received the 2nd shot of shingrix later than the recommended interval, which led to lengthening of vaccine schedule.