chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; abdominal pain; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.
Case number PHEH2015US006026, is an initial spontaneous report received from a consumer (patient) on 25 Mar 2015. This report refers to a 52-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 14650) intramuscularly on 21 Oct 2014. On an unknown date after the vaccination he was diagnosed with Parsonage-Turner syndrome. The outcome of the event was unknown. The seriousness and causality assessment of the event was not reported. Seriousness assessment of Parsonage-Turner syndrome was upgraded based on available information in the source document.
diarrhea; can't stop going to sleep; L arm (injection site) is sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Type 2 diabetes mellitus and High cholesterol. Concomitant products included FISH OIL (OMEGA 3 PLUS [FISH OIL]) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore). At the time of the report, DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included.
25 hrs after injection non itching dermatitis on both legs and arms. It appeared to be a rash but there was no itch. It disappeared about 2 hrs later.
Throat tightening can't swallow; Throat tightening can't swallow; 48 hrs no sleep; This is a spontaneous report from a contactable consumer (Patient)or other non health care professional. A 48-years-old non pregnant female patient received first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 27Mar2021 at 11:45 (Age a vaccination: 48 years) as dose 1, single for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccinations. Patient has been tested for COVID-19 since the vaccination. Patient had Allergies to medications, food, or other products: Maybe latex and Bactrian in lg doses. Medical history included patient had 1 kidney/asthma/chronic bronchitis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTH) 12.5 mg, METOPROLOL 50 mg both taken for unspecified indication. The patient experienced throat tightening can't swallow and 48 hrs no sleep on 28Mar2021 at 04:00. The patient visited emergency room and the patient received Methylprednisolone 4mg for 6days/be banophen 50mg was administered as treatment for the events. The patient under-went lab tests and procedures which included sars-cov-2 test: negative on 28Mar2021. The outcome of the events not recovered.  No follow-up attempts are needed. No further information is expected.
Severe soreness inside the arm where the needle penetrated. Difficulty raising arm over my head or sleeping on it without sharp pain. Pain has been present for now over 2 months. Feels like a nerve issue.
Acute disseminated encephalomyelitis (ADEM). Patient first experienced dysarthria, facial droop, R sided weakness and gait instability on 8/25. On 8/27 he deteriorated and was intubated. CT and MRI showed no acute intracranial abnormalities. He has been intubated and comatose since 8/27. Tests for infectious diseases, hematologic abnormalities, and other possible etiologies have been negative.
Shortness of breath when he was sleeping; Red rash on back of his legs (left and right)/Red rash on left hands; Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also; Red rash on stomach; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath when he was sleeping), RASH ERYTHEMATOUS (Red rash on stomach), RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands) and RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to yellow peppers).    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on stomach). 04-Aug-2021, the patient experienced RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also). On 11-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands). On 18-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath when he was sleeping). On 20-Aug-2021, RASH ERYTHEMATOUS (Red rash on stomach), RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands) and RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also) had resolved. At the time of the report, DYSPNOEA (Shortness of breath when he was sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Heart rate: increased High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
A couple of weeks after the 2nd dose I started losing clumps of my hair this went on for a few months.   I started taking Minoxidil after a couple of months and the hair has not grown back.
consumer reported broke out in herpes all over face day p/daughter was vaxed w/varicella vax; mom noted the herpes was confined to face only;
Minor body aches during the afternoon following the vaccination, then starting ~9:00pm body aches accompanied by fatigue, chills, and a fever of 101.5°F. As of time of reporting (9:30am, 04/11/2021) body aches have mostly subsided, still minor fatigue, and fever is at 100.9°F.
vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125072, 2019SA125094, 2019SA125008, 2019SA125047, 2019SA125041, 2019SA125033, 2019SA125054, 2019SA125066 and 2019SA125066 (same reporter).  This case involves a four years old male patient (also reported as 5 years) who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 12-Mar-2019 which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Information on the batch number was requested.  List of documents held by sender: none.
Client recieved a 0.3 cc Booster dose of the Pfizer vaccine yet was not eligible due to age.  She is 15 years old.   Mother and client was informed of the error.
Employee received Hepatitis B Vaccine on 08/14/18. Donor had no reactions post vaccination. On 08/16/18, employee reported to nurse that she experienced shakiness, dizziness, headache and feeling hot on 08/15/18 around 1630 when at home. Nurse encouraged employee to seek PCP evaluation. On 08/17/18, employee reported to another nurse all her previous s/s experienced on 08/15/18 and that on 08/16/18 around 1900, she went to her PCP for evaluation due to chills and headache. She was then diagnosed with throat infection and swollen tonsil. Her PCP mentioned that it could be a reaction from the vaccine. Employee was prescribed Amoxicillin and Motrin. Employee reported that she felt stable and healthy on this date 08/17/18.
erroneously vaccinated with expired vaccine; The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.; vial undergo temperature excursions; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions).    No concomitant medications were reported. It was reported that the patient was administered dose after 30 day use by date.  The size of the vial was 2.5 ml.  Beyond use date was reported as 02-Nov-2022.  The vial underwent temperature excursion.  9 days past expiry date the patient received the vaccine. The last date the vaccine with lot number 057F22A was administered on 11-Nov-2022. No treatment information was reported.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX nine months prior. The patient was vaccinated with another dose of PNEUMOVAX. The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck. The patient also experienced fever. No other information was available at this time. The patient recovered. This is one three reports from the same source. Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry-day; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) positive COVID- RNA test. On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) positive Binax test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was non-immunocompromised. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-504341 (Patient Link).
Information has been received from a health professional concerning a 22 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
pt recvd vax; exp high fever w/ screaming episodes;apap given immed p/ vax;
2:30-injection 2:45-warming sensation/redness-2" circle noted 2:50-itching, redness turned to hives and spread down arm 3:10 -face, neck, chest covered with hives and itchy 5:00-Full body hives Benadryl 100 mg Pox's 3 days and 50 mg for 2 days
Always got the flu right after getting the shot for some reason; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer .  This case involves female patient who always got the flu for some reason (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who always got the flu for some reason (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Low grade fever - first 24 hours. Vomiting - since shot. Screaming - off and on since shot. Poor appetite - since shot. Fatigue -since shot.
clavicular lymphadenopathy appeared 1/1 then arm that vaccine was received in developed a red raised round lesion 2 inches in diameter that was itchy.  the benadryl helped it resolve
no adverse event reported yet, we administered an expired vaccine that had been on the shelf for 27 hours at room temp
I started with mild low back pain that went away.  It then came back with a vengeance on 7/11/21.  I could not move without screaming in agony.  I couldn't get comfortable.   I ended up having to sleep in a recliner.  I couldn't walk and was very debilitated.   In October, my sense of taste changed and nothing tasted right.  Flavors were magnified.  Salt was super salty.  Regular pepper burned my mouth.   Wine tasted like vinegar.   At the beginning of November, I started having numbness and tremendous pain in my fingertips, like someone is cutting them with a knife.  I also had random numbness in my head.  At the beginning of December, I started having numbness in my toes and lose my footing easily.   Walking and climbing stairs was a challenge.   In the middle of December, my lips and tongue started getting numb.
Information has been received from a nurse practitioner and two registered nurses, concerning a female patient in her late teens, who was vaccinated (date not specified) with the second dose of Gardasil. Subsequently the patient experienced induration and erythema, associated with the second dose. The reporters indicated they believed the induration and erythema lasted "a couple of days." Additional information has been requested.
Arthropathy aggravated/right knee had a flare up during raining season; Fever; Headache; Vaccination site pain/had sore arm on first covid shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season), VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot), PYREXIA (Fever) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot). In May 2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season). In 2021, VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-623287 (Patient Link).
Sneezing, coughing starting at 3:30 (approx) Saturday, September 18, Fever of 100-101 from approximately 5pm-6am on Sunday, September 19, vomiting from approximately 8pm Saturday-7am Sunday, hallucinations throughout the night, arm felt like it was on fire, brain felt like it was on fire, headache
pt recv 1st dose of vax;10feb94,devel a swollen rt arm w/ numbness & circulatory problems;exp general malaise,loss of strength, soreness at the inject site & pain "radiating in both directions";subsequently sx abated;
No known adverse effects.; A patient received an expired dose of VARlVAX; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 13-APR-2020, the patient was vaccinated with an an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, route, dose, frequency, and anatomical location were unknown) with lot # R009820 and expiration date 03-APR-2020 for prophylaxis. No known adverse effects were reported.
Incident due to needle malfunction with retractable needle/syringe.  After nurse injected 0.2 mls, needle hub became loose within syringe and began leaking from hub for remainder of dose.  Needle was unable to be retracted.  Patients mother refused revaccination.  Syringe was discarded.