chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized and diagnosed with Guillian-Barre Syndrome.  Weakness in upper extremities. 2/10/09 Received hospital medical records of 1/20-1/30/2009. FINAL DX: acute inflammatory polyradiculopathy; uncontrolled HTN; intractable nausea & vomiting; quadriparesis. Records reveal patient experienced UE & LE weakness, pain in shoulders, back & legs.  Tx w/IVIG x 3 w/o improvement.  Tx w/plasmapheresis w/modest improvement.  Transferred to higher level of care.  2/18/09 Reviewed hospital medical records of 1/30-2/5/2009. FINAL DX: acute motor axonal neuropathy; acute stroke. Records reveal patient experienced weakness of all extremities.  Had N/V/D approx 1 week after flu vaccine on 1/4/09.  Started w/weakness of extremities on 1/20.  Had been transferred to ICU from outlying hospital after IVIG x 3 & plasmapheresis x 4 w/only minimal improvement.  LP done.  Tx w/high dose steroids & plasmapheresis x 3 more.  Improved minimally but was able to ambulate w/mod assist & walker when transferred to inpatient rehab.
Onset of pain on 10/17/09. Dx with otitis media. Pain (+) with vomiting. Poor po. Presented to facility. Enter ER Dx with intussusception. Transferred to hospital on 10/20/09. Reduced by surgery radiographically. 11/27/09 DC summary received for date 10/18/09 to 10/19/09.  DC DX: Intussusception. Contrast enema reduction of intussusception successful. 11/23/09 Medical records received for date 10/21/09. Presenting with f/u 2 post hospital stay for intussusception. No complications at this time. OV 10/17/09 parent c/o pt. decreased PO, irritable, (+)runny nose. 11/23/09 ER records received for date 10/21/09. DX: gastroenteritis, vomiting.  ER visit on 10/21/09  Parent present pt with c/o irritability, abd pain, vomiting, decreased PO intake, ear pain, cough.  Pt is 3 days s/p intussusception. US WNL. On 10/22/09 ER visit for cont. c/o abd pain, vomiting. Assessment: normal BM, US(-), abd xray(-).
Slept all day and night; Couldn't see anything - "it shouldn't have been like that dark"; "Explosive diarrhea"; Had "absolutely no energy"; Little bit of fever; Headache "but not a big deal"; Arm got sore; Could not eat anything until Friday night; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") and DIARRHOEA ("Explosive diarrhea") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Breast cancer since 2008.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore) and FEEDING DISORDER (Could not eat anything until Friday night). On 10-Sep-2021, the patient experienced ASTHENIA (Had "absolutely no energy"), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark"), DIARRHOEA ("Explosive diarrhea"), PYREXIA (Little bit of fever) and HEADACHE (Headache "but not a big deal"). On 10-Sep-2021, VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") had resolved. On 11-Sep-2021, SOMNOLENCE (Slept all day and night) and HEADACHE (Headache "but not a big deal") had resolved. On 12-Sep-2021, DIARRHOEA ("Explosive diarrhea") had resolved. At the time of the report, ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore) and PYREXIA (Little bit of fever) outcome was unknown and FEEDING DISORDER (Could not eat anything until Friday night) was resolving.            Concomitant product use was not provided. Treatment information was not provided.  It was reported that patient was not sure whether she was immunocompromised.   This case was linked to MOD-2021-318772 (Patient Link).
I have had extreme hair loss. My head hair is falling out daily by the literal handfuls. I pull handfuls of hair out of the vacuum sweeper daily, not including the hair that I lose in bed or while sitting in a chair or in the car. I have not hair under my arms left, no pubic hair left, the hair on my legs that is left, currently, is on just my shins. I am also losing my eye lashes and eye brows. I am still losing hair and have maybe a third of the hair left on my head.  In addition to the severe and extreme hair loss, the injection site is still sore.
Painful Left Arm; Nausea; Stomach Ache; Dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid shot (were less of a problem).   On 24-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Painful Left Arm), nausea (Verbatim: Nausea), stomach pain (Verbatim: Stomach Ache) and dizziness (Verbatim: Dizziness). The outcome of the pain in arm, nausea, stomach pain and dizziness were not reported.   It was unknown if the reporter considered the pain in arm, nausea, stomach pain and dizziness to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm, nausea, stomach pain and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient and his/her daughter shingles vaccine on Friday. The patient's daughter had no reaction. The patient experienced painful left arm, nausea, stomach ache and dizziness. The follow up would not possible as no contact details were available.
Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.  Reporter stated that on 24-May-2021 vaccines were received and immediately placed vaccines into refrigerated storage and they administered this vaccine to patients after this 30 day mark. That vaccine vials were never punched until use.  Reporter also stated that patient did not report any adverse events and symptoms. And also stated that they performed an antibody test on all of the patients and antibody numbers were in the 800-900 range.
Vaccinator went to inject Pediatric Pfizer vaccine into left arm of client and client pulled away from vaccinator, less than half of the dose went into arm and leaked out, remaining dose in syringe was 0.15. Dose was repeated immediately per CDC guidelines.
Patient said that symptoms started about 2 days after she received vaccine.  Left arm was swollen and she noticed skin redness around the injection site and it spread down to the elbow. She stated it was very itchy.
Fever, Diarrhea, throat tightness, dyspepsia, injection site pain Narrative: Experienced throat tightness immediately after the vaccination. Observed by occupational health. Recovered with rest.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878 and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Getting headaches from the vaccine (second dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Getting headaches from the vaccine (second dose)) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Getting headaches from the vaccine (second dose)). At the time of the report, HEADACHE (Getting headaches from the vaccine (second dose)) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
sore right upper arm radiating into shoulder neck and ear on day 5. on day 7 vertigo severe lasted a solid week. lightheaded after. with vertigo had dry heaves, nausea.
After receiving one dose of Engerix B the pt developed upper deltoid muscle atrophy which if two fingerbreaths in length. Subsequently the pt received the second doe of Engerix B IM in the right deltoid. As of 09/22/1999 the pt had not yet recovered.
MMR, VARICELLA, HEP A WAS GIVEN  TO 7MTH OLD CHILD...NO IMMEDIATE SIDE EFFECTS..PATIENT WAS KEPT IN OFFICE FOR 2 HOURS AND NO REACTION...DR. SPOKE WITH INFECTIOUS DISEASE AT HOSPITAL, AND WAS INFORMED THAT NO SIDE EFFECTS WERE EXPECTED FROM THE VACCINES GIVEN TO 7NTH OLD CHILD..
Patient states that 1 hour 30 minutes after vaccination with Boostrix she started to feel extremely itchy all over. She has red itchy spots on her legs, her arms were itchy, and her head was itchy. Patient stated that she felt shortness of breath, but she normally feels shortness of breath from heart failure. She had not seen a provider for this reaction yet at 4:00pm on 9/26/22, but i did still see red spots on her legs that she showed to me. I advised her to contact her PCP physician as she still had the reaction and she says she will go talk with her PCP.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 at 11:00 as dose 1, single (Lot number: EL1284), in left arm, on 22Jan2021 at 11:00 as dose 2, single (Lot number: EL3247), in left arm and on 22Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2023) Positive, notes: Positive antigen home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Dizziness, Headache, Fever, chills, body aches, palpitations Narrative:
Mom states 2 days after the vaccines she noted the baby had left facial paralysis with droopy left eyelid and left corner of mouth also drooling from left mouth. She was seen at urgent care and days later at hospital ER and given Prednisone and Acyclovir po according to mom she seems to be getting slightly better. she had cold sores in march 2021 and Cx was positive for Herpes Simplex virus
Pt became pale, quiet and fainted. She then went into a seizure, stopped breathing and urinated on herself. Cold compresses were applied, feet and legs elevated. Soft drink given when she came to 5-10 minutes
Only sore arm after the first two doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna vaccine) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-402738, MOD-2021-402682 (Patient Link).
suspected vaccination failure; still have some outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had chronic shingles).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both doses of the shingrix after having chronic shingles. It had helped a lot, but the patient still had some outbreaks. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was sitting and suddenly things went black for a second. Patient thinks they passed out for a few seconds. Patient's first blood pressure reading was 90/64. Patient was shaking and sweating. After resting patient was feeling well and blood pressure returned to 122/72. Patient felt well after resting.
tingling and numbing on left side of torso around rib cage, movement medially and down over a few days.
SWEATING CAUSED ITCHING; Lack of sleep; HEADACHES FROM LACK OF SLEEP; itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep), PAIN IN EXTREMITY (sore arm) and HEADACHE (HEADACHES FROM LACK OF SLEEP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Oct-2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 13-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-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 received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (itching) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep) and HEADACHE (HEADACHES FROM LACK OF SLEEP). At the time of the report, PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) outcome was unknown and HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep) and HEADACHE (HEADACHES FROM LACK OF SLEEP) had not resolved.            No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Pain in arm, Sweating, Sleep deficit, Headache, Itchiness with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Treatment information was not provided.   This case was linked to MOD-2022-617331 (Patient Link).   Reporter did not allow further contact
Hospitalized 1/04/2022-still currently admitted; COVID-19 positive 01/04/2022; fully vaccinated  CHIEF COMPLAINT: COVID ASSESSMENT/PLAN # COVID-19 pneumonia # Acute respiratory insufficiency Symptom onset approximately 2 weeks ago Date of positive test 1/4 Current imaging:  Chest x-ray which shows no significant infiltrates S/p Jansyn vaccination on 03/30/21 Out of window for monoclonal antibody infusion and remdesivir Continue to treat with dexamethasone Daily COVID labs Will monitor respiratory status closely   # Chronic atrial fibrillation with RVR Exacerbated by acute illness and hypoxia Will hold BB secondary to soft BP Will monitor HR Continue cardiac monitor 01/06/2022 notes: Chief complaint COVID   Assessment and Plan Principal Problem:   COVID Active Problems:   Atrial fibrillation with RVR    Recurrent major depressive disorder, in full remission   Pneumonia due to COVID-19 virus   Benign prostatic hyperplasia without lower urinary tract symptoms   Respiratory failure      PLAN # COVID-19  # Acute respiratory insufficiency Symptom onset approximately 2 weeks ago Date of positive test 1/4 Current imaging:  Chest x-ray which shows no significant infiltrates S/p J&J vaccination on 03/30/21 Out of window for monoclonal antibody infusion and remdesivir Continue to treat with dexamethasone (1/4-present) ECHO EF 69%  Daily COVID labs Will monitor respiratory status closely Disposition: Continue decadron. Has been weaned to room air. Will have pulm rehab see him tomorrow to ensure no oxygen is needed at home with activity. Rates seem better controlled with metoprolol dosing. Blood pressure remains stable. Likely DC next 1-2 days
Patient began having symptoms of severe headache 2 days after receiving flu vaccine.  2 days later vomiting began and she was hopitalized for treatment of symptoms.
This spontaneous report received from a pharmacist, via a company representative, concerning to a 52 year old male patient. Medical history and concurrent conditions were not reported. On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K000327, expiration date 05-MAR-2015, 0.65 ml, subcutaneous. Concomitant therapies included PROAIR, Meloxicam and Omeprazole (manufacturer unknown. The pharmacist reported to the representative that "the patient experienced joint, muscular and nerve pain in the arm that the vaccine was administered, and a feeling of numbness and tingling in the opposite leg of the vaccine administered arm, after receiving ZOSTAVAX, on 08-AUG-2014. At the time of the report the outcome was reported as not recovered. Patient received treatment with TYLENOL and MOTRIN. Additional information has been requested.
sore arm day after, which cleared. (I expected this)  However, a couple days after vaccine, I started developing hive like rash on right side.    At first I thought it might be scratches/irritation from sharp edges on a torn leather sofa, but more red welts appeared in unrelated locations: chest and back.  I have had childhood chickenpox, and have also considered stress as a possible trigger for shingles, but that seems remote to me.
A non-serious spontaneous report of "inadvertent administration of expired FLUMIST" was received from a certified medical assistant concerning a five-year-old male. The patient's medical history and concomitant medications were not reported. On 23-Feb-2010, the patient was inadvertently administered a dose of expired FLUMIST. The product expired on 17-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Throbbing feeling between temples; Pressure in head; Pain; Terrible headache; Aches; Barely turn neck; This spontaneous case was reported by a non-health professional and describes the occurrence of NECK PAIN (Barely turn neck), PAIN (Throbbing feeling between temples), HEAD DISCOMFORT (Pressure in head), PAIN (Pain) and HEADACHE (Terrible headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced NECK PAIN (Barely turn neck), PAIN (Pain), HEADACHE (Terrible headache) and MYALGIA (Aches). On 12-Jan-2021, the patient experienced PAIN (Throbbing feeling between temples) and HEAD DISCOMFORT (Pressure in head). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, NECK PAIN (Barely turn neck), PAIN (Throbbing feeling between temples), HEAD DISCOMFORT (Pressure in head), PAIN (Pain), HEADACHE (Terrible headache) and MYALGIA (Aches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DVT (blood clot) in right leg below knee; leg cramps with sharp pain in calf with pressure, dull pain throughout leg and up to arm and shoulder when seated or laying down; prescribed blood thinners and scheduled follow up with primary care on Monday.