chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report of vomiting x2 on Jan 18, 2007, vomiting x 1 on Jan 19, 2007. Also complained of diarrhea. Mother also reported diarrhea x1 week prior to Jan 17, 2007 then improved.  Now symptoms occur again day after vaccinated.  Jan 23, 2007-reports improvement. States diarrhea getting better and no vomiting.
Patient had arm pain immediately after immunization. Patient called 10/25/18 and still had arm discomfort and soreness.
appx 48 hrs after the vaccine, he had several episodes of cyanosis, (perioral and oral) and hypotonia,with possible post ictel periods (total duration per episode 20 sec) witness initially by the parents and in an emergency room x3.
Numbenss of limps-progressing to paresis; loss of strength in arms; pos lyme titer to date;
Patient with history of dementia and brought to the ED on 12/2/22 by her family. Family reports for the past two days, patient has become increasingly weak to the point where she is no longer able to walk with her walker. Additionally reports new and worsening productive cough and fatigue. COVID PCR test performed in the ED resulted positive. Ultimately, patient admitted 12/2/22 - 12/4/22 for COVID-19 pneumonia, among other problems. She did not require supplemental O2.
4 pt's recvd 3 doses of Engerix-B & 2 pts JUN92, 2 pts JUL92 had neg titer; nonresponder;
Inflammation through out the body that developed into infection.  Diverticulitis, electric shots, cramps, paralysis muscle stiffness, extreme fatigue, dizziness, total lack of strength. CRP elevated by 80%.
body was achy; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body was achy) and FATIGUE (felt tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included PAROXETINE, VALSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (body was achy) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (body was achy) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
My head hurts a lot every day, days, before it didn't hurt and my legs and feet swelling and I feel like burning pain and it hurts between my legs and tingling in my left leg it was weird but I honestly I didn't think about the vaccine until now that I read the message I got worried about the headaches and my left leg
10/26/2019, 8:30 a.m. - foggy head, clogged ears, extremely dizzy. Only lasted 30 minutes, then I was fine the rest of the day. 10/27/2019 8:30 a.m. - Diarrhea and vomiting for 8-12 hours. Stomach pain and cramps.
Information has been received from a physician concerning a 3 year old male who, "at his one year check up, in approximately 2004, was vaccinated with a dose of varicella virus vaccine live. On 14-MAR-2006 the patient developed shingles on his left cheek, late in the evening. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt. with some SOB, headache, stomachache, nausea , decrease appetite   5 hrs after   receiving 2nd Covid-19 Vaccine (Pfizer). Epi (111000)She improved after giving 0.3 mg and giving Prednisone .     She was sent home on tab Prednisone 20 mg  bid x 3 days
About 20 min after receiving vaccine, patient developed throat itching, skin itching, rash to face. EMS was called to clinic and administered IV Benadryl, transported patient to ED. In the ED, patient received methylprednisolone 125mg IV and famotidine 20mg IV. She was monitored for 3 hours and discharged with a prescription for prednisone 20mg BID x 5 days, and instructions to take benadryl 50mg  every 6 hours x 2 days.
Both her arms really itchy; allergic reaction; has red bumps like a rash on her arms; has red bumps like a rash on her arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Both her arms really itchy), HYPERSENSITIVITY (allergic reaction), ERYTHEMA (has red bumps like a rash on her arms) and RASH (has red bumps like a rash on her arms) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PRURITUS (Both her arms really itchy), HYPERSENSITIVITY (allergic reaction), ERYTHEMA (has red bumps like a rash on her arms) and RASH (has red bumps like a rash on her arms). At the time of the report, PRURITUS (Both her arms really itchy), HYPERSENSITIVITY (allergic reaction), ERYTHEMA (has red bumps like a rash on her arms) and RASH (has red bumps like a rash on her arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. no treatment information provided by the reporter
Reported symptoms daily to V-Safe immediately following date vaccine was given. After that process was completed, "Covid Arm" began on 2/26/2021 as red patch on left arm (injection site), about 3" diameter. As of this morning 3/2/2021, patch has expanded around upper arm towards body, now about 6" long in a more rectangular pattern. Still bright red, tender to touch but not particularly itchy. Reported initial event to PCP who agreed it is harmless, as I had read, and asked me to monitor and report to her if other symptoms (fever etc) presented. So far, no fever.
redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; fever; body aches; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (for 1st dose refer case US2019GSK107242).   On 2nd June 2019 12:00, the patient received the 2nd dose of Shingrix. On 2nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache. The patient was treated with non-drug therapy (Cold Compress). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovering/resolving and the outcome of the fever, general body pain, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix at noon and that night he experienced shivering, headache, body aches and fever.  The shivering, headache and body aches resolved the next day but the fever lasted all day Monday. Also on Sunday night, he experienced redness, swelling and itching at the injection site.  The injection site reactions became worse on Monday and severe by Tuesday. It was at its worse last night. It was treated with a cold compress and is a little better today but not resolved. The reporter Consented to follow up.
reported that a 4-month old consumer was prescribed DTap, but was given both a DTap and PENTACEL at the same visit with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient who was prescribed dtap, but was given both a vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 14-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left thigh for prophylactic vaccination. On 14-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UJ674AA and expiry date: 04-Jun-2023)  via intramuscular route in the left thigh for Immunization.  On 14-OCT-2022 the patient developed a non-serious event of reported that a 4-month old consumer was prescribed dtap, but was given both a dtap and pentacel at the same visit (extra dose administered) (Latency: same day)  Action taken : not applicable.  Outcome: Unknown.   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 the 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.
the diarrhea has returned; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (the diarrhea has returned) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Chronic diarrhea. Concurrent medical conditions included HIV infection.    On an unknown date, the patient received fifth 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 DIARRHOEA (the diarrhea has returned). At the time of the report, DIARRHOEA (the diarrhea has returned) outcome was unknown.            Concomitant medication was not reported.  Patient was taking medication for chronic diarrhea for a couple of years. Patient was fully vaccinated with Moderna (2 original, 2 boosters & 1 variant booster). Patient received first Moderna dose and diarrhea has disappeared and has stayed gone for 1.5 or 2 years. Now, however, the diarrhea has returned. Patient was asking possibility that a person can get a 6th shot. Treatment medication was not reported.   This case was linked to MOD-2023-704247 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (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 Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Painful, red, hot, firm area at site of injection began after injection and progressed; 6/23 visited ER and area was about 10cm diameter. ER doctor gave SOLU-MEDROL IM 125mg; prednisone Rx for 20mg qd x5 day.
After administration of tetanus shot, donor fell to the floor after standing up from the donor bed. Less than 3 seconds loss of consciousness.  Vitals assessed. Low BP noted. Oral fluids  administered.  Contusion to right forehead, left knee area , two chipped lower front teeth.Donor transported to hospital.
Approximately 25 minutes after receiving the COVID vaccination, patient reporting not feeling well. She stated she felt like it was difficult to swallow and to speak and that her tongue felt bigger, she also experienced voice changes, and pallor. BP 126-68, HR 65. 0.5mL of epinephrine were administered intramuscularly in the opposite deltoid, and the patient verbalized an improvement in symptoms. EMS arrived on scene and evaluated the patient. Patient refused EMS transport, but did take private transportation to the local hospital - where she was evaluated and discharged home.
Was supposed to start my menstrual cycle 7/26 and still hav not.  In addition I?ve been experiencing nausea off and on
Large swelling in lymph node above left clavicle   the size of a 50 cent piece  Injection in the left arm Use warm compresses for 3-4 days and it went away
Seen on 9/12 for swelling around injection site and given 3 days of Prednisolone 15 mg/5ml. Seen on 9/13 for swelling, redness and temp of 99.1. Continue steroids and add in MOTRIN.
The morning of 11/10 I developed an allergic reaction, possibly in response to a shampoo I used, but the reaction was full body. I developed widespread hives, rash, and swelling in my hands and face. On 11/11 I saw a virtual urgent care provider and started a course of prednisone along with antihistamines. The reaction continued until 11/23, and now I?ve developed dermatographia, which I did not have before the reaction.  I?m concerned that the sensitization of my immune system and mast cells in particular could have been related to the my moderna booster about 10 days prior.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 25-NOV-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
7x5 cm red swollen warm area right deltoid. Varivax given 3-25-08 right deltoid
Woke up 1/9/21 with pain in my L axilla and swelling.  Improved with ice and ibuprofen.  Continued to get better of the course of 3 days.  No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
Past the 42 day mark; Left arm soreness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), PAIN IN EXTREMITY (Left arm soreness) and PRURITUS (Itchiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, GLIPIZIDE and vitamins for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), PAIN IN EXTREMITY (Left arm soreness) and PRURITUS (Itchiness). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), PAIN IN EXTREMITY (Left arm soreness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were taken.
inflamed lymph nodes; jaw hurting bad/jaw pain; knot in wrist; Ear infection; second dose 02Mar2022/Booster dose 19Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4277625-00 (Company).  A 44-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunization. The patient's relevant medical history included: "Difficulty in opening jars" (unspecified if ongoing); "Knee pain" (unspecified if ongoing); "Difficulty in yard work" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Daily dose: 1)first dose (1 in 1 once), Route of admin: 1)intramuscular, Indications for use: 2) covid-19 vaccination), administration date: 09Feb2022, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Mobility decreased", "Lymph node inflammation", "Jaw pain", "Nodule", "Ear infection", "Psoriatic arthritis aggravated"; BNT162b2 (Daily dose: 2)second dose (1 in 1 once), Route of admin: 2)intramuscular, Indications for use: 2) covid-19 vaccination), administration date: 02Mar2022, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Lymph node inflammation", "Jaw pain", "Nodule", "Ear infection". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Mar2022, outcome "unknown", described as "second dose 02Mar2022/Booster dose 19Mar2022"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "inflamed lymph nodes"; PAIN IN JAW (non-serious), outcome "not recovered", described as "jaw hurting bad/jaw pain"; NODULE (non-serious), outcome "recovering", described as "knot in wrist"; EAR INFECTION (non-serious), outcome "not recovered".  Additional information: The reporter's causality for the event(s) of difficulty getting in and out of bed/tub, difficulty climbing flight of stairs, inflamed lymph nodes, jaw hurting bad/jaw pain, ear infection and flare up of psoriatic arthritis was not provided. The reporter's causality for the event(s) of knot in wrist with Humira (Adalimumab) was a reasonable possibility. It was unknown if patient was enrolled in a covid-19 vaccine trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received the Moderna vaccine and she is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 glasses per week) on 15-Aug-2020. Concurrent medical conditions included Allergy to antibiotic. Concomitant products included FOLIC ACID, IRON (PRENATAL [FOLIC ACID;IRON]) and DOCOSAHEXAENOIC ACID (DHA) for Pregnancy, VITAMIN C [ASCORBIC ACID] for Routine health maintenance, ALCOHOL from an unknown date to 15-Aug-2020 for an unknown indication.    On 22-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Received the Moderna vaccine and she is pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) Positive. In October 2020, Ultrasound scan: results not reported (Inconclusive) Results not reported. In November 2020, Ultrasound scan: results not reported (Inconclusive) Results not reported. In January 2021, Glucose tolerance test: results not reported (Inconclusive) Results not reported.     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 information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Engerix-b expired administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HBV (Engerix B) (batch number 5NY2K, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022 16:30, the patient received Engerix B. On 8th June 2022, the patient started Engerix B Pre-Filled Syringe Device. On 8th June 2022 16:30, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: The reporter reported that, the patient was administered with expired dose of Engerix-B. No reactions were reported. The reporter consented to follow up by email. Additional Supportive Information: The patient was administered with expired dose of Engerix-B, which led to expired vaccine used.
Onset of multiple symptoms approximately 1 week after vaccine receipt (right hand tremor, bilateral ulnar neuropathy, worsening of headaches). Tremors, headache, general, paresthesia,allergic rhinitis,