chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainting; Chest pain; heart palpitations; extreme blood pressure drop at some times out of no where; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose brand unknown=True,, Is bivalent=False,, Vaccine location=Left arm), administration date: 14May2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHEST PAIN (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering"; BLOOD PRESSURE DECREASED (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "extreme blood pressure drop at some times out of no where"; SYNCOPE (hospitalization, medically significant, life threatening) with onset 30Jun2022, outcome "recovering", described as "fainting"; PALPITATIONS (hospitalization, life threatening) with onset 30Jun2022, outcome "recovering", described as "heart palpitations". The patient was hospitalized for syncope, chest pain, palpitations, blood pressure decreased (hospitalization duration: 14 day(s)). The events "fainting", "chest pain", "heart palpitations" and "extreme blood pressure drop at some times out of no where" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (30Jun2022) drop at some times, notes: extreme blood pressure drop at some times out of no where. It was unknown if therapeutic measures were taken as a result of syncope, chest pain, palpitations, blood pressure decreased, inappropriate schedule of product administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 10 hours after vaccine, I developed chills, fever of 102, muscle weakness and soreness in legs, body aches, injection site very sore-difficult to move arm
Chest pain and back pain, nurse initially reported rash on forehead and stomach. Pharmacist went to visually inspect her forehead and stomach there was no visible rash on forehead and arm
Fever, chills. cough, headache, vomiting, body aches, joint aches, racing heart, stomach pains.
diarrhea; stomach ache; sore throat; nausea; body aches; chills; head ache; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea) and MYALGIA (body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included THYROID (ARMOUR THYROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Adverse event, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-043709 (Patient Link).
The soreness in my shoulder since second day after injection still continues today, 46 days later.
Increased risk of GBS; Severe muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and muscle weakness. On an unknown date, the outcome of the guillain barre syndrome and muscle weakness were unknown.   It was unknown if the reporter considered the guillain barre syndrome and muscle weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by the patient via interactive digital media. There was an increased risk of Guillain Barre syndrome, severe muscle weakness was observed after vaccination with Shingrix. Additional supportive information: Follow-up would not possible as no contact details were available.
Have felt awful; Chills; Fever; Exhaustion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: Have felt awful), chills (Verbatim: Chills), fever (Verbatim: Fever) and exhaustion (Verbatim: Exhaustion). The outcome of the feels awful, chills, fever and exhaustion were not reported.   It was unknown if the reporter considered the feels awful, chills, fever and exhaustion to be related to Shingles vaccine.     It was unknown if the company considered the feels awful, chills, fever and exhaustion to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had the first vaccine a couple of days ago and have felt awful, chills, fever and exhaustion. The patient hope it was worth it. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Presented with increased irritability, especially with feeds, as well as bloody stools mixed with mucus that started approximately one week following 2 month immunizations. Abdominal ultrasound showed target sign in right lower quadrant. Contrast enema performed with reduction of small right ileocolic intussusception.
Severe muscle weakness, could not life my head off the pillow, nausea, dizziness, muscle pain. High fever, 104 °F, within 4 hours after vaccine. Within 6 months began having severe joint pain, muscles felt on fire occasionally. Began getting sick a lot.  After many different ER and doctor visits and then seeing a rheumatologist I was eventually diagnosed with lupus.
Broke right leg after 2nd vaccine; Dizzy Spells after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine), DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer (4 years ago, Removed by dermatologist, Patient has been visiting dermatologist regularly.) in 2018.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose). In October 2021, the patient experienced LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine). On 05-Jan-2022, LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine), DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Heart rate: 144 (High) 144 BPM.         No concomitant medication were provided.  The patient got a cast after right leg broken.   This case was linked to MOD-2022-535957 (Patient Link).
ZOSTAVAX given 1-15-14 - 2 days later developed diffuse rash involving bilateral upper extremities with papules as well as intact vesicles, approximately 50 lesions measuring 2-4 mm.
Employeed stated after she wake up Saturday at noon she noticed her left arm was sore. She also stated it was warm to touch, swollen, had a large red circle, and a stinging sensation.
Had flu shot at 3p;woke up at 2a and was dizzy,nauseated,& lost her equalibrium.Tx w/ Meclazine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, single, Batch/Lot No: Unknown , Location of injection: Arm Left), administration date: 30Jan2021, when the patient was 67-year-old, for COVID-19 immunization; moderna (Dose 2, single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 27Feb2021, when the patient was 67-year-old, for COVID-19 immunization; moderna (Dose 3 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 29Oct2021, when the patient was 68-year-old, for COVID-19 immunization; moderna (Dose 4 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunization; moderna bivalent (Dose 5 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 23Sep2022, when the patient was 69-year-old, for COVID-19 immunization; moderna bivalent (Dose 6 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 03Jun2023, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Negative; (26Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Oct2023 to 21Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Right deltoid hump, skin rash, abdomen rash, back 10/5/06-slight dizziness, slight dumpiness of tip of tongue.
Information has been received from a physician concerning a patient with unknown medical history who was vaccinated with a dose of Rotateq. Concomitant vaccination administered that day included "other" vaccines. "Two months ago", in approximately February 2007, the  patient developed pseudomonis sepsis after vaccination with Rotateq. The patient's case was "very severe". An "amputation' was ruled out". Two immunodeficiency tests were performed and were both negative. The patient was "negative" for immunocompromise. The patient was recovering. The healthcare provider stated that there was a "temporal association" with Rotateq because it was the "newest" vaccine administered and because it was a live viral vaccine. Upon internal review the patient's pseudomonis sepsis was considered to be an other important medical event. Additional information has been requested.
Allergy; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NUS2023US038615_OS (RA).  A 55-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy"; RASH (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of swelling arm in a 5 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Previous vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis 3 recombinant and inactivated poliovirus vaccine combined (Pediarix, GlaxoSmithKline). Three doses of Pediarix were given on unspecified dates prior to two doses of Infanrix. On 18 July 2007 the subject received 2nd dose of Infanrix at 0.5 ml in an unknown arm. On the same day of vaccination with Infanrix, the subject returned with a swelling arm. At the time of reporting the outcome of the event was unspecified. Follow up information was received on 01 August 2007 via the nurse, who reported that the event was resolved at the time of reporting.
The week after my first injection I started feeling shaky like you would feel if your sugar was dropping. I would eat something and it would seem to get a little better and then come back again. It waxed and waned. After my second injection 1/27/21, in addition to the shakiness I started having significant trouble sleeping, had increased anxiety and restlessness, extreme exercise intolerance, easily fatigued and short of breath, and tachycardia. These symptoms gradually worsened over the course of the next two months. I experienced chills for no reason and general sick feeling. I had pain and pressure on both sides of my neck and up into my ears and face. I made a doctors appointment and had a two week wait. I ended up in the ER three times in one week in the middle of April while I was waiting for my doctors appointment date, and was found to have a TSH of less than 0.02.
Fever:102-103 for 6 hours Nausea/Vomit: 2 times  Extreme fatigue and muscle/joint pain High heart rate/needing to rest after walking a few feet (ie getting a drink, going to the bathroom)
At about 15 minutes the patient experienced nausea, headache, then face flushing.
Currently Pregnant. Symptoms include headache, fever, chills, body aches, and sweats.
Aches, fevers, chills-within 24 hrs Nausea and vomiting-within 48 hrs Heart attack and death on third day
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004090: US-009507513-2306USA004089: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004082: US-009507513-2306USA004084:
Received "bumps" after 4 days after first dose,; extremely itchy; crusted; dark scars; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: ER8732 and expiry date was not provided) via an unspecified route of administration in arm left on 24Mar2021 at 15:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) 37.5mg, from an unknown date to an unknown date, for an unknown indication. On an unknown date, the patient previously took sulfamethoxazole (MANUFACTURER UNKNOWN), trimethoprim (SEPTRA); both for an unknown indication and experienced drug allergy on an unspecified date. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021(4 days after the first vaccination), the patient experienced bumps, extremely itchy, crusted and dark scars. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of all events was not resolved.  Follow-up attempts completed. No further information expected.
Pt experienced a vasovagal response following  vaccination with a drop in blood pressure and pulse rate, dizziness, and diaphoresis. Pt never lost consciousness and recovered with juice, trendelenberg position, and rest.
rash on lt forearm @ site;7 days following vax fussy, low-grade fever, no temp taken;8 days following t99.1, MD visit, irritated throat, strep cult neg;ATB & decongestant given;31MAY96 sz, to ER t104, v,d;
joint ache; Headache; Feels very weak; fever of 100.6 degrees F; Chills; feels very tired; arm at site of vaccination is sore; Arm at injection site tender; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feels very weak), PYREXIA (fever of 100.6 degrees F), CHILLS (Chills), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm at site of vaccination is sore) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Lung disorder NOS and Allergy. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], VITAMIN D NOS, BIOTIN, MAGNESIUM and POTASSIUM for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (Feels very weak), PYREXIA (fever of 100.6 degrees F), CHILLS (Chills), FATIGUE (feels very tired), VACCINATION SITE PAIN (arm at site of vaccination is sore) and INJECTION SITE PAIN (Arm at injection site tender). On an unknown date, the patient experienced ARTHRALGIA (joint ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL at a dose of 1 dosage form; BUDESONIDE;FORMOTEROL at a dose of 1 dosage form; UMECLIDINIUM BROMIDE at a dose of 1 dosage form; ALBUTEROL SULFATE at a dose of 1 dosage form and IPRATROPIUM at a dose of 1 dosage form. At the time of the report, ASTHENIA (Feels very weak), PYREXIA (fever of 100.6 degrees F), CHILLS (Chills), FATIGUE (feels very tired), VACCINATION SITE PAIN (arm at site of vaccination is sore) and INJECTION SITE PAIN (Arm at injection site tender) had not resolved and ARTHRALGIA (joint ache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.6 f (High) 100.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also  included, water pills, thyroid medication and cholesterol medication.  Treatment medication also included nebulizer and CPAP machine.   This case was linked to MOD21-080713 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information was and patient's contact details updated.Treatment medications updated. On 22-Apr-2021: Live follow-up received and appended on 23-Apr-2021.New events headache and joint pain updated.; Sender's Comments:  MOD21-080713:
Information has been received from a physician concerning a female between the age of 14-50, who on Nov 04 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently, the patient experienced pain at the injection site, myalgia, arthralgia, low grade temperature and fatigue, The patients outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. The physician requested an investigation into this lot number. Additional information has been requested. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and experienced adverse effects (WAES0501USA03390, WAES0501USA03391). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.
A report was recieved from a health care profesional on 10/03/2002, concerning a child vaccinee less than 4 years old who experienced a medication error after receiving Fluvirin on an unknown date. The vacccinee experienced no adverse events at the time of the reporet. At the time of administration, the health care professional were not aware that Fluvirin was no approved for vaccinees less thanm 4 years of age. There was unsufficient information to determine the reoporters causeality assessment.