chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, pink and red at injection site; Rash, pink and red at injection site; Swelling(3.5 inches in circumference) at injection site; A spontaneous report was received from a consumer concerning a 94-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, pink and red at injection site, swelling(3.5 inches in circumference) at injection site.  The patient's medical history was not provided. Concomitant medications reported were Heart Medications, HBP Medications, Vitamin D, Lutein Vitamin, Diuretic for drug use for unknown indication.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events, rash, pink and red at injection site, swelling(3.5 inches in circumference) at injection site.  Treatment details mentioned as agent forgot to ask.  Action taken with mRNA-1273 in response to the events were  not reported.   The outcome of events, rash, pink and red at injection site,swelling(3,5 inches in circumference) at injection site was unknown.  Based on comment, events LLt coded to Vaccination site erythema, Vaccination site Rash and Vaccination site swelling
This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9, (lot # L038503, expiration date: 18-DEC-2017) (lot # M026306, expiration date: 30-APR-2018) (lot # L026602, expiration date 19-OCT-2017) for prophylaxis (dose number, route and anatomical location of administration were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004094: US-009507513-1705USA004193: US-009507513-1705USA004194.
Weight gain (around my bra area toward my back on the side); This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)). At the time of the report, WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)) outcome was unknown.            No concomitant medications was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: added reporter demographic details and contact information. patients Gender height weight and race  was added current condition was added dose1& dose2 information was added
Achy, tired, high fever, confusion, sweating, chills, dizziness, nausea, could not eat. Currently with hospitalized with severe pneumonia and congestive heart failure.  12/03/09, 12/07/09, 12/17/09 DC Summary, ED, and hospital records received for DOS 11/27/09-12/05/09.  Pt. received H1N1 vaccine and following day developed diffuse body aches and muscle pains.  Over next several days developed cough, shortness of breath and fever. Presented to ED with confusion, poor appetite, and was found to have bilateral pneumonia. ID consult obtained and treated with antibiotics; tested positive for Legionella.    Nephrology consult for elevated BUN and creatinine. Insulin adjustment partially cleared confusion. Discharged home with supplemental oxygen, continued antibiotics and insulin changes. DX: pneumonia; hypoxic respiratory failure; mental status change
On 11/5/2021 around 11AM I has trying to read and couldn't say anything correctly. Later in the day. I was talking to someone who told me I didn't sound right. He took me to the ER and they diagnosed me with a stroke. They did a bunch of testing including an MRI. blood work, EKG, chest XR, ECG, brain/head/neck CT. I was in the hospital from Friday night 11/5 to Sunday evening 11/7. That's the best I can remember.
Three doses of the MMR-II that were not supported in that temp stability case were inadvertently administered in the ensuing time since that case; This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 18-SEP-2020, the patient was vaccinated once with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S025155, which have been verified to be valid, expiration date reported and validated as 13-AUG-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit (F): 71.92 degrees F for 4 hours and 55 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one from several reports received from the same reporter.
Rash around Deltoid/Bicep of left arm. Circular pattern around injection site with itching. Symptoms have began resolving themselves with no intervention or treatment.
This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses PNEUMOVAX 23 lot # K007826, expiration date: 03-FEB-2016. No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mom reports, 09/01 slight temp left arm, 09/02 redness at sight, 09/03 called Dr and instructed to give Benadryl. 09/04 red area approx 3x size with blisters, took to ER at which time was informed local reaction and to report to Health Dept. 09/06 mom telephoned our office with info of report area only has slight redness now, swelling gone and some blisters broke or drying up.
a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body; fatigue; symptoms of a minor cold; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0170) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot no: ER8733, Expiration date not provided.), administration date: 31Mar2021, for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body"; FATIGUE (non-serious) with onset 2021, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "symptoms of a minor cold". The events "a moderate to severe rash/in the form of mild to moderate rashes on hands and other parts of body", "fatigue" and "symptoms of a minor cold" required physician office visit.  Additional Information: The patient was a healthy individual. After 2nd dose, patient experienced a moderate to severe rash that appeared within 2-5 days after injection. The rash had persisted till 03May2023, in the form of mild to moderate rashes on hands and other parts of body. He had sought out medical attention from a dermatologist and would have an appointment with allergist within next month. Dose 3 with lot number lot number FJ8762 was administered on 15Dec2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 6 year old male who in 1998 was vaccinated with Varicella virus vaccine live (site unknown), On 03/19/2001, the pt was presented with break through chicken pox. The pt sought unspecified medical attention. Follow-up information received from the nurse indicated that she was unable to locate the pt's record. No further information is available.
3 year old child was administered Fluzone Quadrivalent .25 instead of 0.5/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 3 years old male patient who received 0.25 ml dose instead of 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.   On 17-Oct-2019, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6653BD via intramuscular route in the left thigh.  It was of actual medication error case due to vaccine underdose.  It was reported that no adverse event was observed.  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.
contracted a cold; This is a spontaneous report received from a contactable consumer (the patient) from Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she should reschedule her second dose of the COVID vaccine. She contracted a cold from her daughter, on an unspecified date. She tested negative for COVID, on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
-Received vaccination at 17:30 -20:30-Dry cough; swelling in throat; hoarse and "cracky" voice; sinus congestion; Headache -23:00- Heart Palpitation; red and watery eyes. pt took Benadryl and started to feel better
LONGER MENSTRUAL PERIOD; CHEST PAIN; INCREASED HEART RATE; PAINFUL MENSTRUATION THAN USUAL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced longer menstrual period, chest pain, increased heart rate, and painful menstruation than usual. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the longer menstrual period, chest pain, increased heart rate and painful menstruation than usual was not reported. This report was non-serious.
1st dose Dec2020, now wants 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comments: The reporter was pharmacy purchaser reporting on behalf of nurse.  The patient missed all of their follow-up appointments, but now the patient was interested in receiving second dose.  Health care professional (HCP) gave permission for follow-up The reporter consented to follow up  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician concerning a 15 month old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced rash. A specimen was collected, sent to a lab and it was not wild type or vaccine varicella. The rash resolved and was recurrent over 3 months. It was reported that the patient is a twin and the sibling did not have any reaction to "VARIVAX". No additional information is available at this time. There was no product quality complaint involved. Additional information has been requested.
Dizzy; Feeling weak; Chills; Slight fever; Headache; Body ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROBIOTIC 10, LOSARTAN, POTASSIUM, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), CAPTOPRIL, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE + CAPTOPRIL), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM PLUS VITAMIN D3), ATORVASTATIN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.    This case was linked to MOD-2021-033460 (Patient Link).
DIFFICULTY IN CONCENTRATING; EXHAUSTED/FATIGUE; INJECTION SITE PAIN; NAUSEA; CHILLS; LOST SENSE OF SMELL; LOST SENSE OF TASTE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced lost sense of smell. On 11-APR-2021, the subject experienced lost sense of taste. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced difficulty in concentrating. On 14-APR-2021, the subject experienced exhausted/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea, had not recovered from lost sense of smell, lost sense of taste, difficulty in concentrating, and exhausted/fatigue, and the outcome of injection site pain was not reported.
I had Covid in December, 2020. Test result positive on 12/16, tested 12/15. Symptom's then were- chills, complete body sweats (soaking), fever (spiked to 102F, but would subside quickly), intense body aches and pain, lost taste and smell.  All symptom's lasted for apprx 3 weeks, except sense and smell, that took  3 + additional weeks to return to almost pre-covid.  I drank pedialyte and cranberry juice, took EmergenC, a daily Multi as well as extra vitamins C and D everyday.  For pain a took 6-800 mg of Ibuprofen as needed.  Did not lose my appetite.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-20.
I've had minor neuropathy in my feet since undergoing chemo treatments in 2017, but following my latest covid vaccine shot, the neuropathy has gotten SIGNIFICANTLY worse, by legs below my knees are virtually 100% numb and throbbing.
multiple outbreaks of herpes zoster, and post herpetic neuralgia.; multiple outbreaks of herpes zoster, and post herpetic neuralgia.; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after received zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the patient suffered multiple outbreaks of herpes zoster, and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers currently still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of multiple outbreaks of herpes zoster and post herpetic neuralgia was considered not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Severe body aches, especially the lower half of my body with the most severe in my bum. It hurts to sit but body aches every else make it sore to walk around so there?s no relief. Even my eyes hurt to keep them open.
Patient states that she felt something on the area surrounding the vaccine, when she looked at it she found that it was red, swollen and warm. She came to the pharmacy today 3/30 and the area is still light red and a little warm. Patient was instructed to apply hydrocortisone on the area and she will visit her physician later today.
Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection;  mild and lasted for 1-2 hours.
Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Hypertension-Severe, Additional Details: Patient (and female he came with) were sitting at the vaccination table. Female said he was feeling lightheaded and getting pale. Intern and pharmacist went out to take blood pressure. Patient was talking to us. Pharmacist suggested he sit on floor with back to wall. At that point, he passed-out. Pharmacist had lead tech call 911, while pharmacist and 2 interns gently lowered him to the floor. At this point he regained consciousness. We placed ice packs on patient and took blood pressure.
malaise Narrative:   Patient with ESRD on dialysis, HIV and h/o of positive COVID 19 in 7/2020. COVID vaccine 2/5/21 Reaction on 2/6/21 - fever, cough, malaise, confusion Admitted to hospital on 2/7/21 * Fever at home 101-102, fever causing patient to miss dialysis session Fever in ER of 102.1, Gram positive cocci found in blood during admission
Information has been received from a registered nurse concerning an 8 year old male with no allergies or medical history who on 12/3/96 was vaccinated SC with a dose of varicella virus vaccine live (lot # 612222/0241D). Concomitant vaccination on 12/3/96 included a dose of MMR. On 5/31/04, the child developed a headache. On 6/1/04, the child was seen with a vesicular non-herpetic rash (a few spots) on the back and shoulders which was noted as breakthrough chicken pox. There were no laboratory tests performed. On 6/2/04, the mother called the office to report that the spots were everywhere. The child had no fever and was not scratching, but the mother had given oral diphenhydramine HCl just in case. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information was received from a physician who indicated that on 6/1/04, the patient had a vesicular rash that continued to appear over several days. It was noted to be itchy and had bumps to blisters to crusting. Diphenhydramine HCl and acetaminophen were used as needed. No further information is expected.
Left collar bone area is swelling up and causing discomfort. At first it was just the bone but the third day the whole top area  of the collar bone felt bruised.
The pt experienced a local reaction to vaccine. 5 cm x 5 cm circular erythematous, warm area left forearm.