chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My child came in to receive Varicella vaccine, parent signed form acknowledging child was receiving Varicella, Nurse confirmed it was Varicella and administered vaccine; a few hours later, I (mom) received a call from the nurse apologizing and said she had accidentally gave my daughter the MMR vaccine. I'm not sure how the nurse discovered it, I guess when she went to add the information to my daughter's vaccine record it scanned different? But the nurse called me and admitted MMR was given instead of Varicella.   Reporter's recommendations: No rush. Treat each patient like your own child. Open the vial in font of the parent and confirm the vaccine.
Difficulty breathing, shortness of breath. Fever, numbness and tingling in both left hand and left foot. Injection sight was left arm. Dizziness. Headache, change in vision. weakness, fast heart beat, numbness on left side of face, thought I was having a stroke.
pt recv vax & devel elevated liver enzymes; other lab eval revealed SGOT & SGPT in the low one hundred range, & elevated LDH of around 450; MD reported two pts;
Patient did not notice it till the next day when she started to complain about pain and having swollen arms and with a large rash. Pt was given antibiotics and a steroid cream and Benadryl on the 14 Oct 2012.
interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GU2524), in left arm and on 24Apr2023 at 10:30 as dose 6 (booster), single (Lot number: GL2042) at the age of 78 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL2349), in left arm, on 12Feb2021 at 15:15 as dose 2, single (Lot number: EL9269), in left arm, on 03Sep2021 at 10:30 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 26May2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Sep2023 at 15:30 as dose number 7 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CML" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing). Concomitant medication(s) included: SPRYCEL, start date: Oct2017; ZETIA; ESTRACE; LASIX [FUROSEMIDE]; KCL; MINOXIDIL; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2023) Positive; (04Oct2023) Negative; (06Oct2023) Negative; (08Oct2023) Positive; (10Oct2023) Positive; (11Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 28Sep2023 to 03Oct2023 for COVID-19.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Mom states that each time patient would get the HPV shot, her menses would delay for 1 - 2 months.
Child's mother, a physician, administered vaccines at her place of employment. Child's father brought patient in to office for well visit. Pt received same vaccines at our office. Our office was unaware that pt was current with vaccines.
Injection site area was hot, red, blotchy and painful. Patient sought care with physician's office and was prescribed antibiotics. Physician told the patient she had cellulitis.
after 1 min pt experienced blacked out - rph reported pt being in shock grabbing chest and shaking arms. loss consciousness but regained in a few minutes  - called 911 pt received help -pt states anxious about getting vaccine - pts father took the patient to the hospital
Fever, muscle aches, pain at injection sight, headache, fatigue.  Lasted about 12 hours. No adverse reaction to first dose of the vaccine other than pain at injection sight.
Approximately 6 PM January 18, 2021 felt stomach upset-immediate loss of appetite & chills. Unable to stay awake.  January 19th  temperature of 101.6 , body aches, loss of appetite. Unable to stay awake.  Took Advil (1); Aleve reduced fever somewhat, continued body aches through night. Continued loss of appetite.   January 20th continued loss of appetite, reduced fever and body aches-tired and still felt unwell.
A non-serious, spontaneous report of partial dose of FLUMIST administered was received from a physician concerning her 32-month-old son.  This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications was not reported.  The physician reported that she was not trained in FLUMIST administration hence, she did not remove the divider clip when administering FLUMIST.  She complained that the syringe did not state clear instructions on administration such as removal of clip and to use both nostrils.  There was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Entirely liquid diarrhea after second shot. Stopped taking Miralax even though I need it to be able to go to the bathroom.
rash around the injection site; blood blister where the injection site was; his arm started itching where he got his shot; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband) that:  A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 22Feb2021 (at the age of 74-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lymphoma (product injected into an arm that previously had lymphoma). The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in right arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation with no adverse effect. Patient went a week ago to get his last COVID-19 shot(22Feb2021) and caller states that she didn't notice it before but last night (28Feb2021), his arm started itching where he got his shot, and the caller looked at it and her husband had a rash around where the shot was administered, and he had like a blood blister where the shot was administered (rash around the injection site and also he had a blood blister where the injection site was). Caller states that she put some coconut oil on it so that he would not scratch it anymore, and it was warm to the touch. Caller states that the coconut oil helped to stop the itching, but caller is concerned because her husband had lymphoma in that arm, and the VA did not ask which arm her husband wanted the shot in, they just gave it to him in his left arm. But caller states that her husband got his first dose of the product in the right arm. Caller is wondering if the vaccine will take if it was administered in the arm that her husband had lymphoma and he didn't have a lot of muscle mass in his left arm. Patient received treatment for event vaccination site pruritus. The clinical outcome of the event vaccination site pruritus was recovered on 2021 while other was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
6/26 Day of vaccination - mild pain at injection site 6/27 Evening the next day - very sore arm, small red area around injection site 6/28 Two days after - larger red area around injection site with smaller blotchy red areas around the larger red area, plain mostly subsided and itching started 6/29 Three days after - larger red, swollen area and more itching. Area is hot to touch and mildly swollen 6/30 Four days after - brighter red ring around the blotchy red area with some smaller blotchy areas that also have a darker red ring around them, itching, swollen, and still hot to touch but very little pain
Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Awoken about 7 AM Oct 20 while working arms noticed small rash. That nite Oct 20 took hot shower. Next day Oct 21 rash had increased to stomach and each day it kept increasing. By Oct 26 rash covered arm, leg, stomach and on Oct 26 that night hives on arms and stomach about the size of a dime.
Site felt warm and sore to the touch, had inflammation, took Benadryl per provider. Felt feverish a couple days after. Still have 1 in X 1 in discoloration at site of injection on 12/23/2013  (no lingering effects other than slight sensitivity and scarring).
Large local reaction around injection site with 8x8 cm area of erythema, swelling and TTP 1 week after administration.  Area swelling and redness did not extend beyond shoulder or elbow.  Pt was restricted from some duties becuase of arm pain.
pt felt "dizzy" after 15 mins post vaccine, resolved within 5 minutes.  BP obtained x3: 181/110, 180/106, 179/109 pulse 70-99 denies vision change or other symptoms. advised to have a family member pick her up and go to urgent care/ PCP. ER precautions reviewed.
Without any history of heart Disease I was Diagnosed with Dilated Cardiomyopathy with frequent PVCs on May 24, 2021. Tests showed two incidents of myocarditis
Sensitivity to light, sound and movement.  Emotional disturbances. Irritability,  paranoia, uncontrollable anger. Cognitive issues. Can't read, trouble thinking. Headaches.
sinus not being 100%; tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) and SINUS DISORDER (sinus not being 100%) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E, 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced SINUS DISORDER (sinus not being 100%). At the time of the report, COVID-19 (tested positive for Covid) and SINUS DISORDER (sinus not being 100%) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
blood in urine; needed assistance getting up; fell down; cough; gurgling sound in throat; pneumonia; felt ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, 4 hrs after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant) and feeling unwell (serious criteria hospitalization). On 28th December 2019, the patient experienced fall (serious criteria hospitalization), cough (serious criteria hospitalization), throat discomfort (serious criteria hospitalization) and difficulty in standing (serious criteria hospitalization). On 31st December 2019, the patient experienced blood in urine (serious criteria hospitalization). The patient was treated with antibiotics nos (Unspecified Antibiotic). On an unknown date, the outcome of the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing were unknown.   It was unknown if the reporter considered the pneumonia, feeling unwell, fall, cough, throat discomfort, blood in urine and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose of Shingrix in the right arm in reported pharmacy. Several hours, perhaps 4 hours after vaccination, the patient had pneumonia, blood urine and felt ill and went to bed to lie down. 1 day after vaccination, the patient had fall, cough, throat discomfort and difficulty in standing. The patient got up to use the bathroom  and fell down, and needed assistance getting up. The patient experienced cough and a gurgling sound coming from the throat. The patient went to urgent care and had X ray test which showed pneumonia in both lungs. The patient was given an unspecified antibiotic as a treatment medication and sent home. On 29th December 2019, the patient fall again and 911 was called. The patient was admitted to the hospital on Sunday, 29th December 2019 and discharged on 2nd January 2020. The patient was diagnosed with pneumonia. The reporter stated that emergency visit required. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Pt. developed body aches, chills and dizziness. Site immunization was administered resulted in swelling no redness or streaks present. Recommended ibuprofen, TYLENOL, cool compress, increase fluid intake.
Pt showed larger than expected area of redness at left deltoid area, reported waking up with feeling of muscles being stiff "like iron" and general malaise. She thought she may have had a low-grade fever also. Muscle symptoms and fever are gone now but maybe 3-4 inch area of redness at injection site still present.
patient fainted about 2 minutes after receiving vaccine. patient woke up shortly after and drank water. He felt fine and went home afterwards. Patient stated he usually feels faint after receiving shots but did not mark on form.
According to the Lot Number recorded on record the vaccine was expired at time of administration. Patient has not reported any ADR in regard to the records.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored RECOMBIVAX HB lot # L038018 with expiration date: 13-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Patient was vaccinated with Moderna shot at 17 years old. Patient was asked by staff if any adverse reactions to vaccine; patient stated no adverse reactions. Patient was monitored for 15 minutes and no signs and symptoms of adverse reactions.
Student reports severe shoulder joint pain, swelling occurring 1 week post injection. Pain radiates up her neck and inhibits her ability to dress herself. Seen at the health center for bursitis and tendinitis in the left shoulder. She was prescribed cyclobenzaprine HCL 10 mg and high dose ibuprofen. Currently, she is at the clinic waiting for a reassessment and steroid pack.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. The patient was vaccinated intramuscularly with the first dose of GARDASIL (dose and not number not reported) in 2011, about a year and a half ago. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient would be vaccinated intramuscularly with the second dose of GARDASIL (dose and lot number not reported) on 10-JAN-2013. No adverse effect was reported. Additional information has been requested.
Information has been received from a medical assistant concerning her 13 year old daughter who on 06-SEP-2009 was vaccinated with her second dose of GARDASIL series. There was no concomitant medication. The reporter stated that "at the time of the vaccination, the patient had her menstrual cycle and after the vaccination, the patient continued to menstruate for the rest of the month when it usually last for 5 days. The patient recovered (date unspecified by reporter) but they did not know if she should receive the third dose". The patient sought unspecified medical attention. Additional information has been requested.
Infant developed a large lump which developed a yellow center. Mother took infant to MD at which time he was put on antibiotics. Mother states she is still able to express purulent material. Right thigh area discolored and slightly tender. Infant received antibiotics for 2 weeks.
still has shakes on and off; Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (still has shakes on and off). At the time of the report, SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) was resolving and TREMOR (still has shakes on and off) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient was treated with IV medication in emergency room that helped her stop the seizures. She was discharged from the emergency room once she stopped having tremors. She still had shakes on and off and saw her primary care provider who had referred her to a neurologist.  Company Comment:  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.; 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.
This spontaneous report received from a healthcare worker via company representative referred to a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2007, the patient took 2 doses of GARDASIL (lot and expiry date not reported). The field representative reported that an unspecified time after receiving the 2 doses of GARDASIL, the patient developed nausea, palpitations, abnormal walking, an abnormal electrocardiogram and had fainting episodes. Outcome and causality assessment for the events were not reported. Additional information has been requested.