chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient age more than 65 years. patient received other medication in 2weeks. Anti-viral COVID 19 Treatment included Paxlovid, treatment start date: 11Nov2022, treatment stop date: 15Nov2022. Symptoms completely resolved. Then rebound symptoms developed 7d after initiation of Paxlovid (2d after completing course). Mild rebound symptoms w/ test positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported). On an unknown date, the patient experienced redness and swelling of the arm at the injection site after receiving PNEUMOVAX 23. The outcome of the events redness and swelling of the arm at the injection site was unknown. The reporter did not provide the causality between the events and th suspect drug. This case is linked to the case 1402USA012785 (same reporter link). Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Came down with covid/Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with covid/Covid). At the time of the report, COVID-19 (Came down with covid/Covid) outcome was unknown.No concomitant medication were provided. Patient received 2 primary series doses and first booster dose but was due for second booster dose in April but was unable to get the second booster dose as patient came down with COVID and stated that patient also got an infusion of antibody on 07-Apr-2022. Company comment: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non-serious event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non-serious event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
received Shingrix on 8/1/19 and 11/29/19 then was subsequently diagnosed with Shingles; This case was reported by a other health professional via out of hour services and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 19th December 2019, 20 days after receiving Shingrix and 140 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had shingles.
Redness at the site, gradually increasing, warm to touch discomfort locally -> SHINGRIX #2.
Patient's mother reports to pharmacy that patient had 2 Grand Mal seizures, 1 occurring at school on 11/3/21 and another at home on 11/4/21.
Redness in forearm.  Warm to touch.  Soreness in whole arm, shoulder, and near breast area.  Low grade fever.
These are expected side effects, I was told I still need to fill out this form by my boss. Temp 100.2, extreme fatigue, chill, extreme muscle pain, cough, left eye irritaion
Patient fainted after receiving 1st dose of Janssen 0.5ml at 1537.  Patient was given 15 minutes of observation. While waiting for her husband to receive his shot. Patient stated, "I don't feel good".  LVN called RN to assess patient. Upon assessment, patient appears perspiring, clinched both hands (fist) to her chest. Right away, RN asked Husband assist patient to the floor. Patient was unconscious for about 30 seconds. 911 was called and paramedics arrived on seen at 1548. During 911 phone call, patient began responding to verbal command  to name, time, place. Vitals was taken O2 98 RA, 79HR, R .20, B/P 128/92. Patient then stated she has history of epilepsy, and allergic reaction to tetanus shot. Did not want to go to the ambulance. We had patient wait in observation for 30mins. Vitals before she left were 02 99% and Pulse 76.
Severe full body itching, currently on 3 antihistamines. Unable to stop. Symptoms reappear when and med is reduced.
Information has been received from a registered nurse concerning an approximately 16 year old female with no known drug allergies who on 30-DEC-2009 (lot# 662229/1497X, Exp 15-APR-2011), 06-MAR-2010 (lot# 658271/0558X, Exp 21-MAR-2010), and 06-JUL-2010 (lot# 665607/1332Y, Exp 25-JUN-2012) was vaccinated IM into left deltoid with a first, second, and third dose of GARDASIL. there was no concomitant medication. The nurse stated on well check visit 30-DEC-2009, the patient's periods were documented as irregular every 20 to 60 days. The patient had not had a period, menstrual cycle, since December 2009. The nurse stated the patient told her she was not sexually active and she was not pregnant. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a registered nurse concerning a 17 year old patient with a history of missed menses and no sexual activity. It was reported that since the first dose given on 30-DEC-2009 at 15:00, the patient had not had period. This said Hx no diagnosis. At the time of this report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information is not expected.
Information has been received from an LVN concerning a 12 month old white male with nutritional abnormality and hearing impairment who on 4/13/01 was vaccinated with varicella virus vaccine live (lot 637669/0088L), SC in the left thigh. Concomitant therapy included MMR (lot 637425/0025L), SC in the right thigh. On 4/21/01, the pt developed a rash and on 4/24/01, the pt developed a fever of 102F. The next day, the pt was seen at the physician's office and had developed red papular clusters on the thighs, arm and the tip of the penis. The nurse reported that the pt was dx'd with "chickenpox 2 degrees to vaccine". The pt was treated with Caladryl. Subsequently, on 5/8/01, the pt recovered. No further information is available.
fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse event; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 68 years old female patient who reported that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was leaking from a patient's arm when the vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8084BA, Expiry date : 30-Jun-2024, Frequency : Once, strength, formulation was unknown) via intramuscular route in the right deltoid for Immunization.  On 22-Sep-2023 the patient developed a non-serious event of fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse event (accidental exposure to product) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high-dose quadrivalent was leaking from a patient's arm when the vaccine was given with no reported adverse event.  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.
Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and while driving home from the pediatricians, she developed anaphylaxis with symptoms of throat tightness, wheezing and respiratory distress. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by vomiting after milk-based formula as an infant and angioedema of hands after contact with spilled milk at one year of age. Laboratory testing showed the patient had increased IgE levels (96.1) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03280 and -03281. Documents held by sender: None.
Mild symptoms after the vaccine with nausea for 2 days. In Jul 2021, my blood pressure was low 70s over 60 and falling down and broke bones in both my feet. I was hospitalized, too weak to do the test to check on low blood pressure. I have high blood pressure.
pt recv vax in infancy & 1887 pt devel mild case of chickenpox;
Several days after shot, arm was in pain and slightly swollen. Next week, the area of the shot was itchy. On the morning of 4/22 (more than a week of receiving shot) woke up with a large itchy rash around the site of the shot.
Injection site warmth; sore down to hands; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 24-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (sore down to hands) and INJECTION SITE ERYTHEMA (Redness at injection site) had not resolved.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.
sick and had to stay in bed for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick and had to stay in bed for 24 hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301420) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick and had to stay in bed for 24 hours). At the time of the report, ILLNESS (sick and had to stay in bed for 24 hours) had resolved.      No concomitant medications provided. No treatment medications provided. Patient stated that they are healthy and not immunocompromised.
Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a female who was vaccinated with a dose of GARDASIL (lot # not reported) when she was 3 to 4 weeks along in her pregnancy. The patient lost the baby during the twelfth or thirteenth week of gestation period. It was unknown if the patient sought medical attention. Upon internal review, lost the baby during the twelfth or thirteenth week of gestation period was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
a patient was vaccinated with liquid portion of the Pentacel vaccine, and the vaccine was not reconstituted first, No AE; Initial information received on 24-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional .  This case involves a patient of an unknown age and gender who was vaccinated with liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date and the vaccine was not reconstituted first (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (latency same day).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Swelling around injection that eventually encompassed entire thigh & caused pt. to walk w/ straight leg & w/ foot supination for a few days. Pt. is no fine.
right arm pain since getting second COVID vaccine on 6/22/21.  Describes intermittent pain as "unbearable at times."  Pain starts at right deltoid where she received her injection and shoots down her arm.   Arm has felt weak since the shot.  Can use arm normally.  Also has had intermittent chills that started one week after receiving vaccine on 6/22/21.
Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy; fogginess this feeling lasts all day; Hard to focus, hard to concentrate, and does not feel like himself; Major headaches in temple, top of head and whole head; Extreme Fatigue once he got home; Nauseas within 15 minutes of the vaccine; Arm was warm at injection site within 15 minutes of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself) and HEADACHE (Major headaches in temple, top of head and whole head) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A - 51 - 042870) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, NAPROXEN, CYCLOBENZAPRINE, GABAPENTIN and MARIJUANA for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), HEADACHE (Major headaches in temple, top of head and whole head), FATIGUE (Extreme Fatigue once he got home) and NAUSEA (Nauseas within 15 minutes of the vaccine). On an unknown date, the patient experienced SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ) and DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-May-2021, NAUSEA (Nauseas within 15 minutes of the vaccine) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was warm at injection site within 15 minutes of the vaccine), SOMNOLENCE (Describes a feeling of taking a nap in a deep sleep and he wakes up and things are groggy), FEELING ABNORMAL (fogginess this feeling lasts all day ), DISTURBANCE IN ATTENTION (Hard to focus, hard to concentrate, and does not feel like himself), HEADACHE (Major headaches in temple, top of head and whole head) and FATIGUE (Extreme Fatigue once he got home) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A 39-years-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 09Jun2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated had a question about side effects from the COVID vaccine. Stated she received the first dose of the Pfizer COVID last week on Wednesday, 9Jun2021 and this week on Tuesday, 15Jun2021, she started throwing up and nauseous for 24 hours and "still doesn't feel right is it possible to have side effects a week after the dose". On 16Jun2021, 7 days later first dose of vaccine, the patient had diarrhoea. The patient wanted to know was it a normal side effect of vaccine. It was reported that, in clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild to moderate. The patient declined to provide contact information, declined to file a report, she would like to be transferred for information on side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CHRONIC SHOULDER PAIN; LEFT LEG WAS SORE FOR WEEKS; FELT WEAK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chronic shoulder pain, left leg was sore for weeks, and felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg was sore for weeks, and the outcome of felt weak and chronic shoulder pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211042950.
Myalgia & Arthralgia Narrative:  day 1-12 hours after receiving vaccine developed joint and muscle pain lasting 24 hours. did not take anything for symptoms. resolved within 24 hours.
Depression, Chills, body swollen Comes in waves  No symptoms till 5 days after shot had 2 shots same thing but stronger with 2nd shot feels like its leaving than bang it comes back again stronger over 2 months cant get better
Lump appeared overnight on left clavicle - appears to be swollen lymph node. Was painful initially but pain subsided in a few days.  As of 03/07/21, lump is still present.
p/vax T105.2; tx:tylenol; would go to 103 for short time then go back to 105.2; MD exam; no other symptoms; 5/17 fever went to 101 for 24hr; no swelling or marks at inj site;
Tinnitus felt 2 weeks after vaccine.  Tinnitus changes pitch when jaws are moved
I experienced a redness and heat coming from my chest on the third day (Sunday) and a few bumps -rash. I contacted my Dr and he prescribed steroids and I took one week course. It calmed it down a little. My chest wasn't red any more after that. I got another bump last week  (on my finger) but it disappeared and then it went away.  I started having dizziness about two weeks ago. I still am a little dizzy. I feel a little dizzy when I go to bed at night  - the bed spins. I wake up and I'm okay but during the day, I get a little dizzy and lose my step and get it back but at night when I lie down I notice it the most.