chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild Shingles rash on chest and arm after 2nd shot; Swollen tongue; throat was swollen; Chills after 2nd shot; Fever 100.3 F  after 2nd shot; Headache after 2nd shot; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Mild Shingles rash on chest and arm after 2nd shot), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (throat was swollen), HEADACHE (Headache after 2nd shot) and CHILLS (Chills after 2nd shot) in a 74-year-old female patient who received mRNA-1273 (batch nos. 046A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (Headache after 2nd shot). On 26-Apr-2021, the patient experienced HERPES ZOSTER (Mild Shingles rash on chest and arm after 2nd shot), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (throat was swollen), CHILLS (Chills after 2nd shot) and PYREXIA (Fever 100.3 F  after 2nd shot). On 26-Apr-2021, SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (throat was swollen), CHILLS (Chills after 2nd shot) and PYREXIA (Fever 100.3 F  after 2nd shot) had resolved. On 10-May-2021, HERPES ZOSTER (Mild Shingles rash on chest and arm after 2nd shot) and HEADACHE (Headache after 2nd shot) had resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   Reporter had reported that the first shot made the patient very energetic. Patient had rash on chest and arm and her tongue and throat was swollen and she had similar reaction after taking Penicillin. No concomitant medication was given by reporter. No treatment medication was given by reporter.
PATIENT REPORTS FLU-LIKE SYMPTOMS AND SORE ARM FOR 1 DAY
Cramping 2 days after the vaccine and then bleeding 2 weeks after.  I am 54 years old and haven't had a period in 4 years until after the first covid vaccination.  I am scheduled to see my OB/GYN this week.
Uncontrollable shaking; Couldn't lift up head; 103-106 fever; Chills; Nausea; Tired; Little rash with little bumps; Worse headache that he has ever had in his life; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable shaking), HEAD DISCOMFORT (Couldn't lift up head), PYREXIA (103-106 fever), CHILLS (Chills) and NAUSEA (Nausea) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.   On 24-Feb-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 an unknown date, the patient experienced TREMOR (Uncontrollable shaking), HEAD DISCOMFORT (Couldn't lift up head), PYREXIA (103-106 fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Tired), VACCINATION SITE RASH (Little rash with little bumps) and HEADACHE (Worse headache that he has ever had in his life). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TREMOR (Uncontrollable shaking), HEAD DISCOMFORT (Couldn't lift up head), PYREXIA (103-106 fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Tired) and VACCINATION SITE RASH (Little rash with little bumps) had not resolved and HEADACHE (Worse headache that he has ever had in his life) had resolved.            Wife of a patient reported that her husband received the 2nd dose on 24FEB2021 and on an unknown date reported 103-106 fever (lasted a few days), uncontrollable shaking, chills, nausea, tired, couldn't lift up head, worse headache that he has ever had in his life (ended), little rash with little bumps (ongoing). Patient said that she got her second vaccine shot and she still has side-effects   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR received-Reaction outcome information provided.
Patient is not having any adverse events and does not need treatment. Gave 2nd dose 20 days after 1st dose
This spontaneous report has been received from a Registered Nurse and refers to a 16 month old female patient with no per-existing allergies, birth defects or medical conditions. The patient's concomitant therapies was not reported. On 01-DEC-2017 at 10:30 am, an alarm was noted on log tag. It was reported to company representative and State Immunization Program, after excursion amount of time the reporter was told she could use the vaccine until normal expiration date. It was reported that within 4 weeks prior the vaccination the patient did not receive any other vaccine and she did not present any illness at the time of vaccination. On 01-DEC-2017 at 02:22 pm, the patient was vaccinated with improperly stored doses of VARIVAX first dose, subcutaneously lot # N010107, expiration date 18-MAR-2019, also reported as 28-MAR-2019, in the right arm, M-M-R II first dose, subcutaneously lot # M045392, expiration date 17-NOV-2018, in the left arm, and PEDVAXHIB dose fourth, intramuscularly lot # N081149, expiration date not reported, in the left thigh, for prophylaxis  (doses were not reported for any vaccine). On 25-DEC-2017, a telephone call to the mother's child was made for evaluation of any adverse reaction to immunization, the patient's mother stated that the child did very good and she didn't run a fever or anything. VARIVAX was exposed to a temperature excursion of 6 F to 14 F for a time frame of 2 hours which were call because of a data logger. This is one of several reports received from the same reporter (case: 1712USA013941).
pt developed peri rectal abscess 4/1 requiring inpatient management due to sepsis and I&D also noted to have incidental finding of pseudocyst  pt has no h/o etoh use or any abd pain or diarrhea has had abd cramps on and off in the past will be getting referred to GI for IBD work up
patient experienced genital herpes outbreak. Herpes outbreak on left butt cheek; This is a spontaneous report from a contactable consumer (patient herself). This case refers to the first vaccination of two vaccines. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER2613; expiration date was not reported), via unspecified route of administration, in the left arm, on 23Mar2021 at 14:00 (at the age of 52-year-old), as single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included progesterone, estradiol (ESTROGEN), testosterone and multivitamins. On 25Mar2021 at 04:00 patient experienced genital herpes outbreak. Herpes outbreak on left butt cheek. 3 days after 1st dose. Patient received the valtrex treatment for the genital herpes outbreak. Patient did not have known allergies. No COVID prior vaccination. Patient did not positive for COVID post vaccination. Patient did not receive other vaccine in four weeks. Outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Bm in black; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Bm in black) in a 25-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced FAECES DISCOLOURED (Bm in black). At the time of the report, FAECES DISCOLOURED (Bm in black) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Extreme muscle aches, headache, lethargy, very swollen lymph node in left arm pit.
Pneumovax 23 vaccine was injected into patient's left shoulder joint instead of her deltoid muscle.  A few hours after the injection the patient's left arm began hurting and she no longer could lift her left arm.  The next day she went to an Urgent Care because of loss of mobility in her arm.  A few days later she went to see her primary doctor.  She still cannot move her arm and has another doctor appointment coming.
Debilitating headache about 10 hours post-inoculation, lasted about 8 hours. Treated effectively with 400 mg ibuprofen.  Migraine?
5NOV92 reddened swelling of site, positive red streak extending into axillae; elevated temp; inc pain upon palp;
Within 8 hrs began to experience pruritus and edema to adjacent skin, by 24 hrs erythema extending distally to medial elbow. No fever/chills. Tx with hydroxyzine for now.
Around 5pm I was at work and began feeling stomach cramps and a feeling of flatulence. Approximately 6pm I started to become mildly agitated with a mild headache with intermittent stomach cramps and repeated flatulence. The cramping and gas continued and severe diarrhea started at 8:15pm and has been ongoing.
ITCHY FROM BEING OUTSIDE LITTLE BUG BITES; ITCHY FROM BEING OUTSIDE LITTLE BUG BITES; 1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES), PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC ).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Solution for injection in pre-filled pen). On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021). On an unknown date, the patient experienced ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES). At the time of the report, ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021) outcome was unknown and PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) was resolving.            Concomitant drugs not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Formulation for suspect HUMIRA given as Solution for injection in pre-filled pen. The reporter causality for the event Bug bite was reported as Not Reported and for the event Itchy was reported as (no reasonable possibility) Not Related. Treatment information was not reported.
Information has been received from a physician concerning her son who was vaccinated with a second dose of MMR. The patient experienced a measles like rash after receiving his second dose of vaccine. The measles like rash resolved within a few days after receiving the vaccine. Additional information has been requested.
pt recv vax 4NOV96 early AM;6NOV96 AM pt felt nauseated, run down, fatigue;no fever;pt daughter exp similar sx day a/vax;
Moderna COVID-19 Vaccine EUA  For the first 8 days, I experienced no reaction to the vaccine.  On day 9, I developed a rash on my right arm surrounding the vaccination  site. I was also flushed and my eyes were red.  And, I experienced diarrhea.  I began taking Benadryl 25mg  every 4 hours during the day (and took zolpidem only at night). In the subsequent 4 days, In addition to the rash, I experienced minor headaches and body aches (not unusual with my Fibromyalgia) so I added Tylenol 500 mg every 6 hours. The rash remained the same. Today is Day 5 and I awoke feeling better and the rash is the same size but not as vibrant. I used a cortisone cream on the rash today and only took Benadryl once when I began to feel lousy at the end of my work day.
Per mom, child developed erythema, tenderness, swelling about 10 x 6 cm diameter in size on Rt thigh.
On June 19 I was exposed that person positive on June 21 I developed a sore throat and a drippy nose. I tested on the 21 and it was positive. June 22, told to my doctor and was give PAXLOVID and I took this medication June 22-June 26. June 29, I developed a retuned of sinus issues and a cough for 3 or 4 more days. I took over the counter TYLENOL when I was feeling very ache.
Patient had presumed seizure activity on 6/3/2007, 4 days after vaccine administration.  Patient found unconscious by father -- not breathing and incontinent of urine.  Event lasted approximately 2-3 minutes.  Patient taken to ER by ambulance. 1/11/2010 In October of 2007 she started having severe frequent urination-all other possibilities eliminated through blood work, urninalysis, diabetes checks, MRIs completed on spine to insure for absence of cysts and/or tumors. She was having to urinate 15-20 times in a 10-15 hour period. Finally sent her to OBGYN. They put her on birth control to try to help. Severe mood swings and pain. Could be part of her body or adjusting to her cycle however, this was one year past when she started her menstration cycle. Hormones have balanced things out; however she still hs frequent urnination just not as bad-"could be related to vaccine"-who knows.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, route, lot# and expiration date unknown). On an unknown date the patient developed gastroparesis after receiving GARDASIL. The outcome of gastroparesis was unknown. This patient was not seen by the physical but by another unspecified pediatrician who in turn talked to the physician. In addition, the patient's mother started a blog, which had "multiple pediatricians commenting". Additional information is not expected.
Pt received dose of J&J vaccine (Janssen) on  3/13/2021.  Symptoms began around 3/27 similar to COVID-19.  Pt presented to ED at another local hospital 3/29/2021, tested positive for COVID-19 and was transferred to be admitted to our hospital for treatment of COVID-19.  Notes from hospital admission H&P: Patient is a 59 y.o. male with history DM, Who presented to Urgent care then hospital ER with covid positive, PNA, Fever and a cough. Real tachycardic there to 117, temp to 103, confused, moving slow. Altered mental status (slow cognition), 94% on 2L"
Stated that she "Passed Out."   It was reported by observer individual exhibited  rolling eyes activity.
Slight pain/itchiness at injection site, arm is also warm  At time of vaccine I also got a tickle in my throat within a few minutes while still at the site, it was gone again before I was done with the 15 minute waiting period.
Fourteen days post one dose of varicella virus vaccine live the pt developed a rash that started with 3 small bumps and was believed to be a spider bite. The rash progressed to his legs, stomach, arms and face with under 20 mild, blister-type lesions that crusted. He also experienced cold symptoms.
Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Per provider discharge note, "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient was readmitted with pancytopenia in setting of linezolid use and hepatic abscess. Admitted, given blood, antibiotics changed and abscess re-drained. Found to have covid and recurrent pleural effusion, drained repeatedly, found to be transudate and from inadequate volume removal. Will dc with micofungin, daptomycin and zosyn through 10/6/23, ct abdomen pelvis on 10/2 and follow up with ID."
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. In 2014 (exact date unspecified), those patients were vaccinated with an improperly stored for 8 days from 24-OCT-2014 through 31-OCT-2014 PNEUMOVAX 23 (dose, route of administration, anatomical location, lot number were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Father reports pt had temp up to 102 degrees F orally last night, home sick today with fever in low 100s.
Pt. reported allergic type symptoms within 1 minute of receiving dose. SOB, faintness. Pt. was seated. Emergency kit was obtained. He provided his own Epinephrine auto-injected and I administered in right thigh. Oral diphenhydramine  was given. His blood pressure was obtained and was appropriate. Pulse was ten and remained strong. No frank tachycardia or bradycardia noted.  Emergency service had been contacted and arrived shortly and assumed care and transported patient to the ER.
Patient presented with HR of 38 and BP was 90 palp. Loss of consciousness. HR returned to 60s . Patient refused transport.
Eyes rolled back into head, turned pale with blueness around lip area, lost consciousness, dizziness. Doctor called immediately, still in office. Rapid heartbeat, quickened pulse, chest pain, hard to breathe.
Running itching nose; Itching nose; Sick; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick). At the time of the report, RHINORRHOEA (Running itching nose), PRURITUS (Itching nose) and ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter  Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
a dose of expired Ipol was given to a patient/No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional. This case involves a patient (with unknown demographics) who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 17-Mar-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) lot number not reported, expiry date 13-Mar-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (Latency same day).  The facility reported the event to their compliance quality organization. The caller stated she does not have additional details, including lot, patient ID, or patient dob. She stated she is helping out, but not familiar with all aspects of these situations including AE reporting, because the nurse who handles these situations is currently out of the office. AE template was not completed due to the caller providing all the information that is currently available to her.  At the time of report no adverse event was reported.  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 available on the batch number for this case.
Patient was tested positive/ tested positive twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was tested positive/ tested positive twice) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (Patient was tested positive/ tested positive twice). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient was tested positive/ tested positive twice) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Continued testing negative for next 9 days, with no symptoms. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) tested positive twice.         No Concomitant product use was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient took Paxlovid on first day of testing positive and tested negative for Covid on Day 3 of Paxlovid course. The patient continued testing negative for next 9 days, with no symptoms. On Day 12, the patient experienced congestion and sore throat, tested positive twice. The device date reported as 31-May-2022.  Company Comment: This is an spontaneous case concerning an 31-year-old female patient with medical history of PAXLOVID  for COVID-19 treatment from 19-May-2022 to 24-May-2022 who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd. dose of  mRNA-1273 vaccine. On 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case concerning an 31-year-old female patient with medical history of PAXLOVID  for COVID-19 treatment from 19-May-2022 to 24-May-2022 who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd. dose of  mRNA-1273 vaccine. On 19-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a consumer concerning her 4 year old grandson who, on an unspecified date, was vaccinated with a dose of MMR. Subsequently, the patient developed redness in his shoulder and arm. The patient visited the emergency room and was treated with antibiotics. Subsequently, the patient recovered from redness of shoulder and arm. The consumer also reported that she had heard of a child who had developed autism after receiving MMR (WAES0406USA02469). Additional information has been requested.