chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Discharge Provider:MD Primary Care Provider at Discharge: MD Admission Date: 5/31/2022 Discharge Date: 6/2/2022   PRESENTING PROBLEM: Hypoxia Ureteral calculus, left AKI (acute kidney injury) Acute kidney injury COVID-19   HOSPITAL COURSE:    Patient is a 62-year-old female admitted to hospital on 5/31/2022 with significant left-sided nephrolithiasis, acute renal failure COVID 19 viral pneumonia.  Patient had a CT of the abdomen pelvis done that showed a 7 mm calculus in the distal left ureter.  It CT was repeated on 06/02/2022 due to the patient's increased reports of pain.  The patient's case was discussed with Urology 2 times did not feel that she needed transferred for any intervention.  On repeat CT they do review the left kidney stone as 8.5 mm however the stone has migrated distally to the left ureterovesical junction with decrease in the hydronephrosis.  The patient's renal function has improved but is not back at her baseline.  Would recommend repeat BMP in 1 week to ensure continued improvement.  The patient's pain has been controlled on oral pain medication, she has Percocet prescribed at home, she was instructed he uses as needed for pain.  The patient was also given a 30 day prescription for Flomax in the setting of a kidney stone.  On 06/01/2022 the patient did pass a stone however this was likely from the right side as it was smaller.  On 06/01/2020 the patient had a eventful day where she was lightheaded in the a.m. and found to be orthostatic.  She was continued on IV fluids later in the day she develops chest pain that was reproducible to palpation but also hurt with deep inspiration.  A troponin was done at this time and was not elevated an EKG was also completed at this time and did not show any ST elevation or T-wave inversion.  In regards the patient's COVID-19 viral pneumonia.  She did develop hypoxia on 05/31 requiring 2 L nasal cannula.  A chest x-ray was done which showed subtle early atelectasis verses right lung base pneumonia.  The patient was quickly weaned off oxygen but she was started on Decadron during the hospital stay and received a total of 2 doses.  Given she was quickly weaned off oxygen will continue Decadron upon discharge.   Continue outpatient follow-up for chronic lower back pain, GERD, tobacco abuse, essential hypertension and diabetes.  Recommend post hospitalization follow-up with PCP in 1 week
receiving both a Pentacel dose and a dose of ACTHIB, on the same day with no reported adverse event; Initial information received  on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination.  On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation.  On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine.  Action taken: Not applicable.  Outcome: Unknown.   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.
Rash across upper stomach, rash at injection site roughly size of egg, rash across entire upper right arm, orange size rash on upper right leg, and egg size rash on lower left leg.  All rashes are in the exact same location as one experienced after the two shot Shingles vaccine.
Unsure about the exact type of flu shot and pneumococcal vaccine that patient received. She had pain and erythema at both of her arms at both injection sites. More noteworthy is that she became dizzy, profound weakness, nausea, and had internal warmth/sweats. Upon arrival to hospital, she was found to have an elevated WBC of 12.0 and a lactic acid of 3.4. She had been in her normal state of health in the days prior to vaccination. CXR clear. Urinalysis normal. Her WBC and lactic acidosis returned to normal range within 12 hours. She had been given IV fluids.
Body aches; Headache; Nausea; Fever; Dizziness; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 17May2021 at 17:30 (at the age of 27-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included bronchitis, COVID-19, penicillin allergy and exercise endured asthma. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) administered via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 27-years-old), 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a pharmacy or drug store. On 18May2021 at 09:00, the patient experienced body aches, headache, nausea, fever, dizziness, and injection site pain. The events were reported as non-serious. The patient received unspecified over the counter medication and nurse directed to take rest. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Lightheaded and diaphoretic, pt reports occurs with every injection. Pt rested and given water. Pt left with spouse complaining of abdominal cramps.
On approximately June 8, 2021 I began feeling bad in late afternoon.  Had extreme chills (couldn't stay warm), a headache and ran a slightly elevated temp (for me).  The next day I slept for 22 hours, my whole body hurt, getting up to get water or anything took all my strength.  The 2nd day I felt slightly better but by the time I got out of the shower I had to go back to bed. The 3rd day I felt like I could get up and get around, did very little & required frequent naps.  The next couple of days I continued to get better but still required extra sleep.  I did go get a COVID & FLU test on the 2nd day.  Both were negative.
Muscles hurt in legs and arms.  Became feeling cold and trembling. Took two aspirin at 2:00 AM 12/10/2014 and ate a banana. Went from cold to hot and got the sweats. Feel better now and I seem to be stable.
Two weeks post vaccination, pt noticed the onset of fatigue, headaches, light-headedness, vertigo, nausea, cramps and stomach aches which lasted 2 months.
Information has been received from a woman in a medical office concerning a 8 year old white female patient who on 6/4/98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 625047/1574E). On 5/3/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407usa00537, 0407USA00540, 0407USA00542, 0407USA00544, and 0407USA00548). Additional information is not expected.
Started as small red raised bumps on neck. Spread to both lower arms, upper left arm, left shoulder and left underarm. Bumps are itchy. Neck is red and almost large welt like circular rashes.
Information has been received from a medical assistant, referring to an 18 month old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On 01-MAR-2018, the patient (at 15 months) was vaccinated with the first dose of VAQTA (strength:25/0.5(unit unknown), lot # N026997, expiration date 10-NOV-2018; dose and frequency were unknown) intramuscularly for prophylaxis. On 01-JUN-2018, the patient was vaccinated with the second dose of VAQTA (strength:25/0.5(unit unknown), lot # N026997, expiration date 10-NOV-2018; dose and frequency were unknown) intramuscularly for prophylaxis (inappropriate schedule of product administration). No adverse effect was reported.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, feeling hungry and loss of energy. In March 2019, the outcome of the feeling hungry was recovered/resolved. On an unknown date, the outcome of the tiredness and loss of energy were not recovered/not resolved. It was unknown if the reporter considered the tiredness, feeling hungry and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX was administered by a pharmacy in a grocery store in the right deltoid. The reporter was a patient herself, who was vaccinated a couple of days before reporting and the only symptom she had was no energy. The patient asked whether she was correctly vaccinated or not. The patient stated that she was tired/no energy/fatigue and was hungry after receiving a dose of SHINGRIX. Every source the patient googled stressed how painful it was and she had found virtually nothing. The patient did notify her physician, however, she did not mention the side effects. The reporter stated that the tiredness had not resolved completely but she thought she was probably just operating at a slower pace today due to lack of exercise. The patient was asking will the second dose have the same side effects she experienced, or, will it be double painful. The patient expected to be fully functional again by 9th March 2019. The patient was unable to locate a lot number.
Onset fever, chills, lips turned blue 30min p/inject; Seen by MD; @ 2AM fever was 104.8 w/vomiting & nose bleed; Referred to ER given APAP & suppository for fever;
pt recvd vax & 16NOV93 & exp a recurrence of  testicular swelling; pt recovered in a few days; No further details were provided
1/15/21 sore injection site arm and fever 100.5F. Treated with acetaminophen. 1/16/21 soreness improved but not gone. Fever resolved. 1/17/21 to present stomach ache with diarrhea. Eating bland diet, taking zyrtec 10 mg daily, taking lomotil per label direction, taking probiotic.
high blood Pressure; fever 104F; right arm hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (high blood Pressure), PYREXIA (fever 104F) and VACCINATION SITE PAIN (right arm hurting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurting) (seriousness criterion hospitalization). On 10-Mar-2021, the patient experienced HYPERTENSION (high blood Pressure) (seriousness criterion hospitalization) and PYREXIA (fever 104F) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (high blood Pressure) and PYREXIA (fever 104F) outcome was unknown and VACCINATION SITE PAIN (right arm hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) high. On 10-Mar-2021, Body temperature: 104 (High) 104 F. On 10-Mar-2021, Oxygen saturation decreased: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment medications was provided.  It was reported that patient got transferred to a big hospital within 3 days and was put on ventilator, patient was later transferred to another Rehab Centre.  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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 01Apr2021 as dose 2, single (Lot number: EN6208), in left arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing); "shoulder surgery" (unspecified if ongoing), notes: Patient is recovering from rotator cuff bicep left shoulder surgery. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I did my treatment and I tested negative; Positive, notes: After they day treatment then had symptoms return after 8 days having treatment. And am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient's age was reported as 65+ years. Patient received other medication in 2 weeks. Anti viral details for COVID-19 treatment included treatment start date was on 23May2022, treatment stop date was on 27May2022, lot number of product: 196905. Patient did treatment and tested negative after they day treatment then had symptoms return after 8 days having treatment, and patient is positive again.  No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from non-healthcare professional (office manager, patient's father) on 21 Jul 2016. This case involves a 14-year-old female patient who received a first dose of IMOVAX (batch number: L1355-1 and expiry date: 04 August 2017 and route of administration: not reported) intramuscularly in left deltoid on 29 Jun 2016. The patient's illness at time of vaccination was reported as none, the patient had no known allergies, birth defects and medical conditions were not reported. Concomitant medications were not reported. On 29 Jun 2016, same day post vaccination, the patient had a fever and aches. It was reported that, they do not want to give any further vaccines. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender none
pt recvd vax 945AM 19OCT95 & started crying & was not able to console for 2hrs starting about 1PM;leg was very swollen;APAP given 1130AM, 330PM, 730PM; had temp elevation but not documented;seen by family MD about 430PM;
Severe hypotension, loss of consciousness, vertigo. Unresponsive. Transported to ED by RN at bedside.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), on 21Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Nov2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Atrial septal defect" (unspecified if ongoing); "Low back pain" (unspecified if ongoing); "Cerebral infraction" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE oral; ACYCLOVIR [ACICLOVIR] oral; ASPIRIN [ACETYLSALICYLIC ACID] oral; IVERMECTIN topical; MUPIROCIN topical; DENAVIR topical; UBRELVY oral; VITAMIN B2 [RIBOFLAVIN] oral; MAGNESIUM OXIDE oral; VITAMIN B12 [CYANOCOBALAMIN] oral. Past drug history included: Hydrocodone, reaction(s): "known allergies: Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
legs were exhausted; not much pain just a little; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (legs were exhausted), PAIN (not much pain just a little) and FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (legs were exhausted), PAIN (not much pain just a little) and FATIGUE (fatigue). At the time of the report, LIMB DISCOMFORT (legs were exhausted), PAIN (not much pain just a little) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No Treatment details were provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 08:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2weeks. Received Covid treatment start date on 14Dec2022 and stop date on 19Dec2022 with lot number GE3010, indication for Treatment of COVID-19. It was unknown that the patient had known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the parent. A 68-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) as dose 3 (booster), single (lot number unknown), as dose 2, single (lot number unknown) and as dose 1, single (lot number unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot in the right leg". Clinical course: It was reported that the patient was diagnosed with a blood clot in the right leg, and he had just found out. The patient had all three doses. The reporter (patient's mother) stated that they have heard of several people getting blood clots after getting this vaccine; and then asked if Pfizer COVID-19 vaccine causes blood clots. The lot number for bnt162b2 was not provided and will be requested during follow-up.
About two weeks after getting the shot, I started getting a dull, deep pain in my arm around the injection site. It seems to be getting worse and spreading up towards my neck.
Patient presented to COVID clinic accompanied by mother and sibling, vaccine drawn, RN double checked the vaccine name and dose (0.2ml), vaccine administered per mothers consent. At the end of the clinic received call from pharmacist and she asked if pfizer-peds vaccine was diluted, because she found the normal saline vial in the vaccine clinic unused. Confirmed with her this RN did not dilute the vaccine and verified the other RN  also stated she did not dilute the vial either. This RN assumed the vial was already prepared and drew up and gave vaccine as is. The pediatrician, immediate supervisor and vaccine coordinator (pharmacist) were all notified of the medication error, adminstration of undiluted COVID dose. Parent was called and notified of incident.
Did not feel well, mild fever of 100.4, seemed achy, blood in stool next morning and for 2 days, but not in every stool.
Pt. and mom returned to clinic on 10-31-06 at approx. 6:50pm and reported "hives starling on upperback and chest them spreading to trunk and down arms and legs on Sat., 10-28-06 and swollen eyes on Sun, 10-29-06. Denies SOB, Denies redness or swelling at L deltoid injection site. Mother says hives resolved with Benadryl No redness or swelling observed at L deltoid by NP.
I did not have an adverse reaction to the vaccine. I woke up on 12/13/2022 with a bad cough and things progressed from there. I saw my doctor on 12/19/2022 and he heard a wheezing sound in my lungs. I was diagnosed with a lower respiratory infection. I was prescribed an inhaler. I was sick for 15 days.