chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2013, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) at a pharmacy for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Tenderness at injection sight, severe enough to awaken during the night; Tenderness at injection sight, severe enough to awaken during the night; The day after the injection, I broke out in sweats to the point that my shirt was wet; This is a spontaneous report from a non-contactable nurse reported for herself. A currently 50-year-old (reported age at vaccination was 50) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for covid-19 immunization in Hospital. Medical history was not reported. Patient is not pregnant at the time of vaccination. Not allergies to medications, food, or other products. Concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of bnt162b2 on 22Dec2020 via Intramuscular at left arm at single dose for covid-19 immunization. Patient experienced tenderness at injection sight, severe enough to awaken during the night (12Jan2021); relieved with ibuprofen. Lasted about one week. The day after the injection, patient broke out in sweats to the point that my shirt was wet. This occurred multiple times but resolved about 24 hours post injection. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the events included OTC med. Patient was recovered from the events tenderness at injection sight, severe enough to awaken during the night in Jan2021 and recovered from sweats on 13Jan2021. It was non-serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
numbness behind his temple area and cheek; tired; headaches have gotten worse; chills; body aches; severe migraines; pain shot up to behind his right eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired) and HEADACHE (headaches have gotten worse) in a 36-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 Tuberculosis (Tuberculosis as a child). Concurrent medical conditions included Malaria.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced EYE PAIN (pain shot up to behind his right eye). On an unknown date, the patient experienced MIGRAINE (severe migraines), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment was provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 27-JAN-2007, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 06-NOV-2015, the patient was treated by a physician at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
HBCV vax given 4MAR91 developed choking & producing nasal & oral mucus. Increased irritability & diaphoretic. Given Epinephrine 0.1 ml improvement noted immediately. Sent to Er for observation (3hrs). No reaction w/dose #1 of HBCV.
I'm breastfeeding and my son who is 10mths old; 10mths old could not sleep/nap for 48 hours following my shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 11Aug2021 (Lot number: FA7485) as dose number unknown, single for covid-19 immunisation. The mother of the patient was 34 year-old. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset Aug2021, outcome "unknown", described as "I'm breastfeeding and my son who is 10mths old"; SLEEP DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "10mths old could not sleep/nap for 48 hours following my shot.".  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. No treatments received for adverse event.  No follow-up attempts are possible. No further information is expected.
After receiving the vaccine my foot was sore and after about eight days my foot stated to swell up very badly, and it started to hurt very badly and then after a few more days my knew started to swell up and I called the doctor. The doctor sent me to the emergency room to have a Doppler done on my leg on January 7th 2022. That's where they found the blood clot and I am now taking Xarelto.
pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a female patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Jan-2023 Reporter's Comments: The nurse reported that the pediatric patient received an adult dose of Havrix. The reporter consent to follow-up. Additional supportive information: A pediatric patient received an adult dose of Havrix which led to overdose and adult product administered to child.
Red, warm to touch, larger area(5in wx2.5in) area. Told to start Clindamycin, ER Rx'd. Return to clinic in 5 days if worsen go to ER.
Brain bleed; His platelets were only 9000; This is a spontaneous report from a contactable consumer reporting for her husband. A 63-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 14:00 (Batch/Lot Number: EW0172) as  single dose  for covid-19 immunisation (Age at vaccination 63 years) .  The patient medical history was not reported. Concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported.   On 23Apr2021 the patient received the first dose of BNT162B2 vaccine Lot # EW0169. The patient experienced brain bleed  on 30May2021 causing patient's death on an unknown date, and his platelets were only 9000  on 30May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count: 9000   on 30May2021   , sars-cov-2 test: negative   on 29May2021  .   The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Reporter's comments: My husband was rushed to the ER one week after his 2nd vaccine.  He had a brain bleed, they couldn't operate because his platelets were only 9000.  He died!  I believe it was from the vaccine  Information about lot/batch number has been obtained. Additional information is requested.; Reported Cause(s) of Death: Brain bleed
We were contacted by HD who received a call from a MD stating pt received flu shot on 10/09/01 and developed rigors and a fever of 103F later that night. He was seen in ER and developed cardiogenic shock and died.
This spontaneous report as received from a consumer refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with GARDASIL 9 in a many school health care clinics which were dosing GARDASIL 9 according to the Center for Disease Control dosing guidelines, and not the Merck dosing guidelines (strength, dose, frequency, route of administration, lot#, expiry date were not reported). The reporter also believed that he or she was also dosed via the Center for Disease Control guidelines on an unknown date. No adverse effect were reported. Additional information is not expected as no contact details were provided.
Flublok mistakenly given instead of Fluzone. Tolerated vaccine well. Developed a sore throat on 09/22/2022 but was in contact with sister who had a URI the week prior.  Sanofi contacted for information on Flublok in children. Parent notified of error. Given information on trials in children in this age group. Dose does not need to be repeated.
Two days after the vaccination patient noticed a rash on the upper chest.  She called the ER but they said to just use benadryl (the rash was mild).  She did not visit the ER and the rash is improving.
Product recalled by manufacturer 10/12/22 due to incorrect expiration date  - Product expired 9/30/22 - Vaccine was given 10/12/22 - Parent reports no adverse outcomes
Information has been received from a pharmacist concerning a male patient who on 20-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 657039/0698U). On approximately 20-NOV-2007, within 24 hours of receiving the vaccine, the patient developed a localized reaction of redness, swelling and pain. Recovery status of the patient was not reported. The patient sought unspecified medical treatment. It was reported that this patient may be a liver failure patient. Additional information has been requested.
I broke out in a blotchy rash near the injection site two days after the injection.  Arm has been sore since the injection but the blotches don't itch.  I have taken an NSAID for the pain.
numbness and tingling sensation to right hand 4th digit and ulnar border of right hand palm
Red shoulder, hot, hard (L) shoulder swelling and redness 7 x 7 cm area, headache neck pain.
First trimester miscarriage after receiving both vaccine doses while pregnant.  Granada 5, Para 3 at time of vaccine administration.  Due date 9/17/2021
High fever; chills; tiredness; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NUS2022US032691_NC.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "High fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 18 yr old niece who was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot unk). There was no concomitant medication. Subsequently, shortly after vaccination, the pt developed a high fever and seizures. The pt was diagnosed with Ashberger's. Unspecified autism testing was done (results not reported). Unspecified medical attention was sought. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. Upon internal review, seizures and Ashberger's were considered to be other important medical events (OMIC). No additional information was available.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M003661, expiration date 15-SEP-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to date logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
an improperly stored dose of PEDVAX was administered to lhe patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N024570 and expiration date 01-MAY-2020, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  The administered dose of the vaccine experienced a temperature excursion below 36°F: 32.1 Fahrenheit (F) for 8 hours, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported.
Received Pfizer vaccine on 3/10/21, 4/7/21 and 10/15/21. Presented to ER on 1/27/22 and found to be COVID positive. presented with generalized weakness suspected CVA. CT head & MRI-brain -negative for stroke.              COVID positive 01/27/2022 , patient was vaccinated. initially was requiring 2 L NC oxygen  Dexamethasone, remdesivir was started.  Clinically improved.  Now on room air.  Medication discontinued.             AKI- hydrochlorothiazide -triamterene on hold.  AKI improved with hydration. Dischaged to home health care on 2/1/22
Started with severe arm pain one day after injection. Second day,  sweating, faint, weak for about 2 hours then just weakness for rest of day.  By third day I was fine.
Intense stomach pain 3 months post injection, 8/10 pain level and doctors determined it was my appendix being inflamed and needed to be removed
Vomiting 4 times over the course of 4 hours. Fatigue and loss of appetite for the next 2 days. Vomiting 36 hours after first episode of vomiting also. No fever or very mild.
Varivax given 10/17/1997 at age 18 months. Diagnosed with varicella 11/18/2002.
I had an appointment with my doctor. She advised my thyroid looked enlarged. She ordered an Ultrasound. The ultrasound showed that it was abnormally large and they recommended a biopsy. I had a biopsy completed on 01/13/2022. On 01/20/2022 I had a follow up with an Endocrinologist and the Biopsy results came back benign. Since the biopsy I have been experiencing pain in my thyroid. 04/21/2022 I went to urgent care for the pain. I was sent to the ER because the pain was impeding my breathing. They did test for COVID-19 which came back negative. They did told CT Scan which showed my airway was not blocked. I was referred to an ENT.   I did have a breakthrough COVID-19 case: 04/28/2022. I was exposed   I did see the ENT on 05/18/2022 and they said my thyroid nodule was enlarged and due to the size of it they can see it is pushing on my trachea. They have recommending it to be removed.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose 4 (booster), single (Lot number: fp4554) at the age of 65 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 was not reported. The patient took concomitant medications. Other medication in 2 weeks: Product: Cough medicine, Other medication in 2 weeks, Brand: , Other medication in 2 weeks, Start date: 09Apr2022, Other medication in 2 weeks, Stop date: 16Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 10Apr2022, Treatment stop date: 15Apr2022, Lot number: FX2740, Indication: Treatment of COVID-19. Adverse event: I had a relapse 4 days after taking Paxlovid. Adverse event start date: 18Apr2022, Adverse event start time: 05:00 PM, If patient recovered: Not recovered, If treatment ae: No. Known allergies: NKA (No known allergies). Covid vaccine details. Vaccine brand unknown: False. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
itchy bumps legs and elbows, itching; itchy bumps legs and elbows; red bumps legs and elows, rash started to get worse this afternoon; soreness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 24th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, 24 hrs after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site pain and injection site erythema. On 27th October 2021, the patient experienced itchy rash, papular rash and red rash. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the itchy rash, papular rash and red rash were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the itchy rash, papular rash and red rash to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for himself. The also stated that he got flu shot at the same time, but in his left arm. The patient Shingrix shot in his right arm on the evening. The patient stated that 24 hours after the shot, he had redness and soreness at the injection site. The redness traveled down his arm for about 48 hours, but the redness and soreness in his arm (right arm) had resolved. The patient stated he started to see some mild, slightly itchy red bumps on his legs and elbows.  The patient now called to report that the rash started to get worse this afternoon. The patient stated that there were more red bumps effecting both his arms and the rash was itching.  The patient had no further data on either of the shots. Spoke per PI about side effects.  Referred him to health care professional and gave medical disclaimer.  He stated that if he started to have issues breathing, to go immediately to local emergency room. The reporter did not consent to follow-up. Refer linked case US2021224261, wife's case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224261:Wife's case