chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized skin reaction. Area, where given was swollen (golf ball size), hot, & red. Lasted a couple days then resolved. Patient told to use BENADRYL & hydrocortisone for itching & ibuprofen for swelling.
Narrative: Patient was complaining of some Shortness of Breath and has tested positive for Covid despite the 2 dose series of Moderna
At about 2 hours after receiving the injection, the injection site began to itch and puff up as if I had a mosquito bite, it also became warm to the touch. It stayed like this for about 1 to 1.5 hours before my arm was back to normal and had just a bruise left.
Case number PHEH2014US024295, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up report received from the nurse on 19JAN2015. This report refers to a 29 years old female patient. Her previous vaccinations (unspecified) were well tolerated. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml in left deltoid on 17NOV2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19JAN2015: Updated vaccination history, recent vaccination site and reporter's statement.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: He tested negative; (23Aug2022) Positive, notes: and then positive again after finishing drug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:anti viral details: product: COVID 19 Treatment, treatment start date:16Aug2022, treatment stop date: 22Aug2022. Patient experienced COVID rebound after completing Paxlovid. He tested negative and then positive again after finishing drug.  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 the information provide and plausible temporal association, the causality between BNT162B2 and events (DRUG INEFFECTIVE,  COVID 19 Treatment) cannot be completely excluded.
This spontaneous report as received from a consumer refers to a patient of unknown age. On an unknown date the patient received ZOSTAVAX (dose, route of administration, lot#, indication unspecified). On an unknown date the patient developed shingles after receiving ZOSTAVAX and passed away on an unspecified date. The outcome of shingles after receiving ZOSTAVAX was reported as fatal. The cause of death was reported as shingles. Autopsy results were not provided. This case is linked to 2 more reports from same reporter. Additional information has been requested.
I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at the site.  This gradually dissipated over a few days, but not completely.  On Friday, 01/15/21 a couple hours after exercising (elliptical and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up Saturday, 01/16/21, the redness, soreness, and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to Urgent Care, which I did and was prescribed Doxycycline for possible cellulitis.  Today, 01/18/21, sx's have much improved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by her primary care physician and was diagnosed with herpes zoster, or shingles. The patient was prescribed FAMVIR and PERCOCET for management of her painful symptoms. As a direct and proximate result of 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
fever 99.4, h/a, body aches, tired, hurts to breath, shakes, jaw pain, back pain;
Extreme Fatigue, slurring speech, unable to stand, eat.  Death on 2/5/21
17JUL97 mom reported incidence of projectile vomiting w/diarrhea approx 6:00 that evening;mom gave child bottle;pt still exp diarrhea & colicky sx;
Immunization was administered after 12hrs of vial being punctured for the first and only time
I have been on radiation since 01/20/2022. I have had 13 rounds of radiation by 02/08/2022. Beginning on 02/08/2022 at dinner time, I lost vision on my right eye. It just sort of bubbled out. I waited only minutes before heading to the emergency room. My eye cleared, like a tank draining. It just came back from the top to the bottom, like a draining tank, so I went home before even reaching the emergency room. The next morning, I called my radiologist to inform him of my eye issue. I also called my eye doctor who wanted to see me right away, but the radiologist set up a scan for my legs to check for blood clots. My eye doctor switched the scan from my legs to my carotid artery. The carotid artery looked fine, and my eye appears to be fine, so the vision loss was sort of a mystery. I have an appointment for the leg scan in the near future. My radiologist says that there is no way that radiation would have caused the vision loss and presumes there was some sort of blood clot. My oncologist insisted that I do not go on blood thinners as my radiologist recommended. I have not had any problems with my eye since then. On 02.14.22 my primary care physician contacted me after hearing of all these events from my other doctors and insisted that I go immediately to the emergency room. At the emergency room, I had blood work and an MRI of the brain and there was no indication of a stroke. I was also advised to see my cardiologist. I made an appointment with him, and I will be getting more tests done with him to see if I have a hole in my heart which would have allowed a blood clot to travel from my leg to my brain. By 02.18.2022 I had a disc implanted to monitor my heart. I also had an echocardiogram to check for that hole in my heart. I was prescribed a statin and an aspirin regimen. No issues were found with my heart.
POSSIBLE UNDERAGED CHILD. CHILD DOB RECORDED ON CONSENT.  DOB IN IMMUNIZATION REGISTRY LISTED.
not feeling well for a day or two and needing to rest.; urine was dark; got really sick; She is progressively ill.; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Jun2021 (Lot Number: Unknown) (at the age of 69-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. AE(s) following prior vaccinations was none. The Patient Medical History (including any illness at time of vaccination) was none. No Family Medical History Relevant to AE(s). The patient concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. The patient experienced not feeling well for a day or two and needing to rest and urine was dark (in morning) on an unspecified date in Jun2021. She got really sick and was progressively ill on an unspecified date in 2021. The clinical details of the events as follows: About two weeks following her first injection, she had typical reactions. She was not feeling well for a day or two and needing to rest. Two weeks after that, she did not connect the two events. Her urine was dark and two weeks following the injection to It continued on until she got really sick. It was an ongoing, progressive state of getting worse. She has been diagnosed with a medical condition as a result of receiving the vaccine. She was progressively ill. The AE(s) did not require a visit to emergency Room. The patient visited Physician Office. On an unknown date, she received heart tests, lab tests, and ultrasound for all the result was unknown. Relevant Tests were none. She wanted to report a severe side effect. She feels like it needs to be brought to our attention. She was not sure her doctor was going to send it in. Her urine was no longer brown. The patient outcome of the event urine was dark was resolved on an unspecified date in 2021 and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe tinnitus in right ear about one hour after second dose, now lasting nearly 2 weeks.
pt recv vax & within 2 min, pt went into resp failure (anaphylactic shock);Epi given, Solumedrol;
INFLAMMATION IN THE URINARY TRACT; NOT FEELING WELL; CONSISTENT HEADACHE; EXTREME FATIGUE; NO ENERGY; INCREASE IN INTENSITY OF FIBROMYALGIA AT ALL TRIGGER POINTS QUADRUPLED IN SIZE AND VERY PAINFUL; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, irritable bowel syndrome, insomnia, penicillin allergy, social alcohol drinker, cigarette smoker, and cyclines allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the patient experienced increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful. On 19-JUN-2021, the patient experienced not feeling well. On 19-JUN-2021, the patient experienced consistent headache. On 19-JUN-2021, the patient experienced extreme fatigue. On 19-JUN-2021, the patient experienced no energy. On an unspecified date, the patient experienced inflammation in the urinary tract. Laboratory data (dates unspecified) included: Urine analysis (NR: not provided) Came back clear. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from consistent headache, increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful, extreme fatigue, no energy, inflammation in the urinary tract, and not feeling well. This report was non-serious.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the routine health maintenance and for the prevention of shingles. On an unspecified date after the vaccination, the patient suffered a painful rash in her pelvic region, which has caused her considerable pain and impacted her bowl and urine function. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with Herpes Zoster. Thereafter, the patient has continued to suffer the effects of Herpes Zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
About a month after the second dose of the vaccine I had bleeding for two weeks after my period. It was the first period I had since the vaccine. I was also experiencing increased pain with my menstrual cycle. I had a couple of months with extra pain and excessive bleeding with my periods. I had an Ultrasound at the end of May 2021 and I was diagnosed with Uterine Fibroids. I have also been diagnosed with an Ovarian Cyst. I have never had any of these issues before. It has been six months since my second dose of the vaccine and I am scheduled to have one of the Fibroids removed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Aug2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right 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: "Arthritis" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity; "Pre diabetic" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity; "Obesity" (unspecified if ongoing), notes: Arthritis/ pre diabetic/ obesity. There were no 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Sep2022) Positive, notes: Covid symptoms with positive home test returned on 21Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Prescribed Paxlovid as a treatment to a patient from 13Sep2022 to 18Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
felt tired after her second Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired after her second Moderna Covid-19 vaccine.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt tired after her second Moderna Covid-19 vaccine.). At the time of the report, FATIGUE (felt tired after her second Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.    Reporter did not allow further contact
Injection site irritation after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Injection site irritation after 1st dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE IRRITATION (Injection site irritation after 1st dose). At the time of the report, VACCINATION SITE IRRITATION (Injection site irritation after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient was receiving a newmedication since a week ago due to her blood pressure regulating problem.  No treatment medications were reported.
Was itchy after receiving vaccine.  This itching increased on the 11th so she took Benadryl at bedtime.  Itching increased Thursday so took more Benadryl.  By Friday had hives everywhere.  Continued with Benadryl.  After 2 weeks, eyes swelled shut so saw dr who gave her epineprine and told her to keep using Benadryl.  During this 2 week period also had a little trouble breathing at times and had some wheezing.  Still has hives.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 16-year-old female patient who received BEXSERO. Co-suspect products included BEXSERO. Concomitant products included MENVEO. On 13th July 2017, the patient received the 1st dose of BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. In July 2017, less than a month after receiving BEXSERO and not applicable after receiving BEXSERO, the patient expeirenced pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported, but it could be 15 or 16 years old. The patient received BEXSERO vaccine into an unknown arm. The patient experienced arm pain which resolved after ADVIL therapy. On the same day, the patient was also given MENVEO in the other arm, but did not experience any adverse events. The patient chose not to receive the 2nd dose of BEXSERO in the series, which led to an incomplete course of vaccination. This case was linked with US2017126956, reported by the same reporter. This case was a medication error associated with an adverse event.
Pt recv vax on 4/2/99; on 4/3/99 pt exp red/ swollen/ itchy vax site
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On unknown dates, since December 2014, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot numbers were not provided). No adverse effects were noted. Additional information has been requested.
Patient initially called on May 21st with complaints of an itching sensation 3 days following vaccine. No visible hives or swelling at that time. Was given instructions  for topical cream to relieve symptoms. Patient was then seen on May 24th with itchy hives of the lower abdomen and vagina areas along with facial and orbital swelling. Was started on a Medrol Dose Pack
felt faint w/in minutes p/leaving clinic; apparently fainted while driving down driveway out of clinic;
The patient had tioters drawn and were negative for measles / the titers were negative again for measles / patient had titers drawn again a week later, and they were still negative for measles; The patient had tioters drawn and were negative for measles / the titers were negative again for measles / patient had titers drawn again a week later, and they were still negative for measles; This spontaneous report was received from a physician concerning a 22-year-old female patient. The patient's medical history, concurrent conditions , and concomitant medications were not reported.   On unspecified dates (reported as "at the recommended age"), the patient received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for prophylaxis.  On an unspecified date, the patient had titers drawn for entry into a school program and the titers were negative for measles (measles antibody negative), but positive for mumps and rubella. Subsequently, on 14-JAN-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for the negative measles titers. On 22-MAR-2019, the titers were negative again for measles; therefore, on 15-MAR-2019, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for the negative measles titers. Finally, in approximately March 2019 (reported as "a week later"), the patient had titers drawn again and the were still negative for measles (therapy non-responder).  At the time of reporting, the patient had not recovered from the events.  The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Positive Covid-19 diagnosis; low grade fever; muscle aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive Covid-19 diagnosis), PYREXIA (low grade fever) and MYALGIA (muscle aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015-M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (muscle aches). On 07-Feb-2021, the patient experienced COVID-19 (Positive Covid-19 diagnosis) (seriousness criterion hospitalization). The patient was hospitalized on 07-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive Covid-19 diagnosis), PYREXIA (low grade fever) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with the antibody. Concomitant medications were not provided.  Company Comment : Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. 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 biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. 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.