chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an epidemiologist refers to a 3 years old male patient. On 13-MAY-2011 the patient was vaccinated with first dose of M-M-R II (route of administration, dose, lot # and expiration date not reported). On 19-FEB-2014 the patient was vaccinated with second dose of M-M-R II (injection, dose and route not reported, lot # J006954 and expiration date 07-JUN-2015). On 01-MAR-2014 the patient experienced a mild case of mumps (coughing and congestion with parotitis and low grade fever) following the second dose of M-M-R II. The patient had a blood test on 06-MAR-2014 with a positive IGM (immunoglobulin M) of 3.33 (units not provided). The patient sought medical attention by contacting with physician. The outcome of the mild case of mumps was reported as recovering. Additional information has been requested.
Had Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had Covid) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (Had Covid). On 08-Oct-2022, COVID-19 (Had Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive. On 08-Oct-2022, SARS-CoV-2 test: Negative.         The concomitant medication was not reported by reporter. It was reported that patient had Covid at the beginning of September and tested negative on 08-Oct. Patient said he heard there was some waiting period of when you test negative and when you could get the Moderna Bivalent and patient wanted to know what that was. Patient did not have their vaccination card in front of them but got the first and second dose and then a booster dose. The treatment medication was not reported by reporter.
Pt came in days after vaccine complaining of redness covering most of his upper arm and still suffered from soreness from the injection. Rph recommended NSAIDS and to call Dr if anything got worse. Arm did not look infected.
Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
pt recv vax & 1 wk later pt devel flu-like sx; No further info could be obtained;
10/06/21 COVID-19 1st dose  14/06/21-18/06/21 Sharp pains on left side building up everyday.  18/06/21 heavy sharp pains, cramping front and back and brown gooey stretchy substance came out which felt like when you are passing clots and tissue during miscarriage.  And then pains subsided over the next few days. Ultrasound confirmed pregnancy loss.  Previous missed miscarriage Dec 2019 for reference (however COVID-19 didn?t exist then nor did I take any vaccines at that time. Please concentrate on the fact that I miscarried and got miscarriage pains right after I took the COVID-19 Jab, this is NOT a coincidence).
Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days.  The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath.  I was coughing up a lot of mucus.  The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme.  8 days after the vaccine I started to have pain at the injection site.  My upper hurt if I touched it.  Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them.  This seems like a muscle pain from the injection site to my shoulder.
Vaccination Failure; positive for COVID-19 on 17Mar2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: ek9231) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (lot number: 301ssba, route: Intramuscular, administration time: 01:00 PM, dose 1, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (lot number: el3249, route: Intramuscular, administration time: 01:00 PM, dose 2, vaccine location: Left arm), administration date: 03Feb2021, for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Mar2022, outcome "unknown"; COVID-19 (medically significant) with onset 17Mar2022, outcome "unknown", described as "positive for COVID-19 on 17Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2022) Positive, notes: Nasal Swab.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
pt recv vax 19DEC95&20DEC95 pt exp a fever of 103 which eventually dropped to 101;22DEC95 fever inc again to 103,& pt had green mucus&OM;10 days p/vax pt exp rash w/100 chicken pox-type lesions,none of which blistered,scabbed or crusted
Fever began 15 days after vaccination and ran 103 degrees for 3 days. Rash appeared 30 days after shot; first on back of thighs then spreading to arms, torso, and face. Fever returned with rash ranging from 101-105 degrees F and continued from day 30 to day 40 when child was admitted to hospital. Treatment given was Motrin. Diagnosis: Juvenile rheumatoid arthritis. No family history of any auto-immune issues. Per follow up report- While joint pain has resolved itself, from time to time vaccine recipient still gets rash on thighs.  This is where the rash first appeared and is sometimes accompanied by low grade fevers (less than 102F). Patient will continue to be seen by a pediatric rheumatologist every 3 months for evaluation. 12/31/09 At the present time, patient is symptom free in his joints. He is still being seen by a pediatric rheumatologist and has not yet been declared in "remission" from his systemic JRA.
Myalgia, Fever, CoughWheeze, Chills, redness, pain and swelling at injection site Narrative:
Mild erythema and noted edema to left deltoid area. Right deltoid hot to touch, erythematous and edematous. Mild firmness noted at site. Area approx. 10 cm in length. BENDARYL 25mg q 6-8 hours prn, prednisone 20mg BID x3 days and continue ice packs.
4/7/05 Student complained of body itch on observation the undersigned noticed scattered papules on abdomen and chest.
It hurt a little where the shot was; there is a slight lump; still warm; This is a spontaneous report from a contactable 76-years-old female consumer reported for herself that she received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 11Mar2021, as single dose in left arm for covid-19 immunization. Medical history included neurological condition (she is unable to receive vaccine in her right arm). Concomitant medications were not reported. On an unspecified date in Mar2021, the patient had it hurt a little where the shot was and there was a slight lump, and it was still warm. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Heart palpitations with lightheadedness (continued for 1 week, subsided on own without interventions).
I felt kind of tired, my arm was really sore. I was weak for a day or day and a half. I had already been going through flare-ups with cirrhosis; burning, itching and persistent burning and itching. After the vaccine, with a couple of days my flare-ups and these symptoms got worse. I sought medical attention. As time went on, it got better. It took some time to get my immune system back to where the inflammation came down. Otezla started that a week or two before the shot. The doctor stayed the course with my medications but eventually I quit that by weaning myself off and we've been treating with steroids since, mostly due to insurance. That was in March when I got off the Otezla. I am still on steroids and I am supposed to stay on that as needed for the whole year.
Diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the first dose of Shingrix a week ago before reporting, did not say exact date, and experienced diarrhea, the patient had not recovered. The reporter did not consent to follow up. No patient or vaccine data. Health care professional said had no time to answer.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated a dose of with GARDASIL (dose, route, lot# and expiration date unknown) for prophylaxis. On 20-JAN-2017, the patient received a dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) for prophylaxis as the next dose in the HPV vaccination series. No adverse effects were reported. The causal relationship between the event and suspect therapies was unknown. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009743:
10 days after my booster shot, I woke up itchy.  By that evening I was itching over my whole body and there were large welts all over my body from where I itched.  From research I have found what my body is experiencing is dermatographia or skin writing.  The first 6 days were completely miserable, but after getting on Zyrtec my symptoms are manageable.  However it has now been over 8 weeks and the dermatographia has still not gone away.  I am on Zyrtec daily.
pt died at home; notes from HCP on 07/29/21; PMH: kidney disease stage 3, congestive heart failure, hypertension, osteoarthritis, depression, anxiety, falls, urinary incontinence; allergic to all steroids and bendryl pt complained of generalized weakness and unable to ambulate; fatigue, skin color changes from previous bruising to bilateral lower extremities; bilateral hearing aids, shortness of breath, chronic dyspnea on exertion, edema, back pain, achy joints vital signs: temp 97.2, spo2 98% at rest, BP 142/74, pulse 62
Patient main reason for hospitalization was for hypoxic respiratory stress secondary to covid pneumonia. Pt had two separate hospitalizations, but the hospitalization at time of positive test was admit on 8/8 and discharged to hospice on 8/12. Death: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19
Electrical seizures; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Electrical seizures) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Electrical seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (Electrical seizures) 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 were reported. No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender, who experienced the unexpected  events of Seizure. The event occurred an unknown number of days after the most recent dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the unexpected  events of Seizure. The event occurred an unknown number of days after the most recent dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Case vaccinated and boosted against Covid by October 2021,. He contracted Covid while hospitalized for non-covid issues in January 2022. Hospitalized at:  Hospital.   COVID-19 virus infection Assessment & Plan Noted febrile 1/20. COVID test turned +. Likely nosocomial as he had been admitted 10 days. Placed in contact/droplet isolation. On room air. Seemed more confused late last week, this is probably why. Is fully vaccinated against covid. Chronic liver disease probably places him at higher risk for severe disease.  -Discussed use of monoclonal abs with the ID service and his transplant team, both prefered he receive so administered 1/21 without adverse reaction -Coughing frequently but held off on CXR given normal oxygen levels -No indication for specific covid treatments otherwise -Continue isolation. Discussing discharge options with family, but has high-risk elder at home, also vaccinated and boosted per report.
optic neuritis of left eye.  diagnosed by MRI, optho eval. Antibodies pending. Severe vision loss <20/200 over 2 days. Given IV steroids and improved to 20/40 - 20/63
The child has no adverse signs or symptoms. The concerns is that the Modern vaccine was inadvertently administered to the 14 y.o. child by our staff.  This was discovered when the child returned for the second dose, and another staff member noted on his CDC card that the Moderna injection as  documented.  The second dose was therefore withheld.  The parent  was notified of the medication error, and was very distraught.  I notified the  Immunization Consultant for our  County, who advised me of the appropriate next steps.  I had a meeting with the father of the child, and advised him to monitor his son closely, and to report any adverse effects on the V-Safe app.  I also advised him to take his son to the ER immediately in the event  of any significant signs or symptoms.
Information has been received from a physician concerning a 17 year old female patient, with asthma and drug hypersensitivities to ibuprofen and BACTRIM, who in January 2007, was vaccinated with the first dose of GARDASIL. Concomitant therapy included DEPO-PRVERA and pre-natal vitamins (started on 24-MAY-2007). On approximately 07-JAN-2007, the patient had her LMP. On 12-APR-2007, the patient was vaccinated with the second dose GARDASIL (Lot# 657621/0387U), with the patient reported as "20 weeks gestation" (estimated date of delivery on 14-OCT-2007). There were no problems reported. On 18-MAY-2007, the patient's pregnancy was confirmed by a pregnancy test. On  24-MAY-2007, 04-JUN-2007 and 07-JUL-2007 the patient had an ultrasound for fetal dates and growth. It also revealed left pyelectasis. On 07-SEP-2007, an ultrasound confirmed that the left pyelectasis had resolved. There were no previous pregnancies, deliveries or spontaneous abortions. On 08-OCT-2007, the patient gave birth to a healthy and normal baby boy. He weighed between 6 to 7.5 lbs. and his apgar score was reported as 8/9. The patient was 38 weeks and 2 days from her last menstrual period. There were no congenital anomalies reported. It was reported that all was fine. Additional information is not expected.
Flu like symptoms were experienced but extreme vertigo flare up resulted. Vertigo experienced after head injury had been under control utilizing epling maneuvers.  Vertigo that was constant and unrelenting was experience for 6 months after 2nd dose
On 10/25/2003 became ill.  Body aches, severe pain of right arm where fluvirin was given down the arm.  Fever of 101.  10/28/2003: Still feels ill and have sore throat.  Referred to MD.
This retrospective pregnancy case was reported by a consumer (mother) and described the occurrence of deafness in a neonate subject of unspecified gender who was exposed to Influenza vaccine (manufacturer unspecified) transplacentally during the second trimester of pregnancy when the mother received the vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included: The mother had the Kell antibody in her blood (Kell antibody transfusion) and gestational diabetes; and the father had the Kell antigen in his blood. In October 2006, the 28 or 29 year-old mother received a dose of Influenza vaccine (unknown, unknown arm). The mother's last menstrual period was on June 2006 and the estimated delivery date was 13 March 2007. Around March 2007, approximately 5 months after vaccination with Influenza vaccine, the subject experienced bilateral deafness and jaundice. Around 13 March 2007, at unknown weeks gestation, but reported as full term, the neonate was delivered by an unknown method. The neonate's weight and APGAR scores were not provided. The mother's pregnancy was full term and the baby was hospitalized with jaundice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason. This was reported as medical history by the mother. The mother was aware of the Kell antibody issues, her gestational diabetes and genetic link prior to the influenza vaccination. The mother reported that for the bilateral deafness, there had been some testing which had a genetic link from a cousin. The maternal vaccine exposure occurred during the second trimester. At the time of reporting, the outcome of the events was unknown. At the time of reporting the outcome of the events were unspecified. The subject's mother was planning to get the flu vaccine during her current pregnancy at the time of the report (14 September 2013) and had experienced events for previous flu vaccinations. See case A0995817A for details on the mother.
I had horrible migraines and headaches. I had one bad last Tuesday 10/5/21 and on Wednesday evening 10/6/21. On Thursday 10/7/21 it go so bad I went the ER. I had a CT scan in the ER, I had no bleeds they were looking to see if I had a stroke. I had some IVS while I was there, and it really helped the pain while I was there. I was in the hospital for about 3 hours.  The ER also prescribed me amoxicillin for 10xdays thinking I may have a bad sinus infection. This past Friday, Saturday, and Sunday I had bad headaches as well I took some medicine Maxalt, and Benadryl and it helped tremendously in about 1 hour. I had a bad headache again last night about 2 AM and I took 1 Tylenol and 1 Excedrin, and it helped it and I was able to go to sleep. Today is the first day since last Tuesday that I have not had a headache.
3/20/2003 Pt went to ER with nausea and vomiting. Temp 102. Left arm injection site swollen with palpable mass approx 15mm to LUA. States ER MD told her it was reaction to Td.
This also happened directly after the first vaccine, and then again after the second. My eyelids become intermittently swollen and red and also the place on the top of my cheekbone directly under my eyes. It shifts from the right to left eye. I do not use dermal fillers of any kind. I do not use Botox.  It appears to be some sort of skin-based allergic reaction to the vaccine, Nothing else has changed about my cleansing, makeup or other facial routines,
Large red swollen itchy patch on upper arm below injection site; Large red swollen itchy patch on upper arm below injection site; Large red swollen itchy patch on upper arm below injection site; Now turning into a bruise.; Bruise at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 16Apr2021 at 15:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and multivitamins; all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021, the patient experienced large red swollen itchy patch on upper arm below injection site. It turned into a bruise and also bruise at injection site on an unknown date in Apr2021. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event large red swollen itchy patch on upper arm below injection site; turned into a bruise and bruise at injection site were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.