chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a severe case of shingles (Herpes Zoster ) on the C8 dermatome on or around 3/26/21. I visited an urgent care facility on 3/29/21 and was given a shot of steroids in the buttock, and prescribed Acyclovir 200mg/5ml oral susp (20ml 5x per day for 7 days), and Prednisolone 15mg/5ml soln (20ml for 5 days, then 10ml for 5 days, and 5ml for last 5 days); On 3/30/21 I visited the emergency room where the diagnosis was confirmed and told to take medications as prescribed by the urgent care. On 4/2/21 my PCP prescribed Gabapentin 250mg/5ml soln (6ml 3x per day). As of 4/22/21 100+ blisters are drying up with larger blisters still healing.
Nurse inadvertently administered Pfizer COVID-19 vaccine product authorized for 5-11 year age population to 3y/o. Nurse also documented the incorrect lot number (Moderna AR9271B) and vaccine type (Pfizer) on the vaccination card and patient consent form. Parent reports no signs/symptoms as of 8/17/22.
PT. RECEIVED  MENINGITIS B OUTSIDE OF RECOMMENDED AGE RANGE PER PROTOCOL. PT. AT AVERAGE RISK.  PT. NOTIFIED USING INTERPRETER TO EXPLAIN TO PT'S MOM OF INCIDENT. PT'S MOM STATES, "CHILD IS FINE, NO COMPLAINTS"
Narrative: Patient was initially admitted to the ICU for COVID-19 PNA w/acute hypoxic respiratory failure. Pt received Remdesivir for 5 days (8/15/21 - 8/19/21) and 9 days of Decadron (8/15/21 start.) Decadron will be stopped at discharged per guidelines. He was able to be weaned off O2 on the morning of 8/23/21. He didn't require home o2 and was discharged 8/24/2021 to home.
Patient vaccinated on 1/12/21 at 10:19 and returned to vaccination clinic at 11:55.  Appeared short of breath when walking in  with respiration rate 24-26.  Staff reported he presented with same appearance with first arrival prior to vaccination.  Patient stated "I just don't feel good and I'm shaky".  He was asked to be seated and within 5 minutes respiratory rate decreased to 20-22.  Vital signs taken RR-22, B/P-110/80, HR-70 and regular, Temp-97.1.  Pt states his primary care provider office is closed today.  I instructed him to go to our Emergency Room for evaluation which he refused stating "I hate hospitals".  After 30 minutes of observation patient stated "I'm leaving and going to see my sister who is a nurse".  Treatment in our ED offered multiple times with refusal.  Patient appeared stable when leaving.
Patient received 1st dose covid-19 vaccine Moderna, today he received 2nd dose Pfizer. Patient was seen by a provider today and was given information and further guidance.
Patient presents for evaluation after a fall. Found down in garage with open door in the cold, estimates he was down more than 2 hours. Denies pain or trouble breathing. He reportedly had a positive COVID test this morning. His wife is admitted to the hospital as of yesterday for COVID-19.  While he denies trouble breathing, he is tachypneic and wheezing, hypoxic on room air. O2 applied per NC. Patient with COVID-19, likely COVID-19 pneumonitis.  On presentation, patient was in significant respiratory distress respiratory rate up to 40s, HR 140s 130s, atrial fibrillation with RVR, blood pressure soft 90s to low 100s. He has multiple bruises on the head, back.  Patient given IV fluids, maintained on the cardiac monitor. Heart rate did improve with fluids.  Patient was given additional IV fluids given his elevated lactic acid and his continued soft blood pressure. The patient is given broad-spectrum antibiotics with potential other source of infection. ASSESSMENT/PLAN Principal Problem: Acute hypoxemic respiratory failure  Active Problems: COVID-19 virus infection, Fall, Acute hypoxemic respiratory failure, multifactorial COVID-19 pneumonia, Severe sepsis, suspected aspiration pneumonia, mild rhabdomyolysis, A-fib with RVR Plan ? Admit patient to telemetry, continuous pulse oximetry, oxygen therapy with nasal cannula, wean as needed, ? Broad-spectrum IV antibiotic coverage with cefepime and vancomycin, check MRSA PCR, Legionella antigen, strep antigen ? Follow-up confirmatory COVID PCR, IV remdesivir 200 mg followed by 100 mg daily for 4 doses if positive due to ongoing oxygen requirement ? S/p IV Decadron 10 mg in the ER, plan for Decadron 10 mg x 2 more doses, Decadron 6 mg x 7 doses with confirmed COVID 19 infection ? ID consulted Atrial fibrillation with RVR ? HR initially 120s to 140s, controlled atrial fibrillation with RVR on EKG ? New onset, likely precipitated by hypoxia ? Anticoagulated with Lovenox, HR gradually improved to 110s, BP soft, digoxin 0.25 mg x 1 dose ? Cardiology consulted Hospital Course: 91-year-old male with history of hypertension, coronary artery disease, gout, dyslipidemia, and paroxysmal atrial fibrillation hospitalized with sepsis and acute hypoxic respiratory failure in the setting of COVID-19 pneumonia after falling and being found down at home. His wife was hospitalized at the same time and died of COVID-19 on 3/20. Patient was vaccinated against COVID-19. ID was consulted for help with management. COVID-19 was treated with remdesivir and dexamethasone. He also developed atrial fibrillation with RVR. EP cardiology was consulted for help with management. He was started on therapeutic Lovenox and rate/rhythm controlling medications. His respiratory status further decompensated on 3/29. He was transferred to the ICU and died on 3/28 at 2204. Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital.
Dizziness, followed by chest pain, then difficulties breathing. Couldn't take deep breaths without pain or coughing.
Dizziness, and Feeling faint approximately an hour after injection, was gone by the next day. Redness, swelling, hot to the touch, itchy approximately 1 day after injection continuing until present (04/30/2021).
Afib x multiple times in and out Has not resolved  140 BPM heart rate x 1.5 hours steady
I had minor Tinnitus in my left ear but after my vaccination, ringing has increased and is now present in both ears at an equal level.
Sore throat; Pain in arm/ sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Jul2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single and intramuscular, administration date 26Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 01Jan2019 (Batch/Lot number: unknown) at unk(citrate free) for rheumatoid arthritis; rituximab (RITUXAN) (Batch/Lot number: unknown); varicella zoster vaccine rge (cho) (SHINGRIX), administration date 05Jan2020 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: " humira not  working ", start date: 01Jan2020 (unspecified if ongoing); "Erythropapular rash", start date: 05Jan2021 (unspecified if ongoing) (events  of non-serious taking shingles vaccine and developing red raise rash from  armpit to elbow); "Allergic reaction to drug", start date: 01Feb2021 (unspecified if ongoing); "Throat swelling", start date: 01Feb2021 (unspecified if ongoing). The patient had no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 05Jul2021, outcome "recovered" (2021), described as "Sore throat"; PAIN IN EXTREMITY (non-serious) with onset 05Jul2021, outcome "recovered" (2021), described as "Pain in arm/ sore arm". On 05Jul2021, the patient experienced taking covid vaccine and developing sore arm and sore throat. The action taken for rituximab was unknown. The action taken for adalimumab was dosage permanently withdrawn. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with RITUXAN(RITUXIMAB) was not reported. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was possible. The reporter's causality for the event(s) of taking covid vaccine and  developing sore arm and sore throat onset 05Jul2021 with SHINGRIX(VARICELLA ZOSTER VACCINE RGE (CHO))(VARICELLA ZOSTER VACCINE RGE (CHO)) was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Oropharyngeal pain and Pain in extremity and BNT162B2.
Felt stickers or stinging sensations on the back and I went to the doctor at 6/11/201. It went from the sternum all around the left side of my waist under my arm. Red blisters like chicken pox. Painful. Diagnosed as Shingles - gave me a 10 day regiment of Valtrex and that ended two days ago. All of the blisters have popped and are scabbing over and still have the pain and the itching. It's healing up. It will go on with pain and itching for awhile the doctor said.
Immediately after receiving MMR, varicella, Dtap, in combination vaccines in clinic, patient developed hives on face and back. Pt received BENADRYL and ORAPRED and monitored for 1 1/2 hours - hives resolved completely.
This spontaneous case reported by a consumer, describes the occurrence of severe tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced severe tinnitus. At the time of the report, severe tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Onset with 1 hour of severe chills and trembling to the point of being unable to hold a glass of water.  Moderate to severe nausea lasting about 40 hours, onset about 10 am on 2/7/20.  Extreme migraine headache starting about 2 pm on 2/7 and resolving  around 9 am 2/10 intermittent but mostly present), vomiting onset around 2 pm 2/7 and continuing  to 2/9 at 10 pm with dry heaves mostly, inability to keep down water 2/7 and 2/8, loss of appetite and no food from 2/6 at 6 pm to 2/ 9 at4 pm.  Chills from 2/7 to 2/8 evening.  Body pain from onset to throughout first day of symptoms.  Extreme fatigue, significantly increased sleeping as possible.  DIsorganized and intense dreaming for nights 2/8 and 2/9.  Difficulty sleeping due to pain and nausea. Treatment:  Zophran for nausea, mildly effective, didn't really stop nausea or vomiting.  Tylenol for migraine, no effect. Outcome:  Symptoms except for fatigue began to slowly resolve on 2/9 late morning.  Better on 2/10, eating and drinking some but not back to normal.  Fatigue moderate but better.   Considered presenting to ER for IV fluids and medications, but consulted with physician and decided to wait to see if symptoms decrease by 2/10.
Irregular menstrual bleeding for 3 weeks post both vaccines, body aches, chills, fatigue, nausea and vomiting
Pruritic inflammatory papules on hands at joints 1 wk after injection. Then 1 wk later started with polymyositis symptoms. Migrating arthralgia and myalgias.
Pt came into office on 10/20/09 with numerous lesions, appears to be chicken pox. Pt was vaccinated with vaccine on 2/1/02
Dizziness, fatigue, light-headedness, aches, dull pains throughout body, and difficulty composing thoughts
PATIENT'S HUSBAND CAME TO PHARMACY TO PICK UP PRESCRIPTIONS AND THEN NOTIFIED PHARMACY STAFF THAT PATIENT IS CURRENTLY IN INTUBATED IN ICU. PATIENT WAS TOLD BY HOSPITAL STAFF THAT IT WAS DUE TO THE RSV VACCINE. SPOUSE SAID HE READ SOMEWHERE THAT THERE ARE 6 MAIN SIDE EFFECTS CAUSED BY VACCINE AND PATIENT EXPERIENCED ALMOST ALL OF THEM. HE STATED THAT PATEINT EXPERIENCED FEELING TIRED, LOSS OF APPETITE, AND BULGING EYES. HE SAID THAT HE CONFIRMED WITH DOCTORS IN HOSPITAL THAT THESE ARE THE MAIN SIDE EFFECTS OF RSV VACCINE
diarrhea; feeling fatigued; fevers / fevers were 100.9; feels sick / very sick; temperature consistently around 99.4 and 99.2 / technically not a true fever; This spontaneous report was received from a female patient of unknown age who was a veterinarian. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, anatomical location, lot# and expiration date not reported) intramuscularly (IM) for prophylaxis.  The patient was "OK" for the 3 days following the vaccination, but then on 02-AUG-2020, the patient was felling fatigued and ended up having diarrhea (diarrhoea) and fevers (pyrexia). Her temperature was 100.9 (units not reported) for 4 days. On an unspecified date in August 2020 (reported as now), the patient's body temperature was 99.4 (units not reported) and 99.2 (units not reported) and she reported that she knew that it was technically not a fever but it was for her (hyperthermia) and that she felt sick all the time (malaise) and could not work. She stated that these events were affecting her life and had to figure this out. The patient sought medical attention and notified her health care professional (HCP) who performed some test like a fecal exam (unspecified), a metabolic profile and a test for Lyme disease, all these tests were negative. The HCP refused to test the patient for coronavirus disease 2019 (COVID-19) due certainty that the patient did not have it; however, the patient had a nasal swab for COVD-19 at a pharmacy which came back negative. At the time of the report, the patient had not recovered from the events. She felt worse than before, on an unspecified date in August 2020, she was feeling better for a couple of days, but unfortunately, she felt that she was rebounding back to being very sick. Her HCP was aware of how she felt at the time of the report. No treatment was given for the events.  The causal relationship of fatigue, diarrhea, pyrexia, hyperthermia and malaise with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Second dose is 42 days after my first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is 42 days after my first dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is 42 days after my first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is 42 days after my first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
On 10/13/15 patient comes back to pharmacy reporting. The night he got flu shot he got flu symptoms runny nose, on 10/12/15 he got diarrhea, vomiting.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26. cov2.s for (Janssen, Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 206A21A, expiry unknown) dose was not reported, 1 total, administered on 07-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The patient was fully COVID vaccinated with Janssen vaccine. On 25-DEC-2021, the patient's symptoms started which were cough, fever, runny nose, congestion nasal and sneezing. On 26-DEC-2021, the patient took a COVID test and was COVID negative. On 30-DEC-2021, the patient was tested COVID positive using the JNJ supplied home rapid antigen test (coded as suspected COVID-19 infection and suspected clinical vaccination failure) (Dose number in series 1). The patient's partner tested positive on same day also and had same symptoms as patient.  The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 13-DEC-2021 in left arm for prophylactic vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20211266272.; Sender's Comments: V0: 20211265944-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
She got her vaccine, in the late afternoon about 5-6 hours she had itching, swelling and redness at the vaccine site.  After 2 days these symptoms disappeared.  She did not have to take as much BP medication as her #'s were lower than normal.   She may have taken a Tylenol for her symptoms.    She did not have any reactions with the previous COVID vaccines.    She got her flu vaccine yesterday in her left arm, and has a small bit of soreness and nothing like she had with the COVID vaccine.
Information has been received from a registered nurse concerning a 13 month old white male with no allergies or medical history who on 3/24/04 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 647521//1108N). There was no illness at the time of vaccination. The nurse reported that the patient developed chicken pox. Unspecified medical attention was sought and not treatment was required. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Follow up information was received from the registered nurse who indicated that on 5/18/04, 30 lesions on the torso were noted. Some were in clusters with vesicles and fever. He was seen again on 5/19/04 to recheck the rash and was diagnosed with mild chicken pox. Subsequently, the patient recovered. No further information is expected. The nurse also reported another child who had a similar experience after therapy with varicella virus vaccine live (WAES0405USA01555).
Hep B was nonreactive; Hepatitis B antibody negative; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Twinrix. On 30th October 2019, the patient received the 2nd dose of Twinrix. On 22nd November 2019, the patient received the 3rd dose of Twinrix. On an unknown date, less than a year after receiving Twinrix, Twinrix and Twinrix, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   It was unknown if the reporter considered the hepatitis b antibody negative to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The patient received 3 Twinrix doses on the accelerated dosing schedule and he had an antibody test which showed Hep B was nonreactive, and Hep A & Hep AB showed reactive. No other symptoms were reported. The reporter consented to follow up. The HCP did not had the lot and exp at the time of report.  The patient was expected to get the booster dose.
CHIEF COMPLAINT:   pt. c/o sinus infection x 2 weeks, just started PO antibiotics yesterday, c/o congestion, sore throat, body aches etc.   HISTORY OF PRESENT ILLNESS:     Patient is a 47-year-old male with history of hypertension and medication noncompliance, hyperlipidemia that presents for headache.  Associated with high blood pressure.  Patient thought he had a sinus infection for 2 weeks, was given antibiotics and steroids by the urgent care yesterday.  Patient states that he did not feel any better and continued to feel worse which prompted his visit.  He is supposed to be on antihypertensives but does not take them, states he feels worse when he takes his medications.  Patient denies chest pain, shortness of breath, abdominal pain, nausea, vomiting, fever, chills, numbness, weakness, vision changes
Headache came two days after injection and lasted for 18 hours; soreness at injection site came six hours after injection and is ongoing at time of this writing; low-grade fever and chills came on six hours after injection and lasted nine hours, then returned for two hours next day; loss of appetite day after the injection and lasted two days; overall body soreness came six hours after injection and lasted two days; sinus pressure came day after injection and lasted all day.
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On 01-AUG-2002, 02-OCT-2002 and 02-JUN-2003 the patient received doses of RECOMBIVAXHB)(lot#, dose, route not reported) vaccine series. Concomitant medications included PENTASOL. The consumer reported that the patient was "recently", in appropriately 2014, found to have negative titers for Hepatitis B during a screening for initiation of treatment with immunomodulator drugs for treatment for what appears to be Crohn's disease. The consumer reported that the patient was perfectly health her entire life until February 2014, she got a 'stomach bug,' and it never went away." The consumer stated that, at 11 years old, the patient was "failing to gain weight," but she didn't start to manifest any symptoms of Crohn's disease until "this year", in 2014. Outcome of Crohn's disease was reported as not recovered. Outcome of negative titers for Hepatitis B was unknown. Additional information has been requested.
A male who did not receive the COVID-19 vaccination developed chest pain and pericarditis after being in the same space as ten vaccinated people on a daily basis. The male had to be prescribed one medication to alleviate the symptoms. Echo limited showed the pericarditis. The male also gets an upset stomach and a feeling of lightheadedness every time he goes near at least six of the vaccinated people. After the male self-isolates for several days, his symptoms clear. Then as soon as he goes near the vaccinated people, his symptoms return.
This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-MAY-2016 (reported as "today"), the patient was administered, by an unspecified nurse, an expired dose of ZOSTAVAX lot # L003216, expiration date 30-APR-2016 (dose and route of administration not reported). It was reported that an unspecified physician prescribed ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Patient's parent noted rash (blotchy spots on entire body) since immunizations were given Tuesday 10-02-07. Benadryl dye-free prescribed for rash.