chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; METALLIC TASTE IN MOUTH; This spontaneous report received from a patient concerned a patient of an unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concomitant medical history included: Drug allergy. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 01 total administered on 11-MAR-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had Covid-19 (coded as suspected covid-19 and suspected clinical vaccination failure) (Dose number in series 1) and received treatment. The patient was taking other medications/products within 2 weeks of initiation of COVID-19 treatment (Dose number in series 1). The patient additionally received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate for birth control, and dextromethorphan hydrobromide/ethanol/guaifenesin for cough suppressant. The patient received non-company suspect drug Plaxovid (form of admin, route of admin, batch number were not reported), dose was not reported administered on 25-MAY-2022 for Covid-19 treatment.  On 25-MAY-2022, the patient experienced metallic taste in mouth (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable, and for Plaxovid not reported. The outcome of the metallic taste in mouth, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This case is associated with product quality complaint number: 90000235217. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220609401-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
No addition adverse event; An expired dose of V AQTA was given; This spontaneous report was received from a medical assistant and refers to a 1 year old patient (gender not reported). The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On 02-SEP-2020 (also reported as "today"), the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) lot # S019435, expiration date 23-AUG-2020, 0.5 milliliter for prophylaxis (route was  not reported). So, medical assistant called inquiring about stability data and confirmed no addition adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Seizure 10/7/03 (approx 10 minutes, resolved without meds given), concomitant fever 103 F, approx 6 hours post injection. (Seen in ER). F/U no abnormalities, no lingering fever.
Dizziness lasting more than 6 hours,  fainting, stomach upset, headache
Patient developed a rash consistent with erythema multiform (minor form) 1 day after 2nd flu vaccine.
I have a decrease complement 1, 2, and 3 are low in my blood test. I am also having headache and sinus extraction with fluids. These symptoms are still going since December. I went to the doctor about and they are unsure if the vaccine has affective my immune system. They did a MRI of my head and a CT scan of my sinus. I have an appointment with an EMT in the next two weeks and then he will decide if I need surgery.
Hospitalized 12/15/2021-still admitted currently; COVID-19 positive 12/15/2021; fully vaccinated  ASSESSMENT / PLAN: Patient is a 69 yo M with past medical history of chronic atrial fibrillation (on Xarelto), NICM with recently improved EF to 52%, morbid obesity who presented to BL ED 12/15 due to 3 weeks of progressive dyspnea. He was known to be COVID 19 positive from 12/12. On arrival to ED, the patient was hypoxemic on NRB mask. He was in AF with RVR with rates 180-200. Labs showed lactic acid 9, stable renal function, procal 2.7. CXR showed diffuse bilateral airspace disease. He initially stabilized on HFNC. Sputum (+) for S aureus. DCCV was attempted to x2 without conversion to sinus rhythm. He was given amiodarone bolus and started on infusion. Upon arrival to ICU, the patient was in extremis and was emergently intubated. Following intubation, the patient remained in uncontrolled AF and DCCV was attempted again, that time with conversion to sinus rhythm, but later returned to A fib. Course complicated by shock requiring pressors and AKI requiring CRRT   ASSESSMENT / PLAN:      Assessment and Plan Acute hypoxemic respiratory failure Assessment & Plan Differential includes pulmonary edema in setting of Afib RVR with cardiomyopathy / acute on chronic CHF, COVID-19 pneumonia, CAP, aspiration, or some combination of these.  Unlikely PE in setting of chronic anticoagulation with Xarelto and pulmonary infiltrates on CXR No supplemental oxygen use at baseline Progressive dyspnea for 3 weeks, presenting with HR 180's, respiratory distress, hypoxemia requiring HFNC COVID-19 positive on 12/15 - Moderna vaccine April/May 2021 Limited additional history provided, spouse unaware of details  Intubated 12/15 on arrival to ICU  * COVID-19 Assessment & Plan Moderna vaccine April/May 2021 Progressive dyspnea x 3 weeks prior to admission - other symptoms unknown. Unclear if dyspnea is related to worsening CHF Temp 38.9 on presentation, Procalcitonin 5.9, WBC 9.3 Test positive on 12/15 in ED Treatment  Remdesivir 12/15 -  Request for monoclonal Ab use, pending 12/24/21 notes:  * COVID-19 Assessment & Plan Moderna vaccine April/May 2021 Test positive: 12/15 in ED Admission: 12/15 Intubated: 12/15 Remdesivir: 12/15, discontinued due to renal failure Dexamethasone: 12 mg IV daily 12/15 -    - management of respiratory failure as above - continue steroids as respiratory status remains poor (today is day 10) - empiric antibiotics for possible secondary infection, f/u infectious work-up - on therapeutic anticoagulation for afib - continue volume management via CRRT (goal negative) Per daughter, if patient were to have no improvement by ~1/2, family would consider withdrawal of care
Itchy pea sized bump at injection site 1 week after shot. Arm pain was bad for 2 days and started to go away then all of a sudden got bump and itching at site.
Information has been received from a nurse referring to a 33 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-AUG-2016, the patient was inadvertently received a dose of PROQUAD (lot # L051101, therapy type rHA, route, dose and expiration date not reported) (drug administered to patient of inappropriate age. No adverse effects were reported. Additional information has been requested.
The patient reported pain on 10/21 at the injection site. She was evaluated, diagnosed with a hematoma , given medication for pain. She then came back on 11/13/2019 stating  that she had not improved and had limited mobility in her R shoulder. She was referred to Physical Therapy.
7x4cm area of induration at injection site right.  Immediately following immunization 2 days later.  Ice, Tylenol, Benadryl.  No fevers, vomiting or systemic symptoms.  Vital signs WNL stable.  Stable and expected to recover.
Active-duty soldier, 181 cm tall, 180 lbs, found unresponsive in barracks 5-6 days post smallpox vaccination. Post-mortem toxicology positive for methadones (0.26 mg/L), diazepam (0.33 mg/L), nordiazepam (0.22 mg/L), but not temazepam, alprazolam, or dextromethorphan. Autopsy revealed concentric L ventricular hypertrophy, but no myocarditis. Conclusion: Vaccination unrelated to soldier's death.
it hurt ,for 2, days; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine. The patient reported that it hurt for 2 days.
shortness of breath, fever, headache, chills no treatment providers said symptoms will fade in 24 to 48 hours
soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; This is a spontaneous report from a contactable consumer.   A 72-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On Mar2021, the patient experienced soreness in shoulders, buttocks, hips, thighs, and legs. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
17 year old son had one dose of moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna) in a 17-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.
Broke out with genital herpes; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Broke out with genital herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced GENITAL HERPES (Broke out with genital herpes). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, GENITAL HERPES (Broke out with genital herpes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient begain running fever the day after vaccine given. Fever got up to 102°. Went to his primary doctor & had bloodwork & xray (chest). These were clear Feeling better by 7/18/19. Had a localized reaction on R arm - red, swollen, hardened area.
Loose stools with blood and mucous off and one since 4 days after vaccine for rotavirus - mom noticed foul smell to stools also. Afebrile, feeding well. No treatment at this time pt improving.
WEAKNESS AND FATIGUE, TACHYCARDIA, DECREASE IN APPETITE, URINATY INCONTINENCE
Fever, erythema, swelling and increased skin temperature erythema 3 1/2 x 4 1/2, temp 100.4.
Patient developed Segmental Vitiligo within 2 months of getting this shot. It progressively spread and covers her abdomen, chest, and back and she has a gray spot in her hair on one side of her body
Raised, warm,, hard, itchy, 3? reaction at vaccination site continuously since just after injection  Moderna COVID?19 Vaccine EUA
No symptoms at time of vaccination and I only noticed the slight inflammation / bump in my left arm when I was going to bed on 1/21/2021. No pain, a little swelling (feels harder than normal tissue), and its slightly red.
Extreme fatigue, nausea, weak muscles in arms and legs, anxiety, rapid heartbeat, tingling skin, muscle aches and pains, shortness of breath . Soreness and itching at site of injection.  All symptoms became apparent within five minutes of vaccine and lasted until I went to bed at 10:30 PM. When I woke up at 7 AM the next morning all symptoms were gone.
Woken by strong intestinal ache; continued until 3 AM when I vomited several times.  The next day was confined to couch with intestinal crampiness and achiness.
Tiny muscle spasms, feels like the chills, but without being cold. Not constant, but daily.
Pt recvd Engerix-B 3 doses & did not seroconvert; Booster doses were administered; no tx was given;
Currently have had a 102.1 fever since around 10:00pm on March 8th 2020.
A BOOST VACCINE WAS ADMINISTERED UNDER THE AGE OF 14 WITHOUT BEING AUTHORIZED FOR THAT 12+ POPULATION. PATIENT DID NOT PRESENT ANY ADVERSE REACTION, HE TALKED WITH THE MOTHER AND KEPT MONITORING FOR SEVERAL DAYS BY PHONE CALL.
ROTARIX vaccine ordered, only ROTARIX diluent administered. GSK contacted, advised that vaccine be given as soon as possible. No adverse reaction noted to diluent administration.
Unusual and persistent fussiness and crying (immediately following vaccine), fevers ranging from 100.8 F to 101.4 F (day of and following vaccine).
chest pain; strong palpitation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation). At the time of the report, CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation) outcome was unknown.            After a week of the vaccine Patient experienced chest pain and strong palpitation; Doctor prescribed a CTA scanned but the result come back good and no problems. Concomitant Medications were not provided by the reporter. Treatment Medications were  not provided by the reporter.   Reporter did not allow further contact
throat closing sensation; minor hives; This is a literature report.  A 48 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Belimumab, reaction(s): "anaphylaxis"; Rituximab, reaction(s): "IgE-mediated reaction". Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation, reaction(s): "Anaphylaxis - developing dyspnea, wheezing, throat closing sensation and an erythematous rash in her upper extremities". The following information was reported: THROAT TIGHTNESS (medically significant), outcome "unknown", described as "throat closing sensation"; URTICARIA (medically significant), outcome "unknown", described as "minor hives". The patient underwent the following laboratory tests and procedures: skin testing to vaccine components (PEG3350, polysorbate 80, polysorbate 20) and the vaccine itself were negative. Therapeutic measures were taken as a result of throat tightness, urticaria. Clinical course: Authors presented a case of a successful graded-dose administration of the second dose of the Pfizer-mRNA vaccine for SARS-CoV-2 in a patient with previous anaphylaxis to the first dose. The use of skin testing to the vaccine and its components remains controversial. Graded-dose administration of vaccines may improve vaccination rates in patients with high-risk of hypersensitivity reactions to these vaccines. She successfully completed a five-step graded-dose administration of the COVID-19 vaccine (1. Dose: 0.05ml, Dilution: 1:10 Dilution, Time: 0 min; 2. Dose: 0.05ml, Dilution: Full-strength, Time: 15 min; 3. Dose: 0.1ml, Dilution: Full-strength. Time: 30 min; 4. Dose: 0.15ml, Dilution: Full-strength; Time: 45 min; 5. Observation, Time: 75 min), presenting only throat closing sensation and minor hives, which were treated with IM diphenhydramine.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of throat closing sensation and minor hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a healthcare professional (nurse and subject) and described the occurrence of flu-like symptoms in a 52-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included rheumatoid arthritis. Concurrent medications included "a biologic immunosuppressant for his rheumatoid arthritis." In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, 3 to 4 days after vaccination with FLUARIX, the subject experienced flu-like symptoms. At the time of reporting the outcome of the event was unspecified.
Little diarrhea; A spontaneous report was received from a physician assistant on 19APR2023 regarding a patient of unknown age and gender who experienced "little diarrhea" (PT: Diarrhoea) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.   The patient's medical history, concomitant medications, or known allergies were not reported.   It was reported that the patient received Vivotif following which the patient had little diarrhea. Reportedly, Vivotif was well tolerated by the patient.  The outcome of the reported event was unknown, at the time of this report.    The action taken with Vivotif with respect to the reported event was unknown.    No additional information was reported.  Based on the information available in the document three individual case safety reports 23000151 (patient-1), 23000152 (patient-2) and 22000250 (patient-3) were created and cross-linked in the database.  Company comment: It was reported that a consumer took Vivotif for immunisation and experienced little diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif for immunisation and experienced little diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non serious as per medical assessment. 23000152:Linked case (Patient 2) 22000250:Linked case (Patient 3)
1/25/2022: Patient schedule for routine, yearly follow up visit with oncologist and CT scan for surveillance of Stage III primary peritoneal carcinoma. CT scan showed an Acute left lower lobe lobar and segmental pulmonary embolus. The patient exhibited mild shortness of breath upon assessment. She was prescribed the oral anticoagulant rivaroxaban for which she will need to take for at least 6 months.
Approximately 1 1/2 hour after receiving vaccines, Carilee experienced a headache, approximately 15 minutes after that she started to experience shortness of breath, Nausea, and she felt "very hot, like my skin and hair were on fire." she was also experiencing tightness in her chest. She was seen by the doctor at the Health Department, Her blood pressure was elevated, 160/100. He recommended that she go to the emergency room. She was transported by ambulance. At the hospital she was diagnosed with medication allergy and was sent home with Methylprednisone and Tagamet. She continued to have severe headaches, mild fever, body aches and fatigue for several days after the incident. She continued under the care of a medical doctor for malaise and vomiting until 11/15/2007.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received BEXSERO. Concurrent medical conditions included latex allergy. In June 2017, the patient received BEXSERO. In June 2017, less than a month after receiving BEXSERO, the patient experienced allergic reaction and documented hypersensitivity to administered product. On an unknown date, the outcome of the allergic reaction was recovering/resolving and the outcome of the documented hypersensitivity to administered product was unknown. It was unknown if the reporter considered the allergic reaction to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that her physician was aware about the latex allergy, but administered the vaccine anyway. She was vaccinated 12 days before the reporting date and her physician told her that she had received one dose of GSK's meningitis B vaccine. The patient did have a reaction after vaccination. The patient did not want to provide additional information at this the reporting time. The caller was transferred to a pharmacist for additional information.
Extremely low blood pressure, persistent low-grade fever (still have the fever and it has been over a year), peripartum cardiomyopathy.
I have a gray/white spider web type anomaly in my mouth. I've been told it's ? skin growth. I suspect cause by HEP A B vaccination. Been evident for apprx 1 year, no treatment although seen at clinic as well as ENT .
Redness, swelling, pain which increased per patient's father over the past 2 days. Affected area was (R) thigh.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concomitant medications, concurrent conditions and medical history was not reported. On 26-JAN-2016 the patient received an expired dose of M-M-R II (lot # K000998 with expiration date 22-JAN-2016, dose 0.5 ml) subcutaneously. No adverse effects were reported. Additional information has been requested.