chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slept more than normal Saturday and Sunday. Monday morning left eye was completely turned in, balance and coordination was off. pediatrician sent us to ER, Diagnosed with Guillian Barre, Ataxia transferred to Hospital, pressure in brain.  5/10/07 Received partial medical records from hospital.  No D/C Summary done.  No labs done.  T/C to medical records to confirm d/c date & request MRI report.   Admitted 11/14/06-11/16/06.  Handwritten medical records very difficult to read but reveal patient experienced crossing of eyes, unsteady gait & excessive sleepiness x 3 days.  Neuro consult done but unable to read it.  Had been seen at outlying hospital & had CT of head & LP done there.  Will request those medical records also. FINAL DX: None given. 5/10/07Received medical records from initial hospital which reveal patient experienced crossed eyes, excessive sleepiness & unsteady gait.  LP done in ER & noted to have less crossed eyes s/p LP.  Transferred to higher level of care. FINAL ER DX: possible GBS; opthalmoplegia; ataxia. Information received from the annual follow up indicated patient had not recovered. Had acute left esoptropia after being given the flue vaccine. She had a medical rectus muscle repair surgery in July 2007. She still has some residual problems with her eye after the surgery. Information received from annual indicates patient had not recovered. Her vision is still impaired, had to have eye surgery, still having regular appts. & MRI. Eyes still cross. Per 60 day follow up: Increased intracranial hypertension, vision loss due to pressure build up, chronic headaches. Follow-up: Sudden eyes crossed, head aches, intracranial hypertension.
Covid19 breakthrough.  1st vaccine received on 07/06/2021.  66 y/o female with PMHX of ESRD on hemodialysis MWF, Asthma, CAD s/p PCI 2017, HTN, gastritis, DM, Hypothyroidism, scolosis presents to ED with c/o SOB, wheezing, productive cough, dizziness and chest pain x1 day.   Room air sat 97%, CXR with no focal consolidation and pt with low grade temps.  Treated with IV steroids.  Covid severity score=0 per Admitting MD.
Local site reaction/hive. Singular. Approx 1.5 inches diameter. No other hives noted.
This spontaneous report was received from a registered nurse regarding patients (age and gender not reported). The nurse reported 2 doses of improperly stored VARIVAX (Merck) was inadvertently administered to patients. The dates of vaccination were not reported. (The number of patients was not reported. It is unclear if it was 2 patients or more than 2 patients.) No adverse effects reported. No additional information was reported. Additional information is expected.
rash on the injection site 8 days after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the injection site 8 days after) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the injection site 8 days after). At the time of the report, VACCINATION SITE RASH (rash on the injection site 8 days after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 2AUG95 & devel 12-15 lesions;
dizzy; chills; weak; tingle; tired; joint and muscle soreness; joint and muscle soreness; fatigue; unwell; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:00 (age at vaccination 46 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included Diabetes, mild asthma and PCOS (Polycystic ovarian syndrome) from an unknown date and unknown if ongoing PCOS, blood clots from an unknown date and unknown if ongoing (2 blood clots from injury and flying). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. it was reported that the patient was not a pregnant at the time of vaccination. The patient concomitant medica-tions included empagliflozin (JARDIANCE), metformin, rosuvastatin calcium (CRESTOR), albuterol [salbutamol], sudafed (PSEUDOEPHEDRINE HYDROCHLORIDE) all for taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have covid prior vaccination. Patient was not covid tested post vaccination. The patient previously took levaquin and experienced allergies, hydrocodone and experienced allergies and Iron Supplements and experienced allergies. On 12Mar2021 04:15 the patient reported approximately 5 minutes after receiving the shot I started to get dizzy. It got worse over the next 30 minutes and she got the chills. The nurse checked my BP and it was fine so they let she leave. After leaving it got worse and started to get weak and to shake slightly. Then my cheeks started to tingle. She thought it was low blood sugar so she ate but it didn't help. she got extremely tired so she laid down and slept for about 3 hours. The dizziness subsided for the most part and then she got nauseated. Now she was feeling the side effects that most common - Joint and muscle soreness, fatigue, and just generally unwell. I did not seek medical treatment even though the dizziness and weakness are listed as a severe allergic reaction she did not feel like it was bad enough to go to the ER. The patient underwent lab tests and procedures which included BP (blood pressure): fine on unspecified date. No treatment was received for adverse events (ae). The clinical outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2016US022697 is an initial spontaneous report received from a pharmacist on 06 Sep 2016. This report refers to 26 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618901, expiry date: Apr 2017) at dose of 0.5 ml intramuscular on 03 Sep 2016. It was reported that, the patient received partial dose of FLUVIRIN. No adverse event was reported following this medication error.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 68 years 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: "No" (unspecified if ongoing), notes: Known allergies: No, Other medical history: Looking at the patient's meds, you can probably figure it out. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 Treatment, brand: Pfizer, from 20May2023 to 21May2023 orally.  No follow-up attempts are possible. No further information is expected.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 61-years old female patient who experienced psoriasis and hives, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI998AC via unknown route in unknown administration site. On 14-Oct-2018, the patient developed a non-serious psoriasis and hives 11 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was hives and psoriasis. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events (symptoms are continuing as of today (15 Nov 2018)). List of documents held by sender: none.
3/9/09 IZ received @ bedtime T-101.0; pt woke parent up in am (3/10/09) with febrile Sz (temp in ER 102.7 (R)) tonic-clonic upper extremities stiffening of legs; acyanotic, mother took child to ER.
Fever of 100.2F, fussiness, loss of color, constipation, soreness, vomiting, constipation, and rash on back. Fever treated with Tylenol until taken to the ER on 01/02/2015 for spiked fever. Blood was tested and she has a low white blood cell count that's continuing to drop. Antibiotics started around 4:00 PM 01/02/2015. Admitted to hospital for observation for 24 hours.
Pt came to get 1st dose of Moderna at our location today 4/19/21 at approximately 4:45pm.  I confirmed the dose was correct that the intern pulled up before administering . I counseled patient regarding the vaccine and my intern,  provided the immunization.  The intern administered the vaccine and claimed the barrel separated from the needle after the plunger was pressed.  Some residue was noticed on the patient's arm but undetermined how much but felt it was quite a bit. Patient was concerned that she did not receive a full dose and didn't feel as she'd be protected. I spoke to the patient and informed her we'd contact our PCSM and contact Moderna. Upon contacting Moderna, they instructed that if less than half was administered OR if proportion of dose leaked out could not be estimated the to administer 2nd dose immediately (did not give a time cap) in the opposite arm.  I shared this information with staff members  who agree it'd be best to follow Moderna's direction. Patient was contacted at 6pm since she had left the pharmacy after 15 min post immunization and gave her Moderna's recommendation. She was not able to return to pharmacy this evening and said she could not come in until noon on Wed 4/21.  IF she could come sooner, she'd call. I will inform other RPhs at the store of this situation.
Swollen lymph nodes; tender lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included nicotine (MANUFACTURER UNKNOWN) and (salbutamol) ALBUTEROL. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 00:00 hours, the patient experienced swollen and tender lymph nodes. Therapeutic measures and treatments were not taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen and tender lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came to the pharmacy to report he had fever, chills, fatigue and that he had to call off work for two days.
No additional AE's; Pharmacist reported that an expired dose of ROTATEQ was administered to a patient today, 9/12/2022.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 12-SEP-2022 (also reported as today), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot #1741381, expiration date: 04-SEP-2022, (strength, exact dose and dose number were not provided), indication was reported as: use as directed for prevention of rotavirus (expired product administered). At the time of reporting, the patient has had no reported adverse side effects. No additional adverse events (AE's) was reported (no adverse events).
Hives; rash in all over his body; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site) in a 39-year-old male patient who received mRNA-1273 (batch no. 014021A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site). At the time of the report, URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment drug information was not given.
Experienced heart palpitations and shortness of breath the day after I received the first Moderna dose.  Still experiencing the shortness of breath on day 3.   I'm currently 19 weeks pregnant and am due Aug 2nd.
Minutes after vaccine admin., pt. walked back into the waiting room complaining of dizziness.  Assisted into a chair with mother at side.  Several attempts at a BP (auto and manual) made.  Called Dr.  BP 51/21.  Ordered to call 911 & admin 0.3 ml epi.  EMT arrived & epi admin into right thigh.  EMT @ side.  BP 100/50 & pt more conscious.  Reported to Dr Pt mother refuse ambulance but would take daughter to ER.  Pt walks out with mother and EMTs.
Swelling of neck lymph nodes and left eye. Swelling of under tongue. Ongoing off and on body aches, headaches and fever.  Esophagitis and heartburn. Treatment has been a short dose of prednisone (6 days) and motrin/Tylenol off and on. Clindamycin oral and IV clindamycin (10 days) carafate(30 days)
10x15cm patch of erythema, induration, warmth & tenderness that began 24-36 hours after vaccine in (L) thigh. Nausea & vomiting started 18 hours after vaccine x only one hour but had also started ORTHO TRI-CYCLEN the night before.
She felt the vaccine was given too high and developed sharp stabbing pain in her arm, difficulty moving her arm without pain and some nausea and vomiting with the pain of movement
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and chronic obstructive pulmonary disease. On an unknown date, the outcome of the vaccination failure, whooping cough and chronic obstructive pulmonary disease were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and chronic obstructive pulmonary disease to be related to dTpa vaccine. Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. It was reported that let the kids get their childhood diseases and then they would be good for their life. Forgot about the chemicals the patient survived them all and experienced polio from the damn shot. The patient probably would never experience it otherwise. The patient experienced  whooping cough from it. The patient also experienced chronic obstructive pulmonary disease (COPD). The patient survived it. The patient stated that hell the doctors did not knew what they had and tried telling them. that could not experience the events from the vaccine. It was reported that a year later they told the patient that he was right. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case was linked with case US2019AMR084174 reported by the same reporter for patient's son.
This case involves a patient (unknown demographics) who had high temperature (pyrexia) and received 0.5 mL of vaccine instead of 0.25 mL, while he/she received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (underdose). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious high temperature (pyrexia) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. This was a case of actual medication error due to overdose (latency 1 day). There were no other lab data/results available. It is unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no batch number available for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications/The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the Anti-viral COVID 19 Treatment, Paxlovid, of started on 11Jul2022 and stop on 15Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm pain beginning 3 hours after the second dose, worsening over the next 8 hours, slowly ebbing at the 24 hour mark. Unable to sleep or lift arm above head due to pain. Migraine beginning 12 hours after second dose, continuing until 36 hours after 2nd dose. 102.5-103.1 fever beginning 15 hours after 2nd dose, continuing until 28 hours after 2nd dose. Low grade fever (hovering around 100) 28 hours after 2nd dose to current. Generalized body pain and joint aches beginning 12 hours after 2nd dose until 36 hours after 2nd dose. No appetite and upset stomach beginning 12 hours after 2nd dose until 36 hours after 2nd dose.
Patient arrived at the clinic for their second dose. They received an initial dose of Pfizer on 2/26/2021. The received a second dose of Moderna 3/19/2021. Per CDC guidance, In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. This patient received the 2nd dose at 21 days. Patient was called and a voicemail was left requesting a return call at 3:00pm when the error was discovered.
This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot numbers: J013394, K020216, K026666, L000877, L025738, L027733, L040458, L048848 and M034894 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis.  It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of RECOMBIVAX HB were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001210: US-009507513-1705USA001211: US-009507513-1705USA001212: