chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely ill for 2 days, sores in my mouth and nostrils, hallucination. BP was high, diarrhea, chills, no fever weak and fatigue and couldn't get out of bed, 11 and 12 Sep2021. I thought I was going to feel better but I didn't saw my doctor 28 Sep2021. Gave prednisone and changed BP medicine. BP gone down but heart rate 107 this am, yesterday was 119 and 113- shortness of breath. Dry cough heart high, bp not perfect, I cant do much without having shortness of breath. Prednisone is finished and going back to the doctor soon.
Pt experienced syncopal episode while in observation post vaccination. Vital sign stable. Pt denied shoirtness of breath, swelling of mouth, or difficulty swallowing. Pt reports previous syncopal episode during medication administration.Pt reported hitting head. emergency services called. Emergency services evaluated pt. Pt refused medical transportation. Pt left self ambulating with another person proving transportation. Recommended pt seek further medical evaluation and to contact primary healthcare provider.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/11/2022 Discharge Date: Dec 15, 2022 COVID positive Date: 12/11/2022 PRESENTING PROBLEM: DKA, type 1, not at goal   HOSPITAL COURSE: Pt is 70 y/o female with past medical history of Type 1 DM, diabetic neuropathy, CKD Stage 2, hx of CVA, htn who presented with DKA. Pt presented to ED on 12/11. She had been feeling ill for 3-4 days prior to admission. On admission, pH of 7.04, beta hydroxyutyrate  > 9.0, a1c 10.6. CMP showed Na 123, K 5.3, bicarb 7, AG 34, BUN 64 cre 1.46. Pt was also found to be COVID +. She was admitted for further treatment.   Pt was maintained on endotool on admission. Organization was consulted and she was transitioned to basal bolus on 12/12. Pt remained on RA in regards to COVID, she did have symptoms of nausea, diarrhea and cough. Pt was offered 3 day ocurse of remdesivir which she declined and continued supportive care. Her BP medications were held on admission and pt became hypertensive on morning of 12/14. This improved with resumption of her home medications. She also had mild AKI which resolved with fluid resuscitation. Patient was able to resume oral diet, minimal nausea and vomiting on day of discharge. Patient had her insulin regimen adjusted by Endocrinology. Given lack of hypoxia, no COVID specific treatments given aside from supportive care. Patient then considered stable for discharge home. She was set up with the hospital at home program prior to discharge. She was instructed on signs and symptoms of when to return to the ER. She was discharged home in stable condition with plan to follow up with her Endocrinologist in a few days.
I had a really bad headache that seamed to have started in the front of my head and moved all over my head from front to side and ended at the back of my head, headache last two days could not sleep due to pain also felt nauseous, also had really bid chills and sweating, as well as muscle aches in my arm and legs and back.
This spontaneous report as received from a physician refers to a 3 patients of unknown age and gender. On an unknown date patients were vaccinated with VARIVAX (Merck) (lot # and expiration date unspecified) injection (dose, therapy route and anatomical location unspecified) to prevent chickenpox. The physician reported that the 3 patients received an expired VARIVAX (Merck) and no adverse effect was reported. Patients sought medical attention, laboratory tests were not performed. At the time of the report the outcome of 3 patients was unknown. Additional information has been requested.
Severe muscular pain - fatigue. Arm stiff from injection (soreness) - headache, swollen and sore eyes, cough, muscular pain lasted 24 hours. Hoarseness fatigue lasted for 4 days.
shoulder is starting to hurt; 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 ARTHRALGIA (shoulder is starting to hurt) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder is starting to hurt). At the time of the report, ARTHRALGIA (shoulder is starting to hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up was received on 26-MAY-2021 and contain no significant information
doctor asked the patient to get second dose of menactra where its not indicated in age above 55 years with no reported adverse event; received a dose of MENACTRA over a year ago with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 76 years old male patient whose doctor asked to get second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] where its not indicated in age above 55 years with no reported adverse event and received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] over a year ago with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asplenia.   In 2021 (over a year ago), the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization (product administered to patient of inappropriate age, Latency: same day). Information regarding batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of doctor asked the patient to get second dose of menactra where it was not indicated in age above 55 years with no reported adverse event (product prescribing issue) (latency: unknown). Reporter stated that she saw on the packing that the MENACTRA was not indicated for patients older than 55 years of age and would like some guidance on dosing.   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Body ache; Elevated temp; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant product use was not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
DRY MOUTH, PAIN OF SITE OFVACCINATION, INCREASE OF BLOOD PRESSURE
UNABLE TO MOVE ARM AND NECK (COMPLETELY STIFF); BRUISES ALL OVER MY BODY FROM WHERE IT FELT LIKE VESSELS BURSTING; VOMITING; DIZZY; BACK PAIN; TIREDNESS; This spontaneous report received from a consumer via a company representative concerned a 5 decade old female. 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 (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced unable to move arm and neck (completely stiff). On 10-JUN-2021, the subject experienced bruises all over my body from where it felt like vessels bursting. On 10-JUN-2021, the subject experienced vomiting. On 10-JUN-2021, the subject experienced dizzy. On 10-JUN-2021, the subject experienced back pain. On 10-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to move arm and neck (completely stiff), bruises all over my body from where it felt like vessels bursting, vomiting, dizzy, tiredness and back pain was not reported. This report was non-serious.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # M028323, expiration date: 26-SEP-2018) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Pt recvd 1st dose of Hep B vax on 3SEP91 & w/in 2 hrs of vax pt devel generalized urticaria; pt sent to ER & tx DPH & Pred; pt later recovered;
Left thigh w/ oval shaped area of warmth and erythema, mildly swollen and tender where he received imms (PENTACEL/Hep A).
Tested positive for covid Cough stuffy nose ear ache tooth ache trouble breathing tiref
This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional, concerning a 34-year-old, adult male patient. On 18-Jan-2018, the patient was administered with AFLURIA after the first excursion (dose: 0.5 ml, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018, route of administration: not reported)(explicitly coded incorrect product storage and drug administration error). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Diagnosed with APL Leukemia; Anemia; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACYCLOVIR [ACICLOVIR] for Antiviral treatment.    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 ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) (seriousness criterion medically significant) and ANAEMIA (Anemia). At the time of the report, ACUTE PROMYELOCYTIC LEUKAEMIA (Diagnosed with APL Leukemia) and ANAEMIA (Anemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was diagnosed with APL Leukemia and because of anemia as a result, was told not to get the second dose until cell counts are at an acceptable level.  Treatment information was not provided.  This case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected event of Acute promyelocytic leukaemia. The event occurred after unspecified lapse of time after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge is not applicable as there is no information regarding the second dose of the vaccine.  Anemia is a non-serious and intercurrent event. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected event of Acute promyelocytic leukaemia. The event occurred after unspecified lapse of time after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge is not applicable as there is no information regarding the second dose of the vaccine.  Anemia is a non-serious and intercurrent event. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.
seizure- involuntary movments of face and mouth and right arm.  no loss of consciousness lasted about 2-3 minutes.  onset after went to sleep.
Technician was administering the patient's second Covid dose. After watching over 1/2 of the dose go in the arm, the barrell of the syringe separated from the needle. The needle remained in the arm and the barrell was in the technicians hand. No additional dose was administered since over 1/2 of the dose went in the patient's arm.
Information has been received from a registered nurse concerning her 17 year old niece who on an unspecified date was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. The nurse reported that her niece experienced nausea, vomiting, loss of appetite, fatigue and depression after the 2nd immunization. The patient did not seek medical attention for her experience. The patient's outcome was not reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). On an unknown date "shortly after" receiving the ZOSTAVAX, the patient developed a painful rash on her back. In response to these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. The outcome of the herpes zoster was considered to be not recovered. Herpes zoster was considered to be disabling. Additional information has been  requested.
No adverse reaction as of 2/5/19 at 1120 AM. Expired vaccine - 12/7/2018.
She broke out in shingles / suspected vaccination failure; She broke out in shingles; covid; quarantined for 2 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (experienced in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19 and quarantine. On an unknown date, the outcome of the vaccination failure, shingles, covid-19 and quarantine were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient had Covid twice, the 1st time was in 2019 and the 2nd time was in 2020.  The 2nd time she had the virus, she quarantined for 2 weeks with her daughter.  On 5th April 2021, the patient received the 2nd dose of Covid-19 vaccine. However, after her 1st dose, she said she experienced soreness at the injection site, and felt as if a truck ran over her. The patient already had 2 shingle shots last year and broke out in shingles so she was confused as to why the vaccine would cause her to get it again. This case was considered as suspected vaccination failure as time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
felt sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacture unknown), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt sick".  Additional information: Age reported as 35-49 years old. The reporter consider event as caused by suspect product. The patient stated that having Pfizer was good for him; even though he felt sick after the vaccine shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. was administered incorrect dosage of Pfizer (0.1) : Vaccinator  notified site leader in regards to the above. Site leader contacted Pt. and advised  Pt. to return to receive the remaining dosage of 0.2. 0.2 was was administered and Pt. was fully vaccinated with the correct dosage of 0.3
expired dose of Shingrix was dispensed; Shingrix had expired on 23Sept2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug dispensed in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CE5S, expiry date 23-SEP-2023) for prophylaxis.   On 30-OCT-2023, the patient received the 1st dose of Shingrix. On 30-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired drug dispensed (Verbatim: expired dose of Shingrix was dispensed) and expired vaccine used (Verbatim: Shingrix had expired on 23Sept2023). The outcome of the expired drug dispensed and expired vaccine used were unknown.   Additional Information: GSK receipt date: 30-Oct-2023 Pharmacy technician reported that an expired dose of Shingrix was dispensed and administered to a patient, which led to expired drug dispensed and expired vaccine used. Mailing address was provided in health care professional's details. The reporter consented to follow-up.
Hives, numbness, severe pain, fatigue, swollen, attacks, high blood pressure, headaches, neurological issues, etc.
pt recv vax & 5 days post vax pt began to exp urticaria, pruritus, round lesions around elbow, & swelling around eyes;tx DPH sx resolved in 3 days;
An adverse effect did not occur. Patient was to receive Moderna Bivalent but was given 0.5ml of Moderna Monovalent. Per CDC if patient still desires to have the bivalent vaccine the patient has to wait for 2 months before receiving that vaccine.
received 2nd dose of Pfizer COVID vaccine 1/11/2021.   On 3/1/2021 developed body aches, headache, cough, sore throat, rhinorrhea, loss of taste/smell, nausea / emesis
This spontaneous report as received from a physician refers to an approximately 12 year old male patient. Concomitant therapy included unspecified immunosuppressive medication. In 1996 the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot number not reported). In 2008 the patient experienced renal transplant. On 25-FEB-2014 the patient was vaccinated with the second dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot number not reported). On 25-MAR-2014 the patient was admitted to the hospital with a diagnosis of chickenpox. The reporting physician stated that the lesions were primarily located on the patient's upper extremities, face and scalp. The patient was immunocompromised due to a renal transplant. The outcome of renal transplant and chickenpox was reported as not recovered/not resolved. The relatedness between the events and the therapy was not reported. Upon internal review, renal transplant was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # M012495 and expiry date 10-SEP-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information had been requested.