chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/27/2023 Discharge Date: Mar 23, 2023 PRESENTING PROBLEM: Hypomagnesemia Debility  Alcohol abuse Weakness COVID-19   HOSPITAL COURSE: 72M with past medical history significant for alcohol use disorder, presented with overall body pain, generalized weakness and fall. He has been seen 4 x in the E.D. in the past few weeks mostly for etoh. He was planning to go to a rehab but sent to the E.D. for medical clearance. He was unable to ambulate in the E.D. so admission was requested for PT / OT and potentially SAR .He had a CT scan head showing mild soft tissue swelling on the right frontal scalp no intracranial hemorrhage midline shift or mass effect.  Left knee x-ray showing sclerotic changes in the proximal tibia concerning for metastatic disease.  PSA within normal limits.   Due to the patient's abdominal pain and CT abdomen and pelvis done showed fatty liver and questionable cirrhosis.    He was given multivitamin thiamine folic acid and Ativan p.r.n. for alcohol withdrawal.   PT and OT recommended skilled nursing facility, neurology patient was awaiting placement he spiked fevers greater than and 39 C. A chest x-ray was negative for any acute processes..  Patient was initiated on vancomycin and cefepime. Work up was positive for COVID on 3/10/23. He was titrated off antibiotics. He developed AKI 2/2 uncontrolled fever and this resolved with IVF as well as fever suppression with tylenol. He developed TME and this improved with fever suppression and correction of AKI. Blood cultures were negative. He remained on room air during his acute COVID episode.    He completed 10 days of COVID isolation on 03/21 and was discharged In stable condition.
Local rxn /w fever of 102 F.  2nd DPT, no problems /w 1st.
neuropathy; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around April 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles and neuropathy.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), she 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. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles and neuropathy was considered to be not recovered. The reporter considered shingles and neuropathy to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of shingles and neuropathy were determined to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
KINRIX given 1 - 6 -14 (R) deltoid/upper arm swollen, red and warm starting 1 - 7 - 14 (evening).
vision problems; nearsightedness; farsightedness; This is a Spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 09Jun2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and no reaction with first dose. On 10Jun2021, patient experienced vision problems. Her nearsightedness has been affected & her farsightedness has also been affected. She reported blurred vision by the end of the day. Event took place after use of product. The outcome of the events was unknown.    Information about Lot/batch number has been requested.
cough, runny nose, headache, sore throat, fever-highest 100.5, sinus congestion, nasal congestion, post nasal drainage. starting on 10/18/21
I received my fourth dose of the Moderna Bivalent on 09/09/2022 and tested positive for COVID-19 on 10/13/2022. I started experiencing mild symptoms on 10/12/2022. On 10/13/2022, I started feeling really bad and tested myself for COVID-19 and it was a positive result. I contacted my physician, and she wrote me a prescription for Paxlovid. As of today, I feel that the medication is not helping. It's very hard for me to even take this medication because it has a terrible taste to it. I've taken it for 4 days now and it doesn't seem to be doing anything. My symptoms are improving, but slightly. I'm still getting a fever and feeling fatigued.
n/v, h/a, sore arms, legs;rx w/APAP;
Jynneos vaccine is administrated intradermally instead subcutaneously; An expired dose of Jynneos is administered to a patient; Case reference number US-BN-2022-003696 is a spontaneous case report initially received from a nurse via  Communication (reference number: USBAV22-1578) on 29-Sep-2022 and concerns a 42-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 29-Sep-2022, the patient was vaccinated with first dose number of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016), at a dose of 0.1 mL, intradermally (ID) (explicitly coded as 'Intradermal injection'), at an unknown site of administration, for monkeypox prophylaxis.   On the same day, immediately after vaccination the reporter realized that they administered an expired dose (explicitly coded as 'Expired vaccine administered').  At the time of this report, no adverse events were reported.  Additional information received from Bavarian Nordic on 29-Sep-2022 included an updated narrative where is stated that the vial had already been punctured on Monday (26-Sep-2022) and the vial was given today (29-Sep-2022) intradermally.  Additional information received from Bavarian Nordic on 29-Sep-2022 included local BN case ID.; Reporter's Comments: A 42-year-old male patient was vaccinated with first dose number of Jynneos vaccine, at a dose of 0.1 mL, intradermally (ID), which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, immediately after vaccination the reporter realized that they administered an expired dose, which is considered as expired vaccine administered. At the time of this report, no adverse events were reported. Intradermal injection and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 42-year-old male patient was vaccinated with first dose number of Jynneos vaccine, at a dose of 0.1 mL, intradermally (ID), which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, immediately after vaccination the reporter realized that they administered an expired dose, which is considered as expired vaccine administered. At the time of this report, no adverse events were reported. Intradermal injection and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head; This is a Spontaneous case report a contactable consumer(patient). A 17-years-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0196), via an unspecified route of administration on 05Jun2021 at 18:30 into left arm as a single dose for COVID-19 immunization (at the age of 17 years). The patient medical history and concomitant medications were not reported. The historical vaccine includes the patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration on 04May2021 at 19:00 pm into left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.On 05Jun2021 at 20:30, patient had Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head. The patient underwent lab tests and procedures which included blood test, computerised tomogram, electroencephalogram, urine analysis was unknown on an unspecified date.  The patient was visited to Emergency room/department or urgent care for the events. The patient had received Benadryl as a treatment for the adverse event. The outcome of the events was recovering.
Narrative: Patient with red, warm petchiae rash from head to toe that started approximately 12 hours after receiving 2nd COVID vaccine. Started out painful but is now itchy. CBC, BMP and UA ordered to further evaluate and make sure kidneys are not affected. Solumedrol 125 mg IM given in urgent care. Meds prescribed for home use: prednisone.
patient received Menveo expired first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30-JUN-2023) for prophylaxis.   On 05-JUL-2023, the patient received the 1st dose of Menveo. On 05-JUL-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received Menveo expired first dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  The patient received Menveo expired dose, which led to expired vaccine used.
BUMP AND REDNESS TO LEFT THIGH THE NEXT DAY AFTER RECEIVING VACCINATIONS.  ADVERSE REACTION TO VACCINE.   CELLULITIS AND INFECTION TO LEFT THIGH.  FOLLOW UP NEXT DAY MOM STATES THE BUMP IS STILL THERE BUT IT IS NO LONGER RED AND DOES NOT BOTHER THE PATIENT. DR STATES IMPROVED CONTINUE ANTIBIOTICS RETURN IF NOT IMPROVED.  AUGMENTIN 4.5 MLS BY MOUTH 2 TIMES DAILY FOR 10 DAYS
No adverse event; More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AR9236B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.).    Concomitant drugs were not reported. It was reported that it was not known if patient had any adverse reactions after dose 1 and dose 2. Treatment medications were not provided.   This case was linked to MOD-2023-722155 (Patient Link).
2 1/2 hrs after administration of Tdap + Bexsero - fever to 103' for 24' w/ shakes + "feeling" awful unable to work next day - mom refusing Bexsero Booster
sudden onset of hands and feet itching; throat tightening mild for 2-3 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 16:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Hypermobility spectrum disorder" (unspecified if ongoing), notes: Hypermobility Spectrum Disorder (subset of, Ehlers-Danlos).; "known allergies: legumes" (unspecified if ongoing), notes: known allergies: legumes. Concomitant medication(s) included: ARMOUR THYROID; GINGER ROOT EXTRACT. Past drug history included: Corticosteroids, reaction(s): "known allergies: corticosteroids". Vaccination history included: Covid-19 vaccine (DOSE: 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: THROAT TIGHTNESS (medically significant) with onset 09Sep2022 at 17:30, outcome "recovered" (2022), described as "throat tightening mild for 2-3 hours"; PRURITUS (non-serious) with onset 12Sep2022, outcome "recovered" (2022), described as "sudden onset of hands and feet itching". Therapeutic measures were taken as a result of throat tightness, pruritus.  Clinical Course: No other vaccine in four weeks. Other medications in two weeks included Armour Thyroid 90, Ginger root supplements 1100 mg. No covid prior vaccination and not tested for covid post vaccination. known allergies included legumes, corticosteroids. 1 hour after administration, throat tightening mild for 2-3 hours (history of this will legumes or corticosteroids/carry epipen). 55 hours after administration, sudden onset of hands and feet itching. Administered Benedryl and Pepcid. Within 60 minutes, SX subsided. Ae treatment included when 2nd SX started, Benedryl 25mg  and Pepcid.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 19Apr2021 as dose 2, single (Lot number: EW0151), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: CARVEDILOL, start date: 01Nov2021; LOSARTAN, start date: 01Dec2021; ZOLPIDEM, start date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE/PQC; An expired dose of VAQTA was inadvertently administered to the patient today 10/04/2023.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot number u036184, expiration date 02-MAR-2023) (strength, route of administration and anatomical location were not provided).    No adverse event reported.
A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender.  The pharmacist who was giving vaccinations yesterday and upon administration to a patient there was a small leakage from the needle onto the patients arm. The patient's medical history was not provided.  Concomitant product use was not provided. The patient received their first of two planned doses. Batch number not provided on 04 Feb 2021 for prophylaxis of COVID-19 infection. On 04 Feb 2021,the pharmacist was giving vaccinations and upon administration to a patient there was a small leakage from the needle onto the patients arm.  The pharmacist was informed that in the event of a deviation from the interval between doses or deviation from the recommended dose, the vaccine recipient should be followed closely for safety outcomes, but the dose should not be repeated, as data are not available on the administration of 3 doses of the COVID-19 Vaccine. Action taken with first dose in response to the events was not provided. The outcome of the events small leakage from the needle onto patients arm (Vaccine under dose and Exposure via skin contact) were considered as resolved on 04 Feb 2021.; Reporter's Comments: This report concerns a subject of unknown age and gender who experienced non-serious unexpected events of a small leakage from the needle onto the patient's arm (Exposure via skin contact) and Vaccine under dose for lot # not provided. At the time of this report, there were no associated adverse events. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Information has been received froma registered nurse concerning a 27 month old female with no medical history and NKDSA who on 05/25/00 was vaccinated with a dose of varicella virus vaccine live SC. There was no concomitant medication. On 09/07/01, the pt was seen by a physician with a 100.1 F temperature (rectal) and a rash, scabbed with vesicle lesions on her face and trunk which had started three days before on 09/04/2001. The pt was diagnosed w/ varicella. The pt was treated with colloidal oatmeal (Aveno Bath). Subsequently on 09/08/01, the pt recovered. No further information is expected.
Patient was given an HPV #2 IM right deltoid. Upon MA administering the HPV patient stated that he was feeling dizzy. He put his head back turned pale and passed out for about 15 seconds, he did not fully lose consciousness but patient stated he was still dizzy. Provider was called. BP, blood sugar, hemoglobin was taken and patient was monitored until provider gave the ok to let him go. Upon pts. departure from the clinic patient stated that he was feeling much better. Water was also given. Vasovagal syncope.
After 1st vaccine , patient had mild ptosis to left eyelid that was intermittent.  After the 2nd dose on 1/27/21, patient had more pronounced ptosis to left eyelid, worsening after approximately 3 weeks.  The patient is experiencing improvement at this time, but seems to be aggravated with seasonal pollen experience.
Received PE on 7-29-10. T 100.4. On Aug 8, 2010 took to ED for evaluation pruritic rash. Rash started 8-7-10. No fever. Dx chicken pox - uncomplicated. Rash most extensively covering upper chest/back, lower abdomen, face, followed by upper & lower extremities, proximal >distal. Seen office on 8/12/10.
tingling over entire body low level.  vision blurry . balance issues in the am. headache
Redness/swelling of arm, migraines, shortness of breath, irregular heart beat, fast heart rate, fatigue, fever.  14 weeks pregnant with first dose, 17 weeks pregnant with second.
an expired dose of Pentacel was accidentally administered to a 7 month-old child with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient to whom an expired dose of pentacel was accidentally administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH (PNEUMOVAX VACCIN) for Prophylactic vaccination.  On 30-Oct-2023, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection lot UJ794AB, expiry- 08-Oct-2023 via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.   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 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.
1/20/2023-Presents to ED, was seen at PCP (1/18- started on PO doxy and Paxlovid), Covid + test. C/O weakness, lethargy, cough and headache. Afebrile, HR-40. Spo2 100% RA. CXR- no evidence of acute cardiopulmonary disease. Admit acute hypoxic resp failure s/t Covid. AKI eGFR 27-hold remdesivir. Start Decadron, IV doxy and ceftriaxone. Start Combivent . Will consider remdesivir if renal function improves BUN/ Creatnine 44/1.9. On 3L Spo2 now 94%. 1/23/2023-Cont. V decadron, doxy and ceftriaxone. Start remdesivir, eGFR >60. Spo2 93% in RA.  1/30/2023-Covid downgrade awaiting d/c to snf. 2/1/2023-Finished IV antibiotics, continue decadron taper. D/c to sub acute rehab.
pt recvd vax;awoke 7pm,turned white then began crying & turned grey; t 98.6ax;apap given;t was never inc above 98.6ax;mom called MD next day;
Patient felt chills the evening she received the vaccine on 5/28/19.  On Thursday 5/30/19 she had a fever of 99.9 degrees F. On Friday she felt nauseous and vomiting and then fainted. She also had spots that she described as a measles like rash on her leg.
Moderna COVID -19 Vaccine EUA Fever, chills, ache all over, slight headache ? started at 18 hrs after 2nd vaccine.  This is Sunday February 28 at 12:00 noon. I don?t have a fever but I don?t feel good. I took Aleve yesterday (Saturday, 27) ,, then I took Tylenol. No relief . Took Tylenol this morning? still don?t feel great but no  fever, no headache, no body aches.