chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MS; UTI; Staph infection; This case was reported by a nurse via sales rep and described the occurrence of multiple sclerosis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant), urinary tract infection and staphylococcal infection. On an unknown date, the outcome of the multiple sclerosis, urinary tract infection and staphylococcal infection were unknown.   It was unknown if the reporter considered the multiple sclerosis, urinary tract infection and staphylococcal infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comment: The reporter was a GSK field representation reporting a Shingrix AE (adverse event) that was given to him by a nurse at one of his accounts.  The reporter had limited information.  The reporter had reported all the information provided. The nurse reported that a patient received a dose of Shingrix (not confirmed if 1st or 2nd dose) and shortly after receiving dose got a staph infection, UTI, and was diagnosed with MS (Multiple sclerosis).  The reporter consent to follow up.
Body aches and pain Severe headache Chills Exhaustion All lasted approximately 24-36 hours
pt recv vax 6FEB97 & started vomiting that afternoon;8FEB97 went to family MD in AM WBC's were inc placed on Suprax;went again to family MD 1wk later had a bladder infect;placed on a sulfa containing ATB;
SEVERE HEADACHE STARTING AFTER VACCINE AND LASTING UNTIL THE NEXT MORNING. RELIEVED MY TYLENOL AND MOTRIN.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, dosage schedule, lot # and expiration date were not reported). It was stated that a little liquid leaked from injection site post ZOSTAVAX vaccination (injection site extravasation). At the reporting time, the outcome of the event was unknown. The reporter did not assessed the causality between the event and the use of ZOSTAVAX. Additional information has been requested.
Approximately 8 days after getting the first shot,  redness and  moderate itchiness at the injection site.   One day later I developed hives on the opposite arm, covering about 1/3 of the arm at the inside elbow.  It was intensely itchy and burning.  I eventually treated it successfully by the application of Voltaren topical gel (anti-inflammatory) and multiple ice packs.  I also took an Allegra.  A day later I noticed I had two very small bruises on the inside of each upper arm.  These were not painful, just curious since that is not an area of the body I am likely to bump into something..
Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022; No adverse event; 1st Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022).    This case for patient 1 of 8 patients. No concomitant medication information were given. Vial was initially stored in the refrigerator. Thawed on 29th JUL 2022 and kept in the refrigerator. Vial doesn't undergo any temperature excursions. Patient received booster dose. Reporter stated that patient was not pregnant. No treatment information were given.
Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 13-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 22(unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.
8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 29th September 2021, the patient received Shingrix. On 29th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional reported that they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of the 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209483:Same reporter. US-GLAXOSMITHKLINE-US2021209458:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter.
head started to itch; hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on 09Mar2021 16:00 (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 09Mar2021 19:00, the patient head started to itch, patient had hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades. The patient stated she took BENADRYL to treat with no relief and then took another BENADRYL 20 minutes later and the symptoms finally began to subside. The patient wanted to know if she should get the second dose. The patient asked if it is okay to delay the second dose of the vaccine and what if she waits a whole year to get the second dose. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
COVID vaccine breakthrough case J&J 4/6/21 041A21A and 12/17/21 213D21A
MA incorrectly administered MENQUADFI which is for 2 years of age and older with no adverse event; a 2-month-old patient should be given VAXELIS but MA incorrectly administered MENQUADFI with no adverse event; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2-months-old male patient who was incorrectly administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] which is for 2 years of age and older instead of diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid [Vaxelis] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the 2-months-old patient received unknown dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7632BB; expiry date: 14-Apr-2025) instead of Vaxelis not produced by Sanofi Pasteur (formulation, batch number and expiry date unknown) via unknown route in unknown administration site for immunization with no adverse event (product administered to patient of inappropriate age) (wrong product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
On 07 Jan 2020, the patient was inadvertently administered two doses of the liquid component of the Pentacel vaccine (DTaP-IPV), and none of the Hib component/No AE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a four months old male patient who was inadvertently administered 0.5ml two doses of the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and none of the HIB component on 07-Jan-2020 lot number and expiry date not reported via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  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 and Module VI of the 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.  Information on the batch number was requested.
Day after the shot, woke with left eye infection, pain in left arm (still pain in left arm) and now have a-fib. Blood test showed possible blood clot, but test did not find any. In hospital for observation. Now on a medicine to slow heart rate. Never had heart issue before vaccine shots.
One dose Vivotif was taken incorrectly after a 72 hour time lapse; A spontaneous was received on 03AUG2020.  A pharmacist reported that a male consumer (age between 16 and 21) "took one dose of Vivotif incorrectly after a 72-hour time lapse" (PT: Inappropriate schedule of product administered). The consumer was receiving Vivotif for immunization. It was reported that the consumer took all four doses of Vivotif. However, one dose was taken incorrectly after a 72-hour time lapse. The reporter did not know the dates. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown at the time of report.  Company Comment: A consumer took one dose of Vivotif incorrectly after a 72-hour time lapse (inappropriate schedule of product administered) instead of taking every other day.This consumer completed taking all four doses of Vivotif. Considering the nature of the event, the causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took one dose of Vivotif incorrectly after a 72-hour time lapse (inappropriate schedule of product administered) instead of taking every other day.This consumer completed taking all four doses of Vivotif. Considering the nature of the event, the causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif.
Chills Low grade temp 99.2 - Took Tylenols Mild body ache Sleepy Injection site tenderness All symptoms disappeared next morning, except for arm tenderness.
Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.
The day after the vaccine was administered her arm was red and sore and hurt a lot. It kept hurting for 2 weeks. Also the next day after the vaccine was given she felt nauseous, dizzy and shivery but that only lasted for 1 day. Now, two months later all symptoms are resolved but patient was hesitant about taking the second dose.
Patient presented to the clinic reception area today noting that he experienced rapid heart beat the evening of 3/18/06.  He had received the menactra vaccination around noon on 3/18/06.  He complained of no other symptoms except a slight headache on 3/19/06 which has been resolved as of today (3/20/06).  After conversing with the doctor, it was determined that the patient should rest and refrain from physical exertion until symptoms went away.  He was also advised to report to the office immediately should his symptoms continue or worsen.
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently  on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
Over the course of several days post vaccine patient experienced increase discomfort in arm. Heat and swelling down to elbow by Sunday (9/2) 4 days post vaccine. MD diagnosed patient with cellulitis and prescribed 7 day course of Doxycycline 100 mg twice daily. Patient reports
This spontaneous report as received from a nurse refers to a 7 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
The patient was vaccinated with the dose which was past the expiration date; The patient was vaccinated with the dose which was past the expiration date; Case reference number US-BN-2022-003736 is a spontaneous case received from other health professional on 30-Sep-2022 via Communication (reference number: USBAV22-1584) and concerns a patient of unknown demographics.   The patient's relevant medical history and concomitant medications were not provided.  On 30-Sep-2022, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; lot number: FDP00004; expiration date: 27-Sep-2022), at an unknown dose, route or anatomical site and for an unknown indication (explicitly coded as 'expired product administered' and 'product administration error'). As reported on 27-Sep-2022, product reached eight weeks in the fridge.  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 03-Oct-2022 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose, route, or anatomical site and for an unknown indication on 30-Sep-2022. As reported on 27-Sep-2022, product reached eight weeks in the fridge, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. Expired product administered and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered and product administration error 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 patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose, route, or anatomical site and for an unknown indication on 30-Sep-2022. As reported on 27-Sep-2022, product reached eight weeks in the fridge, which is considered as expired product administered and product administration error. At the time of this report, it was unknown if the patient experienced any adverse event. Expired product administered and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Multisystem inflammatory syndrome in children (MIS-C) confirmed case, onset 12/25/21.
Shooting pain down entire arm and arm pit.  Swelling of armpit, shoulder and elbow, loss of muscle strength of entire arm. Inability to move arm.  Symptoms continuously got worse for next 5 days. Pain started to decrease on February 6 and symptoms gradually improved over the following week.