chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: administering dose post temperature excursion with reported adverse event; vaccine had multiple temperature excursion with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA327223(CLUSTER).  This case involves a 18 years old male patient to whom  IPV (VERO) [IPOL] was administered a dose post temperature excursion with reported adverse event and vaccine had multiple temperature excursion 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Immunisation; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 05-Jul-2022, the patient received a 6th dose of suspect IPV (VERO), suspension for injection, at dose of 0.5 ml once (lot U1A452M and expiration date: 20-Feb-2023) via intramuscular route in the left arm for immunization post temperature excursion with reported adverse event (poor quality product administered) (latency: same day).  It was reported that vaccine had multiple temperature excursion with no reported adverse event (product storage error) (latency: same day) the first on unopened MDV on 05-APR-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes and the second excursion occurring on 05-JUL-2022 at a high of 11.22C out of range for 10 hours, and on 18JUL2022 a low of 1.17C for 45 minutes, on 29JUL2022 at 10.93C for 12 hours, and on 06AUG2022 at 1.6C for 1 hour.   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.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administering dose post temperature excursion with reported adverse event; vaccine had multiple temperature excursion with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who was administered dose post temperature excursion with reported adverse event and vaccine had multiple temperature excursion with no reported adverse event ,while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); HEPATITIS A VACCINE INACT (HEP A IN VAC); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 22-Jul-2022, the patient received a 5th dose of suspect IPV (VERO)( lot U1A452M and expiration date: 20-Feb-2023) at a dose of 0.5ml once via intramuscular route in the right arm for immunization.  On 22-Jul-2022, the patient was administered doses post excursion (poor quality product administered) (latency: same day). It was also mentioned  that the vaccines had multiple excursions (product storage error), the first on unopened MDV on 05-APR-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes and the second excursion occurring on 05-JUL-2022 at a high of 11.22C out of range for 10 hours, and on 18JUL2022 a low of 1.17C for 45 minutes, on 29JUL2022 at 10.93C for 12 hours, and on 06AUG2022 at 1.6C for 1 hour.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both 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 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.; Sender's Comments:  01226710: 01226726: 01226027:
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: got an extra hib dose with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case from health professional. GMI number: 01227578   This case involves a 2-year-old male patient who experienced got an extra HIB (PRP/T) VACCINE [ACT-HIB] dose with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA329894(pentacle case).  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunization; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 08-Aug-2022, the patient received ACT-HIB VACCINE at dose 0.5ml once (lot UJ647AAA, expiry date: 05-Mar-2023) via intramuscular route in the right arm for prophylactic vaccination with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  It was reported that "Caller states that a patient was given an extra Hib dose and IPV 1 year early. The doctor ordered Dtap, hib and Prevnar13 but the patient was administered PENTACEL and ACTHIB, which means the patient got an extra hib dose as well as the 4th IPV dose before age 4. Requesting information on whether this will harm the child and what to inform the parents. "  Action taken: Not applicable.  At time of reporting, the outcome was 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.
Sex: M
Vaccine: HIBV, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: given an extra Hib dose and IPV 1 year early with no reported adverse event; given an extra Hib dose and IPV 1 year early with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was given an extra HIB dose and IPV 1 year early with no reported adverse event , and it involved vaccines HIB and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 08-Aug-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, with an unknown formulation and strength, once, ( lot: UJ620AAA  ; expiry date: 07-Dec-2022) via intramuscular route in the left thigh for immunization and also received an unknown dose of suspect HIB not produced by Sanofi Pasteur , with an unknown formulation and strength , (lot number and expiry date: not reported) in unknown administration site for immunization.  It was reported that the doctor ordered Dtap, hib and Prevnar13 but the patient was administered PENTACEL and ACTHIB, which means the patient got an extra hib dose as well as the 4th IPV dose before age 4  On 08-Aug-2022 the patient was given an extra Hib dose and IPV 1 year early with no reported adverse event (inappropriate schedule of product administration) (extra dose administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE and following the administration of HIB. The patient turned 3 , a day after administration.  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.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 year old patient was inadvertently administered a dose of QUADRACEL with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case via health professional. (GMI number: 01227747)  This case involves a 9-year-old female patient who was inadvertently administered a dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] 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 Varicella Zoster Vaccine (Varicella Vaccine) for Immunization.  On 28-Jul-2022, the 9 years old patient received suspect Quadracel vaccine at dose 0.5 ml once via intramuscular route in the left thigh (lot U7526AA, expiry date: 07-Sep-2024) for prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) same day latency".  It was reported that "Caller reporting a 9-year-old patient was inadvertently administered a dose of QUADRACEL. Caller reporting the patient is now caught up on her vaccinations but had been behind. Caller with questions on whether QUADRACEL counts as a valid dose of DTAP. This situation is reported as a medication error due to patient receiving dose outside of approved age range on PI. No further information provided by the reporter.   Action taken: Not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: RAB
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IMOVAX that was put in a freezer for an unknown duration of time with no reported  adverse event; administration after post excursion with no reported  adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited non-valid  non-serious case received from a pharmacist.  This case involved product storage error in which RABIES (HDC) VACCINE [IMOVAX RABIES] that was put in a freezer for an unknown duration of time with no reported  adverse event and it was administered post excursion with no reported adverse event.   On an unknown date, Imovax was put in a freezer for an unknown duration of time with no reported  adverse event (product storage error) (unknown latency). It was given to a patient (Poor quality product administered) (onset date : unknown) and (latency: same day). The caller was asking if this was rendered inactive and its safety after administration post-excursion. The reporter did not have the exact temperature reading . Information regarding batch/lot number requested, but not available at the time of call.   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.
Age: 0.17
Sex: M
Vaccine: HIBV, UNK
Symptoms: Extra dose administered
Clinical narrative: received an extra dose of ACTHIB with PENTACEL with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case via health professional. GMI number: 01228386  This case involves a 2-month-old male patient received an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] 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 CONJ 7V (CRM197) (PREVNAR) for Immunization; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization.  On 02-Aug-2022, the patient received 1st dose of suspect ACT-HIB vaccine at dose 0.5 ml once (lot UJ645AAA) via unknown route in the right thigh and received 1st dose of suspect Pentacel Vaccine at dose 0.5ml once (lot UJ673AAA) via unknown route in the left thigh both for prophylactic vaccination with no reported adverse event (extra dose administered) latency same day.  It was reported that "health care professional (HCP) called to report that a patient received an extra dose of ACTHIB. Caller states that a 2-month-old patient received PENTACEL and ACHIB at the same visit. Caller would like to know what the new dosing schedule for the patient would be. Caller reported that the patient has not shown any signs of an adverse event from the two doses of Hib received."    Action taken: Not applicable.  At time of reporting, the outcome was 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.
Age: 30.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Incorrect route of product administration
Clinical narrative: Yf-vax, was administered intramuscular instead of subcutaneous, with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old male patient to whom YELLOW FEVER VACCINE -  [YF-VAX], was administered intramuscular instead of subcutaneous, 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Prophylactic vaccination; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - lot UJ602AA via intramuscular route in unknown administration site.  On 09-Aug-2022 the patient developed a non-serious event of YELLOW FEVER VACCINE -, was administered intramuscular instead of subcutaneous, with no reported adverse event (incorrect route of product administration) (latency: same day) (dose:0.5ml, batch number: UJ602AA  and expiry date: unknown, strength and formulation was unknown) for Immunization.   Action taken with YELLOW FEVER VACCINE (YF-VAX) was 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 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.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pruritus, Injection site swelling
Clinical narrative: Arm did swell where the shot went,now swelling gone down; Bit itchy every now and then; Feeling yucky; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site swelling, injection site itching and feeling abnormal. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site itching was not recovered/not resolved and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: This case was reported the patient via interactive digital media. The patient got second Shingles shot about a week ago from reporting.  The patient was felt yucky for a day.  The patient's arm did swell where the shot went, now swelling gone down but a bit itchy every now and then.  The patient was glad to be done with shot. Additional supportive information: This case was linked with US2022AMR112122, received from same source. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR112122:Reporter-Patient of this linked case is tagged.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-AUG-2022 Reporter's comment: The healthcare professional from medical office reported 16 year old patient was administered a dose of Bexsero on 09th August 2022, which was expired on of 31st July 2022.  At the time of reporting, dose had not been repeated.  The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero vaccine, which led to expired vaccine used.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a consumer via other manufacturer (Novo Nordisk Inc.) concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total (dose 1) administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. Non-company suspect drug included: Rybelsus (semaglutide) 3 mg (Miligram) (tablet, oral, batch number was not reported, expiry: unknown) 3 mg, 1 time every 1 day, therapy dates were not reported, and 7 mg, 1 time every 1 day, therapy dates were not reported for diabetes mellitus.  On an unspecified date, the patient experienced allergic reaction. On an unspecified date, he was hospitalized for a week and a half. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with semaglutide was not reported. The patient recovered from allergic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220821349-covid-19 vaccine ad26.cov2.s- Allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: administration of IMOVAX in gluteal area, with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient  to whom rabies vaccine [Imovax Rabies] was administered in gluteal area, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered a dose of suspect rabies vaccine, powder and solvent for suspension for injection (dose, strength, lot number and expiry date  not reported) via unknown route at gluteal area, with no reported adverse event (product administered at inappropriate site) (unknown latency). Director of Pharmacy recently just discovered that IMOVAX must not be given in the gluteal area but one of their nurses did just that  Action taken ; not applicable.   At time of reporting, the outcome was Unknown for the event administration of imovax in gluteal area, with no reported adverse event.   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.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccine had multiple temperature excursion with no reported adverse event; administering dose post temperature excursion with reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old female patient and reporter stated that vaccine had multiple temperature excursion with no reported adverse event and administering dose post temperature excursion with reported adverse event involving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (MEASLES MUMPS AND RUBELLA VACCINE LIVE ATTENUATED) for Immunisation.  It was reported that there were multiple excursions, the first on unopened MDV on 05-Apr-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes. The second excursion occurring on 05-Jul-2022 at a high of 11.22C out of range for 10 hours, and on 18-Jul-2022 a low of 1.17C for 45 minutes.  On 19-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot U1A452M and expiry date: 20-Feb-2023) via intramuscular route in the right deltoid for Immunization.  On 19-Jul-2022, the patient developed a non-serious event of vaccine had multiple temperature excursion with no reported adverse event (product storage error).  On 19-Jul-2022 the patient developed a non-serious event of administering dose post temperature excursion with reported adverse event (poor quality product administered) (Latency: same day) following the administration of IPV (VERO).  Further it was reported that the excursion occurring on 29-Jul-2022 at 10.93C for 12 hours, and on 06-Aug-2022 at 1.6C for 1 hour  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 47.0
Sex: M
Vaccine: HEPA, MNQ, SMALLMNK
Symptoms: Dizziness, Erythema, Eye movement disorder, Head injury, Muscle rigidity
Clinical narrative: After receiving the three vaccines, pt. stated he was dizzy and lowered himself to the floor, body rigid with eyes rolling upwards.  This posture lasted approximately one minute.  Ammonia inhalant used after above episode and he stated to take it away.   Pt hit his head on the column of the connecting room.  Slight redness on back of head which disappeared within 5 minutes.  EMS called.  Paramedics arrived, took to truck for evaluation and transported Medical Center.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: One week after receiving the shot I started with a small rash on my left hand. Over the next three days the rash spread rapidly, now over my hands, arms, neck, face, legs, back and buttocks.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Mental status changes, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever, altered mental status
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted twice.   COVID breakthrough infection
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Child given the wrong vaccine. He should have been given the maroon cap, instead given the orange cap.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITAL
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: COVID positive, SOB
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Skin warm, Swelling face
Clinical narrative: patient states the evening after her shot, her face started to swell up and moved down to her eye. The area over her left eye feels warm to the touch and is visibly swollen.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Erythema, Immunisation reaction, Swelling face, Tremor
Clinical narrative: Patient with history of mental disability brought to the ED by caregivers at her group home for complaints of facial swelling, redness and shaking that started the day of vaccination.  The time these symptoms started was not specified in the medical record.  Temperature was 101.4F, HR was 107.  Patient was admitted for possible sepsis vs. allergic reaction and was discharged the next day after symptoms improved and it was determined this was likely a reaction to the COVID vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for a fall (tested positive for COVID 7 days prior) on dates  6/27/2022- 7/5/2022.  Treated with vitamin C 1,000 mg PO daily, zinc 50 mg PO daily.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted once.   COVID Breakthrough infection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Infection
Clinical narrative: Error: Infection/Cellulitis (diagnosed by MD).
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Intentional medical device removal by patient, Product administration interrupted, Skin laceration
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: pt received laceration to left leg after kicking while attempting to inject covid vaccine, no vaccine administered, vaccine was administered in arm instead
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypotension, Mydriasis, Syncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: Also pupil dilation
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: Also pupil dilation
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive, Seizure
Clinical narrative: Hospitalization for altered mental status post-seizure and also tested positive for COVID on dates  6/29/2022-78/2022.  Treated with dexamethasone,  Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had previously fainted with both does of COVID vaccine (given elsewhere).  Patient fainted approximately 30 seconds after administration, caught and laid on floor by pharmacist administering vaccine and patient's mother.  Patient regained consciousness approximately 15 seconds after being laid on floor and legs raised.  Blood pressure was monitored over the next 15 minutes while patient was slowly moved from laying down to sitting to standing and walking.  No further issues.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure increased, Chest pain, Dizziness, Dyspnoea, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: near syncope event-Mild, Systemic: Shakiness-Mild, Additional Details: at 10:30. patient was sitting outside exam room after vaccine.  Patient reports lightheaded. patient appeared pale. Patient was assisted to lying position with legs elevated BP 12060, HR 58 RR 20. patient was given water. After 10 min patient  feeling better and assisted to exam room to lie down. After 5 min BP 120/80 RR 18 HR 72 temp 97.2, 10 min BP 120/78 HR 74 temp 97.2, after 15 min BP 120/78 HR 74 temp 97.2 patient reports absence of symptoms dizziness, SOB, chest pain. Mom drove pt home.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Presyncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: near syncope event-Mild, Systemic: Shakiness-Mild, Additional Details: at 10:30. patient was sitting outside exam room after vaccine.  Patient reports lightheaded. patient appeared pale. Patient was assisted to lying position with legs elevated BP 12060, HR 58 RR 20. patient was given water. After 10 min patient  feeling better and assisted to exam room to lie down. After 5 min BP 120/80 RR 18 HR 72 temp 97.2, 10 min BP 120/78 HR 74 temp 97.2, after 15 min BP 120/78 HR 74 temp 97.2 patient reports absence of symptoms dizziness, SOB, chest pain. Mom drove pt home.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Syncope
Clinical narrative: Hospitalization for syncopal event and tested positive for COVID on dates 6/29/22-7/1/22.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (ex. temperature/location).
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site erythema, Injection site inflammation, Pruritus
Clinical narrative: Patient developed intense pruritus over whole body. Few, diffuse hives noted on arm, back, neck. Redness and slight inflammation at sites where vaccines were given due to presence of bandaids. Patient developed these symptoms less than 24 hrs. of receiving the above listed vaccines. Patient stated that she did not have any adverse reaction to the first doses of these vaccines, nor has she ever had a reaction to a vaccine in the past. Patient has a stated allergy to sulfa drugs. Patient elected to see a physician today. She directly left Health office to be seen at clinic.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, COVID-19, Computerised tomogram abdomen abnormal, Drainage
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/29/2022 Discharge Date: Aug 11, 2022  PRESENTING PROBLEM: Acute abdominal pain  Enteritis Ischemic bowel disease Small bowel ischemia Volvulus   HOSPITAL COURSE: Patient is a 94Y female with PMH of CHF, coronary artery disease, hypertension, GERD, and AFib on Eliquis who presented with severe abdominal pain.  CT scan was concerning for possible bowel ischemia.  Originally admitted to Medicine, was made NPO and given maintenance IV fluids for bowel rest.  Started on prophylactic Zosyn.  Incidentally, patient was also found to be COVID positive.  Serial abdominal exams were done and progressed to having peritoneal signs on exam.  Extensive discussions were had with patient and family and they decided they wanted to pursue surgery despite risks.  She was taken for exploratory laparotomy on 07/30, and had an ileocecectomy with primary anastomosis.  Postoperatively, pain was well controlled and patient was given supportive care while we awaited bowel function.  Overnight on 08/01, patient was transferred to the SICU due to being hypotension and oliguria.  While in the unit, patient underwent ongoing resuscitation and supportive cares.  Patient started having bloody stools with a stable hemoglobin, decision was made to stop Eliquis indefinitely.  Likely bleeding from anastomosis but not requiring urgent intervention.  Patient was transferred out of the intensive care unit to a facility.  Diet was advanced as tolerated, up to a postsurgical soft diet which she tolerated well.  Notably patient also developed pleural effusions, that required IR drainage.  Prior to discharge pain was well controlled, patient was having bowel function, denied any trouble breathing, and was having no other acute issues.  Patient was discharged in stable condition to SAR.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Enteritis, Explorative laparotomy, Haematochezia, Haemoglobin normal, Hypotension
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/29/2022 Discharge Date: Aug 11, 2022  PRESENTING PROBLEM: Acute abdominal pain  Enteritis Ischemic bowel disease Small bowel ischemia Volvulus   HOSPITAL COURSE: Patient is a 94Y female with PMH of CHF, coronary artery disease, hypertension, GERD, and AFib on Eliquis who presented with severe abdominal pain.  CT scan was concerning for possible bowel ischemia.  Originally admitted to Medicine, was made NPO and given maintenance IV fluids for bowel rest.  Started on prophylactic Zosyn.  Incidentally, patient was also found to be COVID positive.  Serial abdominal exams were done and progressed to having peritoneal signs on exam.  Extensive discussions were had with patient and family and they decided they wanted to pursue surgery despite risks.  She was taken for exploratory laparotomy on 07/30, and had an ileocecectomy with primary anastomosis.  Postoperatively, pain was well controlled and patient was given supportive care while we awaited bowel function.  Overnight on 08/01, patient was transferred to the SICU due to being hypotension and oliguria.  While in the unit, patient underwent ongoing resuscitation and supportive cares.  Patient started having bloody stools with a stable hemoglobin, decision was made to stop Eliquis indefinitely.  Likely bleeding from anastomosis but not requiring urgent intervention.  Patient was transferred out of the intensive care unit to a facility.  Diet was advanced as tolerated, up to a postsurgical soft diet which she tolerated well.  Notably patient also developed pleural effusions, that required IR drainage.  Prior to discharge pain was well controlled, patient was having bowel function, denied any trouble breathing, and was having no other acute issues.  Patient was discharged in stable condition to SAR.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Ileocaecal resection, Intensive care, Intestinal anastomosis, Intestinal ischaemia, Nothing by mouth order
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/29/2022 Discharge Date: Aug 11, 2022  PRESENTING PROBLEM: Acute abdominal pain  Enteritis Ischemic bowel disease Small bowel ischemia Volvulus   HOSPITAL COURSE: Patient is a 94Y female with PMH of CHF, coronary artery disease, hypertension, GERD, and AFib on Eliquis who presented with severe abdominal pain.  CT scan was concerning for possible bowel ischemia.  Originally admitted to Medicine, was made NPO and given maintenance IV fluids for bowel rest.  Started on prophylactic Zosyn.  Incidentally, patient was also found to be COVID positive.  Serial abdominal exams were done and progressed to having peritoneal signs on exam.  Extensive discussions were had with patient and family and they decided they wanted to pursue surgery despite risks.  She was taken for exploratory laparotomy on 07/30, and had an ileocecectomy with primary anastomosis.  Postoperatively, pain was well controlled and patient was given supportive care while we awaited bowel function.  Overnight on 08/01, patient was transferred to the SICU due to being hypotension and oliguria.  While in the unit, patient underwent ongoing resuscitation and supportive cares.  Patient started having bloody stools with a stable hemoglobin, decision was made to stop Eliquis indefinitely.  Likely bleeding from anastomosis but not requiring urgent intervention.  Patient was transferred out of the intensive care unit to a facility.  Diet was advanced as tolerated, up to a postsurgical soft diet which she tolerated well.  Notably patient also developed pleural effusions, that required IR drainage.  Prior to discharge pain was well controlled, patient was having bowel function, denied any trouble breathing, and was having no other acute issues.  Patient was discharged in stable condition to SAR.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Oliguria, Pain, Pleural effusion, Resuscitation, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/29/2022 Discharge Date: Aug 11, 2022  PRESENTING PROBLEM: Acute abdominal pain  Enteritis Ischemic bowel disease Small bowel ischemia Volvulus   HOSPITAL COURSE: Patient is a 94Y female with PMH of CHF, coronary artery disease, hypertension, GERD, and AFib on Eliquis who presented with severe abdominal pain.  CT scan was concerning for possible bowel ischemia.  Originally admitted to Medicine, was made NPO and given maintenance IV fluids for bowel rest.  Started on prophylactic Zosyn.  Incidentally, patient was also found to be COVID positive.  Serial abdominal exams were done and progressed to having peritoneal signs on exam.  Extensive discussions were had with patient and family and they decided they wanted to pursue surgery despite risks.  She was taken for exploratory laparotomy on 07/30, and had an ileocecectomy with primary anastomosis.  Postoperatively, pain was well controlled and patient was given supportive care while we awaited bowel function.  Overnight on 08/01, patient was transferred to the SICU due to being hypotension and oliguria.  While in the unit, patient underwent ongoing resuscitation and supportive cares.  Patient started having bloody stools with a stable hemoglobin, decision was made to stop Eliquis indefinitely.  Likely bleeding from anastomosis but not requiring urgent intervention.  Patient was transferred out of the intensive care unit to a facility.  Diet was advanced as tolerated, up to a postsurgical soft diet which she tolerated well.  Notably patient also developed pleural effusions, that required IR drainage.  Prior to discharge pain was well controlled, patient was having bowel function, denied any trouble breathing, and was having no other acute issues.  Patient was discharged in stable condition to SAR.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Volvulus
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/29/2022 Discharge Date: Aug 11, 2022  PRESENTING PROBLEM: Acute abdominal pain  Enteritis Ischemic bowel disease Small bowel ischemia Volvulus   HOSPITAL COURSE: Patient is a 94Y female with PMH of CHF, coronary artery disease, hypertension, GERD, and AFib on Eliquis who presented with severe abdominal pain.  CT scan was concerning for possible bowel ischemia.  Originally admitted to Medicine, was made NPO and given maintenance IV fluids for bowel rest.  Started on prophylactic Zosyn.  Incidentally, patient was also found to be COVID positive.  Serial abdominal exams were done and progressed to having peritoneal signs on exam.  Extensive discussions were had with patient and family and they decided they wanted to pursue surgery despite risks.  She was taken for exploratory laparotomy on 07/30, and had an ileocecectomy with primary anastomosis.  Postoperatively, pain was well controlled and patient was given supportive care while we awaited bowel function.  Overnight on 08/01, patient was transferred to the SICU due to being hypotension and oliguria.  While in the unit, patient underwent ongoing resuscitation and supportive cares.  Patient started having bloody stools with a stable hemoglobin, decision was made to stop Eliquis indefinitely.  Likely bleeding from anastomosis but not requiring urgent intervention.  Patient was transferred out of the intensive care unit to a facility.  Diet was advanced as tolerated, up to a postsurgical soft diet which she tolerated well.  Notably patient also developed pleural effusions, that required IR drainage.  Prior to discharge pain was well controlled, patient was having bowel function, denied any trouble breathing, and was having no other acute issues.  Patient was discharged in stable condition to SAR.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test abnormal, Pyrexia, Urinary tract infection
Clinical narrative: Hospitalization for fever post-treatment for UTI and tested positive upon admission  on dates 6/29/22-7/5/22. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.