chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reporting a temperature excursion for GARDASIL9 RECOMBIVAX ROTATEQ VAQTA that occurred on 12/16/2022 states it is unknown at time of call if any products have been administered.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information regarding the patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies provided.  On unspecified date, the patients were vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, route of administration, vaccination scheme were not provided; lot number 1775808 that was verified to be valid, expiration date reported and established as 20-AUG-2023); hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023);hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023) (strengths, doses, routes of administration and vaccination schemes were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration, at a dose of 2 ml (lot number 1837117 that was verified to be valid,  expiration date reported and established as 3/24/2023) (strength and vaccination scheme were not provided)(product storage error). All of the vaccines were administered as prophylaxis.  The administered doses of the vaccine were stored at a temperature of 27.03 degrees Fahrenheit (F) during a time frame of  6 minutes, and it was mentioned that the temperature excursion occured on 16-DEC-2022. There was no previous temperature excursion. No additional adverse events were reported.    Follow-up information has been received on 24-FEB-2023.  Patient's demographics have been provided, referring a 13-year-old female patient. Suspect vaccine was updated to only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), vaccination anatomical location left deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shot and still got the shingles/Suspected vaccination failure; Still got the shingles; painful; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The patient stated that after received Shingles vaccine still he/she experienced shingles which was miserable and painful. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza, Vaccination failure
Clinical narrative: Got Shingrix twice, got shingles anyway/Suspected vaccination failure; got the shingles; Flu, very unpleasant; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and influenza. On an unknown date, the outcome of the vaccination failure, shingles and influenza were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and influenza to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine twice and got the shingles anyway. The patient also came down with the flu which was very unpleasant. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots. Still got shingles/suspected vaccination failure; shingles/Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's aunt) had the shots and guess what, still got shingles, that's why people were laughing. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034316, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR034316:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034315, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR034315:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with other sterile diluent; Reconstituted with other sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 31st December 2023) for prophylaxis.   On 23rd February 2023, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter did not consent to follow-up. Additional Supportive Information: The nurse reported that Menveo was reconstituted with other sterile diluent instead of the one supplied, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 month old was administered an adult dose; 18 month old was administered an adult dose; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 18-month-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were 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: 24-FEB-2023 Reporter's comment: The reporter consented to follow up with the clinic manager via email. Additional supportive information: 18 month old patient was inadvertently administered an adult dose of Havrix, which had led to accidental overdose and adult product administered to child.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Twinrix and Twinrix 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: 24-FEB-2023 Reporter's comment: The reporter asked how to proceed with the patient and requested safety information of two doses of Twinrix given the same day. The reporter consented to follow up. The HCP did not confirmed if the patient would receive the non-expired Twinrix dose on the same day. Additional Supportive Information: The nurse reported that an expired Twinrix dose was administered to the patient, which led to expired vaccine used.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: given a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 24th February 2023, the patient received Boostrix. On 24th February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-Feb-2023  Reporter's comment: The healthcare professional reported that earlier on the day of reporting, a patient was given a dose of Boostrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered with expired Boostrix vaccine, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired havrix vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Havrix and Havrix 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: 24-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient inadvertently received an expired dose of Havrix vaccine. The reporter consented to follow up. Follow-up via email would be okay. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 13-MAR-2021 and second dose on 18-APR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a, 001b01a, 061e21A and 005M21A) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer stage I (19 years ago, radiation but no chemo). Concurrent medical conditions included Drug allergy.   On 13-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022 at 12:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021 at 2:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-MAR-2021 and second dose on 18-APR-2021) 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 (First dose on 13-MAR-2021 and second dose on 18-APR-2021).    DOB was reported. No concomitant information was provided. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: She got high blood pressure after receiving the second COVID shot which was Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (She got high blood pressure after receiving the second COVID shot which was Moderna vaccine) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (She got high blood pressure after receiving the second COVID shot which was Moderna vaccine). At the time of the report, HYPERTENSION (She got high blood pressure after receiving the second COVID shot which was Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High blood pressure.         No concomitant product reported by reporter.  No treatment medication reported by reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Nurse reports RECOMBIVAX HB that expired 1/25/2023 was administered to one patient today 2/3/2023. Product has been stored at the appropriate storage condition, specified in the product label, through the date of administration. No additional AE deta; This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications  On 03-FEB-2023, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot  T025374, for prophylaxis (route of administration was not reported).  The dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) expired on 25-JAN-2023. Product had been stored at the appropriate storage condition, specified in the product label, through the date of administration.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: experienced shingles after vaccine/ suspected vaccination failure; shingles; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The nurse practitioner reported to a field representative that a patient experienced shingles while taking Nucala. The patient did receive the shingles vaccine, but it was not specified which one.  No further information was provided. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked with US2023031990 reported by same reporter. Note: The suspect Nucala was not captured in the case as separate case was created for the same.; Sender's Comments:  US-GSK-US2023031990:same reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, Hypoacusis, Pyrexia, Tinnitus
Clinical narrative: HEARING DAMAGE(LEFT EAR); FEVER; TINNITUS; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 2021, Laboratory data included: Hearing test Not reported (the hearing test has not changed and this was happening in her left ear). On NOV-2021, the patient experienced hearing damage (left ear). On NOV-2021, the patient experienced fever. On NOV-2021, the patient experienced tinnitus. Laboratory data included: Body temperature Fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hearing damage(left ear), and tinnitus, and the outcome of fever was not reported. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023).    No concomitant medications were reported.  It was reported that, the patient received the COVID vaccine a couple days after the BUD. The vial was initially stored in the fridge on 18-Jan-2023 and 20-Jan-2023. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713016 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2023: Follow-up information received includes patient demographics (initial, DOB and gender), vaccine start date, and event onset date were added. I-narrative supplement was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713016:Master case (child case)
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received  on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).  This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received a Pentacel vaccination that was expired with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received a diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccination that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jul-2022, the patient received 0.5 ml Once (1x) (total) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength and lot number not reported; Expiration Date :09-Jul-2022) via unknown route in unknown administration site for Immunization that was expired with no reported adverse event (expired product administered) (latency: same day). Patient  received a PENTACEL vaccination on 12-JUL-2022 that had expired on 09-JUL-2022. Reporter states that she is in clinic today and could not provide any additional information about the patient that received the expired PENTACEL vaccine on 12JUL2022 or the lot number of the PENTACEL  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 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: having large bruising to left deltoid with pain and itching and burning with intermittent tingling down arm
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea exertional, Fatigue, Spirometry
Clinical narrative: FATIGUE AND DYSPNEA ON EXERTION EVER SINCE GETTING COVID VACCINE
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Bronchitis, Chest X-ray, Fatigue, Full blood count normal
Clinical narrative: EVER SINCE GETTING THE BOOSTER (MODERNA FELT FATIGUED, AND BOUTS OF BRONCHITIS.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased, Metabolic function test normal
Clinical narrative: EVER SINCE GETTING THE BOOSTER (MODERNA FELT FATIGUED, AND BOUTS OF BRONCHITIS.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have reported this to XXXX twice but both times the report ended with XXXX stating they would investigate and get back with me. Issue: XXXX administered my 2nd dose of the Twinrix vaccine, but that dose was never recorded. 4/21/2022: I initiated the series of 3 Twinrix vaccine doses. XXXX in XXXX 7/12/2022: I was late to return and receive my 2nd dose. XXXX in XXXX around 10-11 AM. 7/13/2022: I called XXXX to inquire if I should get my 3rd dose on the original schedule (6 months from the first dose, roughly 10/21/2022) or wait 5 months after my 2nd dose (roughly 12/12/2022). The pharmacist on the phone advised me that I should wait 5 months. 12/14/2022: I returned for my 3rd dose XXXX in XXXX I was informed that there was no record of my 2nd dose. The pharmacist further informed me that he could not administer a 3rd or 2nd dose. He stated that I needed to wait 1 year from my first dose (4/21/2023) to start over. Base on my frustration that the record of the 2nd does was lost, he advised me to go back to the XXXX location to investigate the missing dose. I stated that I would, and asked him to do the same, suggesting to him that his ties with XXXX authority should offer better path of investigation than me. He agreed (seemingly reluctantly), but I never hear back from him. 12/20/2022: I called XXXX at 3:00PM to report the issue. 12/20/2022: XXXX returned my call XXXX at 6:34PM. After I gave the gentleman on the phone a complete explanation of events, he stated he would investigate and let me know what he found out. He also advised me, that the pharmacist at certain location was incorrect, and that I could pursue a 3rd dose immediately without a record of the second dose. I asked him, and he confirmed with me that he was a pharmacist. I thanked him and responded that I would very much like the record/evidence of my 2nd dose found, so that I could have a full vaccine record of the doses, in addition to my knowledge that I received all three doses. He understood and told me he would investigate and let me know.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Got my Moderna COVID 19 shot booster (3rd shot) yesterday. Had small headache most of the day then suddenly before bed got dizzy/nauseated and faint feeling. My hands/arms and feet/legs went tingly, numb and weak. My jaw and throat hurt badly and I had a slight shortness of breath.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain in jaw, Paraesthesia
Clinical narrative: Got my Moderna COVID 19 shot booster (3rd shot) yesterday. Had small headache most of the day then suddenly before bed got dizzy/nauseated and faint feeling. My hands/arms and feet/legs went tingly, numb and weak. My jaw and throat hurt badly and I had a slight shortness of breath.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Patient states they experienced arthritis pain in their hands and a possible flare-up of Multiple Sclerosis symptoms after receiving this medication. Patient did consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Patient stated they were on therapy with Gilenya for an estimated 10 years. During this time, they experienced multiple relapses and possible growth in lesions. Patient also experienced arthritis pain in their hands while on this medication after receiving their Moderna COVID vaccines; reported by patient
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Called and Paramedic assitances arrived on site to evaluate patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer  4/26/21  EW0161 dose 2 Pfizer  5/17/21  EW0179
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, Fatigue
Clinical narrative: Discharge summary: "Patient is a 74-year-old female with a past medical history of Graves disease, hypertension being admitted with COVID pneumonia. Pt's husband was sick a couple of weeks ago, and last week she started feeing ill. SHe has had progressive SOB and coughing, associated with significant fatigue and exhaustion. SHe has body aches and everything smells weird. She has a hx of smoking. Patient denies chest pain, abdominal pain, nausea vomiting diarrhea constipation, swelling, rash, fevers.  No focal weakness.   She is vaccinated against COVID x2. "
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Parosmia, SARS-CoV-2 test positive
Clinical narrative: Discharge summary: "Patient is a 74-year-old female with a past medical history of Graves disease, hypertension being admitted with COVID pneumonia. Pt's husband was sick a couple of weeks ago, and last week she started feeing ill. SHe has had progressive SOB and coughing, associated with significant fatigue and exhaustion. SHe has body aches and everything smells weird. She has a hx of smoking. Patient denies chest pain, abdominal pain, nausea vomiting diarrhea constipation, swelling, rash, fevers.  No focal weakness.   She is vaccinated against COVID x2. "
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test negative, Upper respiratory tract infection
Clinical narrative: I experienced a cough that would not go away when I went to the doctor the diagnosed it as a upper respiratory infection.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered
Clinical narrative: Patient received expired ActHIB, will repeat dose.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Discomfort, Muscle spasms, Poor feeding infant, Sleep disorder
Clinical narrative: Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no color change or weakness Could not breastfeed due to spasms Parents called on call Nurse and spoke with on Call Doctor, given option to  monitor at home or go to ER. Parents chose to monitor at home over night
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood bilirubin increased, Blood test, Malaise, White blood cell count decreased
Clinical narrative: Low white blood cell count: High belly Reuben: generally, wasn't feeling well low energy.
Age: 74.0
Sex: U
Vaccine: UNK
Symptoms: Breakthrough COVID-19
Clinical narrative: Got covid, was vaccinated.
Age: 69.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Vaccinated and contracted COVID
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram, Angiogram cerebral abnormal, Anticoagulant therapy, Arteriogram carotid abnormal, Blood test abnormal
Clinical narrative: 11/20/22 I was hearing a whooshing sound in my left ear, like your heartbeat. I went to see an ENT, had testing and had an appointment already scheduled with a Neurologist who did more testing. I had an MRI of the brain, MRA and MRI of the neck, Ultrasound of the Carotid and found an aneurysm. My diagnosis was a dissecting aneurysm of the left cervical ICA just below the base of the skull, 10mm x 7mm. After the results, my brother-in-law who is a Neurologist told me to go the ER. I ended up testing positive for COVID on 12/11/22. On 12/16/22 I went to the ER and spent 3 days in the hospital. The same tests were run, MRI and MRA and confirmed the diagnosis. They determined it was acute rather than chronic. I was started on PLAVIX and aspirin and sent home. I have continued to have testing and have an appointment with the Neurologist this week. I did have a follow up MRI that showed no change.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Carotid artery dissection, Computerised tomogram neck, Magnetic resonance imaging abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: 11/20/22 I was hearing a whooshing sound in my left ear, like your heartbeat. I went to see an ENT, had testing and had an appointment already scheduled with a Neurologist who did more testing. I had an MRI of the brain, MRA and MRI of the neck, Ultrasound of the Carotid and found an aneurysm. My diagnosis was a dissecting aneurysm of the left cervical ICA just below the base of the skull, 10mm x 7mm. After the results, my brother-in-law who is a Neurologist told me to go the ER. I ended up testing positive for COVID on 12/11/22. On 12/16/22 I went to the ER and spent 3 days in the hospital. The same tests were run, MRI and MRA and confirmed the diagnosis. They determined it was acute rather than chronic. I was started on PLAVIX and aspirin and sent home. I have continued to have testing and have an appointment with the Neurologist this week. I did have a follow up MRI that showed no change.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: 11/20/22 I was hearing a whooshing sound in my left ear, like your heartbeat. I went to see an ENT, had testing and had an appointment already scheduled with a Neurologist who did more testing. I had an MRI of the brain, MRA and MRI of the neck, Ultrasound of the Carotid and found an aneurysm. My diagnosis was a dissecting aneurysm of the left cervical ICA just below the base of the skull, 10mm x 7mm. After the results, my brother-in-law who is a Neurologist told me to go the ER. I ended up testing positive for COVID on 12/11/22. On 12/16/22 I went to the ER and spent 3 days in the hospital. The same tests were run, MRI and MRA and confirmed the diagnosis. They determined it was acute rather than chronic. I was started on PLAVIX and aspirin and sent home. I have continued to have testing and have an appointment with the Neurologist this week. I did have a follow up MRI that showed no change.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Covid vaccine and got covid.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: + COVID-vaccinated
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus / ringing in ears. All the time. It never stops.
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Gait inability, Nausea, Vomiting
Clinical narrative: within 2 hours  of vaccine got  nauseous, vomiting, dizzy and not able to walk.  Had to call 911 adn hospitalized for 2 days
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Blood culture positive, Confusional state, Culture urine, Decreased activity
Clinical narrative: She was a little incoherent decreased activity loss of motivation overall very confused. I then contacted the doctor recommended a neurologist, but we haven't don't that yet and did a urine culture, but we don't have the results back just yet.  The doctor did give her antibiotics for I think a UTI, but I am not sure. We thought the UTI was causing the confusion. I did take her to the ER on 02/18 because I thought she had another UTI, but they said she didn't have a UTI. They said it was something in her blood culture and they gave antibiotics and retested three days later, and it was cleared up.