chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Laboratory test, Urticaria
Clinical narrative: Heart Inflamation; Severe Hives; Facial Swelling; Chest Pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 at 13:00 as dose 5 (booster), single (Lot number: GJ3270) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillian" (unspecified if ongoing); "Known allergies: Sunflower" (unspecified if ongoing); "Known allergies: Eggplant" (unspecified if ongoing); "Known allergies: Fish" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Postmenopausal" (unspecified if ongoing). Concomitant medication(s) included: ZETIA; PREMARIN; BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (dose number=1,, lot number=EL9269, administration time=01:00 PM,, vaccine location=Left arm), administration date: 04Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=2,, lot number=EL9267, dose administration time=01:00 PM, vaccine location=Left arm,), administration date: 25Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number -3, booster, lot number=FC3182,administration time=01:00 PM, vaccine location=Left arm,), administration date: 19Aug2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=4, booster, lot number=FC9895,administration time=01:00 PM, vaccine location=Left arm,), administration date: 31Mar2022, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Chest Pains"; SWELLING FACE (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Facial Swelling"; MYOCARDITIS (medically significant) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Heart Inflamation"; URTICARIA (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Severe Hives". The events "heart inflamation", "severe hives", "facial swelling" and "chest pains" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown results; Electrocardiogram: unknown results. Therapeutic measures were taken as a result of myocarditis, urticaria, swelling face, chest pain.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Myocarditis, Swelling face
Clinical narrative: Heart Inflamation; Severe Hives; Facial Swelling; Chest Pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 at 13:00 as dose 5 (booster), single (Lot number: GJ3270) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillian" (unspecified if ongoing); "Known allergies: Sunflower" (unspecified if ongoing); "Known allergies: Eggplant" (unspecified if ongoing); "Known allergies: Fish" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Postmenopausal" (unspecified if ongoing). Concomitant medication(s) included: ZETIA; PREMARIN; BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (dose number=1,, lot number=EL9269, administration time=01:00 PM,, vaccine location=Left arm), administration date: 04Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=2,, lot number=EL9267, dose administration time=01:00 PM, vaccine location=Left arm,), administration date: 25Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number -3, booster, lot number=FC3182,administration time=01:00 PM, vaccine location=Left arm,), administration date: 19Aug2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=4, booster, lot number=FC9895,administration time=01:00 PM, vaccine location=Left arm,), administration date: 31Mar2022, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Chest Pains"; SWELLING FACE (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Facial Swelling"; MYOCARDITIS (medically significant) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Heart Inflamation"; URTICARIA (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Severe Hives". The events "heart inflamation", "severe hives", "facial swelling" and "chest pains" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown results; Electrocardiogram: unknown results. Therapeutic measures were taken as a result of myocarditis, urticaria, swelling face, chest pain.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Urticaria
Clinical narrative: Heart Inflamation; Severe Hives; Facial Swelling; Chest Pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 at 13:00 as dose 5 (booster), single (Lot number: GJ3270) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillian" (unspecified if ongoing); "Known allergies: Sunflower" (unspecified if ongoing); "Known allergies: Eggplant" (unspecified if ongoing); "Known allergies: Fish" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Postmenopausal" (unspecified if ongoing). Concomitant medication(s) included: ZETIA; PREMARIN; BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (dose number=1,, lot number=EL9269, administration time=01:00 PM,, vaccine location=Left arm), administration date: 04Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=2,, lot number=EL9267, dose administration time=01:00 PM, vaccine location=Left arm,), administration date: 25Feb2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number -3, booster, lot number=FC3182,administration time=01:00 PM, vaccine location=Left arm,), administration date: 19Aug2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (dose number=4, booster, lot number=FC9895,administration time=01:00 PM, vaccine location=Left arm,), administration date: 31Mar2022, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Chest Pains"; SWELLING FACE (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Facial Swelling"; MYOCARDITIS (medically significant) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Heart Inflamation"; URTICARIA (non-serious) with onset 03Jan2023 at 07:00, outcome "not recovered", described as "Severe Hives". The events "heart inflamation", "severe hives", "facial swelling" and "chest pains" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown results; Electrocardiogram: unknown results. Therapeutic measures were taken as a result of myocarditis, urticaria, swelling face, chest pain.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: broke out in shingles rash all over upper body, arms and trunk
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: broke out in shingles rash all over upper body, arms and trunk
Age: 71.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: Caller states the patient has not experienced any adverse events; Pharmacist reports the administration of MMR II to a 71 year old male patient on 16JAN2023. Caller states this was 1 year after patient received stem cell transplant; This spontaneous report was received from pharmacist and refers to a 71-year-old.  The patient's medical history included stem cell transplant on an unspecified date in January 2022. The patient's concurrent conditions, concomitant therapies and historical drug were not reported.  On 16-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) (Contraindicated product administered)  Caller states the patient has not experienced any adverse events.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events; The HCP reports that a patient was administered a dose of PROQUAD that was involved in a temperature excursion. The HCP also reported that VARIVAX had been administered (see AE case 02335887). No addi; This spontaneous report was received from a registered nurse and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 13-FEB-2023, the patient was vaccinated with an improper storage dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5ml, lot #W023869, expiration date: 24-JAN-2024 who had been verified to be a valid number administered for prophylaxis (strength and route of administration were not provided). The vaccine was storage at temperature of 14.1 degrees centigrade (C) with a time frame of 125 Hours and 59 Minutes, there was no information about previous temperature excursion.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient. Products were administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) PEDVAX HIB W021182 2/27/2025; ROTATEQ W02; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 13-FEB-2023, the patient was vaccinated with an improper storage doses of with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W021182, expiration date: 27-FEB-2025 (upon internal validation was determined to be a valid number), administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W026135, expiration date: 31-JAN-2024 (upon internal validation was determined to be a valid number), administered for prophylaxis (strength, and route of administration were not provided). The vaccines were storage at temperature above 9 degrees centigrade (13.25 C) with a time frame of 2 hours 32 minutes and 0 seconds. There was no information about previous temperature excursion (incorrect product storage). No additional adverse events.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Chills, Myalgia, Pyrexia
Clinical narrative: Pain in back, thoracic region, predominately on right side; Burning sensation; Deep muscular pain, spanning both sides of spine; tender to touch; Short duration fever; Short duration chills; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 7th February 2023, 1 days after receiving Shingrix, the patient experienced back pain, burning sensation, muscle pain and tenderness. In February 2023, the patient experienced fever and chills. On an unknown date, the outcome of the back pain, burning sensation, muscle pain and tenderness were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the back pain, burning sensation, muscle pain, tenderness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The patient was calling to report pain occurring in her back at the thoracic region.  She described it as a burning, deep, muscular pain which occurred in the thoracic region of her back, spanning both sides of her spine.  This began one day after her Shingrix vaccine dose received in left deltoid. She also stated that the area was tender to touch.  She reported that, although the pain did span both sides of her spine, it was predominately on the right side of her back.  Other adverse event reported were fever and chills of short duration. The reporter said that the burning in the back, including deep muscular pain and tender to touch remained ongoing at the time of the call.  The fever and chills were resolved and lasted about a day.  Gave medical disclaimer, read from PI, referred to healthcare professional.  Offered after-call survey.  The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pain in back, thoracic region, predominately on right side; Burning sensation; Deep muscular pain, spanning both sides of spine; tender to touch; Short duration fever; Short duration chills; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 7th February 2023, 1 days after receiving Shingrix, the patient experienced back pain, burning sensation, muscle pain and tenderness. In February 2023, the patient experienced fever and chills. On an unknown date, the outcome of the back pain, burning sensation, muscle pain and tenderness were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the back pain, burning sensation, muscle pain, tenderness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The patient was calling to report pain occurring in her back at the thoracic region.  She described it as a burning, deep, muscular pain which occurred in the thoracic region of her back, spanning both sides of her spine.  This began one day after her Shingrix vaccine dose received in left deltoid. She also stated that the area was tender to touch.  She reported that, although the pain did span both sides of her spine, it was predominately on the right side of her back.  Other adverse event reported were fever and chills of short duration. The reporter said that the burning in the back, including deep muscular pain and tender to touch remained ongoing at the time of the call.  The fever and chills were resolved and lasted about a day.  Gave medical disclaimer, read from PI, referred to healthcare professional.  Offered after-call survey.  The reporter did not consent to follow-up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33A27, expiry date 7th November 2022) for prophylaxis.   On 9th February 2023, the patient received Boostrix. On 9th 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: 09-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received expired dose of Boostrix  vaccine. The reporter did consent to follow up via email. Additional supportive information: The patient received a Boostrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult received pediatric dose; Adult received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis.   On 9th February 2023, the patient received Engerix B pediatric. On 9th February 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The only patient information the reporter had at the time of the call was that the patient was an adult female. At the time of reporting, the patient had not been re-dosed. The reporter gave permission for follow-up. Additional supportive information: An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Accidental overdose
Clinical narrative: Double Dtap dose to pediatric patient; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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-FEB-2023 Reporter's Comments:  The reporter reported that Infanrix and Pediarix were administered on the same day to a 2-month-old patient.  Lot number and expiration date information was asked but declined. The reporter was consented to follow up. Additional Supportive Information: The patient received Infanrix and Pediarix on same day, which led to accidental overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 14Feb2022, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th February 2022, batch number D4CZ3, expiry date 10th February 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Linked case(s) involving the same patient:  US2023021233   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments:  The patient reported that she was not received the second dose of Shingrix yet.  The first dose was on 14th February 2022. The reporter declined to provide more information.  Consumer disconnected call when offered to transfer.  The reporter stated she already spoke with agency, so this had already reported.  A pharmacist called to asked for information regarding patient who received the first dose of Shingrix and never got the second dose.  The pharmacist asked if patient could receive the second dose of Shingrix or if the patient had to start over with vaccination.  No other information was provided.  The reporter was consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 3 years ago, 2nd 09Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date 18th June 2024) for prophylaxis.   Previously administered products included Shingrix  (received first dose 3 years ago).   On 9th February 2023, the patient received the 2nd dose of Shingrix. On 9th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: No specific  date for first dose was reported. The reporter consented to follow-up via email. Additional supportive information: The patient received second dose of Shingirx later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired Pediarix administered; 1st or 2nd dose administered to a 6 months-old; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 934NJ, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the expired vaccine used and inappropriate schedule of vaccine administered 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: 9-Feb-2023 Reporter's comment: The patient's mother mentioned  that she thought this was the 1st or 2nd dose that the patient had received, but she was not sure, as the dose schedule was at 2, 4 and 6 months of age. The reporter also did not had the name of the product administered only the lot and she thought was administered in the patient 's right thigh muscle, but she was not sure. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Pediarix followed inappropriate schedule, which led to expired dose used and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 14Feb2022, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments:  The patient self-reported this case. The patient stated that she had her 1st dose of Shingrix vaccine. The patient explained during the call that she was not received the 2nd dose yet. The reporter refused to provide name DOB or demographics.  The patient inquired if she should start again the 1st dose of Shingrix or continue and get the 2nd dose even after almost a year.  No additional information was provided for adverse event report.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Age: 1.42
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Boostrix instead of DTap dose; Boostrix administered to a 17 months-old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 345R4, expiry date 9th February 2023) for prophylaxis.   On 9th February 2023, the patient received Boostrix. On 9th February 2023, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: A registered nurse called in to report that a patient was accidentally administered a dose of Boostrix instead of a dose of DTap.  The reporter called in to receive information about how to proceed and to know if there would be other adverse effects.  The reporter provided adverse event report information and details about the patient.  The reporter was then escalated to second line. During the call, a myriad of audio issues were present. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received Bostrix instead of DTap at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Engerix B. On 20th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: 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 Engerix-B, which led to expired vaccine used.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th 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: 9-Feb-2023 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix earlier on the day of reporting, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: mixed Menveo with sterile water; mixed Menveo with sterile water administration; This case was reported by a other health professional 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 MAA902A, expiry date 31st January 2024) and (batch number AMXA902A, expiry date 20th February 2025) for prophylaxis.   On 3rd February 2023, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 3rd February 2023, 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: 10-Feb-2023. Reporter's Comment: Medical assistant reported having mixed Menveo with sterile water. Additional adverse event details unavailable at this time per HCP. Lot number MAA902A was reported by HCP, batch number not found by medical information agent. HCP gave consent for safety team follow up. Additional Supportive Information: Patient received mixed Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments: inappropriate preparation of medication and inappropriate dose of vaccine.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 9th February 2023, the patient received Havrix. On 9th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: The reporter asked if the patient had to be revaccinated. The reporter consented to follow-up. Additional Supportive Information:Patient received an expired Havrix dose, which led to expired vaccine used.
Sex: U
Vaccine: COVID19-2
Symptoms: Hospitalisation
Clinical narrative: child that ended up in the hospital for two weeks after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (child that ended up in the hospital for two weeks after the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.  Company comment- This is a spontaneous case of a child of unknown age and gender, with no reported medical history, who experienced the unexpected serious (hospitalization) event of hospitalisation after a dose of mRNA-1273.222 vaccine was administered. It was reported that child ended up in the hospital for two weeks after vaccine. No further details regarding clinical course, diagnosis, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-710268 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710268:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: Heart valve replacement, Lung disorder, Sepsis
Clinical narrative: sepsis; lung problems; open heart surgery with 2 valve replacements; This spontaneous case was reported by a patient and describes the occurrence of SEPSIS (sepsis), LUNG DISORDER (lung problems) and HEART VALVE REPLACEMENT (open heart surgery with 2 valve replacements) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1 (Primary series)) in February 2021, Moderna Covid-19 vaccine (Dose 2 (Primary series)) in March 2021 and Moderna Covid-19 vaccine (Booster Dose) in October 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    In September 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (sepsis) (seriousness criteria medically significant and life threatening), LUNG DISORDER (lung problems) (seriousness criterion life threatening) and HEART VALVE REPLACEMENT (open heart surgery with 2 valve replacements) (seriousness criterion life threatening). At the time of the report, SEPSIS (sepsis) was resolving and LUNG DISORDER (lung problems) and HEART VALVE REPLACEMENT (open heart surgery with 2 valve replacements) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient Age or age group was unknown.  Concomitant product use was not provided by the reporter.  spouse told that he had open heart surgery with 2 valve replacements along with some lung problems, and sepsis. He almost died. This was a time when all of the hospitals did not had any non-Covid beds.  Treatment information was not provided.  Company Comment: This is a Spontaneous case reported by a patient, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to life-threatening and medically significant) event of Sepsis, and the unexpected and serious (due to life-threatening) events of Lung disorder and Heart valve replacement, which occurred after mRNA-1273.222 vaccine, administered as fourth dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed.  At the time of the report, Sepsis was resolving, and Lung disorder and Heart valve replacement outcome was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose was administered to 2 patients, 2 days after the vial expiration date on 2/14/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients, 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients on 015B22A 2 days after the vial expiration date on 2/14/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients on 015B22A 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients  2 days after the vial expiration date on 2/14/23).    No concomitant medications were provided.  No treatment medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-710659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710659:Patient 2 out of 2
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; dose was administered 2 days after the vial expiration date on 2/14/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23).    Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710657.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710657:Patient 1 out of 2
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: Covid-19; felt a little sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) and MALAISE (felt a little sick) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19) and MALAISE (felt a little sick). At the time of the report, COVID-19 (Covid-19) and MALAISE (felt a little sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Concomitant medications of Antihypertensives. It was reported that the patient was extremely healthy. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the Moderna Covid-19 vaccine for his Primary Series and booster shots. The patient received his flu shot around the same time as his Moderna Covid-19 booster shot. Treatment information was not provided.   This case was linked to MOD-2023-710668 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration interrupted, Vaccination complication
Clinical narrative: Limited AE; Patient seeking 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose). At the time of the report, VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient received 1st dose of primary series of Moderna Covid-19 on 21Dec2021. Patient seeking 2nd dose.  Treatment Medication use information was not provided by reporter.   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received her first dose on January 4, 2022, second dose on March 25, 2022; No other Adverse Reactions reported; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 067F21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: MODERNA COVID-19 VACCINE (Dose no. 1, Batch no. 012F21A and Right arm of administration) on 04-Jan-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.    On 25-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022) and NO ADVERSE EVENT (No other Adverse Reactions reported) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No other Adverse Reactions reported) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first dose on January 4, 2022, second dose on March 25, 2022).    No other adverse reactions were reported after both the doses.  No concomitant medication reported. No treatment medication reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine).    This case contains the information of male patient.  Concomitant medications were not reported.  Nurse was calling to report that 2 patients (Male 5 and female 4 -year-old) received expired 2nd dose Monovalent Moderna COVID-19 vaccine.  Monovalent 6M-5Y was administered to the patients.  Individual vials or intact cartons : 1 vial inside open cartons.  Vial size was reported as 0.4 mL, 2.5 mL or 5.5 mL*: 2.5 ml.  The date vial was initially stored in the refrigerator was 14-FEB-2023. The vial did not undergone any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710745 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710745:Female case