chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No additional AE; HCP calling to report 5 doses of pediatric doses were accidentally administered to adult patients. Permission to contact HCP was granted. See AE Case 02526665, 02526668, 02526670 and 02526672 filed. No additional information provided. No additional A; This spontaneous report was received from a physician and refers to a patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.  On 13-NOV-2023 the adult patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # W029899 and expiration date 16-MAY-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (incorrect dose administered and no adverse event). ; Sender's Comments:  US-009507513-2312USA010778:02526668
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD  x018730  1/6/2025 Temperature 17.2F Time frame 50 Mi; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-DEC-2023 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X018730 and expiration date 06-JAN-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 50 minutes in 17.2 Fahrenheit degrees (product storage error and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 27-DEC-2023 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X018730 and expiration date 06-JAN-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 50 minutes in 17.2 Fahrenheit degrees (product storage error and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2023, the patient was vaccinated with improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, valid lot #X018730, expiration date: 05-JAN-2025 (strength, and route of administration were not provided) administered as prophylaxis (product storage error). Temperature was reported as 17.2 Fahrenheit (F) and time frame was reported as 50 minutes. No previous temperature excursion were reported. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; HCP reported AE on behalf of an adult patient who was inadvertently administered pediatric dose of RECOMBIVAXHB on 8/7/2023. No symptoms reported. Obtained consent to contact HCP. MIR Filed (Case #02528796). No additional AE/PQC.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 07-AUG-2023 the adult patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 milliliter for prophylaxis (dose number, route and site of administration, lot number and expiration date were not provided) (incorrect dose administered and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reported PROQUAD was administered after expiration; confirmed product has been stored according to PI. No additional AE/no PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 02-JAN-2024, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, recombinant human albumin (rHA) lot # W017568 with expiration date 29-NOV-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was reported that the vaccine had been stored according to product information (reported as "PI"). No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 Year Old Received Heplisav-B; Initial report received on 11-Dec-2023  A nurse reported that a 15-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was not reported. Allergies were reported as unknown.  Concomitant medications at the time of vaccination were not reported.   On an unknown date, the 15-year-old patient received a dose of HEPLISAV-B (route, lot #, and expiration date not reported; NDC #43528-002-01).   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Haemorrhage subcutaneous
Clinical narrative: I have some bleeding under the skin on the arm; Redness; This non-serious case was reported by a consumer and described the occurrence of redness in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunosuppression (am immune suppressed). Concomitant products included RSV vaccine.   On 27-DEC-2023, the patient received Shingles vaccine. On 01-JAN-2024, 5 days after receiving Shingles vaccine, the patient experienced redness (Verbatim: Redness). On an unknown date, the patient experienced hemorrhage subcutaneous (Verbatim: I have some bleeding under the skin on the arm). The outcome of the redness was not resolved and the outcome of the hemorrhage subcutaneous was not reported.   It was unknown if the reporter considered the redness and hemorrhage subcutaneous to be related to Shingles vaccine.     It was unknown if the company considered the redness and hemorrhage subcutaneous to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-JAN-2024 The patient had some bleeding under the skin on the arm was vaccinated in (Outputs under skin of arm vaccination was in). The symptoms were not treated. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Neck pain, Nerve compression
Clinical narrative: Extreme neck pain; Muscle spasms; impinging on nerves; This non-serious case was reported by a other health professional and described the occurrence of neck pain in a 75-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-JAN-2024, the patient received Shingles vaccine. On 05-JAN-2024, 1 days after receiving Shingles vaccine, the patient experienced neck pain (Verbatim: Extreme neck pain), muscle cramp (Verbatim: Muscle spasms) and nerve injury (Verbatim: impinging on nerves). The outcome of the neck pain, muscle cramp and nerve injury were not resolved.   It was unknown if the reporter considered the neck pain, muscle cramp and nerve injury to be related to Shingles vaccine.  It was unknown if the company considered the neck pain, muscle cramp and nerve injury to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 6-JAN-2024 The reporter had extreme neck pain, muscle spasms impinging on nerves causing extreme pain in neck. The patient never had negative response to any vaccine.  His neck muscle spasms were like a serious injury but he had not been injured. The symptoms were not treated. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant female; patient less than 60 years of age; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 26-DEC-2023, the patient received Arexvy .5 ml. On 26-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient less than 60 years of age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant female). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Lost to follow up Delivery Notes: The patient was 35 weeks pregnant at the time of event onset.   Additional Information: GSK Receipt Date: 04-JAN-2024 A pharmacist reported that Arexvy was administered as a single dose to a pregnant patient at 35 weeks gestation.  No adverse events reported; however, Arexvy was not indicated for maternal use or in patients less than 60 years of age, which led to inappropriate age at vaccine administration. The reporter denied consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: pain at the injection; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy .5 ml. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at the injection). The outcome of the injection site pain was resolved (duration 4 weeks).   It was unknown if the reporter considered the injection site pain to be related to Arexvy.  It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-JAN-2024 The patient given one dose of Arexvy and had continued to have pain at the injection site for 4 weeks post injection.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy was administered to a patient before of the approved recommended age/administered to a 34-week pregnant patient; Arexvy was administered to a patient before of the approved recommended age; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GG5HR, expiry date 29-MAR-2025) for prophylaxis.   On 28-DEC-2023, the patient received Arexvy. On 28-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was administered to a patient before of the approved recommended age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a patient before of the approved recommended age/administered to a 34-week pregnant patient). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-Jan-2024 The reporter reported that the 34-week pregnant patient received Arexvy vaccine. The reporter stated that the Arexvy vaccine administered to a patient before of the approved recommended age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Age: 53.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: experiencing chills after the second dose of Shingrix; Consumer stated receiving the first dose of Shingrix back on 8/4/2021 and then received the second dose on 10/14/2023.; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th August 2021).   On 14-OCT-2023, the patient received the 2nd dose of Shingrix and COVID-19 vaccine. On 14-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Consumer stated receiving the first dose of Shingrix back on 8/4/2021 and then received the second dose on 10/14/2023.). In OCT-2023, the patient experienced chills (Verbatim: experiencing chills after the second dose of Shingrix). In OCT-2023, the outcome of the chills was resolved. The outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Additional Information: RA Receipt Date: 03-JAN-2024 The reporter called to inquire that since the second dose was over the 6 months, did he need another dose of Shingrix. The pharmacist told the consumer/patient that they did not need to repeat any dose, but consumer wanted to make sure with RA. The reporter reported experienced chills after the second dose of Shingrix and stated they also received the COVID Booster vaccine dose the same day right after Shingrix vaccine.  The chills went away in a couple of hours of receiving vaccines. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. It was unknown if the reporter considered the chills to be related to Covid-19 vaccine. The consent to follow up requested.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: male patient was administered an expired hiberix vaccine inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 7SZ57, expiry date 30-DEC-2023) for prophylaxis.   On 04-JAN-2024, the patient received Hiberix (right thigh). On 04-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: male patient was administered an expired hiberix vaccine inadvertently). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 4-JAN-2024 A medical assistant reported a patient was administered an expired hiberix vaccine inadvertently, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: request information for potential extra doses of Arexvy being administered to patients; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patients experienced extra dose administered (Verbatim: request information for potential extra doses of Arexvy being administered to patients). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 04-JAN-2024 A healthcare professionals requested information for potential extra doses of Arexvy being administered to patients, which led to extra dose administered. There was a possibility of it taking place and they accepted medical information but the report was not filed at the time of the call. Quality control reached out to mention that an adverse event could had taken place and that a deviation had to be raised. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received Arexvy second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 42B52) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 04-JAN-2024, the patient received the 2nd dose of Arexvy. On 04-JAN-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy second dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 The pharmacist called to report a second dose was given today (on the day of reporting) after the patient received a dose on 29th November 2023, which led to an extra dose administered. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. The case had been linked to the case US2023133480, reported by the same reporter.; Sender's Comments:  US-GSK-US2023133480:Same patient
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: administered a dose of Arexvy without reconstituting with the antigen powder, so the patient received only the liquid adjuvant; administered a dose of Arexvy without reconstituting with the antigen powder, so the patient received only the liquid adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3N3CT, expiry date 29-JAN-2025) and (batch number 54H92, expiry date 29-JAN-2025) for prophylaxis.   On 04-JAN-2024, the patient received Arexvy. On 04-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered a dose of Arexvy without reconstituting with the antigen powder, so the patient received only the liquid adjuvant) and inappropriate dose of vaccine administered (Verbatim: administered a dose of Arexvy without reconstituting with the antigen powder, so the patient received only the liquid adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 The manager reported that one of her nurses administered a dose of Arexvy without reconstituting with the antigen powder, so the patient received only the liquid adjuvant which led to preparation of medication and inappropriate dose of vaccine administered. She stated one part of the lot number is for the adjuvant and one part was for the antigen. She confirmed that the product was Arexvy. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: an expired Engerix B vaccine to a 9 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-month-old patient who received HBV (Engerix B) (expiry date 22-DEC-2023) for prophylaxis.   On 03-JAN-2024, the patient received Engerix B. On 03-JAN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: an expired Engerix B vaccine to a 9 month old). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 and 05-JAN-2024: The nurse reported that the patient was given expired Engerix-B vaccine which led to expired vaccine used. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Infanrix stored at minus 2.4 C for 4 hrs 8 mins; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 15-month-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 29-DEC-2023, the patient received Infanrix. On 29-DEC-2023, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Infanrix stored at minus 2.4 C for 4 hrs 8 mins). The outcome of the incorrect storage of drug 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: 04-JAN-2024. The registered nurse requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 degree C for 4 hours 8 minutes. The patient received Infanrix which was not stored as per recommended storage condition, which led to incorrect storage of drug. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024001091:same reporter US-GSK-US2024001096:Same reporter/diferent product US-GSK-US2024001092:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product US-GSK-US2024001095:Same reporter/diferent product
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: RN requests stability data on Bexsero, Menveo (1 vial), Menveo (2 vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4C x 4 hrs 8 mins; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 29-DEC-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: RN requests stability data on Bexsero, Menveo (1 vial), Menveo (2 vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4C x 4 hrs 8 mins). The outcome of the incorrect storage of drug 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: 4-JAN-2024 A registered nurse (RN) requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 degrees Celsius for 4 hours 8 minutes on 29th December 2023. Infanrix, Kinrix, Bexsero, Menveo (1), Flulaval, Pediarix were administered to patients. The patient received Kinrix vaccine after temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of the 7 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2024001091:Same reporter/diferent product US-GSK-US2024001096:Same reporter/diferent product US-GSK-US2024001089:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product US-GSK-US2024001095:Same reporter/diferent product
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Pediarix stored at minus 2.4 C for 4 hrs 8 mins; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 04-JAN-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Pediarix stored at minus 2.4 C for 4 hrs 8 mins). The outcome of the incorrect storage of drug 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: 04-JAN-2024. The registered nurse requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 degree C for 4 hours 8 minutes. The patient received Pediarix which was not stored as per recommended storage condition, which led to incorrect storage of drug. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024001091:Same reporter/diferent product US-GSK-US2024001096:Same reporter/diferent product US-GSK-US2024001092:Same reporter/diferent product US-GSK-US2024001089:Same reporter/diferent product
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not receive the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received one dose of Hepatitis A vaccine back in 2013).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: Did not receive the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2024 The pharmacist reported patient had received first dose of Hepatitis A vaccine in 2013 but did not receive the second dose and she want to know if it was okay to administer Twinrix when she received one dose of Hepatitis A 13 years ago. The patient wants to get the Hepatitis B vaccine, but her insurance would cover only Twinrix. The reporter did not know which Hepatitis A vaccine the patient received so it could have been the Havrix. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis A vaccine, which led to incomplete course of vaccination. The reporter consented to follow up via postal.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received 1st dose of Twinrix on October 5th 2023 and never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received 1st dose of Twinrix on October 5th 2023 and never got the 2nd dose). The outcome of the incomplete course of vaccination 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: 05-JAN-2024 Till the time of reporting, the patient did not receive the 2nd dose of Twinrix , which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: a nurse give a patient a Vaxelis and Hep B at same time; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: a nurse give a patient a Vaxelis and Hep B at same time). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 5-JAN-2024 The reporter stated that she had a nurse who gave a patient a Vaxelis and Hepatitis B at same time and wanted to know what precautions to take and if would be harmful to the patient. The patient received Vaxelis and Hepatitis B vaccine at same time, which led to extra dose administered. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine/the 2nd dose of Shingrix in August 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix on the year 2018).   In AUG-2023, the patient received the 2nd dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine/the 2nd dose of Shingrix in August 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported an adverse event for Shingrix vaccine. The patient was not informed that she needed a 2nd dose of the vaccine. The patient received the 2nd dose of Shingrix in August 2023. The patient received the vaccines at a local pharmacy and no additional information was provided. Not all information was available and lot and expiration date were unknown. Consent for follow up was not requested. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Death
Clinical narrative: died; This serious case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 04-JAN-2024, the patient received the 1st dose of Arexvy. On 04-JAN-2024, 2 hrs after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: died) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Arexvy.     It was unknown if the company considered the unknown cause of death to be related to Arexvy.   Additional Information: GSK receipt date: 08-JAN-2024 Pharmacist stated that the adverse event was reported to the pharmacist by the daughter of the deceased.   The reported stated that he was informed that a patient had the Arexvy and 2 hours later she died.  No further information was known. The reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Developed a 6 inch by 3 inch area of bruising at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Developed a 6 inch by 3 inch area of bruising at the injection site). The outcome of the injection site bruising was resolved.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.     It was unknown if the company considered the injection site bruising to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-Jan-2024 The reporter was the patient's husband.  The reporter reported that the patient received Shingrix dose in early December 2023. The patient developed a 6 inch by 3 inch area of bruising at the injection site.  The bruise resolved after a few weeks Nothing else was reported. The reporter did not consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: The patient had received a dose of Engerix-B that had expired a month and some days before the date of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: The patient had received a dose of Engerix-B that had expired a month and some days before the date of administration). 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: 08-Jan-2024 The reporter reported that some days ago the patient received dose of Engerix B that had expired a month and some days before the date of administration, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Hot flush, Nasal congestion, Rhinorrhoea
Clinical narrative: Headache; Runny nose; cough; stuffy nose; hot rosy face cheeks.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RHINORRHOEA (Runny nose), COUGH (cough), NASAL CONGESTION (stuffy nose) and HOT FLUSH (hot rosy face cheeks.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Biontech (dose no. 1, batch no.: EL9261, location of injection : left arm, vaccine administration time : 1:15 P.M) on 06-Feb-2021, Pfizer Biontech (dose no. 2, batch no.: EN6203, location of injection : left arm, vaccine administration time : 1:15 P.M) on 21-Feb-2021, Pfizer Biontech (dose no. 4, batch no.: FM9553, location of injection : left arm, vaccine administration time : 12:00 P.M) on 16-May-2022, Pfizer Biontech (dose no. 5, batch no.: 6H9694, location of injection : left arm, vaccine administration time : 12:00 P.M) on 08-Sep-2022, Pfizer Biontech (dose no. 3, batch no.: FF8841, location of injection : left arm, vaccine administration time : 12:00 P.M  and); for COVID-19 prophylaxis: Moderna bivalent (Dose Number: 6 Batch/Lot No: AS71728B Location of injection: Arm Left Vaccine Administration Time: 01:00 PM) on 16-Jan-2023. Past adverse reactions to the above products included No adverse event with Moderna bivalent, Pfizer Biontech, Pfizer Biontech, Pfizer Biontech, Pfizer Biontech and Pfizer Biontech. Concurrent medical conditions included Heart disease, unspecified (Heart disease).    On 23-Sep-2023 at 1:00 PM, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Dec-2023, the patient experienced HEADACHE (Headache), RHINORRHOEA (Runny nose), COUGH (cough), NASAL CONGESTION (stuffy nose) and HOT FLUSH (hot rosy face cheeks.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-Dec-2023 to 26-Dec-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), RHINORRHOEA (Runny nose), COUGH (cough), NASAL CONGESTION (stuffy nose) and HOT FLUSH (hot rosy face cheeks.) had not resolved.            Concomitant medications were not reported.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient has previously received a COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (patient had Moderna's COVID vaccine since it was first introduced.). Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient had received the last booster Spikevax in the fall.    Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-755955 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755955:Husband Case
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: severe vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting) and DIARRHOEA (Diarrhea) in a 51-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030592) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2022.    On 06-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 06-Jan-2024, the patient experienced VOMITING (severe vomiting) and DIARRHOEA (Diarrhea). At the time of the report, VOMITING (severe vomiting) and DIARRHOEA (Diarrhea) was resolving.        Concomitant and treatment medications were not reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Peripheral swelling
Clinical narrative: Arm started to swell as time went on; Patient received 2 ml of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell as time went on) and OVERDOSE (Patient received 2 ml of vaccine) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 2 milliliter. On 20-Dec-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OVERDOSE (Patient received 2 ml of vaccine). On 25-Dec-2023, the patient experienced PERIPHERAL SWELLING (Arm started to swell as time went on). At the time of the report, PERIPHERAL SWELLING (Arm started to swell as time went on) and OVERDOSE (Patient received 2 ml of vaccine) outcome was unknown.        No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available. No treatment medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 antibody test
Clinical narrative: tested positive at home/COVID 19 Treatment; tested positive at home/COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), on 07Dec2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 59 years and on 06Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 as dose 4 (booster), single, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Nov2021 as dose 3, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Apr2021 as dose 1, single), in left arm and on 08May2021 as dose 2, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies; Gluten (Celiac disease)" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID, start date: 15Nov2023; VITAMIN B12 [CYANOCOBALAMIN], start date: 15Nov2023; CALCIUM; VITAMIN D3. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "recovered"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "tested positive at home/COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Dec2023) Negative, notes: Tested negative at home. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid from 22Dec2023 to 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Foetal death, Maternal exposure during pregnancy
Clinical narrative: Lost my child/I was pregnant; lost my child/the reason was vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A fetus patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: not provided, on 14Jul2021 as dose 2, single (Lot number: EW0196), in left arm for covid-19 immunisation. The mother of the patient was 31 years old at the time of vaccination. The mother had no relevant medical history. The mother is expected to deliver one baby(s). The mother's concomitant medications were not reported. The mother's vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: ew0181 , Location of injection: Arm Left), administration date: 23Jun2021, for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (death, congenital anomaly) with onset 14Jul2021, outcome "fatal", described as "lost my child/the reason was vaccination"; FOETAL DEATH (death, congenital anomaly, medically significant) with onset 15Oct2021, outcome "fatal", described as "Lost my child/I was pregnant". Therapeutic measures were not taken as a result of foetal death. The patient date of death was unknown. Reported cause of death: "Lost my child/I was pregnant", "lost my child/the reason was vaccination". It was not reported if an autopsy was performed. Clinical course: The mother reported that "Lost my child. I was pregnant. Now I am again pregnant (last menstrual date 02Aug2023, delivery date 10May2024), and had a test done and I changed my hospital, and they told me the reason was vaccination". The mother received dose 3 of Covid-19 vaccine (brand: Pfizer, lot: f55682, left arm) on 15Jan2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400000096 mother/fetal case;; Reported Cause(s) of Death: Lost my child/I was pregnant; lost my child/the reason was vaccination
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2021 at 13:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Apr2021 at 09:30 as dose 2, single (Batch/Lot number: unknown), in right arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "heartburn" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "recovered" (31Dec2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive; (31Dec2022) Negative; (02Jan2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (treatment start date=27Dec2022, treatment stop date=31Dec2022). Tested positive for Covid on 27Dec2022 and had a negative test on 31Dec2022. Tested on 02Jan2023 got a negative. Other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.