chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient asking about GARDASIL 9.  Patient indicated she had been given the vaccine in 2007 and wanted to know if she can get the vaccine again; This spontaneous report was received from a consumer referring to herself, a female patient of unspecified age. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date in 2007, the patient was administered the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  The reporter wanted to know if she can get the vaccine again since she only had one dose (Inappropriate schedule of product administration).
Age: 1.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/04/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be pr; This spontaneous report was received from certified medical assistant and refers to a 14-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-JAN-2024, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (mL), administered once, lot # X019196, expiration date 25-APR-2025, administered by health professional (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced temperature excursions on 04-DEC-2023: 54.3 degrees Fahrenheit (F) for 9 hours and 32 mintues, 05-DEC-2023: 57.7 F for 15 hours and 30 minutes, 06-DEC-2023: 50.2 F for 5 hours and 43 minutes, 07-DEC-2023: 30.6 F for 1 hour and 55 minutes, 07-DEC-2023: 52.7 F for 11 hours and 3 minutes and 11-DEC-2023: 48.4 F for 1 hour and 47 minutes. No other temperature excursions were reported. The patient did not report any adverse issues or side effect from the administration. ; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463:
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: did not report any adverse issues or side effects from the administration. No other AE information was able to be provided; TE for PEDVAX HIB in which the vaccines had also been administered to a patient on 01/02/2024; This spontaneous report was received from a Medical Assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 02-JAN-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #X003664, expiration date: 10-NOV-2025, administered for prophylaxis (anatomical location, strength and route of administration were not provided); after a temperature excursion (04-DEC-2023: 54.3F for 9 hours 32 minutes; 05-DEC-2023: 57.7F for 15 hours 30 minutes, 06-DEC-2023: 50.2F for 5 hours 43 minutes, 07-DEC-2023: 30.6F for 1 hour 55 minutes and 52.7F for 11 hours 3 minutes and 11-DEC-2023: 48.4F for 1 hour 47 minutes) (Product storage error). The patient did not report any adverse issues or side effects from the administration.; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015463: US-009507513-2401USA015432:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: any adverse issues or side effects from the administration; TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/16/2024; This spontaneous report was received from medical assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-JAN-2024, the patient was vccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #X019196 was valid for formulation pre-filled syringe, expiration date: 25-APR-2025, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). The patient did not report any adverse issues or side effects from the administration (No adverse event). No product quality complaint (PQC). ; Sender's Comments:  US-009507513-2401USA015454:MSD US-009507513-2401USA015432:MSD US-009507513-2401USA015463:MSD
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/12/2024; This spontaneous report was received from medical assistant and refers to a 12-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JAN-2024, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot #X019196 was valid for formulation pre-filled syringe, expiration date: 25-APR-2025, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). The patient did not report any adverse issues or side effects from the administration (No adverse event). No product quality complaint (PQC). ; Sender's Comments:  US-009507513-2401USA015454:MSD US-009507513-2401USA015432:MSD US-009507513-2401USA015463:MSD
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; GARDASIL-9, RECOMBIVAXHB, and ROTATEQ had a prior excursion on 01-JUN-2023 as well as an excursion on 13-SEP-2023 and that these vaccines may have been administered to patients; This spontaneous report was received from a nurse and refers to a 15-year-old female.  The patient's medical history included  anaemia,  anxiety depression, and food allergy. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 11-JAN-2023, the patient started therapy with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), unk, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided). On 11-OCT-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W035197, expiration date: 24-MAY-2024, administered intramuscularly for prophylaxis (strength was not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #W039688, expiration date: 13-DEC-2024, administered intramuscularly for prophylaxis (strength was not provided); and  polio vaccine inact 3v (vero) (IPOL POLIO VACCINE), unk, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) underwent temperature excursion in 51.6 degree Farenheit for 13 hours (Product storage error). No aditional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP calling to report AE for patient that received expired dose of VAQTA.  Expiration 1/7/2024, administered today 1/29/2024.  No adverse effects noted.  No additional AE. No PQC.; HCP calling to report AE for patient that received expired dose of VAQTA.  Expiration 1/7/2024, administered today 1/29/2024.  No adverse effects noted.  No additional AE. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 29-JAN-2024, the patient was vaccinated with a dose of Hepatitis A Vaccine, inactivated (VAQTA) syringe (lot #W028824, expiration date: 07-JAN-2024) (Expired product administered), administered for prophylaxis (strength, and route of administration were not provided).  No adverse effects noted, and no additional adverse event (AE) were reported (No adverse event). No product quality complaint (PQC).
Age: 56.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose, and 2nd Dose Was Received 11 Days Later; Initial report received on 20-Dec-2023.  A medical assistant in the reported that a 56-year-old male (race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received the second dose 11 days later.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 09-Dec-2023, the patient received the first dose of HEPLISAV-B (lot # 943009, expiration date 31-Oct-2025, and NDC # 4352800301) intramuscularly (site unspecified).  On 20-Dec-2023, the patient received the second dose of HEPLISAV-B (lot # 943009, expiration date 31-Oct-2025, and NDC # 4352800301) intramuscularly (site unspecified).   The second dose was given early.   No adverse effects were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: patient tested positive for pertussis/Suspected vaccination failure; Pertussis; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CM7KN) for prophylaxis.   On 20-MAY-2021, the patient received Boostrix. On 05-JAN-2024, 960 days after receiving Boostrix, the patient experienced vaccination failure (Verbatim: patient tested positive for pertussis/Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the pertussis was not reported.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     It was unknown if the company considered the vaccination failure and pertussis to be related to Boostrix.   Additional Information: GSK receipt date: 24-JAN-2024 This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule pertussis were unknown at the time of reporting. The reporter was requested for follow up. This case was one of 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024009488:same reporter US-GLAXOSMITHKLINE-US2024009489:same reporter US-GLAXOSMITHKLINE-US2024AMR011536:same reporter US-GLAXOSMITHKLINE-US2024009486:same reporter
Sex: F
Vaccine: RVX
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain in arm; Cannot use my arm getting dressed, driving car, carrying groceries, etc.; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 76-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 09-JAN-2024, the patient received the 1st dose of RSV vaccine (unknown arm). On 09-JAN-2024, less than a day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Pain in arm). In JAN-2024, the patient experienced activities of daily living impaired (Verbatim: Cannot use my arm getting dressed, driving car, carrying groceries, etc.). On 21-JAN-2024, the outcome of the pain in arm was resolved (duration 12 days). The outcome of the activities of daily living impaired was not reported.   It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and activities of daily living impaired to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-Jan-2024 The patient was self-reported this case. The patient reported that she received RSV vaccine and she cannot use her arm for getting dressed, driving car and carrying groceries due to the pain in arm for over a week. The reporter consented to follow up via email.
Sex: U
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; RSV; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK receipt date: 24-JAN-2024 The health care professional (HCP) shared that he had several patients test positive for RSV after getting the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and time to onset confirming RSV were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: he did have some pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date for tolerance refer case US2024AMR009623).   In JAN-2024, the patient received the 2nd dose of Shingrix. In JAN-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: he did have some pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR009623   Additional Information: RA Receipt Date: 17-JAN-2024 The reporter stated his friend advised on the day of reporting that he had his second dose over the weekend that he did some pain. The rest information was unknown. The reporter did not consented to follow up.; Sender's Comments:  US-GSK-US2024AMR009623:
Age: 54.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given to patient younger than 60 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 54-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 23-MAR-2025) for prophylaxis.   On 06-NOV-2023, the patient received Arexvy (intramuscular). On 06-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Given to patient younger than 60 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The pharmacist stated a fellow pharmacist mistakenly thought that Arexvy was indicated for patients under 60 if they had certain medical conditions (not further specified), so the vaccine was given to a patient under 60 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024010099:Same reporter, different patient US-GSK-US2024010100:Same reporter, different patient US-GSK-US2024010098:Same reporter, different patient
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: female patient received an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 19-JAN-2024, the patient received Boostrix. On 19-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: female patient received an expired dose of Boostrix). 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: 22-JAN-2024 The pharmacist reported that a female patient received an expired dose of Boostrix on 19th January 2024 which led to expired vaccine used. The vaccine expired on 18th January 2024. The reporter consented to follow up via email.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose a couple of weeks late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 07-SEP-2023, the patient received the 2nd dose of Twinrix. On 07-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the second dose a couple of weeks late). The outcome of the drug dose administration interval too long 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: 22-JAN-2024 The reporter reported that a patient received 1st dose of Twinrix on 26th July 2023 and 2nd dose received on 7th September 2023 which was couple of weeks late. The patient was present in the pharmacy requesting third dose, but it was not administered at the time of reporting. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Rash, Rhinorrhoea
Clinical narrative: redness at the injection site; swelling at the injection site; her nose is running; rash on her chest area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-JAN-2024, the patient received Arexvy (left arm). In JAN-2024, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), runny nose (Verbatim: her nose is running) and rash (Verbatim: rash on her chest area). The outcome of the injection site erythema, injection site swelling, runny nose and rash were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, runny nose and rash to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site swelling, runny nose and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The reporter was the patient who received dose of Arexvy last Tuesday (prior to the reporting date) and after her dose, she experienced redness and swelling at the injection site. She also broke out in a rash on her chest area and her nose was running. No symptoms had resolved. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/ never received a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ never received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The patient self-reported this case. The patient reported he received the first dose of Shingrix in 2020 and never received a second dose.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Malaise, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: tested positive for RSV/vaccination failure; positive for RSV after vaccine; not feeling well; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. On an unknown date, 3 weeks after receiving Arexvy, the patient experienced vaccination failure (Verbatim: tested positive for RSV/vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: positive for RSV after vaccine) and feeling unwell (Verbatim: not feeling well). The outcome of the vaccination failure and respiratory syncytial virus infection were unknown and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and feeling unwell to be related to Arexvy.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The physician who was patient himself reported this case. The patient received Arexvy and 3 weeks later he was not feeling well and tested positive for RSV (respiratory syncytial virus infection). No more information was provided. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Pain
Clinical narrative: intense debilitating pain after the administration of one dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9M472, expiry date 30-MAR-2025) for prophylaxis.   On 08-JAN-2024, the patient received the 1st dose of Arexvy. On 08-JAN-2024, less than a day after receiving Arexvy, the patient experienced pain (Verbatim: intense debilitating pain after the administration of one dose of Arexvy). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The pharmacist contacted GlaxoSmithKline via phone to inquired about Arexvy and wanted to know what  information was available about the presence of intense debilitating pain after the administration of one dose of Arexvy.  The patient had intense pain after the Arexvy administration. They provided information about the vaccine, event and patient, yet they stated they would give the phone  number to the patient, and they would contact GlaxoSmithKline.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient only received one dose of Shingrix, and that dose was in 2020; This non-serious case was reported by a pharmacist 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 first dose of Shingrix in 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient only received one dose of Shingrix, and that dose was in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 23-JAN-2024 The pharmacist reported patient only received one dose of Shingrix. The patient called in to ask if she would need to repeat the series and no further doses have yet been administered.  The reporter declined to provide any additional information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 19-JAN-2024, the patient received Boostrix (left deltoid). On 19-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Vaccine Administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-JAN-2024 The pharmacist reported that a patient was inadvertently administered an dose of boostrix vaccine on 19th January 2024, which was expired on 9th December 2024, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Kinrix instead of Pediarix; Kinrix received under 4 years of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Patient received Kinrix instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix received under 4 years of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Jan-2024 The reporter reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011349:Diferent Patient US-GSK-US2024011355:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011352:Diferent Patient US-GSK-US2024011346:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011329:Diferent Patient
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic allergic reaction; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to nuts.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylactic reaction (Verbatim: Anaphylactic allergic reaction) (serious criteria hospitalization and GSK medically significant). The outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.     It was unknown if the company considered the anaphylactic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JAN-2024 The patient received Shingrix and had an anaphylactic allergic reaction that caused him to go to the hospital. The reporter consented to follow up. No additional information available. This case was identified as duplicate of US2024011339. Case US2024011339 was deleted and all the future correspondence will be added in the present case US2024011338 which stands as a case of record for this subject.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: found an extra diluent in box and one patient received it; found an extra diluent in box and one patient received it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: found an extra diluent in box and one patient received it) and inappropriate dose of vaccine administered (Verbatim: found an extra diluent in box and one patient received it). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2024 The pharmacist reported that when they opened the box of Menveo (2 vial) they found an extra diluent in the box and believed that one of the 3 patients from Jan 2023 until now received it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Not sure who it was among the 3 patients. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient may have received only the diluent portion of Arexvy; patient may have received only the diluent portion of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B945F, expiry date 01-FEB-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: patient may have received only the diluent portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: patient may have received only the diluent portion of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 24-JAN-2024 The pharmacist stated a patient may have received only the diluent portion of Arexvy.  He was not certain that the patient received only the diluent portion but there was a possibility. The Vaccine Administration Facility was the same as Primary Reporter. The patient may have received only the diluent portion of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Arthropod bite, Pyrexia
Clinical narrative: fever; Bug bites; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever) and bug bite (Verbatim: Bug bites). The outcome of the fever and bug bite were unknown.   It was unknown if the reporter considered the fever and bug bite to be related to Arexvy.     It was unknown if the company considered the fever and bug bite to be related to Arexvy.   Additional Information: GSK Receipt date: 25-JAN-2024 A reporter reported that receiving bug bites and fever after receiving the Arexvy vaccine.  The reporter did not consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received on January 12th 2024 Arexvy when Shingrix was intended to be given; Arexvy + underage administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-JAN-2024, the patient received Arexvy. On 12-JAN-2024, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: received on January 12th 2024 Arexvy when Shingrix was intended to be given) and inappropriate age at vaccine administration (Verbatim: Arexvy + underage administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 25-JAN-2024 The Vaccine Administration Facility was the same as Primary Reporter The nurse reported that 54 years old patient received Arexvy when Shingrix was intended to be given, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: she did not feel well; fever; chills; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (she did not feel well), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 37-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J and J COVID-19 Vaccine (Dose 1) in 2021, J and J COVID-19 Vaccine (Dose 1) in 2021, J and J COVID-19 Vaccine (Dose 1) in 2021 and J and J COVID-19 Vaccine (Dose 1) in 2021. Past adverse reactions to the above products included Chills with J and J COVID-19 Vaccine; Fatigue with J and J COVID-19 Vaccine; Feeling unwell with J and J COVID-19 Vaccine; and Fever with J and J COVID-19 Vaccine.    In 2022, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced MALAISE (she did not feel well), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). In 2022, MALAISE (she did not feel well), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had no allergy, concomitant diseases and risk factor.  HCP mentioned she received her first J and J COVID-19 Vaccine in 2021, then another Moderna shot during the fall 2021, another Moderna on fall next year and last Moderna dose on 29SEP2023. For all the shots she had side effects during approximately 24 hours  Patient experienced side effects during approximately 24 hours of the vaccination.  No treatment medications were reported.   This case was linked to MOD-2023-745974, MOD-2023-758884 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Upon internal review on 30-Jan-2024, significant correction performed to add Events malaise, fever, chills and fatigue. Added patient initials and age. Suspect coding updated from SPIKEVAX 2023-2024 PFS to SPIKEVAX NOS. Removed classification of "combination product". Delete previously captured events of occupational exposure to product and no adverse event. I narrative updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: she did not feel well; had fever; chills; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (she did not feel well), PYREXIA (had fever), CHILLS (chills) and FATIGUE (fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J and J COVID-19 Vaccine (1st dose) in 2021, J and J COVID-19 Vaccine (1st dose) in 2021, J and J COVID-19 Vaccine (1st dose) in 2021 and J and J COVID-19 Vaccine (1st dose) in 2021. Past adverse reactions to the above products included Chills with J and J COVID-19 Vaccine; Fatigue with J and J COVID-19 Vaccine; Fever with J and J COVID-19 Vaccine; and Malaise with J and J COVID-19 Vaccine.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (she did not feel well), PYREXIA (had fever), CHILLS (chills) and FATIGUE (fatigue). In 2021, MALAISE (she did not feel well), PYREXIA (had fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had no allergy, concomitant diseases and risk factor.  Patient had received Moderna shot during the fall 2021. It was reported that for all the shots patient had side effects during approximately 24 hours.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745974 (E2B Linked Report). This case was linked to MOD-2023-745984 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745974:same patient Master case
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Moderna was awful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Moderna was awful) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Moderna was awful). At the time of the report, FEELING ABNORMAL (Moderna was awful) outcome was unknown.            No concomitant medications were reported.  Patient has brain fog and it was really bad, it comes and goes but thought it was because of Covid and no Paxlovid. Talked about the covid-19 shots. Moderna was awful. No mayor problems with Pfizer vaccine just sore muscles.  No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: a patient started treatment on unreported dates with 3 doses of Moderna COVID-19 vaccine for an unreported indication. It was reported that after vaccination, the patient got COVID-19 in MAY-2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (a patient started treatment on unreported dates with 3 doses of Moderna COVID-19 vaccine for an unreported indication. It was reported that after vaccination, the patient got COVID-19 in MAY-2023) in a 73-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In May 2023, the patient experienced COVID-19 (a patient started treatment on unreported dates with 3 doses of Moderna COVID-19 vaccine for an unreported indication. It was reported that after vaccination, the patient got COVID-19 in MAY-2023). At the time of the report, COVID-19 (a patient started treatment on unreported dates with 3 doses of Moderna COVID-19 vaccine for an unreported indication. It was reported that after vaccination, the patient got COVID-19 in MAY-2023) outcome was unknown.            Concomitant and treatment medications were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 025L20A and 043L20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in June 2020. Concurrent medical conditions included Seasonal allergy and Blood pressure inadequately controlled.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-758817 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: Have symptoms of a cold; Have symptoms of flu; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Have symptoms of a cold) and INFLUENZA LIKE ILLNESS (Have symptoms of flu) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Post-traumatic stress disorder (Post-traumatic stress disorder, unspecified) and Breathing difficult (Breathing problems (used contrast dye, that made me short of breath)). Concurrent medical conditions included Chronic obstructive pulmonary disease (Chronic obstructive pulmonary disease, unspecified), Chronic sinusitis (Chronic sinusitis not otherwise specified), Malignant neoplasm of prostate, Allergy (Omniscan (used contrast dye, that made me short of breath) and (used contrast dye, that made me dizzy)), Allergy to plants (Tree and shrub), Pollen allergy, Allergy to plants (Weed pollen) and Asthma. Concomitant products included DUPILUMAB (DUPIXENT) for Asthma, SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), ACETYLSALICYLIC ACID (ASPIRIN EC), ATORVASTATIN CALCIUM, LOSARTAN POTASSIUM, CLOPIDOGREL BISULFATE (PLAVIX), VERAPAMIL, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MONTELUKAST SODIUM for an unknown indication.    In December 2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2023, the patient experienced NASOPHARYNGITIS (Have symptoms of a cold) and INFLUENZA LIKE ILLNESS (Have symptoms of flu). At the time of the report, NASOPHARYNGITIS (Have symptoms of a cold) and INFLUENZA LIKE ILLNESS (Have symptoms of flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, the patient started taking DUPIXENT with the strength of 300 mg /2mI at a dose of 300 mg QOW for Moderate persistent asthma, uncomplicated and CO VID-19 VACCINE MODERNA.  It was reported that the patient stated, he got his third covid vaccine last week and had symptoms of a cold or flu, about a year ago had imaging and they used contrast dye, that made him dizzy and short of breath. Had breathing problems that require a sleep study, he had this before Dupixent. It was unknown if there were lab data/results available.  Action taken with DUPIXENT was unknown for all events.  It was not reported if the patient received a corrective treatment for all the events.