chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from {HA} On 12-JAN-24 (for last significant version).  This spontaneous report was referring to a male elder patient (age: 70-74). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient started therapy with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, dose lot #, expiry date, and route of administration were not provided).   On an unknown date in 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, Streptococcus pneumoniae serotyping showed Not Available. At the time of reporting, the outcome of the event Streptococcus pneumoniae pneumonia was not known. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding Streptococcus pneumoniae pneumonia was reported as Not Applicable.    The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown. Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Meningitis pneumococcal, Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia caused by Streptococcus Pneumoniae; Meningitis caused by Streptococcus Pneumoniae; Information has been received from Health Authority (agency number was not provided) on 12-JAN-2024.  This spontaneous report was referring to an adult female patient (age group reported as 55-59 years old) of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On unknown date, the patient was vaccinated with pneumococcal vaccine CONJ 13V (PREVENAR 13) 1 time, for prophylaxis (formulation, strength, dose, route of administration, lot#, and expiration date were not reported).  On an unknown date in 2016, the patient experienced streptococcus pneumoniae pneumonia and pneumococcal meningitis. On an unknown date in 2016, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcomes of both events were not known.   The causal relationship between both events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal vaccine CONJ 7V (CRM197) (PREVENAR) was not provided.  Upon internal review, both events of streptococcus pneumoniae pneumonia and pneumococcal meningitis were determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a {HA} on 12-JAN-2024.   This spontaneous report as received from regulatory authority referred to a female patient (age group reported as 15-19 years old). The patient's concurrent condition, medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated 2 doses (times) of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided); 3 doses (times) of pneumococcal vaccine conj 7v (crm197) (PREVENAR), administered for prophylaxis (dose, strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2022, the patient experienced Streptococcus pneumoniae pneumonia (pneumonia pneumococcal). On an unknown date in 2022, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event pneumonia pneumococcal was unknown. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), pneumococcal vaccine conj 7v (crm197) (PREVENAR) regarding event was not applicable.    The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), pneumococcal vaccine conj 7v (crm197) (PREVENAR) was unknown.  Upon internal review, the event pneumonia pneumococcal was determined as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Agency 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to a female patient who is between 55-59 years old. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) for 3 times.  On an unknown date in 2016, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2016, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; Pneumococcal infection; Information has been received from Agency on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to an adult female patient (age: 50-54 years old). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 2 times, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On an unknown date in 2016, the patient experienced Pneumococcal infection and Streptococcus pneumoniae pneumonia, streptococcus pneumoniae serotyping showed Not Available. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the events of Pneumococcal infection and Streptococcus pneumoniae pneumonia were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: pneumococcal infection; Information has been received from {HA} (Surveillance System (SS)) on 12-JAN-2024.  This spontaneous report was referring to an elderly female patient (age: 55-59). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping was not avaliable. At the time of reporting, the outcome of the event pneumococcal infection was unknown.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Bacteraemia; Information has been received from Agency on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to an Elderly female patient (age: 75-79 years old).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2009, the patient experienced Pneumococcal bacteraemia. On an unknown date in 2009, streptococcus pneumoniae serotyping showed Not Available. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from a regulatory authority on 12-JAN-2024.   This spontaneous report was received from regulatory authority referred to an adult female patient (age group reported as 20-24 years old). The patient's concurrent condition, medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated 1 dose (time) of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided); 2 doses (times) of pneumococcal vaccine conj 7v (crm197) (PREVENAR), administered for prophylaxis (dose, strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal infection was unknown. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), pneumococcal vaccine conj 7v (crm197) (PREVENAR) regarding event was not applicable.    The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), pneumococcal vaccine conj 7v (crm197) (PREVENAR)  was unknown.  Upon internal review, the event pneumococcal infection was determined as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from a {HA} on 12-JAN-2024.   This spontaneous report was received from Regulatory Authority referred to an adult female patient (age group reported as 35-39 years old). The patient's concurrent condition, medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated 2 doses (times) of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal infection was unknown. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding event was not applicable.    The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23)  was unknown.  Upon internal review, the event pneumococcal infection was determined as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia caused by Streptococcus Pneumoniae; Information has been received from HA (agency number was not provided) on 12-JAN-2024.  This spontaneous report was referring to an adult female patient (age group reported as 40-44 years old) of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2016, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2016, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was not known.   The causal relationship between the event streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Agency 12-JAN-2024.  This spontaneous report has been downloaded from regulatory authority and referring to an adult female patient (age: 40-44 years old). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 1 time of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2016, the patient experienced streptococcus pneumoniae pneumonia (Pneumonia pneumococcal). On an unknown date in 2016, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was not known.  The causal relationship between event streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: pneumococcal infection; Information has been received from regulatory authority on 12-JAN-2024.  This spontaneous report was referring to an elderly female patient (age: 30-34). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping was not available.  At the time of reporting, the outcome of the event pneumococcal infection was unknown.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: pneumococcal infection; Information has been received from Regulatory Agency (agency number was not provided) on 12-JAN-2024 referring to a 60-64 years old adult female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (strength, dose, lot number and expiration date were not reported) for prophylaxis. Total 1 dose was vaccinated.  On an unknown date in 2022, the patient experienced pneumococcal infection. Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown. The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; Information has been received from Regulatory Authority on 12-JAN-2024 and referred to a female patient (age group: 25-29). The patient's medical history, concurrent condition, and concomitant therapy were not reported.   On an unknown date, the patient received the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).   On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event was not provided. The action taken with vaccine regarding event was not applicable.   The causal relationship between event and vaccine was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medical significant event.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal infection, Pneumonia streptococcal, Septic arthritis streptococcal
Clinical narrative: Septic arthritis; Pneumococcal infection; Information has been received from Agency (Surveillance System) on 12-JAN-2024, concerning an elderly (reported as 75-79 years old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.     On unknown dates, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, lot #, expiry date, and route of administration were not provided) and the first dose of pneumococcal vaccine conj 13v (crm197)(PREVENAR 13) for prophylaxis.  On an unknown date in 2022, the patient experienced invasive pneumococcal disease (IPD) caused by streptococcus pneumoniae, clinically categorized as septic arthritis (septic arthritis streptococcal) and other (pneumococcal infection) (streptococcus pneumoniae serotyping not available). The outcome of the events and causality assessment between the events and suspect vaccines were not provided.   Upon internal review, septic arthritis streptococcal and pneumococcal infection were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Pneumococcal bacteraemia; Information has been received from Regulatory Agency 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to an adult female patient who is between 25-29 years old. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) for one time.  On an unknown date in 2016, the patient experienced pneumococcal bacteraemia. On an unknown date in 2016, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between pneumococcal bacteraemia and both suspect vaccines was not provided.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from agency on 12-JAN-2024.  This spontaneous report was received from public data (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of regulatory authority and referred to an adolescent (10-14 years old) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 4 times of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date in 2017, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal). On an unknown date in 2017, streptococcus pneumoniae serotyping showed not available.   At the time of reporting, the outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the event and suspect vaccine was not provided.  Upon internal review, the event pneumonia pneumococcal was determined as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from Agency 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to a female patient who is between 70-74 years old. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) for one time.  On an unknown date in 2016, the patient experienced pneumococcal infection (reported as other). On an unknown date in 2016, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Agency on 12-JAN-2024.  This spontaneous report has been downloaded from regulatory authority and referring to a child female patient (age: 02-04 years old).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and pneumococcal vaccine conj 7v (crm197) (PREVENAR), 3 times, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2010, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2010, streptococcus pneumoniae serotyping showed Not Available. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and suspect vaccines was unknown.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Regulatory Authority.   This spontaneous report concerned an elderly female patient with age 75-79 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.  On an unknown date in 2017, the patient experienced Streptococcus pneumoniae pneumonia. Streptococcus pneumoniae serotyping was not available. The action taken with suspect vaccine was not applicable. The outcome of the event and causality assessment between the event and suspect vaccine were not provided.   Upon internal review, Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Pneumococcal bacteraemia; Information has been received from Regulatory Authority.   This spontaneous report concerned an adult male patient with age 25-29 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.  On an unknown date in 2017, the patient experienced Pneumococcal bacteraemia. Streptococcus pneumoniae serotyping was not available. The action taken with suspect vaccine was not applicable. The outcome of the event and causality assessment between the event and suspect vaccine were not provided.   Upon internal review, Pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: other-pneumococcal infection; Information has been received from {HA} on 12-JAN-2024 (for last significant version).  This spontaneous report was referring to a male elderly patient (age reported as: 70-74). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection 1 dosage form (strength, dose, route of administration, lot number, and expiration date were not reported) for prophylaxis.   On an unknown date in 2011, the patient experienced a pneumococcal infection, with a Streptococcus pneumoniae serotyping showed not available.  At the time of reporting, the outcome of the event pneumococcal infection was not known. The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was Not Applicable.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia = Streptococcus pneumoniae pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.  This spontaneous report has been received from health authority, regarding an elderly female patient (age reported as 75-79 years).  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date in 2012, Streptococcus pneumoniae serotyping result was not available. On that same year, the patient developed Streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event was not provided.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.   This spontaneous report has been received from Regulatory Authority regarding to an elderly (70 to 74-year-old) female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, vaccination scheme frequency, lot #, expiry date, route of administration and anatomical location were not provided).   On an unknown date in 2012, the patient experienced pneumonia (pneumonia pneumococcal). On that date, streptococcus pneumoniae serotyping was not available.   The outcome of the event and the causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia = Streptococcus pneumoniae pneumonia; Information has been received from Health Authority (Agency Number not provided) on 12-JAN-2024.   This spontaneous report has been received from Surveillance System, regarding an adult male patient (age reported as 45-49 years).  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date in 2012, Streptococcus pneumoniae serotyping result was not available. On an unspecified date of that same year, the patient developed Streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event was not provided.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia = Streptococcus pneumoniae pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.  This spontaneous report has been received from Regulatory Authority, regarding an elderly male patient (age reported as 65-69 years).  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date in 2012, Streptococcus pneumoniae serotyping result was not available. On an unspecified date of that same year, the patient developed Streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event was not provided.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from Health Authority (agency number not provided), on 12-JAN-2024.   This spontaneous report has been received from Regulatory Authority, regarding to an elderly (also reported as an age 85 or older) male patient.   The patient's pertinent concurrent conditions, medical history, past drug reactions or allergies, and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection, (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), for prophylaxis.   On an unknown date in 2011, streptococcus pneumoniae serotyping was untyped. On that same date, the patient experienced Pneumococcal infection. At the time of reporting, the outcome of the event was not provided.  The causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event Pneumococcal infection was considered as medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: No additional AE; Consumer reported she received GARDASIL 9 when she was 4 weeks pregnant. Reported her doctor's office tested her for pregnancy in office and the test was negative (on 12/28/2023); she then received GARDASIL 9 that same day. The next day she tested a; This spontaneous report was received from a consumer and referred to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2023, at her doctor's office, she was tested for pregnancy with a negative result. Therefore, on that day, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, vaccination scheme, anatomical location and route of administration were not provided). The next day, on 29-DEC-2023, the patient had a pregnancy test at home with a positive result, she was 4 weeks pregnant (exposure during pregnancy). This was a prospective report and there was no additional adverse event reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients who received the vaccines reported any adverse issues or side effects; A HCP called to report a TE for VARIVAX; This spontaneous report was received from a medical assistant and referred to a 1-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not provided. Concomitant medications included sterile diluent.  From 05-JAN-2024 through 07-JAN-2024, the vaccine experienced a temperature excursion. The cord from the data logger became dislodged and stopped tracking data during the time frame reported. Then, on that same date (07-JAN-2024), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, administered as prophylaxis (lot number X006982 has been verified to be a valid lot number, expiration date reported and validated as 07-MAR-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided) (product storage error). There was no previous temperature excursion and there was no adverse event. At the reporting time the outcome of the event was unknown.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Maladministration of vaccines after exposure to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B pediatric) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient received Bexsero, Menveo, Boostrix, Engerix B pediatric, Havrix, Infanrix, Pediarix, Kinrix and Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Bexsero, Menveo, Boostrix, Engerix B pediatric, Havrix, Infanrix, Pediarix, Kinrix and Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Maladministration of vaccines after exposure to freezing temperatures). 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: 12-JAN-2024 The clinic manager reported the following temperature excursion for Vaccine for children program vaccines Bexsero, Menveo all liquid, Boostrix, Engerix B, Havrix, Infanrix, Pediarix, Kinrix, Fluarix QIV Dic 2023. The maximum temperature was 3.69 degree celsius and minimum was 23.74 degree celsius.  There was an improper program for the correct date and time.  There was a problem with dates and a wrong set up so there were no dates available.  The reporter stated some of these vaccines were administered.  No data available about patients involved.  The patient received Bexsero, Menveo all liquid, Boostrix, Engerix B, Havrix, Infanrix, Pediarix, Kinrix and Fluarix following the temperature excursion which led to incorrect storage of drug. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first shot of SHINGRIX one year ago and never receiving the second shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on unknown date.).   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: the first shot of SHINGRIX one year ago and never receiving the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 The patient received the first dose of SHINGRIX one year ago and never received the second dose which led to incomplete course of vaccination. The reporter consent to follow up permission denied.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed the subsequent doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 10th July 2023 with batch number 2PG39 and expiry date 19th September 2025) and Twinrix (received 2nd dose on 17th July 2023 with batch number 2PG39 and expiry date 19th September 2025).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Missed the subsequent doses). 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: 16-JAN-2024 The patient was on accelerated dose and missed the subsequent doses. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of Boostrix was administered to a patient before the recommended age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7hs93, expiry date 07-APR-2024) for prophylaxis.   On 25-NOV-2022, the patient received Boostrix. On 25-NOV-2022, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a dose of Boostrix was administered to a patient before the recommended age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 The nurse reported a dose of Boostrix was administered to a patient before the recommended age which led to inappropriate age at vaccine administration. The nurse stated no symptoms were reported.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal
Clinical narrative: she was not feeling good; The patient also mentioned, this was the second time she had covid. she got it 1 week after she got the 1st vaccines; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she was not feeling good) and COVID-19 (The patient also mentioned, this was the second time she had covid. she got it 1 week after she got the 1st vaccines) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (she was not feeling good) and COVID-19 (The patient also mentioned, this was the second time she had covid. she got it 1 week after she got the 1st vaccines). At the time of the report, FEELING ABNORMAL (she was not feeling good) and COVID-19 (The patient also mentioned, this was the second time she had covid. she got it 1 week after she got the 1st vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient receives all the covid-19 from Moderna.  It was reported that patient got it 1 week after she got the 1st vaccine. Patient was not feeling good and she  was off of work for 14 days.  Treatment information was not provided.   This case was linked to MOD-2024-757272 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that patient had common cold symptoms . No treatment medication was reported.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired FLUZONE to patient today due to a mix-up with the vaccines with no reported adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 67 years old male patient who was inadvertently administered an expired Influenza Quadrival A-B vaccine [Fluzone Quadrivalent] to due to a mix-up with the vaccines with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine for Prophylactic vaccination.  On 11-Jan-2024, the patient inadvertently received an expired 0.5 ml dose of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT7759MA and expiry: 30-Jun-2024 via unknown route in unknown administration site for immunization, due to a mix-up with the vaccines with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.83
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine was not given with proper diluent with no reported adverse event; Initial information received  on 11-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 10 months old and unknown gender patient who received Yellow Fever Vaccine [Yf-Vax] vaccine which was not given with proper diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Yellow Fever Vaccine (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) and the vaccine was not given with proper diluent, with no reported adverse event (product preparation error) (latency: same day).  It was reported, "Caller mentioned that a the yellow fever vaccine was given to a 10 month old who was getting ready to travel and the vaccine was not given with proper diluent, and the family was told to come back because the first was one was not effective, and the vaccine needed to be redone. Caller wanted to know if the vaccine really not considered valid if it was not given with the proper diluent, and if it would be okay for a 10 month old to get a second dose."  Action taken with : not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.