chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (COMIRNATY), on 15Jan2021 as dose 1, single (Lot number: EL3246) at the age of 76 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Additional information: The patient was given injections 1 through 5 with only a sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189575 Same patient/product, different dose/AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Infected just 5 months later; Infected just 5 months later; Interchange of Vaccine Products; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Aug2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Infected just 5 months later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2022) Negative; (unspecified date) positive. The patient got her 1st Pfizer booster 11Aug2023 after using Moderna to vaccinate and boost. Even with variants, Infected just 5 months later. The patient was not "vulnerable" (N95-mask in public and tested negative on 24Dec2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: their nurse mixed the ACTHIB component with a Merck sterile water (with no reported adverse event); Initial information received on 16-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 2-year-old male patient to whom their nurse mixed the acthib component with a merck sterile water with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine and pneumococcal vaccine conj 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 11-Jan-2024, the patient received 0.5 mL Dose 4 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once)  (lot number: UJ958AB; expiry date: 02-Jun-2024) via intramuscular route in the right thigh for immunization; their nurse mixed the acthib component with a merck sterile water with no reported adverse event (product preparation error).  Treatment: No   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered a patient with an expired ACTHIB vaccine with no adverse event; Initial information received on 16-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who had accidentally administered with an expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) for Prophylactic vaccination.  On 16-Jan-2024, the patient received a expired dose 4 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown, expiry date: 30-Oct-2023 and lot UJ837AA) via intramuscular route in the right thigh as immunization (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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for ADACEL due to the shipment being too long in transit with no reported adverse event; administration of ADACEL to a patient after it was exposed to temperature excursion, with no reported adverse event; Initial information received from country on 17-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] due to the shipment being too long in transit with no reported adverse event and administration of adacel to a patient after it was exposed to temperature excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller reported that diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U7904AA, expiry date- 05-OCT-2025) for Immunization was exposed to temperature excursion due to the shipment being too long in transit with no reported adverse event (product storage error) (unknown latency) and then On 16-JAN-2024 the patient had administration of total dose of vaccine after it was exposed to temperature excursion, with no reported adverse event (poor quality product administered) (latency- same day) via unknown route in unknown administration site.  Nurse asks for recommendations following the administration of ADACEL to a patient after it was exposed to temperature excursion due to the shipment being too long in transit; caller states that they received the e-mail from Sanofi stating that the vaccines are not recommended for use post temperature excursion after they have administered one dose of ADACEL.  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 Module of the 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.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP reported patient received VARIVAX and PROQUAD concomitantly in error.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reaction/allergies were not reported.  On 08-JAN-2024, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (lot #X012610, expiration date: 29-OCT-2024) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X011424, expiration date: 19-APR-2025) concomitantly in error, both administered for prophylaxis (strength, and route of administration were not provided) (accidental overdose). No additional adverse event (AE) was reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: it messed up her menstrual cycle; This spontaneous report was received from the mom of a patient via company employee referring to her daughter, currently a 27-year-old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On an unknown date in 2009 (also reported as at 12 years old), the patient was completed 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date, the patient's menstrual cycle messed up. The mother reported that because the patient received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) before she started her period it messed up her menstrual cycle and now she had to be on hormone replacement therapy. It was unknown if the patient sought medical attention. At the time of reporting, the outcome of menstrual cycle messed up was not known. The action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not applicable. The reporter considered menstrual cycle messed up to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: HCP reported pregnant patient received GARDASIL 9; No additional AE; Information was received from a registered nurse concerning a pregnancy female patient with unknown age. On 04-JUN-2023, the patient had her last menstrual period (LMP). The patient's pertinent medical history, concurrent conditions or concomitant medications and drug reactions or allergies were not reported.  On 15-JAN-2024 (pregnancy gestation reported as 32 weeks 1 day), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dose, lot number X019863 has been verified to be a valid lot number and expiration date was 14-FEB-2025, frequency, route of administration and anatomical location were unknown) for prophylaxis (exposure during pregnancy). The operator of device was health care professional. At the reporting time, pregnancy outcome was outcome pending and fetal outcome was unknown. The due date was 10-MAR-2024. No additional adverse event (AE) reported (no adverse event).
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a regulatory authority refers to an adult male patient of unknown exact age (age group reported as "35-39"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2015, the patient experienced streptococcus pneumoniae pneumonia (reported as Pneumonia). Streptococcus pneumoniae serotyping result was not available. The outcome of the event was not reported.  The relatedness 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: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; first dose was 01/27/2023 and the patients second dose was 12/26/2023; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 27-JAN-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, anatomical site of administration, lot #, expiry date, and route of administration were not provided). On 26-DEC-2023, it was reported that the patient's dosing schedule was interrupted (patient received second dose late, the exact date of missed dose was unknown) (inappropriate schedule of product administration), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5ml/series, lot #1965044, expiration date: 07-JAN-2026, strength, anatomical site of administration and route of administration were not provided), both administered for prophylaxis. No additional information provided. No additional adverse event (AE) (no AE).
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh; treatment with Bactrim antibiotic for 7 days
Age: 89.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Today (January 22, 2024) we received the patient, who came to the pharmacy with a prescription for the RSV vaccine (Arexvy). Since it is not required to have a prescription. the prescription is returned to the patient and a pharmacy technician processes the vaccine. After another pharmacy technician administered the vaccine, we realized by immunization tool that the patient had already the vaccine (Arexvy) on November 27, 2023.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report was received from a National Notifiable Diseases Surveillance System (NNDSS) and refers to an elderly female patient of unknown exact age (age group reported as 70-74 years old). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date in 2015, the patient experienced pneumococcal bacteraemia. Information regarding serotype was not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Health Authority refers to an elderly male patient of unknown exact age (age group reported as 70-74). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown dates, the patient was vaccinated with three doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2013, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2013, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness 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: M
Vaccine: PPV
Symptoms: Streptococcal bacteraemia
Clinical narrative: Streptococcus pneumoniae bacteraemia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Health Authority and refers to an elderly male patient (age group reported as 80-84 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2013, the patient experienced Streptococcus pneumoniae bacteraemia. On an unknown date in 2013, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: Bacteraemia; Information has been received from Regulatory Authority on 15-JAN-2024.   This spontaneous report was received from a regulatory authority and refers to an adult female patient (age group reported as 60-64 years old). There was no information about the patient's concurrent conditions, concomitant medications, drug reactions, allergies or medical history provided.   On unknown dates, the patient was vaccinated with three doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact doses, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On an unknown date in 2013, the patient experienced bacteraemia caused by Streptococcus pneumoniae (pneumococcal bacteraemia), and her Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided by the reporter.   Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an adult female patient of unknown exact age (age group reported as 35-39). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown dates, the patient was vaccinated three doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2013, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2013, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness 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: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and refers to a female patient (30-34 years old). Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2015, the patient experienced pneumonia (Pneumonia pneumococcal). On an unknown date in 2015, Streptococcus pneumoniae serotyping was 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 not reported.  Upon internal review, the event of pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Streptococcal bacteraemia
Clinical narrative: Streptococcus pneumoniae bacteraemia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Health Authority and refers to an adult male patient (age group reported as 55-59 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown dates, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2015, the patient experienced Streptococcus pneumoniae bacteraemia. On an unknown date in 2015, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an elderly female patient of unknown exact age (age group reported as 70-74). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown dates, the patient was vaccinated with the first and the second doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2015, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2015, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness 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: M
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Meningitis; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a male patient (10-14 years old). His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2012, the patient experienced meningitis (Meningitis pneumococcal). On an unknown date in 2012, Streptococcus pneumoniae serotyping was 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 not reported.  Upon internal review, the event of meningitis (Meningitis pneumococcal) was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Regulatory Authority on 12-JAN-2024.  This spontaneous report was referring to an elderly female patient (age: 70-74). 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 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2010, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2010, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was unknown.   The causal relationship between the event 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: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; Information has been received from health authority (agency number was not provided) on 12-JAN-2024.  This spontaneous report was referring to an adult male 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 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 pneumococcal infection was not known.   The causal relationship between the event 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: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Health Authority and refers to an elderly (between 65 and 69 years old; reported as age group 65-69) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided). It was reported that the patient received total of 1 vaccination.  In 2018, the patient experienced pneumonia, serotype: not available. The outcome of the event was not provided.   The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia has been determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a database refers to an elderly male patient of unknown exact age (age group reported as 70-74). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2018, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness 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: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Surveillance System and refers to a child (between 65 and 69 years old; reported as age group 65-69) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient received a dose of and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) for prophylaxis (exact dose, strength, formulation, lot #, expiry date, and route of administration were not provided). It was reported that the patient received total of 2 vaccinations.  In 2019, the patient experienced pneumonia, serotype: not available. The outcome of the event was not provided.   The causal relationship between pneumonia and the suspect therapies was not reported.  Upon internal review, the event of pneumonia has been determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an elderly female patient of unknown exact age (age group reported as "75-79"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On an unknown date in 2018, the patient experienced Streptococcus pneumoniae pneumonia (reported as Pneumonia). On an unknown date in 2018, streptococcus pneumoniae serotyping result was reported as: not available. The outcome of the event was not reported.  The relatedness between the event 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: Bacteraemia
Clinical narrative: Bacteraemia; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a female patient (65-69 years old). Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2019, the patient experienced bacteraemia (Pneumococcal bacteraemia). On an unknown date in 2019, Streptococcus pneumoniae serotyping was 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 not reported.  Upon internal review, the event of bacteraemia (Pneumococcal bacteraemia) was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a National Notifiable Diseases Surveillance System (NNDSS) refers to an adult female patient of unknown exact age (age group reported as "50-54"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown dates, the patient was vaccinated with first and second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced streptococcus pneumoniae pneumonia (reported as Pneumonia). Streptococcus pneumoniae serotyping result was not available. The outcome of the event was not reported.  The relatedness 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: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from National Notifiable Diseases Surveillance System (NNDSS) on 15-JAN-2024.   This spontaneous report was received from a regulatory authority and refers to an elderly female patient (age group reported as 80-84 years old). There was no information about the patient's concurrent conditions, concomitant medications, drug reactions, allergies or medical history provided.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On an unknown date in 2015, the patient experienced Streptococcus pneumoniae pneumonia (pneumonia pneumococcal), and her Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided by the reporter.   Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Unknown = Pneumococcal infection; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report has been received from a National Notifiable Diseases Surveillance System (NNDSS), referring to an adult female patient of an unspecified age (age group reported as 60-64). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2019, the patient experienced pneumococcal infection. On an unknown date in 2019, Streptococcus pneumoniae serotyping was performed (results not available). The outcome of the event was not reported.  The causal relationship between the event and suspected vaccine was not reported.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Meningitis pneumococcal, Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Meningitis; Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report was received from a National Notifiable Diseases Surveillance System (NNDSS) refers to an elderly male patient of unknown exact age (age group reported as more than "70-74"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown dates, the patient was vaccinated with the first and the second doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2016, the patient experienced Streptococcus pneumoniae meningitis (reported as meningitis) and Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2016, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the events of Streptococcus pneumoniae meningitis and Streptococcus pneumoniae pneumonia were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a National Notifiable Diseases Surveillance System (NNDSS) refers to an adult female patient of unknown exact age (age group reported as "40-44"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced streptococcus pneumoniae pneumonia (reported as Pneumonia). Streptococcus pneumoniae serotyping result was not available. The outcome of the event was not reported.  The relatedness 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: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Other; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an elderly male patient of unknown exact age (age group reported as 70-74). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 2016, the patient experienced Pneumococcal infection (reported as other). On an unknown date in 2016, streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  The relatedness 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: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from HA on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a female patient (80-84 years old). Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2019, the patient experienced pneumonia (Pneumonia pneumococcal). On an unknown date in 2019, Streptococcus pneumoniae serotyping was 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 not reported.  Upon internal review, the event of pneumonia (Pneumonia pneumococcal) was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report as received from a Regulatory Authority refers to an adult male patient of unknown exact age (age group reported as "30-34"). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia (reported as Pneumonia). On an unknown date in 2019, streptococcus pneumoniae serotyping result was reported as: not available. The outcome of the event was not reported.  The relatedness between the event 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: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report was received from a Surveillance System and refers to an adult female patient of unknown exact age (age group reported as 50-54 years old). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date in 2015, the patient experienced Streptococcus pneumoniae pneumonia. Information regarding serotype was not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: other; This spontaneous report has been downloaded from Regulatory Authority and referring to an elderly female patient (age: 70-74). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 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 2010, the patient experienced Pneumococcal infection (reported as Other). On an unknown date in 2010, streptococcus pneumoniae serotyping was performed and the result was 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 Pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Meningitis|Other|Pneumonia; Meningitis|Other|Pneumonia; Meningitis|Other|Pneumonia; This spontaneous report has been downloaded from Regulatory Authority and referring to an adult female patient (age: 40-44). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 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 2010, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia), Pneumococcal infection (reported as other), and Streptococcus pneumoniae meningitis (reported as Meningitis). On an unknown date in 2010, streptococcus pneumoniae serotyping was performed and reported as not available. At the time of reporting, the outcome of the events was not known.    The causal relationship between events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the events of Streptococcus pneumoniae pneumonia, Pneumococcal infection, and Streptococcus pneumoniae meningitis were determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from regulatory authority via Company representative, concerning to an elderly (age group reported as 80-84-year-old) male patient.   His medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine not available for serotype.   On an unspecified date, the patient was vaccinated with the 1st dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis. On an unknown date, patient was vaccinated with an unspecified pneumococcal vaccine (manufacturer unknown) (reported as "vaccine type unknown") (exact dose, lot #, expiry date, anatomical location, route of administration and indication were not provided)   On an unknown date in 2014, the patient experienced pneumonia (pneumonia pneumococcal), and Streptococcus pneumoniae serotyping was reported as not available.   The outcome of the event was not provided.    The causal relationship between pneumonia pneumococcal and the suspect vaccines was not reported.  Upon internal review, pneumonia pneumococcal was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority via Company representative, concerning to an elderly (age group reported as 75-79-year-old) female patient.   Her medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine not available for serotype.   On an unspecified date, the patient was vaccinated with the 1st dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.   On an unknown date in 2014, the patient experienced pneumonia (pneumonia pneumococcal), and Streptococcus pneumoniae serotyping was reported as not available.   The outcome of the event was not provided.    The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, pneumonia pneumococcal was considered to be medically significant.