chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel DTaP was incorrectly administered to a four month old infant, with no reported adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 4 months old female patient who was incorrectly administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Jan-2024, the 4 months old female patient incorrectly received (0.5 ml, once) dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (Suspension for injection (strength: unknown) (lot: U7656AA, Expiry date: 08-Mar-2025) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Action taken : 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.
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Pain; Rash from shoulder to the breast area; This spontaneous case was received on 15-Jan-2024 from other healthcare professional (pharmacist) via Regulatory Authority (reference number: SEQW24-00220) and concerned a female patient of unreported age.  The patient's concurrent condition included diabetes. The patient was not taking any concomitant medications.  On 06-Jan-2024, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) as regular seasonal flu shot. The reported batch number was 370647 and expiration date 24-May-2024.  On 09-Jan-2024, three days after receiving Flucelvax Quadrivalent, the patient got a rash from shoulder to the breast area with severe pain.  At the time of the initial reporting on 15-Jan-2024, the patient had not recovered from the events. As reported, the patient's symptoms continued.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. Three days after vaccination, the patient experienced rash from shoulder to the breast area with severe pain. Information regarding relevant laboratory findings and diagnostic data was not reported. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events rash and pain, due to chronological plausibility.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. Three days after vaccination, the patient experienced rash from shoulder to the breast area with severe pain. Information regarding relevant laboratory findings and diagnostic data was not reported. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events rash and pain, due to chronological plausibility.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided = Pneumococcal infection; Information has been received from agency (Agency# not provided) via company employee on 12-JAN-2024.  This spontaneous report concerned an adolescent male patient with age 15-19 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the 1st dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided), and the 1st, 2nd, 3rd dose of pneumococcal 15v conj vaccine (crm197) (manufacture unknown) 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 was not available. At the time of reporting, the outcome of the event was not known. The causal relationship between event and suspect vaccine was not provided.  Upon internal review, the event pneumococcal infection was determined to be medically significant.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse effects; patient that received MMR II during supported TE; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-OCT-2023, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (0.5 milliliter, lot #W029539, expiration date: 15-SEP-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Exursions included: 52.0F for 47 minutes, 46.6F for 3 minutes and 49.5F for 12 minutes. No adverse effects reported (No adverse event). No product quality complain (PQC).
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number L542P, expiry date 31-OCT-2023) for prophylaxis.   On 15-JAN-2024, the patient received Menveo. On 15-JAN-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received an expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 A pharmacist reported a patient who received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: The patient's husband gave her a Covid-19 test and she tested positive for Covid-19.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (The patient's husband gave her a Covid-19 test and she tested positive for Covid-19.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7146B and AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jul-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient's husband gave her a Covid-19 test and she tested positive for Covid-19.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient's husband gave her a Covid-19 test and she tested positive for Covid-19.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2023, Body temperature: mild fever of 100.9 Farenheit.. On 14-Sep-2023, SARS-CoV-2 test: Positive.         It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text was reported as unknown.  On 14-Sep-2023, the patient woke up with uncontrollable coughing. The patient's husband gave her a Covid-19 test and the patient was tested positive for Covid-19. The patient also had a mild fever of 100.9 Fahrenheit and started to feel better by Friday Night.   This case was linked to US-MODERNATX, INC.-MOD-2024-757304 (Linked Report). This case was linked to MOD-2024-757317 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757304:Husband case
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Cough, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Cough and congestion; congestion; The patient tested positive for Covid-19/Feeling worse/slight sore throat/ did not feel good at all/horrible cough; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient tested positive for Covid-19/Feeling worse/slight sore throat/ did not feel good at all/horrible cough), COUGH (Cough and congestion) and NASAL CONGESTION (congestion ) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7146B and AS7647B) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid disorder.   On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jul-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient tested positive for Covid-19/Feeling worse/slight sore throat/ did not feel good at all/horrible cough). On 08-Dec-2023, the patient experienced COUGH (Cough and congestion) and NASAL CONGESTION (congestion ). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 17-Sep-2023 for COVID-19, at a dose of lower dose. At the time of the report, COVID-19 (The patient tested positive for Covid-19/Feeling worse/slight sore throat/ did not feel good at all/horrible cough), COUGH (Cough and congestion) and NASAL CONGESTION (congestion ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2023, Chest X-ray: Negative. On 15-Sep-2023, SARS-CoV-2 test: Positive.         Patient was taking Thyroid medication.   This case was linked to US-MODERNATX, INC.-MOD-2024-757311 (Linked Report). This case was linked to MOD-2024-757308 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757311:Wife case
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Injection site pain, Injection site pustule, Pain, Pain in extremity
Clinical narrative: painful pustule on injection or torso and extremities
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Psoriasis, Pustule
Clinical narrative: painful pustule on injection or torso and extremities
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 was received from Regulatory Authority and refers to a 65-69-year-old female patient (exact age was not provided). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.   On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (exact dose, frequency, 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 and Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The relatedness between the event and the suspect vaccine was not provided.   Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Regulatory 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 2013, the patient experienced Streptococcus pneumoniae pneumonia and Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.  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 bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority and refers to a female adult patient (age: 50-54). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On unknown dates, the patient was vaccinated with two doses 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 2015, the patient experienced pneumococcal bacteraemia (Streptococcus pneumoniae serotyping was not available). The outcome of the event was not reported.  The causal relationship between the event and suspect vaccine 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: Pneumonia; Information has been received from Regulatory Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a male patient (80-84 years old). His medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with 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 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: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; 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 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 2013, the patient experienced pneumococcal bacteraemia (reported as Bacteraemia). Streptococcus pneumoniae serotyping result was not available. The outcome of the event was not reported.  The relatedness between pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Bacteraemia, Streptococcus test positive
Clinical narrative: Bacteraemia; Information has been received from Regulatory Authority (authority number wasnot provided). This spontanous report was received from regulatory authority and refers to female patient in age group 50-years-old to 54-years-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2013, the patient experienced bacteraemia. On an unknown date in 2013, Streptococcus pneumoniae serotyping showed not avaliable. At the time of reporting, the outcome of the event bacteraemia was not known.    The causal relationship between bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown. Upon internal review the event of bacteraemia was estimated 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 has been received from a Regulatory Authority, referring to an adult female patient of an unspecified age (age group reported as 45-49). 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 2015, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2015, 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 Streptococcus pneumoniae pneumonia  was determined to be 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 an Adult (age: 30-34 years old) female patient. The patient's medical history, concurrent conditions and 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, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).   On an unknown date in 2022, the patient experienced Pneumococcal infection and serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccine was unknown.  This is an amendment report. The event term has been changed from streptococcus test positive to pneumococcal infection. And upon internal review, the event pneumococcal infection has been determined as medical significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
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 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 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: M
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Streptococcus pneumoniae meningitis; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from National Notifiable Diseases Surveillance System (NNDSS) and refers to an adult male patient (age group reported as 40-44 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 2018, the patient experienced Streptococcus pneumoniae meningitis. On an unknown date in 2018, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae meningitis and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae meningitis 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 Surveillance System refers to an adult male 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 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 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 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: 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 an adult (between 50 and 54 years old; reported as age group 50-54) female 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 2019, 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: F
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 database and refers to an elderly (between 70 and 74 years old; reported as age group 70-74) female 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 2013, 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: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Regulatory Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and refers to a male patient (40-44 years old). His medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with 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 2013, the patient experienced bacteraemia (Pneumococcal bacteraemia). On an unknown date in 2013, 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, PPV
Symptoms: Pneumonia, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from {HA} (authority number was not provided). This spontanous report was received from regularory authority and refers to female patient in age group 15-years-old to 19-years-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinatd with one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2018, the patient experienced pneumonia. On an unknown date in 2018, Streptococcus pneumoniae serotyping showed not avaliable. At the time of reporting, the outcome of the event Pneumonia was not known.   The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown. The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)) was unknown. Upon internal review the event of pneumonia was estimated 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 has been received from a Regulatory Authority, referring to an elderly male patient of an unspecified age (age group reported as 65-69). 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 2018, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2018, 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 Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Regulatory Authority on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority and refers to an elderly male patient (age group reported as 65-69 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 2019, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2019, Streptococcus pneumoniae serotyping was not available. The outcome of the event was not reported.  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.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: PATIENT SHOPPED IN STORE FOR SOME TIME,  CLAIMED SHE HAD PALPITATIONS AND ELEVATED AND IRREGULAR  HEART RATE POST IMMUNIZATION ,  SHOPPED FOR 2 HOURS  WENT HOME THEN REACTION OCCURRED,  RAPID AND IRREGULAR HEART RATE   HAD NO PROBLEMS WITH FIRST DOSE ,  STATED SHE HAS HAD PALPITATIONS  PREVIOUSLY ( NO IMZ ) , AND SOUGHT NO TREATMENT,    WAS ADVISED TO SEE PRIMARY CARE MD ,  SAID PALPITATIONS AND SOB STOPPED THAT SAME DAY,   PT STATED SHE WAS GOING TO OBTAIN REFERRAL FROM PRIMARY CARE TO CARDIOLOGIST.
Age: 0.83
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The vaccine was not diluted with 1.1mL of 0.9% NS. 0.3mL was drawn up and given to the patient. Spoke with pediatric hospitalist, 2 of the providers in office, pharmacy and leadership. Patient did not have adverse reaction as reported by mom.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site, treated with Cephalexin.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Low grade dull headache, muscle soreness, fatigued,  pain at site of injection
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Magnetic resonance imaging head abnormal, Seizure, Venous angioma of brain
Clinical narrative: Patient had vaccination on 1/2/24.  On 1/4/24, experienced a seizure.  MRI showed developmental venous anomaly and could have been seizure related to OSA.  Referred to neurology.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Pain
Clinical narrative: Left shoulder pain radiating into wrist. No injection site pain
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction. Patient was given a High-dose flu shot instead of a regular flu shot.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric COVID dose was administered past best used by date. Expiration date on vial is 04/2024, but the best used by date (10 weeks after vaccine was removed from freezer for storage in refrigerator) was 1/10/2024.  Vaccine was administered on 1/18/2024. Pt notified that immediate revaccination recommended.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a second duplicate dose of arexvy on 10/12/2023  Lot 9R25C,  no adverse event
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Computerised tomogram abdomen abnormal, Diverticulitis, Fatigue, Pain
Clinical narrative: Usual Covid vaccine sympsoms of soreness and fatigue followed by sharp abdominal pains on left lower side within 48 hours of vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast abnormal
Clinical narrative: Usual Covid vaccine sympsoms of soreness and fatigue followed by sharp abdominal pains on left lower side within 48 hours of vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death from COVID 01/21/2024
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pateint recieved a second duplicate dose of arexvy on 11/09/2023, lot 9R25L, left arm
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold symptoms, hard time breathing
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypertension, Mental status changes
Clinical narrative: Hospitalization for altered mental status, COVID-19 infection, history of asthma, and hypertension on dates 1/11/2024- 1/20/2024. Treated with dexamethasone and Remdesivir.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Injection site cellulitis, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: Patient presented with swelling and redness to right arm that was warm to touch and caused mild discomfort to patient. Patient was diagnosed with Cellulitis of right upper limb due to adverse reaction to vaccines given on 01/16/2024. He was placed on steroids and PO antibiotics. Medications sent that day by Dr. included Ibuprofen tablet 400mg, Cephalexin Tablet 500mg, Hydroxyzine Tablet 25 mg and Prednisolone Tablet 20 mg. Care instructions were given to patient and they were instructed to come back into office if symptoms worsened he is scheduled for a follow up visit to review progress.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED SEVERE PAIN IN ARM AND INABILITY TO MOVE ARM. WENT TO ER FOR TREATMENT.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Disability, Electroencephalogram
Clinical narrative: Pfizer booster? diagnosis of chronic, inflammatory demyelinating neuropathy. Numbness from the waist down in the arms and radiating to the back.. short term, disability medical leave of absence for more than five months. Having to use Walker and sometimes wheelchair.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Sick leave
Clinical narrative: Pfizer booster? diagnosis of chronic, inflammatory demyelinating neuropathy. Numbness from the waist down in the arms and radiating to the back.. short term, disability medical leave of absence for more than five months. Having to use Walker and sometimes wheelchair.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Pfizer booster? diagnosis of chronic, inflammatory demyelinating neuropathy. Numbness from the waist down in the arms and radiating to the back.. short term, disability medical leave of absence for more than five months. Having to use Walker and sometimes wheelchair.
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness, itching, rash to LUE
Age: 10.0
Sex: M
Vaccine: COVID19, TYP
Symptoms: Expired product administered
Clinical narrative: Vaccine was marked to expire 2 days prior to administration(10 weeks out of the freezer). The marking of the expiration date was on the back of box and I missed seeing it
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Acute kidney injury, Acute respiratory failure, Blood loss anaemia, Cerebrovascular accident, Dementia
Clinical narrative: Hospitalization for acute hypoxic respiratory failure, hypovolemic shock, upper GI bleed, acute blood loss anemia, transaminitis, demand ischemia of myocardium, AKI, high anion gap metabolic acidosis, CVA (dysphagia), dementia, cavitary lesion right upper lung  on dates 11/30/2023- 1/5/2024.   Treated with Ipratropium/Albuterol inhaler every 8 hours, hydrocortisone 100mg IV q8h.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysphagia, Hypertransaminasaemia, Hypovolaemic shock, Lung disorder, Metabolic acidosis
Clinical narrative: Hospitalization for acute hypoxic respiratory failure, hypovolemic shock, upper GI bleed, acute blood loss anemia, transaminitis, demand ischemia of myocardium, AKI, high anion gap metabolic acidosis, CVA (dysphagia), dementia, cavitary lesion right upper lung  on dates 11/30/2023- 1/5/2024.   Treated with Ipratropium/Albuterol inhaler every 8 hours, hydrocortisone 100mg IV q8h.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Myocardial ischaemia, Upper gastrointestinal haemorrhage
Clinical narrative: Hospitalization for acute hypoxic respiratory failure, hypovolemic shock, upper GI bleed, acute blood loss anemia, transaminitis, demand ischemia of myocardium, AKI, high anion gap metabolic acidosis, CVA (dysphagia), dementia, cavitary lesion right upper lung  on dates 11/30/2023- 1/5/2024.   Treated with Ipratropium/Albuterol inhaler every 8 hours, hydrocortisone 100mg IV q8h.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, End stage renal disease, Haemodialysis, Hyperlipidaemia, Hypertension
Clinical narrative: Hospitalization for COVID-19 infection, ESRD on hemodialysis, thrombocytopenia, PAD s/p bilateral AKA, hypertension, history of colon cancer, hyperlipidemia on dates 1/15/2024- 1/19/2024. Treated with dexamethasone, Remdesivir,
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Leg amputation, Peripheral arterial occlusive disease, Thrombocytopenia
Clinical narrative: Hospitalization for COVID-19 infection, ESRD on hemodialysis, thrombocytopenia, PAD s/p bilateral AKA, hypertension, history of colon cancer, hyperlipidemia on dates 1/15/2024- 1/19/2024. Treated with dexamethasone, Remdesivir,
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: N/A.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BUD exceeded. Dose admin 12/27/23; put in fridge 10/14/23, should have been pulled 11/13/23
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Full body rash started within hours of vaccine
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, MMRV, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse outcome per patient mother
Age: 14.0
Sex: F
Vaccine: MMR, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event. client provided vaccination prior to notation of temperature excursion below -0 Celsius. Excursion was not noted with daily checks, but with download of temperature data logger. Notification of recommendation for repeat of 2 vaccine (Tdap, MCV) was made.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient wanted RSV vaccine and was given Covid accidently. Patient did not have any adverse effects from it just reporting it. He had a Covid Cominarity vaccine previously on 10/29/23.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: NONE
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Student is special needs and he was non verbal and when asked if he was 18 years of age he nodded yes.  I should have calculated his proper age to have him inoculated with proper vaccine.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event. Client provided vaccination prior to notation of temperature excursion below - 0 Celsius. Excursion was not noted with daily checks, but with download of data logger. Notification of recommendation for repeat of vaccines was made.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, DTAP, HIBV, PNC20
Symptoms: Febrile convulsion, Human rhinovirus test positive, Muscle twitching, Pyrexia, Unresponsive to stimuli
Clinical narrative: Six and a half hours following her vaccinations, she had a 10 minute long, febrile seizure.  She was laying on the ground twitching with spit coming out of her mouth and not responding to me. I called 911 and they treated her and took her to the emergency room. Her fever got up to 105°.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, DTAP, HIBV, PNC20
Symptoms: Febrile convulsion, Human rhinovirus test positive
Clinical narrative: Six and a half hours following her vaccinations, she had a 10 minute long, febrile seizure.  She was laying on the ground twitching with spit coming out of her mouth and not responding to me. I called 911 and they treated her and took her to the emergency room. Her fever got up to 105°.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event. Client provided vaccination prior to notation of temperature excursion below - 0 Celsius. Excursion was not noted with daily checks, but with download of temperature data logger. Notification of recommendation for repeat of MCV vaccine made. Flu vaccine stored in different unit and repeat not indicated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Retinogram, Vision blurred
Clinical narrative: Patient woke up on 1/13/23 with blurry vision but it went away later that day. then on the morning of 1/15/24 she woke up with blurry vision again but it has not gone away since
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt has medium size  rash on chest on left side where she got her vaccine
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given dose of Arexvy on 9/2/23 at Pharmacy, and was given a second, unnecessary dose, on 9/30/23, due to reporting system not being verified prior to administration.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient stated she was having a local reaction to the varicella vaccination. Reaction being hives, redness at the injection site, golf ball sized swelling, pain/tenderness, and warm to the touch.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Patient stated she was having a local reaction to the varicella vaccination. Reaction being hives, redness at the injection site, golf ball sized swelling, pain/tenderness, and warm to the touch.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client received 12+ dose incorrectly. Client was 11 years old.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Right arm swollen and warm tenderness.   MA administer the vaccine on the wrong   route.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I contracted Shingles.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Patient informed pharmacy that she is still experiencing arm pain from her first Shingrix vaccine.  It is believed to be due to a nerve injury after vaccination. She has not sought medical care for the pain but stated that she has been going to the gym to try and improve her arm pain.
Age: 1.83
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Juvenile chronic myelomonocytic leukaemia
Clinical narrative: Diagnosed with JMML 1 year later
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Surveillance System (SS) and refers to an elderly male patient (aged between 75 and 79 years of age). Vaccination history was reported as vaccine/s given. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (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 pneumonia (pneumonia pneumococcal). On an unknown date in 2019, the streptococcus pneumoniae serotyping was reported as not available. The outcome of the event of pneumonia pneumococcal  was unknown.  The causality assessment between the reported event and the suspect vaccine was not provided.  Upon internal review, the event of pneumonia pneumococcal  was determined to be medically significant.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Skin warm
Clinical narrative: The day after vaccine, I could feel a lump in my arm which grew to the size of a small chicken breast.  It was warm to the touch and slightly red.  On day 4 it was smaller and no longer red or warm. I did NOT call my physician because it had improved. I didn't know if you needed this information so I am taking the time to fill this out.
Age: 0.5
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product preparation error
Clinical narrative: Improperly diluted vaccine, no adverse out come.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had a stroke 3 weeks after the vaccine. He believes it was from vaccine.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Dysstasia
Clinical narrative: could not stand the day after vaccine; still having issues