chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: U
Vaccine: DTPPVHBHPB, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient that was administered Vaxelis on 05Jan2024 by a different facility and was then administered Pentacel today on 17Jan2024 with no reported adverse event; Initial information received on 17-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3 months old and unknown gender patient where patient that was administered vaxelis on 05jan2024 by a different facility and was then administered diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] today on 17jan2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jan-2024, the patient received a dose of suspect Vaxelis not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength, lot/batch number and expiration date: not provided) for Immunisation.  On 17-Jan-2024, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ970AA and expiration date- 03-Nov-2024) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (extra dose 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 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB that was reconstituted with sterile water instead of the 0.4% NaCl solution and administered to a patient with no reported adverse event; ACTHIB that was reconstituted with sterile water instead of the 0.4% NaCl solution and administered to a patient with no reported adverse event; Initial information received from country on 18-Jan-2024 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 1 years old male patient who was administered with Hib (Prp/T) Vaccine [Act-Hib] that was reconstituted with sterile water instead of the 0.4% nacl solution, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Immunisation.  On 15-Jan-2024, the patient received (0.5 ml, once) dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: unknown), that was reconstituted with sterile water instead of the 0.4% nacl solution, with no reported adverse event (product preparation error) and (poor quality product administered) (latency: same day) (lot: UJ855AB, expiry date: not reported) via intramuscular route in right leg for immunization.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  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: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Pneumococcal infection; Information has been received from {HA} on 12-JAN-2024.  This spontaneous report was received from public data set 2009 to 2022 (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of Regulatory Authority and referred to an elderly (age: 70-74 years) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 1 dose 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 Streptococcus pneumoniae test positive. On an unknown date in 2022, streptococcus pneumoniae serotyping was not applicable. At the time of reporting, the outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the event and suspect vaccine was not provided.  This is an amended report. The event was changed from Streptococcus pneumoniae test positive to Pneumococcal infection, medically significant was checked for the event Pneumococcal infection upon internal review.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Pneumococcal infection; Information has been received from {HA} on 12-JAN-2024.  This spontaneous report was received from public data set 2009 to 2022 (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of Regulatory Authority and referred to an elderly (age: 75-79 years) male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 2 dose 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 Streptococcus pneumoniae test positive. On an unknown date in 2022, streptococcus pneumoniae serotyping was not applicable. At the time of reporting, the outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the event and suspect vaccine was not provided.  This is an amended report. The event was changed from Streptococcus pneumoniae test positive to Pneumococcal infection, medically significant was checked for the event Pneumococcal infection upon internal review.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: she received a prescription written by HCP for Arexvy for a patient under 60 years of age who is immunodeficient due to other medication; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 49-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised (was immunodeficient due to other medication and other external causes per diagnosis code).   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug prescribing error (Verbatim: she received a prescription written by HCP for Arexvy for a patient under 60 years of age who is immunodeficient due to other medication). The outcome of the drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 18-JAN-2024 The patient was under 60 years of age. The registered pharmacist received the prescription written by healthcare professional for Arexvy. The prescription was written for patient under 60 years of age, which led to drug prescribing error. The reporter did not consent to follow-up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Muscle tightness, Pain
Clinical narrative: Significant deltoid Muscles tension and pain with arm movement.; Significant deltoid Muscles tension and pain with arm movement.; Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.; Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.; Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Significant deltoid Muscles tension and pain with arm movement.), PAIN (Significant deltoid Muscles tension and pain with arm movement.), INJECTION SITE WARMTH (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.), INJECTION SITE ERYTHEMA (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.) and INJECTION SITE PAIN (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Jan-2024, the patient experienced MUSCLE TIGHTNESS (Significant deltoid Muscles tension and pain with arm movement.), PAIN (Significant deltoid Muscles tension and pain with arm movement.), INJECTION SITE WARMTH (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.), INJECTION SITE ERYTHEMA (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.) and INJECTION SITE PAIN (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.). At the time of the report, MUSCLE TIGHTNESS (Significant deltoid Muscles tension and pain with arm movement.), PAIN (Significant deltoid Muscles tension and pain with arm movement.), INJECTION SITE WARMTH (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.), INJECTION SITE ERYTHEMA (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.) and INJECTION SITE PAIN (Warmth, Redness, tenderness to where vaccine was injected which expands about 1.5 inches from injection site.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms or events. The patient had no medical history, concomitant disease or risk factor. There were no lab data or results available.  No treatment medication was reported.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash on face inner thighs neck and chest
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Headache, Neuralgia
Clinical narrative: Patient reported headache and nerves pain developed 20 minutes after the above vaccines which lead to a doctor's visit two days later.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: joint pain: both knees, both elbows, Muscle pain thighs and legs lower back pain
Sex: U
Vaccine: COVID19, RSV
Symptoms: Asthenia, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Within 12 hours; fever, aches, sore throat, coughing, possibly swollen throat, weakness
Sex: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Glycosylated haemoglobin increased, Type 1 diabetes mellitus
Clinical narrative: My son was suddenly diagnosed with Type 1 Diabetes when he was 14 and he never had any symptoms. Neither we have a family history of it. He had to be hospitalized for being under Diabetic KetoAcidosis. We suspect it was because of the Pfizer covid shots taken earlier that year
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: I have experienced persistent nausea from the first dose of the Shingrix vaccine which was administered on 91/19/2024
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Cardiac stress test abnormal, Coronary artery bypass
Clinical narrative: Triple bypass surgery. From covid 19 vax
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: On tymlos for 4 weeks when daily numbness in hands and lower forearms began. This worsened for 24 hours after I had my updated Covid vaccine and then returned to pre shot levels of numbness. I reduced the dose to 60mg and numbness subsided. Told my pharmacist and he felt perhaps it was a mild allergic reaction to a preservative in the drug.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site pain, Nausea, Pyrexia
Clinical narrative: Bad headache. Sore arm at injection site. Numbness in arm in which shot was given. Nausea and fever
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Patient, a 90 year old male, received Comirnaty 30mcg/0.3m vaccine on 01/04/2024. Patient experienced an increased bleeding event which required hospitalization.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Other; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS)".   This spontaneous report as received from a National Notifiable Diseases Surveillance System (NNDSS) refers to an elderly male patient of unknown exact age (age group reported as "80-84"). 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 unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2015, the patient experienced Pneumococcal infection (reported as Other). 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 the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Surveillance System (SS) and refers to a child female patient of unknown exact age (age group reported as "05-09"). 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 dates, the patient was also vaccinated with three doses of pneumococcal vaccine conj 7V (CRM197) (PREVENAR) (dose, route of administration, anatomical location, indication, lot number and expiration date were not reported). On an unknown date in 2012, 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 suspect vaccines was not provided.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to a 65-69-year-old male patient (exact age was not provided). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.   On unknown dates, the patient was vaccinated with first and second doses 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 2012, 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
Clinical narrative: Pneumonia; This spontaneous report was received from Surveillance System and refers to an adult male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strengths, lot numbers, expiry dates, and routes of administration were not provided).  On an unknown date in 2015, the patient experienced pneumonia. At the time of reporting, the outcome of the event was not known. The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: other; This spontaneous report has been downloaded from Regulatory Authority and 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 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 2015, the patient experienced pneumococcal infection (reported as Other). Streptococcus pneumoniae serotyping result was 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: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS) via Company representative, concerning to an elderly (age group reported as 70-74-year-old) male patient.   His medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine/s given.   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 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.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from a database, referring to an elderly male patient of an unspecified age (age group reported as 80-84). 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 Streptococcus pneumoniae pneumonia. 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 Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority.   This spontaneous report as received from a Regulatory Authority refers to an elderly male 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 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 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: PNC, PPV
Symptoms: Peritonitis pneumococcal, Pneumococcal infection
Clinical narrative: Other; Peritonitis; This spontaneous report has been downloaded from regulatory authority and refers to a female patient of unknown exact age (age group reported as "10-14"). 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 unknown dates, she was also vaccinated with three doses of pneumococcal vaccine conj 7V (CRM197) (PREVENAR) ) (dose, route of administration, anatomical location, indication, lot number and expiration date were not reported). On an unknown date in 2019, the patient experienced pneumococcal infection (reported as Other) and peritonitis pneumococcal (reported as peritonitis). Streptococcus pneumoniae serotyping result was not available. The outcome of the events was not reported.  The relatedness between the events and suspect vaccines was not provided.  Upon internal review, the events of pneumococcal infection and peritonitis pneumococcal were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from database and refers to an adult (between 60 and 64 years old; reported as age group 60-64) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an 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, and route of administration were not provided). It was reported that the patient received total of 2 vaccinations.  In 2016, 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 infection, Streptococcus test
Clinical narrative: Other; This spontaneous report has been downloaded from Regulatory Authority and refers to a 75-79-year-old male patient (exact age was not provided). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.   On unspecified day, the patient was vaccinated with a 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 2016, the patient experienced Pneumococcal infection (reported as Other), and 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 Pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; This spontaneous report was received from Surveillance System (SS) and refers to an adult female patient of unknown age (reported as 55-59).   There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided. Vaccination history was provided as vaccine not available for serotype.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 3 time in total, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia. Streptococcus pneumoniae serotyping was not available. 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 Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and 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 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 2019, 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; This spontaneous report has been downloaded from a Regulatory Authority, referring to an adult female patient of an unspecified 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 two doses of 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 Streptococcus pneumoniae pneumonia. 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 Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; This spontaneous report has been downloaded 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 unknown dates, the patient was vaccinated with three doses of 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 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, 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: PNC, PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from Surveillance System".   This spontaneous report as received from a Surveillance System refers to a male patient of unknown exact age (age group reported as "15-19"). 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 dates, the patient was vaccinated with a three doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (dose, route of administration, anatomical location, lot number, expiration date, and indication were not reported).  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 the suspect vaccines 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: Unknown; This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS) via Company representative, concerning to an adult (age group reported as 45-49-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 in 2020, the patient experienced pneumococcal infection, and Streptococcus pneumoniae serotyping was not available.   The outcome of the event was not provided.    The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, pneumococcal infection was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Infectious pleural effusion, Pneumococcal infection
Clinical narrative: Pleural effusion; Other; This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS) via Company representative, concerning to an adult (age group reported as 50-54-year-old) female patient.   Her medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine/s given.   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 2020, the patient experienced pneumococcal infection and pleural effusion (infectious pleural effusion). Streptococcus pneumoniae serotyping was not available.   The outcome of the events was not provided.    The causal relationship between pneumococcal infection, infectious pleural effusion and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, pneumococcal infection and infectious pleural effusion were considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from a Regulatory Authority, referring to an elderly male patient of an unspecified age (age group reported as 80-84). 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 2016, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2016, 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.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain, Swelling
Clinical narrative: The reactions is localized swelling. redness, pain and soreness. Gave cold compress, with relieve. Pain was at a 7 then to 5 after cold compress. But will follow us with patient.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Alanine aminotransferase, Anti-cyclic citrullinated peptide antibody, Arthralgia, Aspartate aminotransferase, Blood creatinine
Clinical narrative: Muscle pain began within a month.  first right shoulder and arm, later included left arm and hand.  within 4 months left hand had almost severe pain.  Both hands affected,primarily the left hand.  motion of fingers was difficult for at least 30 minutes after waking.   The only medication that has reduced the pain is Prednisone.  Now 2.5 mg per day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Borrelia test, C-reactive protein, Differential white blood cell count, Epstein-Barr virus antibody, Full blood count
Clinical narrative: Muscle pain began within a month.  first right shoulder and arm, later included left arm and hand.  within 4 months left hand had almost severe pain.  Both hands affected,primarily the left hand.  motion of fingers was difficult for at least 30 minutes after waking.   The only medication that has reduced the pain is Prednisone.  Now 2.5 mg per day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Glomerular filtration rate, Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis B surface antigen, Hepatitis C antibody
Clinical narrative: Muscle pain began within a month.  first right shoulder and arm, later included left arm and hand.  within 4 months left hand had almost severe pain.  Both hands affected,primarily the left hand.  motion of fingers was difficult for at least 30 minutes after waking.   The only medication that has reduced the pain is Prednisone.  Now 2.5 mg per day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Parvovirus B19 test, Red blood cell sedimentation rate
Clinical narrative: Muscle pain began within a month.  first right shoulder and arm, later included left arm and hand.  within 4 months left hand had almost severe pain.  Both hands affected,primarily the left hand.  motion of fingers was difficult for at least 30 minutes after waking.   The only medication that has reduced the pain is Prednisone.  Now 2.5 mg per day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rheumatoid factor, Spinal X-ray, X-ray limb
Clinical narrative: Muscle pain began within a month.  first right shoulder and arm, later included left arm and hand.  within 4 months left hand had almost severe pain.  Both hands affected,primarily the left hand.  motion of fingers was difficult for at least 30 minutes after waking.   The only medication that has reduced the pain is Prednisone.  Now 2.5 mg per day.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Productive cough, SARS-CoV-2 test negative, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection, productive cough, fatigue.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Death
Clinical narrative: Resident died 1/24/2024
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Bone pain, Crying, Gene mutation identification test, Loss of personal independence in daily activities
Clinical narrative: The next day patient was not her self and still is not. She was not there. Blank look. She wouldnt look at you when you talked to her. She was clingy, crying, not her happy self. Her personality has changed so much. She won't participate in activities that used to bring her joy.  She has nightmares since the vaccination. Complains of her bones in her legs hurting.  She was the light in the room and it's as if her light has been dimmed.  She has a completely different personality overnight!
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Nightmare, Pain in extremity, Personality change
Clinical narrative: The next day patient was not her self and still is not. She was not there. Blank look. She wouldnt look at you when you talked to her. She was clingy, crying, not her happy self. Her personality has changed so much. She won't participate in activities that used to bring her joy.  She has nightmares since the vaccination. Complains of her bones in her legs hurting.  She was the light in the room and it's as if her light has been dimmed.  She has a completely different personality overnight!
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Pt is 32 weeks pregnant.  Dr ordered Arexvy vaccine for pt and RN administered the vaccine.  This pt should have received Abrysvo.  No adverse event occurred, but pt received the wrong vaccine.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Diluent (normal saline) was expired at time of event (11/30/23).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: body stiffness
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called the pharmacy at approx 5pm and asked to speak with a pharmacist regarding a vaccine he had received earlier in the day.  I got on the phone with patient who proceeded to describe pain in his arm and shoulder that he had received the vaccination in.  Upon questioning he described pain, and difficulty moving and/or lifting arm.  He had tried cold and warm compresses and also taken ibuprofen and/or acetaminophen.  I told him to continue with those things and that I would contact him in the morning to see how he was doing.  Upon calling the patients home this morning at approx. 9:10am and patient's wife answered the phone;  I asked how patient was doing this morning and she stated "not well".  She went on to say that they had gone to the Emergency Department at Medical Center. The ED doctor had told them that the injection had been given "in the joint". She did not offer what treatment or recommendations (if any) were given. I apologized and let her know that I would be reporting to VAERS. There was a voicemail for me this morning from an ED physician asking me to email him. I have emailed him and have not yet received a response.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second flu vaccine given too early. 1st dose given on 1/9/24 and 2nd one given on 1/23/24. Dr. called parent and informed does is invalid and will need repeated. Patient stable with no symptoms.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: pain upon injection in lt arm.  my within a few hours, my left shoulder completely froze up.  my shoulder was paralyzed at the shoulder joint. painful, took ambien sleeping pill to sleep.  The next morning my lt shoulder was not frozen completely.  pain in the arm and shoulder.  I had to see a doctor when I realized this bad pain was not going away after vaccine.   I saw DR Orthopedics.  Dr. sent me to PT.  After little improvement.  Dr ordered an MRI.  The Mri indicated there is a tear in Lt shoulder.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: pain upon injection in lt arm.  my within a few hours, my left shoulder completely froze up.  my shoulder was paralyzed at the shoulder joint. painful, took ambien sleeping pill to sleep.  The next morning my lt shoulder was not frozen completely.  pain in the arm and shoulder.  I had to see a doctor when I realized this bad pain was not going away after vaccine.   I saw DR Orthopedics.  Dr. sent me to PT.  After little improvement.  Dr ordered an MRI.  The Mri indicated there is a tear in Lt shoulder.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head normal
Clinical narrative: Bell's Palsy
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain
Clinical narrative: Mild chest pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: Blotchy red marks on each bicep = a farmers tan of red blotchy skin on both arms, left arm is redder/worse than right. Experienced pain/swelling/soreness (similar to standard flu shot), in both arms after Moderna series 1 and 2. Pain/swelling/soreness stopped after a few days but blotchy red farmers tan remains, 3 years later. I have received covid boosters/flu shots since Series 1/2, but no change in the blotchy red farmers tan. Mar 31, 2021: Series 1 Moderna #008B21A, Public Health  Apr 29, 2021: Series 2 Moderna #047B21A,  Public Health drive-up vaccination location.  Oct 22, 2021: Sanofi Pasteur #UT7377LA, Pharmacy.  Nov 23, 2021: Pfizer #FJ1620, Pharmacy.  Oct 30, 2022: Pfizer #GJG738, Pharmacy. Oct 30, 2022: Sanofi Pasteur #UJ903AA Pharmacy.  Oct 29, 2023: Spikevax #unknown, Pharmacy. Oct 29, 2023: Sanofi Pasteur #unknown, Pharmacy.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: the diluent that was used was NOT the one that accompanied the vaccine.  Merck sterile water was used
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Approx 6-8 hours after injection muscular aches started and worsened within hours to the point of needing pain relieving medication. Muscle and joint aches were centered in the neck, shoulders and spine. Within 18 hours a fever of 101 was present. Body aches, fever and soreness and swelling at the injection site continued for 72 hours. Soreness spread to all joints. After 48 hours, congestion and a fullness in the lungs set in. Congestion, coughing, and tiredness continued for 5-7 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pulmonary congestion, Pulmonary oedema, Pyrexia
Clinical narrative: Approx 6-8 hours after injection muscular aches started and worsened within hours to the point of needing pain relieving medication. Muscle and joint aches were centered in the neck, shoulders and spine. Within 18 hours a fever of 101 was present. Body aches, fever and soreness and swelling at the injection site continued for 72 hours. Soreness spread to all joints. After 48 hours, congestion and a fullness in the lungs set in. Congestion, coughing, and tiredness continued for 5-7 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: large round indurated skin lesion at injection site that resolved after 1 week with conservative treatment.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Magnetic resonance imaging, Paralysis, Periarthritis
Clinical narrative: pain at injection site; left shoulder froze, left shoulder paralyzed
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cyst, Electric shock sensation, Gait disturbance, Induration
Clinical narrative: My hips and thighs started hurting very badly like cattle prods in them like electric shock. It felt like the meat of my legs were being ripped off. I had an MRI and discovered my spine having 2 places of degeneration down to 3mm and there's a cyst inside the spine. I am close to being unable to walk. I have cortisone medication (oral) and muscle relaxers that help me limp around. The varicose vein therapy I was doing right before the shot, the locations they did treatment has turned hard and lumpy. My left arm feels like its broken, I have had that arm broken before so it feels similar. On a previous vaccine (moderna as well) I had it injected in my left arm and it felt the same way but much more extreme, like it was broken all over again.  In May of 2023 I had knee replacement. Now its swollen and dark in that same area, the joint is really stiff and painful. I saw a spinal specialist too.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Magnetic resonance imaging spinal abnormal, Pain in extremity, Procedural site reaction
Clinical narrative: My hips and thighs started hurting very badly like cattle prods in them like electric shock. It felt like the meat of my legs were being ripped off. I had an MRI and discovered my spine having 2 places of degeneration down to 3mm and there's a cyst inside the spine. I am close to being unable to walk. I have cortisone medication (oral) and muscle relaxers that help me limp around. The varicose vein therapy I was doing right before the shot, the locations they did treatment has turned hard and lumpy. My left arm feels like its broken, I have had that arm broken before so it feels similar. On a previous vaccine (moderna as well) I had it injected in my left arm and it felt the same way but much more extreme, like it was broken all over again.  In May of 2023 I had knee replacement. Now its swollen and dark in that same area, the joint is really stiff and painful. I saw a spinal specialist too.