chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded Regulatory Authority.   This spontaneous report refers to an elderly (also reported as 70-74 years-old) female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (strength, exact dose, route of administration, anatomical location, lot #, and expiration date were not provided). Also on an unknown date, she was vaccinated with the first dose of pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) (formulation, strength, exact dose, route of administration, anatomical location, indication, lot #, and expiration date were not provided).  On an unknown date in 2020, the patient experienced bacteraemia (pneumococcal bacteraemia). On the same date, streptococcus pneumoniae serotyping was not available.    At the time of this report, the outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported; neither the causality assessment between the event and of pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) was provided.  Upon internal review, pneumococcal bacteraemia was determined to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; This spontaneous report has been downloaded from Surveillance System".  This spontaneous report refers to an elderly (also reported as 65-69 years-old) female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the third dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (strength, exact dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On an unknown date in 2020, the patient experienced pneumonia (pneumonia pneumococcal). On the same date, streptococcus pneumoniae serotyping was not available.    At the time of this report, the outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.   Upon internal review, pneumonia pneumococcal was determined to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Unknown; This spontaneous report has been downloaded from Surveillance System".  This spontaneous report refers to an adult (also reported as 55-59 years-old) female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (strength, exact dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On an unknown date in 2020, the patient experienced pneumococcal infection. On the same date, streptococcus pneumoniae serotyping was not available.   At the time of this report, the outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.   Upon internal review, pneumococcal infection was determined to be a medically significant event.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from regulatory agency was referring to a male adult patient (age: 35-39). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2020, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2020, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event Streptococcus pneumoniae pneumonia was not known.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Other sterile site; This spontaneous report has been downloaded from Regulatory Authority was referring to a female elderly patient (age: 80-84). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2020, the patient experienced other sterile site (Pneumococcal infection). On an unknown date in 2020, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event Pneumococcal infection was not known.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of Pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority was referring to a male adult patient (age: 60-64). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2020, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2020, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event Streptococcus pneumoniae pneumonia was not known.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, C-reactive protein, Cardiac stress test, Chest discomfort
Clinical narrative: 12/14/2023 at 6:30pm rapid heart rate,  felt faint, blood pressure taken 150/95 and heart rate 145.  Took 2 baby aspirin, rested and blood pressure still elevated, heart rate slowed but still high.  Felt pressure in upper left of chest.  All these symptoms continued for several days.  When to ER where blood pressure was 173/95 wait in ER was to be 4-5 hours went home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Full blood count, Heart rate increased
Clinical narrative: 12/14/2023 at 6:30pm rapid heart rate,  felt faint, blood pressure taken 150/95 and heart rate 145.  Took 2 baby aspirin, rested and blood pressure still elevated, heart rate slowed but still high.  Felt pressure in upper left of chest.  All these symptoms continued for several days.  When to ER where blood pressure was 173/95 wait in ER was to be 4-5 hours went home.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Cold sweat, Loss of consciousness, Malaise, Pain
Clinical narrative: Patient said was fine after she got the vaccine. Later that evening,  she said she couldn't move her right arm up (it was painful). She said  she also was not feeling good and had past out. She said had rested the rest of the  day and the next day she was fine just a little clammy. She took her sugar levels and they were off so called her doctor and he said it could be do to the vaccine. outcome: she got rest and is feeling better
Age: 29.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Myalgia, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Information per provider's note, "1/20 started with fever, muscles ache, rash on face noticed  2 days ago-mild itchy had measles vaccine on 1/10- due to low titer for measles  deneis reaction at the time of vaccine", "skin: erythematous  maculopapular rash on face only/none on body".
Age: 29.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Rash pruritic
Clinical narrative: Information per provider's note, "1/20 started with fever, muscles ache, rash on face noticed  2 days ago-mild itchy had measles vaccine on 1/10- due to low titer for measles  deneis reaction at the time of vaccine", "skin: erythematous  maculopapular rash on face only/none on body".
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: left arm pain with radiation to left neck
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Has had significant pain over the left upper arm for 7 days, worsening over the course of that time. Pain is now waking from sleep. No response to ibuprofen.  No erythema, warmth or induration on exam. Not appreciably tender to palpation over deltoid but has pain at rest and increased with movement at her shoulder
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was  discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires.  We've reached out to the manufacturer and CDC and unfortunately they don't have data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience and adverse reaction from this vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laryngoscopy, Pharyngeal swelling
Clinical narrative: It may be from my asthma med.  My voice box is swollen and has white dots that are assumed to be fungal
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Immediate pain in arm. Tingling in fingers. General numbness in arm. Unable to freely move arm. Pain not relieved with OTC pain medication. Difficulty in sleeping the night of vaccination.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Immediate pain in arm. Tingling in fingers. General numbness in arm. Unable to freely move arm. Pain not relieved with OTC pain medication. Difficulty in sleeping the night of vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, RSV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was  discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires.  We've reached out to the manufacturer and CDC and unfortunately they don't have data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience and adverse reaction from this vaccination.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer COVID vaccine administration after beyond use date.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose administered. No adverse reaction/side effects/symptoms reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer Covid vaccine administration after beyond use date.
Age: 66.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was  discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires.  We've reached out to the manufacturer and CDC and unfortunately they don't have data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience and adverse reaction from this vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nasal congestion
Clinical narrative: Flu like symptoms, chills,stuffy head
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The Comirnaty Pfizer vaccine was  discovered to not have been stored according to the labeling and was kept in the freezer longer than what the manufacturer requires.  We've reached out to the manufacturer and CDC and unfortunately they don't have data to support storage beyond the recommended time allowed. The vaccine was unfortunately administered before the discovery. Patient was contacted and offered to revaccinate. Patient did not experience and adverse reaction from this vaccination.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Cardioversion, Discomfort, Electrocardiogram, Fatigue
Clinical narrative: Paroxysmal Rapid Afib with weakness, discomfort, jitters, fatigue starting about 2 pm on January 18, 2024. Took a nap, ate a small dinner, but could still feel that my pulse was not in sinus rhythm and that I was too fast. Then decided to go to the hospital where that evening I was electrocardioverted back to sinus rhythm and normal heart rate.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Feeling jittery, Heart rate increased
Clinical narrative: Paroxysmal Rapid Afib with weakness, discomfort, jitters, fatigue starting about 2 pm on January 18, 2024. Took a nap, ate a small dinner, but could still feel that my pulse was not in sinus rhythm and that I was too fast. Then decided to go to the hospital where that evening I was electrocardioverted back to sinus rhythm and normal heart rate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Respiratory tract congestion
Clinical narrative: Flu like symptoms, cough, congestion, head ache, extreme fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Flu like symptoms, cough, congestion, head ache, extreme fatigue.
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received Pfizer Covid vaccine administration after beyond use date.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: 12/24/23 started with cold symptoms, had negative COVID home test, symptoms worsened throughout the week. Coughing started 12/27/23. Negative home COVID test on 12/28/23..  12/30/23 felt exhausted, coughing and cold symptoms continued. Went to Urgent Care on 12/31/23,  had another Negative COVID test at Urgent Care. Was given Augmentin, Flonase, and Cough Medicine pills. 1/1/24 called my family doctor and was prescribed Steroids. No improvement. Cold symptoms improved. Started OTC Delsym DM on 1/21/24 and using Vicks on my chest. Feeling relief on 1/23/24. Still coughing but not as frequently.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Ringing in ears (tinnitus) was worsened
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient called the pharmacy on 01/24/2024 around 11 am to state that she has been experiencing extreme arm pain and decreased motion in the arm.  Patient states she spoke with her dr and he said that these are symptoms of SIRVA. I notified patient that this vaccination can cause severe arm pain that should go away after few days .
Age: 72.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Headache
Clinical narrative: Pt started getting a headache(back of head on right side) the day.  Headache did not go away but helped somewhat with ibuprofen and tylenol combination
Age: 72.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Hypertension
Clinical narrative: Pt started getting a headache(back of head on right side) the day.  Headache did not go away but helped somewhat with ibuprofen and tylenol combination
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Monday received shot around 2 PM. Same day pain in arm, tiredness, early to bed (8 PM), woke early (3 AM) with nausea, chills, headache, stayed in bed all day, and the following night,  no food, water, or medication. woke second morning soaking wet from sweat & headache. Mostly recovered by about Noon Wednesday.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pain in extremity, Sleep disorder
Clinical narrative: Monday received shot around 2 PM. Same day pain in arm, tiredness, early to bed (8 PM), woke early (3 AM) with nausea, chills, headache, stayed in bed all day, and the following night,  no food, water, or medication. woke second morning soaking wet from sweat & headache. Mostly recovered by about Noon Wednesday.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Hypotension
Clinical narrative: High heart rate (over 120 while resting), fatigue, and low blood pressure (106 over 70) the day after the vaccine 01/24/24
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4, PNC13
Symptoms: Limb injury, Mobility decreased
Clinical narrative: Shoulder injury. Unable to lift arm for over 6 weeks as of 1-24-2024.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Exposure during pregnancy, Pain, Swelling
Clinical narrative: Redness, swelling, pain
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Chest pain, Diarrhoea, Myalgia, Pyrexia, Swelling of eyelid
Clinical narrative: The side effects including high fever, 39.7C in the afternoon, chest and muscle pain, tachycardia, swollen eyes, vomit and diarrhoea followed by a fainting episode. I assumed ibuprofen and tylenol, rested in bed and tried to remain hydrated. Symptoms resolved spontaneously starting from the following day in the evening, when I manage to drink juice and eat yogurt.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Tachycardia, Vomiting
Clinical narrative: The side effects including high fever, 39.7C in the afternoon, chest and muscle pain, tachycardia, swollen eyes, vomit and diarrhoea followed by a fainting episode. I assumed ibuprofen and tylenol, rested in bed and tried to remain hydrated. Symptoms resolved spontaneously starting from the following day in the evening, when I manage to drink juice and eat yogurt.
Age: 56.0
Sex: F
Vaccine: FLUN4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flumist given to 56 year old, beyond the recommendation age of 2 yr-49 yr. Patient denies any symptoms after receiving vaccine. Patient denies any concerns.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: -Headache, (L) arm swelling and erythema -Augmentin x 5 days and Prednisone x 3 days rx treatment
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Night sweats, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever, chills, night sweats, congestion, nasal drainage
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Echocardiogram normal, Full blood count normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 01-Oct-2023, the patient experienced PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 02-Oct-2023, PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) had resolved.            Concomitant medication was not provided. Patient experienced sensory symptoms of left arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand, some feeling of tightness or cuffing. She was able to drive and went home and took aspirin. She then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours.  Patient was evaluated for possible TIA and kept in the hospital overnight.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Transient ischaemic attack, X-ray normal
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 01-Oct-2023, the patient experienced PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 02-Oct-2023, PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) had resolved.            Concomitant medication was not provided. Patient experienced sensory symptoms of left arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand, some feeling of tightness or cuffing. She was able to drive and went home and took aspirin. She then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours.  Patient was evaluated for possible TIA and kept in the hospital overnight.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 01-Oct-2023, the patient experienced PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 02-Oct-2023, PARAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) and HYPOAESTHESIA (Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand) had resolved.            Concomitant medication was not provided. Patient experienced sensory symptoms of left arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand, some feeling of tightness or cuffing. She was able to drive and went home and took aspirin. She then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours.  Patient was evaluated for possible TIA and kept in the hospital overnight.
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Patient received RSV vaccine Arexvy on 8/18/23 - reported pain and stiffness, difficulty lifting arm. Spoke to patient again on 1/25 to check in, patient reported seeing an orthopedic doctor and was diagnosed with Frozen Shoulder.
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Periarthritis
Clinical narrative: Patient received RSV vaccine Arexvy on 8/18/23 - reported pain and stiffness, difficulty lifting arm. Spoke to patient again on 1/25 to check in, patient reported seeing an orthopedic doctor and was diagnosed with Frozen Shoulder.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from regulatory agency and referring to an elderly female patient (age: 70-74). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).   On an unknown date in 2010, the patient experienced Pneumococcal bacteraemia (reported as Bacteraemia). On an unknown date in 2010, streptococcus pneumoniae serotyping was performed and the result was not available. At the time of reporting, the outcome of the event was not known.    The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of Pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Surveillance System, concerning an adult male patient between 40-44 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2010, the patient experienced pneumonia (Pneumonia pneumococcal) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from database and referring to a child female patient (age: 05-09). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On an unknown dates, she also received other suspect therapy Pneumococcal vaccine conj 7v (CRM197) (PREVENAR) 3 times (strength, dose, indication,lot #, expiry date, and route of administration were not provided).   On an unknown date in 2010, the patient experienced Pneumococcal bacteraemia (reported as Bacteraemia). On an unknown date in 2010, streptococcus pneumoniae serotyping was performed and the result was not available. At the time of reporting, the outcome of the event was not known.    The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of Pneumococcal 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 concerning to an elderly male patient (age: 75-79). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On unknown dates, the patient was vaccinated with the first dose and second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2021, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2021, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was unknown.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) concerning to an elderly female patient of unknown age (age group: 70-74 years). The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage regimen, lot #, expiry date, frequency, and route of administration were not provided), administered as prophylaxis. Also on an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, dosage regimen, lot #, expiry date, frequency, and route of administration were not provided), administered as prophylaxis.  On an unknown date in 2021, the patient experienced pneumonia (pneumonia pneumococcal). Streptococcus pneumoniae serotyping was not available. It was stated that the vaccine was not available for serotype. At the reporting time, the outcome of the event was unknown.   The causal relationship between the event and the suspect vaccines was unknown.   Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS), regarding a elderly female  patient (reported as age group: between 65-69). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided); and first dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), both vaccines as prophylaxis  On an unknown date in 2020, the patient experienced pneumonia with streptococcus pneumoniae serotyping not available (streptococcus pneumoniae pneumonia). The outcome of the event was not provided.  The causal relationship between streptococcus pneumoniae pneumonia and the suspect vaccines was not reported.  Upon internal review, the event streptococcus pneumoniae pneumonia was considered as medically significant.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been received from the National Notifiable Diseases Surveillance System (NNDSS), regarding to a child (reported as between 02 to 04-year-old) male patient. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis and with the third dose of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (strength, dosage, vaccination scheme frequency, indication, route of administration, anatomical location, lot number, and expiration date were not provided).  On an unspecified date in 2012, streptococcus pneumoniae serotyping was reported as not available. On the same date, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event and the causality assessment between the event with the suspect therapies were not reported.  Upon internal review, the pneumonia pneumococcal event was determined to be medically significant. .
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Asthenia, Bladder catheterisation, Gait inability, Intensive care, Lumbar puncture
Clinical narrative: patient developed inability to urinate - came to ER - had Foley placed - Could not walk - had to be in wheelchair, where as the weekend prior to Vaccine was skiing (3 days) and on Jan 20th and 21st played 18 hole golf. He became progressively unable to Move Both legs and had sensory level up to chest wall - Ascending weakness - over the past 24-48 Hours. Today had Left Upper Extremity weakness.
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Musculoskeletal disorder, Sensory loss, Urinary retention
Clinical narrative: patient developed inability to urinate - came to ER - had Foley placed - Could not walk - had to be in wheelchair, where as the weekend prior to Vaccine was skiing (3 days) and on Jan 20th and 21st played 18 hole golf. He became progressively unable to Move Both legs and had sensory level up to chest wall - Ascending weakness - over the past 24-48 Hours. Today had Left Upper Extremity weakness.
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Wheelchair user
Clinical narrative: patient developed inability to urinate - came to ER - had Foley placed - Could not walk - had to be in wheelchair, where as the weekend prior to Vaccine was skiing (3 days) and on Jan 20th and 21st played 18 hole golf. He became progressively unable to Move Both legs and had sensory level up to chest wall - Ascending weakness - over the past 24-48 Hours. Today had Left Upper Extremity weakness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Autoimmune disorder, Biopsy
Clinical narrative: Significant hair loss, starting three weeks after administration of vaccine. Diagnosis of auto immune disorder after alopecia areata.
Age: 70.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Fatigue, Injected limb mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: On 1/12/24, patient woke up and couldn't move left arm upwards in front of her or sideways. She had side effects that were consistent with getting a covid shot (tired, achy, feverish) but the arm pain was not normal.  She had a regular visit with her primary care on 1/16 and the MD did an exam and diagnosed her with suspected interarticular vaccination in the left shoulder.
Age: 70.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Pyrexia
Clinical narrative: On 1/12/24, patient woke up and couldn't move left arm upwards in front of her or sideways. She had side effects that were consistent with getting a covid shot (tired, achy, feverish) but the arm pain was not normal.  She had a regular visit with her primary care on 1/16 and the MD did an exam and diagnosed her with suspected interarticular vaccination in the left shoulder.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Ppneumonia; This spontaneous report has been downloaded from Regulatory Authority on 12-JAN-2024, was referring to an adult female patient of an unknown age (reported as 45-49 years). There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On an unknown date, the patient was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, scheme, route, anatomical location, lot number, and expiration date were not provided).   On an unknown date in 2014, the patient experienced pneumonia (Streptococcus pneumoniae pneumonia). On an unknown date in 2014, Streptococcus pneumoniae serotyping was reported as not available.   At the time of reporting, the outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Surveillance System on 12-JAN-2024, was referring to an elderly male patient of an unknown age (reported as 85-years and over). There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On an unknown date, the patient was vaccinated with his first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, scheme, route, anatomical location, lot number, and expiration date were not provided).   On an unknown date in 2014, the patient experienced pneumonia (Streptococcus pneumoniae pneumonia). On an unknown date in 2014, Streptococcus pneumoniae serotyping was reported as not available.   At the time of reporting, the outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; 33 week old (8 months and 4 day old) female patient received their third dose of ROTATEQ; This spontaneous report was received from healthcare business professional (HBP) and refers to a 33-week-old (8 months and 4 day old) female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first and second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (dose, lot #, and expiry date were not provided). On 03-JAN-2024, at the age of 33 week old (8 months and 4 day old), the patient was vaccinated with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot# X008002, expiry date 29-OCT-2024, administered orally as prophylaxis (product administered to patient of inappropriate age). Confirmed no side effects or symptoms reported.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; HCP called to report that a patient was accidentally administered PROQUAD. The HCP states that the patient should not have received PROQUAD at all on 01/09/2024. No symptomatic adverse events reported. No additional information provided. No Additiona; This spontaneous report was received from a nurse and referred to a 6-year-old patient of unknown gender.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included congenital hypothyroidism.   On 09-JAN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) injection, 0.5 milliliter/series, which was accidentally administered for prophylaxis. The patient should not have received the vaccine at all (wrong vaccine administered) (lot number X018732 has been verified to be a valid lot number, expiration date reported and validated as 06-JAN-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided). There were no symptomatic adverse events reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient receiving 3 doses of PEDVAX HIB at the ages of 2-months-old, 4-months-old, and 6-months-old.; no additional AE; This spontaneous report was received from a medical assistant concerning a 6 month old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date at 2-months-old and 4-months-old, the patient was vaccinated with the first and second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) respectively, at dose of 0.5 milliliter for prophylaxis (route, lot# and expiration date were not reported). At 6-months-old, the patient was vaccinated with the third  dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) at dose of 0.5 milliliter for prophylaxis (route, lot# and expiration date were not reported) (inappropriate schedule of product administration). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Physician reported a pregnant patient was administered GARDASIL9 vaccine; No additional AE; Information was received from the physician concerning a pregnant female patient with unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications and drug reactions or allergies were not reported.  On 04-JAN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dose, lot number X019863 has been verified to be a valid lot number and expiration date was 14-FEB-2025, frequency, route of administration and anatomical location were unknown) for prophylaxis (exposure during pregnancy). At the reporting time, pregnancy outcome was outcome pending and fetal outcome was unknown. The patient was asymptomatic. The operator of device was health care professional. No additional adverse event (AE) reported (no adverse event).
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that an expired MMR II vaccine was administered to a patient.   No additional AEs were reported, no further information provided.; This spontaneous report has bee received from a medical assistant, regarding a 19-year-old patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 19-JAN-2024, the patient as vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, as prophylaxis (lot number: W017557, which was determined to be valid, with an expiration date on 07-JAN-2024, therapy type: rHA) (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) (Expired product administered).  No additional adverse event was reported.   No further information was provided.
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: patient that has an adverse events, stem from GARDASIL 9.  The exact adverse event is unknown.; This initial spontaneous report has been received from a facility and healthcare provider (HCP), via company representative, regarding a case in litigation, concerning a 26-year-old female patient (pt). The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml), administered for prophylaxis (dose number, lot number, expiration date, vaccination scheme, frequency and route of administration were not provided).  On an unknown date, the patient experienced an adverse event, the exact adverse event was unknown. The healthcare provider (HCP) reported that the patient was attempting to have their experience validated by the HCP in order to show proof that the adverse event was linked to her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. The HCP and the facility chose to remain anonymous during that time and was limiting the amount of details provided. At the time of reporting, the outcome of the adverse event was not provided.  The reporter considered the adverse event to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that an expired MMR II vaccine was administered.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from  nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JAN-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dose, lot #w017557, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse events were reported.