chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from a Health Authority on 12-JAN-2024.  This spontaneous report has been received from a database, referring to an elderly female patient of an unspecified age (age group reported as 85+). 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, Streptococcus test positive
Clinical narrative: Pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report has been downloaded from database and refers to a male patient age between 15 and 19 years old (reported as age group 15-19). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided). It was reported that the patient received total of 1 vaccination.  In 2019, the patient experienced pneumonia, serotype: not available. The outcome of the event was not provided.   The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia has been determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from the Regulatory Authority (agency# not reported) on 12-JAN-2024.  This spontaneous report has been received from the regulatory authority concerning to an elderly male patient between 80-84 years old.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient experienced pneumonia pneumococcal. At the reporting time, the outcome for the pneumonia pneumococcal was not provided.  Causal relationship between the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) and the event of pneumonia pneumococcal was not provided. Upon internal review, the event of pneumonia pneumococcal was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from the Regulatory Authority (agency# not reported) on 12-JAN-2024.  This spontaneous report has been received from the Regulatory Authority concerning to an adult female patient between 50-54 years old.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient experienced pneumonia pneumococcal. At the reporting time, the outcome for the pneumonia pneumococcal was not provided.  Causal relationship between the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) and the event of pneumonia pneumococcal was not provided. Upon internal review, the event of pneumonia pneumococcal was considered to be medically significant.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Intensive care, Mechanical ventilation, Syncope
Clinical narrative: Patient received imz on Fri and felt fine Fri Sat but at 3am Sun she got up from bed and collapsed - son took her to hospital and she was admitted from ER; patient states she was placed on a ventilator for 3 days then moved to ICU for 3 days then hospital for 1 more day before being discharged - she stated she did take Tylenol along with regular meds Trazodone Gabapentin and Albuterol Inh before going to bed the night before she entered hospital; she also made mention of a black circle size of quarter around injection site (bruise?)  Event supposedly happened in October Notification to pharmacy did not come until Jan when she was at pharmacy register ringing up a store item (she gets no prescriptions from pharmacy only injections) - she also did not let PCP know until January
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Headache, Myalgia, Respiratory disorder
Clinical narrative: sore muscles, weakness, headache, brain fog, breathing issues
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The patient was given the full vial of vaccine -3 doses - not diluted - No adverse reaction
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Product administration error, Underdose
Clinical narrative: Requested to order immunizations for patient by MA. After reviewing chart, deemed patient due for influenza and COVID immunization. MA requested pfizer COVID vaccine. After ordering immunizations, noticed that vaccines had already been given prior to MA request, and that the pfizer immunization for children 5 to 11 years old was administered. Additionally informed that pfizer immunization for 12 and older not available in clinic. Moderna immunization for 12 and older ordered. Per CDC guidance and recommendation, instructed MA to administer Moderna immunization. Instructed MA to inform family of administration error and document error.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Requested to order immunizations for patient by MA. After reviewing chart, deemed patient due for influenza and COVID immunization. MA requested pfizer COVID vaccine. After ordering immunizations, noticed that vaccines had already been given prior to MA request, and that the pfizer immunization for children 5 to 11 years old was administered. Additionally informed that pfizer immunization for 12 and older not available in clinic. Moderna immunization for 12 and older ordered. Per CDC guidance and recommendation, instructed MA to administer Moderna immunization. Instructed MA to inform family of administration error and document error.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no adverse effects reported at this time. Patient was given an expired vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Injection site reaction, Malaise, Rash
Clinical narrative: I had the vax on Friday afternoon 12/15. On 12/16 I felt awful and had a temp that went up to 102, and a little higher in the evening. On Sunday 12/17 I developed an itchy rash on my lower back that spread to my upper back through the week.  I felt to sick to do anything until Monday evening and all week I had excessive fatigue. The rash continued and we treated with topical cortizone - the lower rash  improved but scarred, and upper rash is still being treated, we are on second round of treatment - 3 weeks later it was extremely itchy and not healing. Some rash also developed on the arm where I rec'd the shot, was milder and a couple of weeks out. I am now on benadryl and stronger topical steroids. Other patients of my phsyicians have had the rash.  I did not have adverse reactions to Johnson and Johnson and 2 other moderna shots.  I was so sick that first week, I felt like the shot was way too strong for my body (I weigh 125 lbs and everyone rec'ing the same dose whether you are 250 or half that doesn't make sense.  For the rash, we are assuming it's an allergic or immune reaction and I will not be able to take the MRNA vax anymore which is scary.  We need a different method and doses related to our size.  It's upsetting to be a month out from your vax and still dealing with health effects.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: I had the vax on Friday afternoon 12/15. On 12/16 I felt awful and had a temp that went up to 102, and a little higher in the evening. On Sunday 12/17 I developed an itchy rash on my lower back that spread to my upper back through the week.  I felt to sick to do anything until Monday evening and all week I had excessive fatigue. The rash continued and we treated with topical cortizone - the lower rash  improved but scarred, and upper rash is still being treated, we are on second round of treatment - 3 weeks later it was extremely itchy and not healing. Some rash also developed on the arm where I rec'd the shot, was milder and a couple of weeks out. I am now on benadryl and stronger topical steroids. Other patients of my phsyicians have had the rash.  I did not have adverse reactions to Johnson and Johnson and 2 other moderna shots.  I was so sick that first week, I felt like the shot was way too strong for my body (I weigh 125 lbs and everyone rec'ing the same dose whether you are 250 or half that doesn't make sense.  For the rash, we are assuming it's an allergic or immune reaction and I will not be able to take the MRNA vax anymore which is scary.  We need a different method and doses related to our size.  It's upsetting to be a month out from your vax and still dealing with health effects.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia, Rash pruritic, Skin discolouration
Clinical narrative: I had the vax on Friday afternoon 12/15. On 12/16 I felt awful and had a temp that went up to 102, and a little higher in the evening. On Sunday 12/17 I developed an itchy rash on my lower back that spread to my upper back through the week.  I felt to sick to do anything until Monday evening and all week I had excessive fatigue. The rash continued and we treated with topical cortizone - the lower rash  improved but scarred, and upper rash is still being treated, we are on second round of treatment - 3 weeks later it was extremely itchy and not healing. Some rash also developed on the arm where I rec'd the shot, was milder and a couple of weeks out. I am now on benadryl and stronger topical steroids. Other patients of my phsyicians have had the rash.  I did not have adverse reactions to Johnson and Johnson and 2 other moderna shots.  I was so sick that first week, I felt like the shot was way too strong for my body (I weigh 125 lbs and everyone rec'ing the same dose whether you are 250 or half that doesn't make sense.  For the rash, we are assuming it's an allergic or immune reaction and I will not be able to take the MRNA vax anymore which is scary.  We need a different method and doses related to our size.  It's upsetting to be a month out from your vax and still dealing with health effects.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness, Tinnitus, Vertigo
Clinical narrative: Within days of receiving the Vaccine (which was less than 2 years from today), patient began experiencing hearing issues including hearing loss, tinnitus, and vertigo. Patient has no preexisting health issue and no preexisting hearing issues.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK, UNK, COVID19
Symptoms: Visual impairment
Clinical narrative: my eye sights has declined dramatically since my first Covid-19 vaccination on 02/07/2021 and all subsequent 4 boosters and again after the last, on 12/12/2023, listed under item 4. I can provide regular eye exam documents all the way back to 1995 to 03/01/2022 to show the drastic decline.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK, UNK, COVID19
Symptoms: Visual acuity reduced, Visual acuity tests
Clinical narrative: my eye sights has declined dramatically since my first Covid-19 vaccination on 02/07/2021 and all subsequent 4 boosters and again after the last, on 12/12/2023, listed under item 4. I can provide regular eye exam documents all the way back to 1995 to 03/01/2022 to show the drastic decline.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Immobile, Laboratory test, Muscle abscess, Sepsis
Clinical narrative: Two weeks after my vaccine I was admitted to ER with severe back pain. I was found to be septic, with abscess  in both psoas muscles. I was previously active and in good health, without any injury, skin break, GI problems, or dental problems. No source for the infection could be found despite extensive testing. I was hospitalized for about 10 days, then sent to the hospital rehab facility for several weeks. I was on IV for 40 days, and then additional antibiotics for 3 weeks. I lost a summer to pain and immobility.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle abscess, Sepsis, Septic shock, Spinal cord abscess
Clinical narrative: Two weeks after my vaccine I was admitted to ER with severe back pain. I was found to be septic, with abscess  in both psoas muscles. I was previously active and in good health, without any injury, skin break, GI problems, or dental problems. No source for the infection could be found despite extensive testing. I was hospitalized for about 10 days, then sent to the hospital rehab facility for several weeks. I was on IV for 40 days, and then additional antibiotics for 3 weeks. I lost a summer to pain and immobility.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no ADR.  administer Tdap instead of Hep B vaccine at birth.
Age: 38.0
Sex: M
Vaccine: EBZR
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Paraesthesia, Rotator cuff syndrome
Clinical narrative: In November 2023, patient's right shoulder started hurting, range of motion severely affected.  On January 17th 2024 at patient's next regular doctor visit, patient reported to Physician's Assistant the pain, lack of range of motion, and occasional numbness and tingling. Eventual diagnosis of calcific tendinitis
Age: 38.0
Sex: M
Vaccine: EBZR
Symptoms: X-ray limb abnormal
Clinical narrative: In November 2023, patient's right shoulder started hurting, range of motion severely affected.  On January 17th 2024 at patient's next regular doctor visit, patient reported to Physician's Assistant the pain, lack of range of motion, and occasional numbness and tingling. Eventual diagnosis of calcific tendinitis
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient had a vasovagal syncope episode. assisted patient to a supine position. monitored vitals encouraged patient to drink water and have a lite snack of chocolate. no inquires no dizziness denies chest pain
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Seizure
Clinical narrative: Two seizures  within 24hrs:  1st at ~10am  next morning, then a 2nd at ~12:40, in otherwise  healthy 18 year old.  (I checked below that I consider Seizure considered Life threatening  because seizures can  happen anywhere -  crossing the street - that would have been life threatening!  Could have cracked his head open in time bathroom floor. It was horrible and traumatic.  I believe the vaccine was the primary factor triggering the seizure, and I would appreciate analysis of seizures within 24 hrs, or longer. My son is now on antiseizure meds for next 3 days and possibly longer. If it was prompted by the  vaccination, then  it is possible it was an AE not a sign of a seizure disorder. He is devastated he can?t drive now for at  least 6mo. (I got my vaccine same day, same lot. I only had injection site soreness Friday and a half).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy stomach, Computerised tomogram abdomen, Heart rate increased, Hypoaesthesia
Clinical narrative: Numbness/tingling  legs/feet, muscle twitching, tremors, muscle pain, joint pain, rapid heart rate
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging spinal, Muscle twitching, Myalgia, Nerve conduction studies
Clinical narrative: Numbness/tingling  legs/feet, muscle twitching, tremors, muscle pain, joint pain, rapid heart rate
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Numbness/tingling  legs/feet, muscle twitching, tremors, muscle pain, joint pain, rapid heart rate
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test positive, Blood immunoglobulin G increased, Blood immunoglobulin M increased, Blood test, Cardiac disorder
Clinical narrative: First, this is the dose His COVID-19 Vaccination Record Card shows. In Chart, the record shows: MRNA (PF) 18yr+ (Moderma) (MM600), Lot #06652A. The second vaccination was exactly one month later. His COVID-19 Record Card shows: Date 3.22.2022, Moderna 066k21A.  In Chart shows: COVID-19 Vaccine MRNA (PF) 12yrs+ (Pfizer) Lot # 330268D. Both vaccinations were provided at Store.  In Chart it shows the second vaccination was at Store.  The latter is incorrect. No prior health problems.  Currently, shortness of breath, swelling and pain in feet and hands.  Outcome: 4th stage heart failure, heart muscle disorder, severe pulmonary hypertension, Cor pulmonale (chronic). Please note the discrepencies between  CHart and the patient's vaccination card.  Patient is currently hospitalized at Hospital  He is dying because of the COVID-19 vaccinations.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Cor pulmonale chronic, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: First, this is the dose His COVID-19 Vaccination Record Card shows. In Chart, the record shows: MRNA (PF) 18yr+ (Moderma) (MM600), Lot #06652A. The second vaccination was exactly one month later. His COVID-19 Record Card shows: Date 3.22.2022, Moderna 066k21A.  In Chart shows: COVID-19 Vaccine MRNA (PF) 12yrs+ (Pfizer) Lot # 330268D. Both vaccinations were provided at Store.  In Chart it shows the second vaccination was at Store.  The latter is incorrect. No prior health problems.  Currently, shortness of breath, swelling and pain in feet and hands.  Outcome: 4th stage heart failure, heart muscle disorder, severe pulmonary hypertension, Cor pulmonale (chronic). Please note the discrepencies between  CHart and the patient's vaccination card.  Patient is currently hospitalized at Hospital  He is dying because of the COVID-19 vaccinations.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pain in extremity, Peripheral swelling, Pulmonary hypertension, Terminal state
Clinical narrative: First, this is the dose His COVID-19 Vaccination Record Card shows. In Chart, the record shows: MRNA (PF) 18yr+ (Moderma) (MM600), Lot #06652A. The second vaccination was exactly one month later. His COVID-19 Record Card shows: Date 3.22.2022, Moderna 066k21A.  In Chart shows: COVID-19 Vaccine MRNA (PF) 12yrs+ (Pfizer) Lot # 330268D. Both vaccinations were provided at Store.  In Chart it shows the second vaccination was at Store.  The latter is incorrect. No prior health problems.  Currently, shortness of breath, swelling and pain in feet and hands.  Outcome: 4th stage heart failure, heart muscle disorder, severe pulmonary hypertension, Cor pulmonale (chronic). Please note the discrepencies between  CHart and the patient's vaccination card.  Patient is currently hospitalized at Hospital  He is dying because of the COVID-19 vaccinations.
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen thigh a few days after the injection.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About a month after taking this vaccine I started to experience ringing in the ears (tinnitus). I was hopping this to go away as few people told me but actually is getting worst. I shared this problem with few colleagues of mine and turned out two of them have developed exactly same problem after exactly same vaccine. This is the reason I connected this ringing ear problem to the Moderna vaccine. Thanks,
Age: 2.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt had vaccine on 1/11/24. She developed fever next day and hives overnight. She was seen in ED and given Benadryl
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Dermatitis exfoliative generalised, Urticaria
Clinical narrative: Within 5 min of vaccine administration, pt. developed splotchy erythroedema to legs with scattered small wheals. Benadryl administered no respiratory trouble. Allergy referral made
Age: 78.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Blister, Constipation, Decreased appetite, Dysgeusia, Hypoaesthesia
Clinical narrative: Pressure in eyes, bitter taste to food, loss of appetite, intermittent nausea, constipation, decrease in urine output, chemical odor to urine, feeling of lumps in left shoulder, hive-like rash on left arm, clusters of blisters on left arm, swelling in axillary lymph nodes of left arm, burning sensation in skin of left arm, numbness in left thumb, limited movement of left arm (unable to lift arm)
Age: 78.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injected limb mobility decreased, Lymphadenopathy, Mass, Nausea, Ocular discomfort
Clinical narrative: Pressure in eyes, bitter taste to food, loss of appetite, intermittent nausea, constipation, decrease in urine output, chemical odor to urine, feeling of lumps in left shoulder, hive-like rash on left arm, clusters of blisters on left arm, swelling in axillary lymph nodes of left arm, burning sensation in skin of left arm, numbness in left thumb, limited movement of left arm (unable to lift arm)
Age: 78.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Rash, Skin burning sensation, Urine odour abnormal, Urine output decreased, Urticaria
Clinical narrative: Pressure in eyes, bitter taste to food, loss of appetite, intermittent nausea, constipation, decrease in urine output, chemical odor to urine, feeling of lumps in left shoulder, hive-like rash on left arm, clusters of blisters on left arm, swelling in axillary lymph nodes of left arm, burning sensation in skin of left arm, numbness in left thumb, limited movement of left arm (unable to lift arm)
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: patient had a pretty bad anaphylactic reaction to Moderna; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (patient had a pretty bad anaphylactic reaction to Moderna) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (patient had a pretty bad anaphylactic reaction to Moderna) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (patient had a pretty bad anaphylactic reaction to Moderna) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication was not provided. The patient could not go for their second dose, so she got a J&J vaccine after the Moderna and did not have any reaction. Treatment information was not reported. Company Comment: This is a spontaneous case concerning a 59-year-old female patient with no reported medical history, who experienced the serious (due to medically significant) expected, event of Anaphylactic reaction which occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the first dose of COVID-19 vaccination schedule. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood uric acid normal, C-reactive protein normal, Condition aggravated, Gout, Gouty arthritis
Clinical narrative: Severe migrating gouty arthritis in both feet and ankles; This spontaneous case was reported by a patient and describes the occurrence of GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 30-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles). At the time of the report, GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gouty arthritis
Clinical narrative: Severe migrating gouty arthritis in both feet and ankles; This spontaneous case was reported by a patient and describes the occurrence of GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 30-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles). At the time of the report, GOUTY ARTHRITIS (Severe migrating gouty arthritis in both feet and ankles) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin disorder
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6204), on 15Apr2021 as dose 2, single (Lot number: ER8729) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2021 (summer of 2021), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Clarified and confirmed patient had COVID 1.5 or 2 years ago, prior to receiving the Pfizer Comirnaty 12 and older vaccine. But had COVID boosters and COVID shots, clarified had a total of 3 doses of the Pfizer COVID vaccine. Patient thought she got COVID in the summer of 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016999 same patient, different vaccine dose/event;US-PFIZER INC-202400017499 same patient, different dose/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6204), on 15Apr2021 as dose 2, single (Lot number: ER8729) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2021 (summer of 2021), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Clarified and confirmed patient had COVID 1.5 or 2 years ago, prior to receiving the Pfizer Comirnaty 12 and older vaccine. But had COVID boosters and COVID shots, clarified had a total of 3 doses of the Pfizer COVID vaccine. Patient thought she got COVID in the summer of 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016999 same patient, different vaccine dose/event;US-PFIZER INC-202400017499 same patient, different dose/event;
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.   This spontaneous report has been received from Regulatory Authority regarding to an elderly (70 to 74-years-old) female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. Her vaccination history included at least one dose of a pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, vaccination scheme frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2017, the patient experienced pneumonia (Pneumonia pneumococcal). On that date, streptococcus pneumoniae serotyping was 3.   The outcome of the event and the causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.  This spontaneous report has been received from the Health Authority, regarding to an elderly (reported as between 70-to-74-year-old) female 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.  On an unspecified date in 2011, streptococcus pneumoniae serotyping was reported as not available. On the same date, the patient experienced Pneumococcal bacteraemia. At the time of reporting, the outcome of the event and the causality assessment between the event with the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the Pneumococcal bacteraemia event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information was received from HA on 12-JAN-2024.   This spontaneous report was concerning an adult male patient between 60 - 64 years-old. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2021, the patient experienced streptococcus pneumoniae pneumonia (Pneumonia pneumococcal). At the time of the report, outcome of the event was not provided.  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: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided), on 12-JAN-2024.   This spontaneous report has been received from Health Authority via Company representative, concerning to an elderly (reported as 80-84-year-old) male patient.   His medical history, concurrent conditions and concomitant therapies were not provided. Vaccination history was reported as vaccine not available for serotype.   On an unspecified date, the patient was vaccinated with the 1st dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.   On an unknown date in 2011, 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: Pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.   This spontaneous report has been received from database regarding to an elderly (80 to 84-years-old) male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. Her vaccination history included at least one dose of a pneumococcal vaccine (unspecified).  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, vaccination scheme frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2017, the patient experienced pneumonia (Pneumonia pneumococcal). On that date, streptococcus pneumoniae serotyping was Not Available.   The outcome of the event and the causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not provided.  Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided), on 12-JAN-2024.   This spontaneous report has been received from database via Company representative, concerning to an adult (reported as 40-44-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: Pneumococcal infection
Clinical narrative: Other; Information has been received from Regulatory Authority on 12-JAN-2024, referring to an adult (20-24-year-old) male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in 2010, the patient experienced Pneumococcal infection (also reported as other). On an unknown date in 2010, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between Pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review the event Pneumococcal infection was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided) on 12-JAN-2024.  This spontaneous report has been received from the Regulatory Authority, regarding to an elderly (reported as between 80-to-84-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.  On an unspecified date in 2011, streptococcus pneumoniae serotyping was reported as Not Available. On the same date, the patient experienced Pneumonia pneumococcal. At the time of reporting, the outcome of the event and the causality assessment between the event with the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the Pneumonia pneumococcal event was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received from Regulatory Authority (Agency # not provided) on 12-JAN-2024.   Information has been received from the Regulatory Authority, regarding an elderly female patient of unknown age (age group: 65  69 years). The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dosage information, route of administration and lot number were not provided) for prophylaxis,   On an unknown date in 2011, the patient experienced pneumonia.  The Streptococcus pneumoniae serotyping was reported as: not available.   The outcome of Streptococcus pneumoniae and the causality assessment with the suspect vaccine were not provided.   Upon internal review Streptococcus pneumoniae was considered to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from Agency 12-JAN-2024.   This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and referring to an Adult (age: 60-64 years old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown date, the patient was vaccinated one time with a 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 2014, the patient experienced pneumonia (streptococcus pneumoniae pneumonia). On an unknown date in 2014, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not provided.   The action taken was not applicable.   The causal relationship between the event and suspect vaccine was not reported.   Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from Regulatory Authority on 12-JAN-2024.  This spontaneous report has been downloaded from Regulatory Authority and referring to an adult female patient (age: 45-49). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2010, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). 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 Streptococcus pneumoniae pneumonia was not known.    The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; Information has been received from National Notifiable Diseases Surveillance System (NNDSS) on 12-JAN-2024.  This spontaneous report was referring to an adult female patient (age: 55-59). The patient's medical history, concurrent conditions, and concomitant drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2010, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2010, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was unknown.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Bacteraemia
Clinical narrative: bacteraemia; Information has been received from Regulatory Authority (Agency # not provided) on 12-JAN-2024.   Information has been received from the Regulatory Authority, regarding an child female patient of unknown age (age group: 02  04 years). The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On unknown dates, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dosage information, route of administration and lot number were not provided); and three doses of pneumococcal vaccine conj 7v (crm197) (PREVNAR) (dosage information, route of administration and lot number were not provided).  Both vaccines were administered for prophylaxis,   On an unknown date in 2011, the patient experienced bacteraemia.  The pneumococcal bacteraemia serotyping was reported as: not available.   The outcome of pneumococcal bacteraemia and the causality assessment with the suspect vaccine were not provided.   Upon internal review Pneumococcal bacteraemia was considered to be a medically significant event.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from database (Agency # not provided) on 12-JAN-2024.   Information has been received from the Regulatory Authority, regarding an adult male patient of unknown age (age group: 55  59 years). The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dosage information, route of administration and lot number were not provided) for prophylaxis,   On an unknown date in 2011, the patient experienced pneumonia.  The Streptococcus pneumoniae serotyping was reported as: not available.   The outcome of Streptococcus pneumoniae and the causality assessment with the suspect vaccine were not provided.   Upon internal review Streptococcus pneumoniae was considered to be a medically significant event.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Agency 12-JAN-2024.   This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and referring to an Adult (age: 25-29 years old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown date, the patient was vaccinated 1 time with a 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 unknown date, the patient was vaccinated 1 time with a dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).    On an unknown date in 2021, the patient experienced bacteraemia (Pneumococcal bacteraemia). On an unknown date in 2021, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not provided. The action taken was not applicable.   The causal relationship between the event and suspect vaccine was not reported. Upon internal review, the event of Pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from the Surveillance System (agency# not reported) on 12-JAN-2024.  This spontaneous report has been received from the Agency concerning to a male patient between 15-19 years old.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis and with two doses of pneumococcal vaccine conj 7v (crm197) (PREVENAR) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient experienced pneumonia pneumococcal. At the reporting time, the outcome for the pneumonia pneumococcal was not provided.  Causal relationship between the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) and the event of pneumonia pneumococcal was not provided. Upon internal review, the event of pneumonia pneumococcal was considered to be medically significant.