chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture negative, Blood fibrinogen normal, Blood lactate dehydrogenase increased, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coagulation test normal, Conjunctivitis, Cough, Cytomegalovirus test, Cytomegalovirus test negative
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Echocardiogram abnormal, Electrocardiogram normal, Epstein-Barr virus antibody negative, Epstein-Barr virus test negative
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Haemoglobin decreased, Headache, Hepatitis A antibody negative, Hepatitis B core antibody negative
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hepatitis viral test negative, Inflammatory marker increased, Interleukin level
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio normal, Laboratory test, N-terminal prohormone brain natriuretic peptide increased, Pericardial effusion, Platelet count decreased
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time normal, Pyrexia, Rash, Red blood cell sedimentation rate normal, Respiratory viral panel
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 antibody test positive, Serum ferritin increased, Streptococcus test, Troponin T increased
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal, Tuberculin test negative, White blood cell count normal
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 59.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No other AE's; Patient was administered a expired MMR II; This spontaneous report was received from a medical assistant and refers to a 59-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency and route of administration were not reported) (lot # S029455, expiration date: 19-SEP-2021) for prophylaxis. No adverse event occurred.
Age: 59.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE's; Patient was administered a expired MMR II; This spontaneous report was received from a medical assistant and refers to a 59-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency and route of administration were not reported) (lot # S029455, expiration date: 19-SEP-2021) for prophylaxis. No adverse event occurred.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Entire back is covered with red bumps; Entire back is covered with red bumps that burn; Entire back is covered with red bumps that burn and itch terribly; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027), via an unspecified route of administration in the left arm on 18Nov2021 at 17:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to vicryl sutures. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included estrogens conjugated/medroxyprogesterone acetate (PREMPRO) and bifidobacterium infantis (ALIGN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3013BA), via an unspecified route of administration in the left arm on 20Oct2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient previously also received amoxicillin (MANUFACTURER UNKNOWN) from an unknown date and experienced drug allergy. On 19Nov2021 at 21:30, the patient's entire back was covered with red bumps that burn and itch terribly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events entire back was covered with red bumps that burn and itch was not resolved at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Rash papular
Clinical narrative: Entire back is covered with red bumps; Entire back is covered with red bumps that burn; Entire back is covered with red bumps that burn and itch terribly; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027), via an unspecified route of administration in the left arm on 18Nov2021 at 17:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to vicryl sutures. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included estrogens conjugated/medroxyprogesterone acetate (PREMPRO) and bifidobacterium infantis (ALIGN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3013BA), via an unspecified route of administration in the left arm on 20Oct2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient previously also received amoxicillin (MANUFACTURER UNKNOWN) from an unknown date and experienced drug allergy. On 19Nov2021 at 21:30, the patient's entire back was covered with red bumps that burn and itch terribly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events entire back was covered with red bumps that burn and itch was not resolved at the time of this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Dyspnoea, Headache, Pyrexia
Clinical narrative: Booster; fever of 101f; chest congestion; headache; trouble with breathing; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 30155BA, Expiry date was not reported), via an unspecified route of administration on 28Oct2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Previously patient received Dose 1 and Dose 2 of COVID-19 Vaccine (Primary Immunization series complete but unknown manufacturer), (Formulation: solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. On 28Oct2021, the patient received booster. On an unspecified date in Oct2021, within 24 hours it resulted fever of 101f, chest congestion, headache, the first week resulted in severe chest congestion and trouble breathing and patient treated with various the counter medicines. Patient finally returned to almost normal condition after two weeks. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Oct2021. The outcome of the events fever of 101f, chest congestion, headache and trouble with breathing was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Immunisation, Pyrexia
Clinical narrative: Booster; fever of 101f; chest congestion; headache; trouble with breathing; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 30155BA, Expiry date was not reported), via an unspecified route of administration on 28Oct2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Previously patient received Dose 1 and Dose 2 of COVID-19 Vaccine (Primary Immunization series complete but unknown manufacturer), (Formulation: solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. On 28Oct2021, the patient received booster. On an unspecified date in Oct2021, within 24 hours it resulted fever of 101f, chest congestion, headache, the first week resulted in severe chest congestion and trouble breathing and patient treated with various the counter medicines. Patient finally returned to almost normal condition after two weeks. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Oct2021. The outcome of the events fever of 101f, chest congestion, headache and trouble with breathing was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Booster; fever of 101f; chest congestion; headache; trouble with breathing; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 30155BA, Expiry date was not reported), via an unspecified route of administration on 28Oct2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Previously patient received Dose 1 and Dose 2 of COVID-19 Vaccine (Primary Immunization series complete but unknown manufacturer), (Formulation: solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. On 28Oct2021, the patient received booster. On an unspecified date in Oct2021, within 24 hours it resulted fever of 101f, chest congestion, headache, the first week resulted in severe chest congestion and trouble breathing and patient treated with various the counter medicines. Patient finally returned to almost normal condition after two weeks. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Oct2021. The outcome of the events fever of 101f, chest congestion, headache and trouble with breathing was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly Stored / Administered V ARlV AX; This spontaneous report was received from a physician and refers to a child patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 25-OCT-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot#U010395 was verified to be valid, expiration date: 01-APR-2023) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccine was exposed was -1.4 degrees of Celsius (C) and the time frame was reported as 1 hour and 30 minutes. Also reported as -15 C for 1 hour 30 minutes. Lowest temperature was -1.4C at about 2:15 pm and went up since then by about -2C to -15C by 3:30 pm. Freezer was not shut properly. No previous temperature excursion was reported. It was unknown if digital data logger was involved. No adverse reaction were reported.
Sex: F
Vaccine: HPV9
Symptoms: Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: Allergic reaction after getting the Gardasil 9; Per patient chart she will not be receiving any additional dose of Gardasil 9; This spontaneous report as received from the office manager referring to a 34 year old female patient with latex and yeast allergy. No information was provided regarding the patient's concomitant medications.     On 29-OCT-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # 1687293 that expierd on 30-APR-2023 for prophylaxis (dose and route of administration were not reported).  On an unknown date the patient, when to the emergency room for an allergic reaction after getting the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine.  It was not reported if the patient was admitted or if she was discharged from the emergency room.  It was noted that in the patient's chart was noted that she will not be receiving any additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration).  At the time of the report, the patient's outcome was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-NOV-2021, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1821791, expiration date 26-JUL-2022, at a dose of 2 milliliter, orally for prophylaxis. No other adverse event reported.   The vaccine was stored in temperatures of below 36°F (34.7F) for 25 minutes; below 36°F (35.4F) for 5 hours; below 36°F (35.6F) for 3 hours and 20 minutes; below 36°F (35.9F) for 25 minutes; below 36°F (35.7F) for 25 minutes; below 36°F (35.2F) for 3 hours and 20 minutes; below 36°F (33.8F) for 18 hours and 20 minutes; below 36°F (32.1F) for 23 hours and 45 minutes and below 36°F (32.5F) for 9 hours and 35 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; post herpetic neuralgia; Information has been received from a lawyer referring to a patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition.As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was considered as not recovered and causal relationship was assessed as related.  Both events herpes zoster and postherpetic neuralgia were considered as disability by the lawyer.
Sex: F
Vaccine: COVID19, DTOX, FLUX, MU, VARZOS
Symptoms: Disability, Pain, Pain in extremity
Clinical narrative: she is a little bit handicapped; after received the vaccine (PNEUMOVAX), she had soreness in her arm; after she received the FLU shot, she had soreness in her arm; still hurts if she bumps it; This spontaneous report was received from an 86-year-old female patient reporting on herself. The patient's current conditions included glaucoma. The patient had not known drug reactions/allergies.  The patient's medical history included 3 surgeries, physiotherapy, shingles, chickenpox, fall and hip fracture.  Concomitant therapies included atorvastatin, lisinopril, amlodipine besilate and eye drops for glaucoma.  On an unknown date, reported as "few years ago", the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one dose, intramuscularly, for pneumonia immunization (dose, site of administration, lot number and expiration date were not reported).   After she received the vaccine, she had soreness in her arm (pain in extremity).  She did not contact her healthcare provider because the soreness was not bad enough and she did not take any medication for treatment of her symptoms.    On 09-NOV-2021, the patient received her annual influenza vaccine (FLU), shot and she had soreness in her arm after vaccination (pain in extremity).  The soreness was better but still hurt if she "bump it" (pain).  The patient stated she recently received her covid-19 vaccine(COVID-19 VACCINE) booster shot.  Also she had received the mumps vaccine (MUMPS VACCINE), diphtheria vaccine (DIPHTHERIA VACCINE), the zoster vaccine live and the shingles vaccine (manufacturer unknown).  The patient stated she was "a little bit handicapped" (disability).  The outcome of disability and pain in extremity was unknown.    The reporter did not assess the causal relationship between suspect therapies with and the events.  Upon internal review disability was determined medically significant.
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous report was received from  a female patient of unknown age who refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 16-NOV-2021, the patient was vaccinated at her physician's office with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and lot # were not provided) for prophylaxis (reported as pneumonia vaccination). The patient stated that the product had an expiration date of 16-NOV-2021 and the physician said that it was safe to administer the vaccine until midnight of the date listed on the product.  On 17-NOV-2021 (reported as "this morning"), the patient experienced sore throat (oropharyngeal pain). The outcome of the event and the causality assessment were not provided.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; VAQTA was administered on 16 NOV 2021 after experiencing a temperautre excursion; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 16-NOV-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T031202, expiration date 14-JUN-2022 (route of administration was not reported) for prophylaxis. The vaccine was stored in temperature of 1 degree Celsius for 40 minutes. There was no previous temperature excursion. It was not reported if the Digital Data Logger was involved. No additional adverse event was reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA006603:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 9 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series. Military Medicine.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and results of post-vaccination tests were collected from existing health records within the system.    Patient ID 1 received an initial hepatitis B series at 20-year-old and a second hepatitis B series at 24-year-old.   A total of 9 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 28-year-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  in prior hepatitis B vaccine nonresponders: a case series. Medicine.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records.    Patient ID 2 received an initial hepatitis B series at 56-year-old and a second hepatitis B series at 57-year-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 71-year-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Therapy non-responder
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series. Medicine.  24 September 2021. https://doi.org/10.1093/milmed/usab397  In a case series (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the system.    Patient ID 3 received an initial hepatitis B series at 37-years-old and a second hepatitis B series at 41-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 43-years-old, the patient received the initial dose of Heplisav-B. The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021.  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the system.    Patient ID 4 received an initial hepatitis B series at 47-years-old and a second hepatitis B series at 48-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 51-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 69-years-old and a second hepatitis B series at 71-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 72-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 7 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021    In a case series by, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 41-years-old and a second hepatitis B series at 42-years-old.   A total of 7 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 55-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 8 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 50-years-old and a second hepatitis B series at 53-years-old.   A total of 8 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 60-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).  On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 58-years-old and a second hepatitis B series at 61-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 65-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 59-years-old and a second hepatitis B series at 60-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 61-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 9 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the health system.    Patient received an initial hepatitis B series at 21-years-old and a second hepatitis B series at 22-years-old.   A total of 9 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 33-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).  On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Therapy non-responder
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 59-years-old and a second hepatitis B series at 63-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 66-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series as a newborn and a second hepatitis B series at 23-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 25-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: little pain for a couple days after second dose; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History), pain (Family History) and generalized rash (Family History) (The patient's sister and brother in law both had Shingles so bad, they were in severe pain and had rash all over their body, after seeing a few pictures of it the patient and her husband decided to get the vaccine). Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient and her husband received both Shingrix shots recently. The patient was in a little pain for a couple days after get 2nd dose.  She commented that, well worth a little pain than suffering for months with nerve pain from shingles. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurted so bad, almost in "tears"; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received a shot of Shingles vaccine and first it hurted so bad was almost in tears. Follow-up would not be possible as no contact details available. For tolerance of 2nd shot, refer case US2021AMR241128, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241128:same reporter - 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Vaccine positive rechallenge
Clinical narrative: hurted so bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021AMR241121).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the 2nd shot and it hurted so bad but it was a breeze. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241121:same reporter - 1st dose